CN1548050A - Sobering-up liver-protecting medicine composition for preventing chemical liver damage and its prepn process - Google Patents
Sobering-up liver-protecting medicine composition for preventing chemical liver damage and its prepn process Download PDFInfo
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Abstract
The medicine consists of mainly soybean extractive, wolfberry fruit extractive and L-cysteine, and may contains haw extractive, oriental water plantain extractive, vitamin C, vitamin B6, etc. The Chinese medicine composition may be prepared into various clinically applied preparation forms, has excellent preventing and treating effect on chemical liver damage and no toxic side effect, and may be used also in sobering up to protect liver.
Description
Invention field
The present invention relates to a kind of pharmaceutical composition, particularly a kind of relieving alcoholism and protecting the liver composition and method of making the same that chemical liver injury is had protective effect.
Background technology
Long-term heavy drinking can cause alcoholic liver disease, comprises fatty liver, alcoholic hepatitis, hepatic fibrosis, liver cirrhosis and hepatocarcinoma etc.After ethanol enters hepatocyte,, form acetaldehyde through the enzyme effect.Acetaldehyde has tangible toxic action to hepatocyte, makes its metabolism generation obstacle, causes hepatocellular degeneration and necrosis.If alcoholic is employed prevention early and treats, can avoid the development of alcoholic liver injury.
Mostly the product that has sobering up and liver protecting functions at present is to have based on Semen Hoveniae (Fructus Hoveniae), Radix Puerariae, Flos puerariae lobatae etc. the Chinese medicine of antialcoholism function, is aided with Radix Panacis Quinquefolii or other one-tenth with nourishing the human Body function assigns to reach the relieving alcoholism and protecting the liver purpose.The invention provides a kind of relieving alcoholism and protecting the liver product that is different from above scheme.
Summary of the invention
One object of the present invention is to disclose a kind of relieving alcoholism and protecting the liver pharmaceutical composition of new prevention chemical liver injury; Another object of the present invention is the method for the relieving alcoholism and protecting the liver pharmaceutical composition of a kind of new prevention chemical liver injury of open preparation.
The crude drug of pharmaceutical composition of the present invention is formed and proportioning following (by weight):
Soybean extract 5-40 weight portion wolfberry fruit extract 15-120 weight portion
L-cysteine 10-60 weight portion.
Optimum ratio is: soybean extract 10-30 weight portion wolfberry fruit extract 30-90 weight portion L-cysteine 15-45 weight portion.
The crude drug of pharmaceutical composition of the present invention is formed can add following medicine:
Fructus Crataegi extract 20-160 weight portion Rhizoma Alismatis extract 10-60 weight portion
Vitamin C 10-60 weight portion vitamin B
60.5-4 weight portion
Calcium pantothenate 0.5-4 weight portion folic acid 0.02-0.4 weight portion
Vitamin B
120.001-0.005 weight portion.
The proportioning of optimizing is: Fructus Crataegi extract 40-120 weight portion Rhizoma Alismatis extract 15-45 weight portion vitamin C 15-45 weight portion vitamin B
61-2 weight portion calcium pantothenate 1-2 weight portion folic acid 0.05-0.15 weight portion vitamin B
120.002-0.003 weight portion.
The preparation method of present composition preparation is: get Fructus Lycii, add 6-10 and doubly measure purified water, boiled 1-3 hour, filter, add 4-6 again and doubly measure purified water, boiled 1-2 hour, merging filtrate concentrates, and spray drying gets wolfberry fruit extract; Get Fructus Crataegi, pulverize, add 50-80% edible ethanol 4-10 and doubly measure the extraction secondary, each 1-3 hour; Extracting solution is evaporated to does not have the alcohol flavor, and spray drying gets Fructus Crataegi extract; The extracting degreasing Semen sojae atricolor is pulverized, extract 2 times in 44-65 ℃ with the 50-80% edible ethanol, each 1-3 hour, reclaim edible ethanol, the gained syrup in 60-70 ℃ by ultrafilter membrane, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; Get the Rhizoma Alismatis decoction pieces, pulverize, cold water soak is extracted with the 50-85% edible ethanol then, reclaims edible ethanol, spray drying; It is an amount of to add dextrin, and mix homogeneously is standby.Cysteine is pulverized, sieved, mix with vitamin C and calcium pantothenate, Rhizoma Alismatis extract mixes with adjuvant, sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively; The fine powder that sieves is added mix homogeneously in the blending tank; At last directly or add pharmaceutically acceptable excipient and make clinical acceptable forms through conventional operation.
Medicine of the present invention also can add conventional drug excipient, as solvent, disintegrating agent, correctives, antiseptic, coloring agent etc.
Following experimental example is used to further specify the present invention.
Experimental example 1 its mouse oral bag toxicity test (LD
50), micronucleus test and sperm malformation test
1, material
1.1 test material: sample is a present composition capsule preparations, and content is a brown ceramic powder, and each experimental group dosage all is mixed with the test desired concn with distilled water.
1.2 animal: the NIH kind healthy mice that Guangdong Medical Lab Animal Center provides, body weight 18～35g.Quality certification 2001A044.
2, method and result
2.1 its mouse oral acute toxicity test: 40 of NIH kind white mice, body weight 18～22g, male and female half and half adopt Horn ' s method, at random mice are divided into 4 dosage groups, irritate stomach once on an empty stomach, irritate stomach amount 0.20ml/10g.b.w, observe a week, the results are shown in Table 1.
Table 1 its mouse oral The acute toxicity tests
Dosage number of animals (only) dead animal number (only)
(g/kg.b.w)
The male and female male and female
21.50????????5????????5????????0?????????0
10.00????????5????????5????????0?????????0
4.64?????????5????????5????????0?????????0
2.15?????????5????????5????????0?????????0
The result shows: not observing animal has any untoward reaction, gets male and female mice LD
50＞21.50g/kg.b.w, submitted sample belong to nontoxic level material.
2.2 mouse bone marrow cells micronucleus test
60 of NIH kind mices, body weight 25～30g is divided into 6 groups at random, by " toxicological evaluation of food safety procedure "
Method is tested: irritate stomach at twice, irritate stomach amount 0.20ml/10g.b.w at every turn,, put to death mice and get the film-making of bone marrow of sternum material, dyeing, microscopy after 6 hours in the second filling stomach, obtain and respectively organize micronuclear rates, by the Poisson distribution method statistic.
Influence during table 2. pair mouse bone marrow cells micronuclear rates
Dosage number of animals (only) polychromatic erythrocyte number (individual) micronucleus number (individual) micronuclear rates (‰)
(g/kg.b.w)
Male and female male and female male and female male and female
10.00???????????5????????5????????5000??????5000??????7??????8??????1.4????????1.6
5.00????????????5????????5????????5000??????5000??????5??????6??????1.0????????1.2
2.50????????????5????????5????????5000??????5000??????7??????8??????1.4????????1.6
1.25????????????5????????5????????5000??????5000??????6??????6??????1.2????????1.2
0.00????????????5????????5????????5000??????5000??????6??????8??????1.2????????1.6
Cyclophosphamide 0.05 55 5,000 5,000 134 114 26.8** 22.8**
Annotate: * * represents to compare p＜0.01 with negative control group.
The result shows that capsular micronuclear rates of each dosage group and negative control group compare, and difference does not all have remarkable result negative (seeing Table 2) statistically.
2.3 mouse sperm deformity test: 25 of the male mices of IH kind, body weight 25-35g, be divided into 5 groups at random, continuous irrigation stomach 5 days (the positive group of cyclophosphamide is made lumbar injection) is irritated stomach amount: 0.20ml/10g.b.w, put to death animal and get the film-making routinely of bilateral epididymis, dyeing after 35 days, check and completely to be skillful in 5000 for every group under the oil mirror, obtain rate of teratosperm, carry out statistical procedures, the results are shown in Table 3 by Wilcoson sum of ranks method.
The influence of table 3. mouse sperm form
Dosage
Number of animals (only) is examined sperm count (bar) teratospermia number (bar) abnormal rate (‰)
(g/kg.b.w)
10.00??????????????5????????????5000????????????109????????????21.8
5.00???????????????5????????????5000????????????103????????????20.6
2.50???????????????5????????????5000????????????102????????????20.4
0.00???????????????5????????????5000????????????110????????????22.0
Cyclophosphamide 0.06 5 5,000 384 76.8**
* and negative control group be p＜0.01 relatively.
The result shows: the rate of teratosperm of each dosage of capsule of the present invention and negative control group relatively, difference there are no significant meaning statistically.Sample does not all find that at dosage sexual cell is had the effect of mutation deformity during up to 10.00g/kg.b.w.The result of the test feminine gender.
The Salmonella typhimurium of experimental example 2 present composition capsule preparations/mammal microsomal enzyme test (Salmonella reversion test) report
1, materials and methods
1.1 test strain: through identifying satisfactory Salmonella typhimurium histidine defect type TA97, TA98, TA100, TA102 test strain.
1.2 metabolism activation system: the inductive rat liver homogenate S9 of Polychlorinated biphenyls (PCB) liquid (when metabolism activates, adding).
1.3 tried thing and dosage is selected: with the sterile distilled water dilution, boiling water bath was for experiment after 30 minutes before the experiment.By trial test, with the minimum toxicity dose that tried thing as maximum dose level.
1.4 test method (flat board mixes method): in the top layer culture medium, add 0.1mL test strain enrichment liquid, 0.1mL tried thing solution and 0.5mLS9 mixed liquor (when metabolism activates, adding), pour into behind the mixing on the bottom culture medium flat plate, each dosage group is three wares.According to being tried thing toxicity test result, establish five dosage groups of 5000,1000,200,40,8 μ g/ wares, establish simultaneously from beaming back change, solvent control, the contrast of positive mutagenic agent, cultivated 48 hours down at 37 ℃, write down the every ware of each test group and return the change clump count.As tried thing and return the increase that becomes clump count and surpass solvent control more than 2 times, and dosage-reaction relation person is arranged, be judged to be the mutagenesis positive.
2, result: as seen by table 4, table 5, capsule of the present invention is to Salmonella typhimurium TA97, TA98, TA100, TA102 four strain test strains, when adding and do not add S9,5000, five dosage groups of 1000,200,40,8 μ g/ wares are returned and are become the bacterium colony number average above 2 times of solvent control clump counts, also do not have dosage-reaction relation, show Salmonella reversion test feminine gender as a result.
3, conclusion: tried thing after above-mentioned four test strains are measured, compare with the solvent control group, when adding and do not add S9, each dosage group does not cause that all the recovery mutation colony number of test strain obviously increases, and shows that this is tried thing Salmonella reversion test feminine gender.
Table 4 capsule of the present invention return to become result's (the 1st time) (x ± s) to Salmonella typhimurium
Dosage TA97 TA98 TA100 TA102
Tried thing
(μ g/ ware)-S9+S9-S9+S9-S9+S9-S9+S9
Sample sets 1 5,000 183 ± 3 185 ± 5 32 ± 3 39 ± 3 144 ± 4 161 ± 3 295 ± 6 304 ± 11
2????????1000???????185±5???????187±6????????39±1???????39±4???????143±8???????165±3????????307±5????????313±9
3????????200????????183±7???????186±3????????32±2???????39±1???????153±4???????170±2????????317±4????????314±9
4????????40?????????182±2???????187±3????????32±1???????40±2???????158±3???????171±3????????317±8????????325±4
5????????8??????????183±7???????182±10???????33±3???????42±2???????164±3???????173±6????????321±10???????323±16
From beaming back change---149 ± 6 172 ± 2 35 ± 3 42 ± 2 169 ± 4 184 ± 4 290 ± 4 304 ± 5
Solvent control---154 ± 3 169 ± 3 37 ± 2 49 ± 2 173 ± 3 185 ± 2 295 ± 2 308 ± 3
Positive control (μ g/ ware)
NaN
3????????????2.5??????????????????????????????????????????????????????????3813±106
2431±
2-AF????????????10.0????????????????????2985±118??????????????????????????????????????????3343±81
102
Fenaminosulf 50.0 1814 ± 174 2928 ± 103
Ametycin 4.0 3599 ± 123
1,8-istizin 50.0 1915 ± 112
Table 5 capsule of the present invention return to become result's (the 2nd time) (x ± s) to Salmonella typhimurium
Dosage TA97 TA98 TA100 TA102
Tried thing
(μ g/ ware)-S9+S9-S9+S9-S9+S9-S9+S9
Sample sets 1 5,000 184 ± 3 188 ± 4 32 ± 2 37 ± 3 146 ± 4 165 ± 7 292 ± 3 306 ± 10
2????????1000??????????185±4?????????187±3??????????33±4???????38±1???????154±2???????164±4???????306±4????????316±11
3????????200???????????183±3?????????185±5??????????31±2???????38±4???????156±5???????163±3???????315±5????????314±6
4????????40????????????182±3?????????183±3??????????32±1???????39±2???????162±1???????166±4???????318±9????????322±8
5????????8?????????????181±7?????????183±2??????????33±3???????42±2???????166±3???????176±2???????318±12???????328±2
From beaming back change---143 ± 1 168 ± 2 36 ± 3 50 ± 3 148 ± 2 187 ± 1 278 ± 8 307 ± 4
Solvent control---169 ± 3 169 ± 2 39 ± 1 48 ± 2 153 ± 2 188 ± 4 284 ± 1 310 ± 2
Positive control (μ g/ ware)
NaN
3?????????2.5???????????????????????????????????????????????????????????????????3816±99
2-AF???????????10.0?????????????????????????2972±114???????????????????2436±109????????????????3315±94
Fenaminosulf 50.0 1824 ± 175 2923 ± 110
Ametycin 4.0 3610 ± 120
1,8-istizin 50.0 1947 ± 161
Fed experiment in experimental example 3:30 days
1, material
1.1 tried thing: sample copy invention capsule, plastic bottle.The human body recommended amounts of sample is every day 2 times, each 2, the 0.3g/ grain, promptly every day 1.2g/60kg, be equivalent to 0.020g/kg.b.w.
1.2 dosage design: basic, normal, high three dosage groups are established in this experiment, and dosage is 0.50,1.00 and 2.00g/kg.b.w, are equivalent to 25,50,100 times of human body recommended amounts, and other establishes the blank group,
1.3 sample treatment: calculate according to rat feed intake 100g/kg.b.w, respectively with 10% conversion of sample by body weight, evenly mix in the feedstuff sample, make the pellet that contains 0%, 0.50%, 1.00% and 2.00% sample respectively, contrast, basic, normal, high dosage treated animal is edible.
1.4 animal: the healthy SD kind healthy white rat that Guangdong Medical Lab Animal Center provides (the animal quality certification number: 2001A046), body weight 65～80g.
2, method
2.1 test method: 80 rats were quarantined under laboratory condition after a week, were divided at random and were tried three dosage groups of thing and four dosage groups of blank group, 20 every group, male and female half and half, sub-cage rearing.To be tried thing and add in the feedstuff and freely to ingest every day, every group guarantees to have sufficient drinking-water and supply of forage, continuous 30 days.Every group guarantees to have sufficient drinking-water and supply of forage, free diet.Experiment begins and experiment periods weighing and write down the weight of animals and the feedstuff intake weekly.
2.2 observation index
2.2.1 the general physiology sign of rat, outward appearance, behavior, defecation, fur etc.
2.2.1 the general physiology sign of rat, outward appearance, behavior, defecation, fur etc.
2.2.2 body weight, dirty hierarchy number and food utilization.
2.2.3 blood routine and biochemical indicator: hemoglobin, red blood cell count(RBC), numeration of leukocyte, platelet count, glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood glucose, total protein, albumin, globulin and A/G, T-CHOL, triglyceride, creatinine and blood urea nitrogen.These parameters detects with full-automatic dirt instrument of Mei Liai and the full-automatic blood counting instrument of AC970EO, and reagent is supplied by former instrument dirt business men:
2.2.4 the gross anatomy of the heart, liver,spleen,kidney, small intestinal, testis organ and microscopically histopathological examination.
2.3 statistical disposition: data are carried out variance analysis with SPSS10.0 software kit (Ver10.0).
3, result
3.1 ordinary circumstance: rat physiology sign, body weight, outward appearance, behavior, defecation, fur etc. are all no abnormal.
3.2 the variation of body weight and food utilization: from table 6, table 7 as seen, each dosage group and blank group comparing difference all do not have significance meaning on the statistics, show that being tried thing does not have obviously rat growth and food utilization and influence.
30 days feeding trial rat body weights of table 6 capsule of the present invention become the situation of returning (g, x ± s)
The dosage number of animals
Initial body weighs the 4th week of the 3rd week the 2nd week the 1st week
(g/kg.b.w) (only)
224.4±
10????????74.1±3.3??????120.2±7.2???????161.5±10.4??????186.5±9.0
12.8
0.00
224.1±
10????????73.3±3.9??????119.7±10.7??????161.8±12.9??????184.6±14.0
Male 0.50
11.7
Property 1.00
220.8±
10????????73.6±4.1??????116.6±10.0??????155.1±13.9??????180.0±15.0
2.00
12.3
233.9±
10????????73.5±3.1??????121.1±6.3???????166.7±11.9??????189.9±9.4
13.1
0.167??????????0.130????????????0.102????????????0.145????????1.509
The F value
P value＞0.05＞0.05＞0.05＞0.05＞0.05
183.9±
10????????73.8±4.3??????116.5±10.3??????142.2±15.6??????161.5±14.6
14.1
0.00
183.2±
10????????74.1±3.4??????117.5±12.3??????141.3±13.4??????158.7±14.2
Female 0.50
13.0
Property 1.00
183.2±
10????????72.8±5.9??????115.1±7.7???????141.2±11.7??????160.0±12.3
13.0
2.00
183.9±
10????????73.8±3.9??????117.4±7.8???????144.2±14.0??????162.5±14.1
19.2
F value 0.088 0.505 1.486 1.106 2.058
P value＞0.05＞0.05＞0.05＞0.05＞0.05
30 days feeding trial rats of table 7 capsule of the present invention food utilization situation of change (n=10, x ± s)
Dosage (g/kg.b.w) weight gain (g/ only) food-intake (g/ only) food utilization (%)
Male 0.00 150.3 ± 12.3 520.0 ± 64.3 236.4 ± 55.0
0.50????????150.8±9.5?????????541.5±43.4?????????338.0±114.5
1.00????????147.1±11.6????????503.9±30.5?????????468.0±254.7
Property 2.00 160.4 ± 12.6 5345.7 ± 39.5 332.9 ± 150.8
Female 0.00 110.0 ± 15.6 5.5 ± 1.3 304.2 ± 125.0
0.50????????109.1±14.7????????5.0±1.4????????????394.1±169.2
1.00????????111.1±18.5????????4.3±0.7????????????343.2±99.6
Property 2.00 121.5 ± 12.5 4.7 ± 1.5 424.9 ± 180.8
3.3 routine blood test index: all do not have significance meaning on the statistics from the routine blood test index and the blank group comparing difference of table 8, visible each the dosage group of table 9,30 days feeding trial routine blood tests of this given the test agent of results suggest index is no abnormal.
30 days final routine blood test indexs of feeding trial of table 8 capsule of the present invention situation of change (n=10, x ± s)
Dosage RBC number hemoglobin leukocyte count platelet
(g/kg.b.w)????(10
12/L)????????(g/L)????????????(10
9/L)?????????(10
9/L)
0.00??????6.25±1.96??????124.4±8.6???????5.2±1.5????????236.4±55.0
Male
0.50??????6.90±1.23??????117.2±8.6???????5.6±1.8????????338.0±114.5
1.00??????4.31±0.69??????112.0±11.8??????6.0±1.3????????468.0±254.7
The property
2.00??????5.39±1.69??????115.4±6.4???????5.7±1.2????????332.9±150.8
0.00??????5.19±1.59??????116.1±8.0???????5.5±1.3????????304.2±125.0
Female
0.50??????5.00±0.90??????119.0±17.2??????5.0±1.4????????3944.1±169.2
1.00??????5.52±1.00??????128.8±10.5??????4.3±0.7????????343.2±99.6
The property
2.00??????5.57±0.79??????127.7±12.1??????4.7±1.5????????424.9±180.8
30 days final leukocyte differential count indexs of feeding trial of table 9 capsule of the present invention situation of change (n=10, x ± s)
Dosage (g/kg.b.w) lymphocyte number (%) mononuclear cell number (%) granulocyte number (%)
0.00????????76.5±4.7????????7.0±2.0????????16.5±3.8
Male
0.50????????78.9±4.2????????6.5±1.4????????14.6±3.4
1.00????????71.2±5.9????????8.8±1.5????????20.0±4.8
The property
2.00????????75.5±8.2????????8.6±2.8????????15.9±5.5
0.00????????68.6±8.6????????9.8±1.9????????21.6±7.0
Female
0.50????????73.1±7.9????????8.5±2.7????????18.4±5.4
1.00????????72.8±6.4????????7.7±2.2????????19.5±5.2
The property
2.00????????76.5±4.1????????6.8±1.6????????16.7±3.7
30 days final serum biochemistry indexs of feeding trial of table 10 capsule of the present invention situation of change (n=10, x ± s)
Dosage glutamate pyruvate transaminase glutamic oxaloacetic transaminase, GOT total protein albumin
A/G
(g/kg.b.w)??????(U/L)???????????(U/L)????????????(g/L)??????????(g/L)
0.00??????91.7±25.4??????262.5±74.5??????74.6±5.2??????35.7±3.1??????0.96±0.26
Male
0.50??????87.0±24.0??????206.2±50.3??????72.0±6.0??????33.8±2.2??????0.91±0.17
1.00??????90.1±17.6??????226.4±41.0??????74.1±6.7??????33.8±3.2??????0.88±0.23
The property
2.00??????93.1±15.6??????250.2±55.1??????74.1±4.6??????32.3±4.1??????0.81±0.25
0.00??????85.3±19.3??????219.4±49.1??????72.2±3.9??????36.0±2.6??????1.02±0.20
Female
0.50??????76.1±13.6??????242.1±31.5??????77.6±5.0??????34.0±4.8??????0.81±0.22
1.00??????97.0±15.7??????252.9±84.6??????81.9±7.9*?????35.1±4.5??????0.82±0.32
The property
2.00??????91.0±14.8??????276.2±34.0??????75.6±5.4??????37.4±2.8??????1.00±0.19
30 days final serum biochemistry indexs of feeding trial of table 11 capsule of the present invention situation of change (n=10, x ± s)
Dosage creatinine blood urea nitrogen blood glucose triglyceride T-CHOL
(g/kg.b.w)??????(μmol/L)????????(mmol/L)????????(mmol/L)???????(mmol/L)????????(mmol/L)
0.00????????51.7±5.6????????7.93±0.83??????6.32±0.92?????0.78±0.16??????1.50±0.20
Male
0.50????????53.5±9.6????????9.89±2.35??????5.68±0.73?????0.86±0.23??????1.50±0.29
1.00????????555.7±7.7???????9.09±2.15??????5.20±1.10?????1.01±0.32??????1.53±0.17
The property
2.00????????52.9±6.0????????8.78±1.39??????5.74±1.09?????0.86±0.28??????1.52±0.36
0.00????????49.8±5.5????????9.70±3.47??????6.02±1.10?????0.86±0.30??????1.66±0.30
Female
0.50????????54.8±6.5????????9.48±1.93??????5.30±0.78?????1.16±0.30??????1.86±0.29
1.00????????56.4±11.2???????10.32±4.03?????5.10±0.54?????1.09±0.39??????1.87±0.41
The property
2.00????????54.9±5.9????????8.12±1.73??????6.59±0.64?????0.83±0.23??????1.60±0.36
30 days dirty hierarchy number situations of change of feeding trial of table 12 capsule of the present invention (n=10, x ± s)
Dosage testis/system
The heart/hierarchy number liver/hierarchy number kidney/hierarchy number spleen/hierarchy number
(g/kg.b.w) number
1.06±
0.00????0.34±0.07?????3.23±0.45????0.78±0.09?????0.37±0.05
0.10
1.02±
Male 0.50 0.31 ± 0.05 3.26 ± 0.52 0.76 ± 0.07 0.37 ± 0.04
0.15
1.00±
Property 1.00 0.29 ± 0.06 3.17 ± 0.48 0.76 ± 0.08 0.34 ± 0.12
0.11
0.97±
2.00????0.29±0.04?????3.17±0.34????0.74±0.11?????0.35±0.07
0.11
0.00????0.34±0.04?????3.38±0.33????0.80±0.06?????0.38±0.07
Female
0.50????0.33±0.04?????3.32±0.41????0.77±0.10?????0.37±0.09
1.00????0.32±0.04?????3.47±0.56????0.79±0.08?????0.38±0.05
The property
2.00????0.31±0.06?????3.10±0.73????0.73±0.14?????0.38±0.04
Pathological examination: device gross examination of skeletal muscle and histopathological examinations such as the heart, liver,spleen,kidney, small intestinal, testis, the no abnormal situation of result.
4, brief summary: contain 0.50%, 1.00% and 2.00% the capsular granule of the present invention every day and raise grain, dosage is 0.50,1.00,2.00g/kg.b.w, be equivalent to 25,50,100 times of human body recommended amounts, be 30 days experimental period, the result, routine blood test and serum biochemistry index in normal range, the gross anatomy and the histopathological examination of organs such as the heart, liver,spleen,kidney, small intestinal, testis, the no abnormal situation of result.
Experimental example 4 capsules of the present invention have protective effect to chemical liver injury
1, experimental condition
1.1 sample: commercially available dress capsule of the present invention, recommending a day dosing is grams every days 1.2, counts 0.02g/kgb.w by 60 kilograms of adults, each test dose group desired concn all is made into the pure water dilute sample.
1.2 dosage design: establish negative control group, hepatic injury matched group and basic, normal, high three dosage groups, low dose group 0.06g/kgb.w is equivalent to recommend 3 times of day dosing.In dosage group 0.20g/kgb.w, be equivalent to recommend 10 times of day dosing.High dose group 0.60g/kgb.w is equivalent to recommend 30 times of day dosing.
1.3 animal and Animal Lab.: NIH kind male white mouse, in age in 6-8 week, body weight 20-24g provides qualified book probatio inspectionem pecuoarem 2000A025 by medical animal field, Guangdong Province.Pellet is provided by medical animal field, Guangdong Province.Laboratory: cleaning level, qualified book Guangdong probatio inspectionem pecuoarem 00C009.Room temperature 22-24 ℃; Humidity 60-76%.
1.4 instrument and reagent: Hitachi's 7060 full automatic biochemical apparatus, the test kit that triglyceride (TG) is measured in alanine aminotransferase in the blood (ALT) and aspartate amino transferase (AST) and the liver homogenate is supplied by this instrument manufacturer.Lipid peroxide catabolite malonaldehyde (MDA), glutathion (GSH) are measured and are adopted Nanjing to build up the test kit that biological product engineering company produces in the liver homogenate.Adopt German MICROMHM5000 type freezing microtome to make freezing pathological section.Adopt American I KA LABORTECHNIK T-25 type high speed shear emulsifying dispersion machine ice bath to make liver homogenate.
1.5 tried the thing approach: irritate the stomach animal by the 20ml/kgb.w amount and tried thing every day.
2, test method:
2.1CCL4 liver injury model: animal was quarantined under laboratory condition after a week, below each experiment be and at random animal be divided into five groups of negative control, hepatic injury contrast and basic, normal, high dosage, every group of 12-13 is only.Experimental group gives sample by various dose filling stomach respectively every day, and negative control group and hepatic injury matched group give pure water.Weekly according to body weight increase and decrease adjustment, experimental period was 4 weeks to the sample amount.After 4 weeks, experimental group and the fasting of hepatic injury matched group are after 16 hours, and disposable injection gives 0.125%CCL4 (0.1ml/10gb.w) through the abdominal cavity.Kill Mus after 24 hours and adopt eyeball blood, separation of serum is made biochemical measurement, gets mouse liver lobus sinister formaldehyde fixed, and the conventional pathology sheet of making, light microscopic are observed pathological change down.
2.2 ethanol liver injury model: animal was quarantined under laboratory condition after the week, below each experiment be and at random animal be divided into five groups of negative control, hepatic injury contrast and basic, normal, high dosage, every group of 10-11 only, experimental group gives sample by various dose filling stomach respectively every day, and negative control group and hepatic injury matched group give pure water.Weekly according to body weight increase and decrease adjustment, experimental period was 4 weeks to the sample amount.After 4 weeks, hepatic injury matched group and each experimental group are once irritated stomach and are given 50% ethanol (12ml/kgb.w), and negative control group gives pure water, and fasting was put to death animal in 6 hours and got liver, carried out the detection of every biochemical indicator.Get fresh mouse liver left side mouth ten and cook frozen section, soudan III and fat drop dyeing back microscopy: and scoring.
2.3 statistical disposition: data are carried out statistical analysis with the SPSS10.0 software kit.
3, experimental result:
3.1CCL4 liver injury model:
3.1.1 capsule of the present invention is to the influence of animal subject body weight:
Capsule of the present invention sees Table 13 to the influence of animal subject body weight, and comparing difference does not have the significance meaning between each group.
Table 13 capsule of the present invention is to the influence of animal subject body weight (x ± S)
Dosage
The body weight end-body was heavy during the number of animals initial body was heavy
Group (g/kg
(only) (g) (g) (g)
b.w)
Negative control 0.00 12 21.84 ± 1.21 27.73 ± 3.22 30.45 ± 3.95
Hepatic injury is right
0.00????12????????21.70±1.32??????28.16±3.46????????29.11±2.67
According to
Low dose group 0.06 13 22.73 ± 1.27 27.44 ± 3.06 31.21 ± 2.93
Middle dosage group 0.20 13 22.25 ± 1.00 27.32 ± 2.44 29.48 ± 2.38
High dose group 0.60 13 22.25 ± 1.52 28.33 ± 2.61 31.23 ± 2.44
F value 0.330 0.106 0.897
P???????????????????????????????＞0.05???????????＞0.05?????????????＞0.05
3.1.2 capsule of the present invention sees Table 14 to the influence of animal subject serum alanine aminotransferase (ALT) and serum aspartate amino transferase (AST) level:
The serum alanine aminotransferase (ALT) of middle dosage group and serum aspartate amino transferase (AST) level of middle and high dosage group are low than the hepatic injury matched group, and difference is learned check by statistics the significance meaning.
Table 14 capsule of the present invention is to the influence of ALT, AST level (x ± S)
Dosage number of animals ALT number of animals AST
Group
(g/kg b.w) (only) (IU/L) (only) (IU/L)
Negative control 0.00 12 50.17 ± 15.07 12 347.25 ± 62.20
Hepatic injury contrasts 0.00 12 1611.92 ± 955.34 12 2569.33 ± 1548.25
Low dose group 0.06 13 1147.46 ± 435.47 12 2405.00 ± 1476.33
Middle dosage group 0.20 13 633.92 ± 322.73**, 12 1009.33 ± 725.77**
High dose group 0.60 13 1623.85 ± 324.58 12 1160.54 ± 373.38**
Chi-Square????????????????????????????44.434???????????????????????????36.269
P?????????????????????????????????????＜0.01???????????????????????????＜0.01
Annotate: * * represents to compare P＜0.01 (KruskaI-Wallis check) with the hepatic injury matched group.
3.1.3 capsule of the present invention sees Table 15,16 to the influence of the hepatic pathology variation of animal subject:
The hepatic pathology of hepatic injury matched group and each dosage treated animal changes based on inflammatory cell infiltration and this two type of hepatic necrosis.From table 15,16 as seen, the be inflamed animal example number of cellular infiltration of low dose group generation hepatic necrosis and middle and high dosage group reduces, and lesion degree alleviates, scoring and hepatic injury matched group relatively, difference has the significance meaning.
Table 15 capsule of the present invention is to the influence of the hepatic pathology variation of animal subject
Negative control group hepatic injury matched group negative control group negative control group negative control group
Degree of injury-I II III-I II III-I II III-I II III-I II III
(only) (only) (only) (only) (only)
Necrocytosis 12 0000165182124240048
Steatosis 12 000 12 000 10 200 11 100 12 000
Inflammatory cell infiltration 75000174066008401 10 10
The balloon sample becomes 12 000 12 000 12 0008400 11 100
Annotate :-no abnormal; The accidental MC of I is for sick cell is dispersed in, rareness; The II MC, for sick cell in lobules of liver central authorities, the number of plies is less; The III moderate changes, and is more extensive for sick cell, surrounds more than 2～3 layers in lobules of liver central authorities.
The influence that table 16 capsule of the present invention changes the hepatic pathology of animal subject (x ± S)
The pathological changes type
The dosage number of animals
Group
Necrocytosis steatosis balloon sample becomes inflammatory cell
(g/kg b.w) (only)
(branch) (branch) (branch) soaks into (branch)
Negative control 0.00 12 0.00 ± 0.00 0.00 ± 0.00 0.00 ± 0.00 0.42 ± 0.51
Hepatic injury contrasts 0.00 12 2.33 ± 0.65 0.00 ± 0.00 0.33 ± 0.65 2.08 ± 0.90
Low dose group 0.06 12 1.25 ± 0.75* 0.17 ± 0.39 0.00 ± 0.00 1.50 ± 0.52
Middle dosage group 0.20 12 1.67 ± 1.15 0.08 ± 0.29 0.33 ± 0.49 1.33 ± 0.49*
High dose group 0.60 12 2.67 ± 0.49 0.00 ± 0.00 0.08 ± 0.29 1.00 ± 0.43*
Chi-Square??????????????????????????37.417????????????5.520?????????????9.301?????????????28.246
P???????????????????????????????????＜0.01????????????＞0.05????????????＞0.05????????????＜0.01
Annotate: 1, according to table 15 ,-no abnormal be that 0 minute, the accidental MC of I are that 1 minute, II MC are that 2 minutes, III moderate are changed into 3 fens.
2, * represents to compare P＜0.05 (Kruskal-Wallis check) with the hepatic injury matched group.
3.2 ethanol liver injury model:
3.2.1 capsule of the present invention sees Table 17 to the influence of lipid peroxide catabolite malonaldehyde (MDA) content in the mouse liver even slurry.
Low, high dose group MDA content is lower than the hepatic injury matched group, and difference is learned check by statistics the significance meaning.
Table 17 capsule of the present invention is to the influence of malonaldehyde in the liver homogenate (MDA) content (x ± S)
Dosage number of animals ADM content P value
Group
(g/kg b.w) (only) be (with hepatic injury matched group ratio) (mmol/ml)
Negative control 0.00 10 9.36 ± 3.63
Hepatic injury contrasts 0.00 10 12.32 ± 6.75
Low dose group 0.06 10 4.88 ± 1.08＜0.05
Middle dosage group 0.20 10 5.08 ± 2.03＞0.05
High dose group 0.60 10 4.49 ± 2.83＜0.05
F value 8.362 (P＜0.01)
3.2.2 capsule of the present invention sees Table 18 to the influence of glutathion in the liver homogenate (GSH) content.
Low, middle dosage group GSH content is higher than the hepatic injury matched group, and difference is learned check by statistics the significance meaning.
Table 18 capsule of the present invention is to the influence of glutathion in the liver homogenate (GSH) content (x ± S)
Dosage number of animals GSH content P value
Group
(g/kg b.w) (only) (mg/g albumen) (with hepatic injury matched group ratio)
Negative control 0.00 10 22.42 ± 5.09
Hepatic injury contrasts 0.00 10 13.54 ± 8.67
Low dose group 0.06 10 29.28 ± 17.67＜0.01
Middle dosage group 0.20 10 25.31 ± 12.73＜0.05
High dose group 0.60 10 16.37 ± 5.70＞0.05
F value 3.406 (P＜0.05)
3.2.3 capsule of the present invention sees Table 19 to the influence of triglyceride content in the liver homogenate.
Each dosage group TG content all is lower than the hepatic injury matched group, and difference is learned check by statistics the significance meaning.
Table 19 capsule of the present invention is to the influence of triglyceride content in the mouse liver even slurry (X ± S)
Dosage number of animals TG content P value
Group
(g/kg b.w) (only) be (with hepatic injury matched group ratio) (mmol/L)
Negative control 0.00 10 1.26 ± 0.39
Hepatic injury contrasts 0.00 10 1.95 ± 0.51
Low dose group 0.06 10 1.32 ± 0.12＜0.01
Middle dosage group 0.20 10 1.55 ± 0.52＜0.05
High dose group 0.60 10 1.43 ± 0.17＜0.01
F value 5.068 (P＜0.01)
3.2.4 capsule of the present invention sees Table 20 to the influence that the mouse liver histopathology changes (steatosis).
Liver frozen tissue section observed result as seen, the scoring of low, middle dosage group steatosis is lower than the hepatic injury matched group, difference is learned check by statistics the significance meaning.
Table 20 capsule of the present invention changes the influence of (steatosis) to the mouse liver histopathology
The imitative degeneration scoring of dosage number of animals fat P value
Group
(g/kg b.w) (only) (X ± S) (with hepatic injury matched group ratio)
Negative control 0.00 11 1.55 ± 1.13
Hepatic injury contrasts 0.00 11 2.91 ± 0.30
Low dose group 0.06 10 1.70 ± 0.82＜0.01
Middle dosage group 0.20 10 2.10 ± 0.57＜0.01
High dose group 0.60 11 2.36 ± 0.92＞0.05
F?????????????????????????????????????13.356(P＜0.01)
Annotate: the P value is the rank test result.
4, conclusion: capsule of the present invention has the certain protection effect to chemical liver injury.
Experimental example 5 relieves the effect of alcohol, sobering-up functions
Picked at random 23 people, mode is: drink at every turn and took the 2-4 grain in preceding 1 hour, the result can obviously improve the malaise symptoms after drinking.
| Sequence number | Sex | Age | Malaise symptoms after drinking before on probation | The situation of malaise symptoms alleviation after drinking after on probation | ||||||
| Headache, dizziness | Weak | Feel sick, vomit | Next day discomfort | Headache, dizziness | Weak | Feel sick, vomit | Next day discomfort | |||
| ????1 | The man | ??45 | ????+++ | ????++ | ????++ | ????+ | ????+ | ??+ | ????- | ????- |
| ????2 | The man | ??37 | ????+ | ????+ | ????+ | ????- | ????+ | ??+ | ????- | ????- |
| ????3 | The man | ??35 | ????++ | ????+ | ????+ | ????- | ????+ | ??- | ????- | ????- |
| ????4 | The man | ??42 | ????++ | ????+ | ????++ | ????+ | ????+ | ??- | ????- | ????- |
| ????5 | The man | ??30 | ????++ | ????++ | ????+ | ????+ | ????- | ??- | ????- | ????- |
| ????6 | The man | ??35 | ????+ | ????+ | ????++ | ????+ | ????+ | ??- | ????- | ????- |
| ????7 | The man | ??33 | ????+++ | ????++ | ????+++ | ????++ | ????+ | ??+ | ????- | ????+ |
| ????8 | The man | ??50 | ????++ | ????++ | ????+ | ????+ | ????+ | ??- | ????- | ????- |
| ????9 | The man | ??34 | ????+ | ????++ | ????+ | ????- | ????- | ??- | ????- | ????- |
| ????10 | The man | ??49 | ????+ | ????++ | ????+ | ????+ | ????+ | ??- | ????- | ????- |
| ????11 | The man | ??41 | ????+ | ????++ | ????- | ????+ | ????+ | ??- | ????- | ????- |
| ????12 | The man | ??44 | ????++ | ????++ | ????+ | ????+ | ????- | ??- | ????+ | ????- |
| ????13 | The man | ??33 | ????++ | ????+ | ????++ | ????+ | ????+ | ??- | ????+ | ????- |
| ????14 | The man | ??36 | ????+ | ????+ | ????+ | ????- | ????- | ??- | ????- | ????- |
| ????15 | The man | ??33 | ????+++ | ????++ | ????++ | ????++ | ????+ | ??+ | ????+ | ????+ |
| ????16 | The man | ??39 | ????++ | ????+ | ????+ | ????+ | ????+ | ??+ | ????- | ????- |
| ????17 | The man | ??35 | ????+++ | ????+ | ????+ | ????- | ????+ | ??+ | ????+ | ????- |
| ????18 | The woman | ??38 | ????+ | ????+ | ????+ | ????- | ????- | ??- | ????- | ????- |
| ????19 | The woman | ??26 | ????- | ????+ | ????+ | ????- | ????- | ??- | ????- | ????- |
| ????20 | The woman | ??22 | ????+ | ????+ | ????++ | ????- | ????+ | ??- | ????- | ????- |
| ????21 | The man | ??36 | ????++ | ????+ | ????+ | ????+ | ????- | ??- | ????+ | ????- |
| ????22 | The man | ??34 | ????+ | ????+ | ????++ | ????- | ????- | ??- | ????- | ????- |
| ????23 | The man | ??51 | ????+ | ????+ | ????+ | ????- | ????+ | ??+ | ????- | ????- |
The situation of malaise symptoms alleviation after drinking after on probation:
Headache, dizziness have 70% to improve
Weak have 87% to improve
Nauseating, vomiting has 83% to improve
Next day, discomfort had 100% to improve
The following example all can be realized the effect of above-mentioned experimental example.
Embodiment 1
Wolfberry fruit extract 60g soybean extract 20g L-cysteine 30g
Get Fructus Lycii, add 8 times of amount purified water, boiled 2 hours, filter, add 5 times of amount purified water again, boiled 1.5 hours, merging filtrate is concentrated into 1/2 volume, and spray drying gets wolfberry fruit extract; The extracting degreasing Semen sojae atricolor is ground into coarse powder, extracts 2 times in 44-65 ℃ with the 60-80% edible ethanol, each 2 hours, reclaim edible ethanol, the gained syrup passes through 100 in 65 ℃, the ultrafilter membrane of 000 molecular weight, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; It is an amount of to add dextrin, and mix homogeneously is standby, and cysteine is pulverized, crossed 80 mesh sieves, crosses 40 mesh sieves on pelletizing machine, sieves wolfberry fruit extract and soybean extract more successively.The fine powder that sieves is added mix homogeneously in the blending tank.After the fine powder of mix homogeneously pack with the double-layer plastic bag, keep in the sealing bucket.Mixed powder fully-automatic capsule filling machine filled capsules is filled 0.3 gram medicated powder, is got product for every.Oral, a twice-daily, once two.
Embodiment 2
Wolfberry fruit extract 70g soybean extract 25g L-cysteine 20g
Get Fructus Lycii, add 8 times of amount purified water, boiled 2 hours, filter, add 5 times of amount purified water again, boiled 1.5 hours, merging filtrate is concentrated into 1/2 volume, and spray drying gets wolfberry fruit extract; The extracting degreasing Semen sojae atricolor is ground into coarse powder, extracts 2 times in 44-65 ℃ with the 60-80% edible ethanol, each 2 hours, reclaim edible ethanol, the gained syrup passes through 100 in 65 ℃, the ultrafilter membrane of 000 molecular weight, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; It is an amount of to add dextrin, and mix homogeneously is standby, and cysteine is pulverized, crossed 80 mesh sieves, crosses 40 mesh sieves on pelletizing machine, sieves wolfberry fruit extract and soybean extract more successively.The fine powder that sieves is added mix homogeneously in the blending tank.After the fine powder of mix homogeneously pack with the double-layer plastic bag, keep in the sealing bucket.Mixed powder fully-automatic capsule filling machine filled capsules is filled 0.3 gram medicated powder, is got product for every.Oral, a twice-daily, once two.
Embodiment 3:
Fructus Crataegi extract 1200g wolfberry fruit extract 1200g Rhizoma Alismatis extract 350g
Soybean extract 350g vitamin C 350g L-cysteine 300g
Vitamin B
625g calcium pantothenate 20g folic acid 2.5g vitamin B
1240mg
Get Fructus Lycii, add 8 times of amount purified water, boiled 2 hours, filter, add 5 times of amount purified water again, boiled 1.5 hours, merging filtrate is concentrated into 1/2 volume, and spray drying gets wolfberry fruit extract; Get Fructus Crataegi, be ground into coarse powder, add 8 times of amounts of 70% edible ethanol and extract secondary, each 2 hours; Extracting solution is evaporated to does not have the alcohol flavor, and spray drying gets Fructus Crataegi extract; The extracting degreasing Semen sojae atricolor is ground into coarse powder, extracts 2 times in 44-65 ℃ with the 60-80% edible ethanol, each 2 hours, reclaim edible ethanol, the gained syrup passes through 100 in 65 ℃, the ultrafilter membrane of 000 molecular weight, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; Get the Rhizoma Alismatis decoction pieces, be ground into coarse powder, cold water soak is extracted with 80% edible ethanol then, reclaims edible ethanol, spray drying.It is an amount of to add dextrin, and mix homogeneously is standby, and cysteine is pulverized, crossed 80 mesh sieves, mixes with vitamin C and calcium pantothenate, and Rhizoma Alismatis extract mixes with adjuvant, crosses 40 mesh sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively.The fine powder that sieves is added mix homogeneously in the blending tank.After the fine powder of mix homogeneously pack with the double-layer plastic bag, keep in the sealing bucket.Mixed powder fully-automatic capsule filling machine filled capsules is filled 0.3 gram medicated powder, is got product for every.Oral, a twice-daily, once two.
Embodiment 4:
Fructus Crataegi extract 1600g wolfberry fruit extract 1000g Rhizoma Alismatis extract 420g
Soybean extract 420g vitamin C 400g L-cysteine 350g
Vitamin B
620g calcium pantothenate 30g folic acid 2g vitamin B
1250mg
Get Fructus Lycii, add 8 times of amount purified water, boiled 2 hours, filter, add 5 times of amount purified water again, boiled 1.5 hours, merging filtrate is concentrated into 1/2 volume, and spray drying gets wolfberry fruit extract; Get Fructus Crataegi, be ground into coarse powder, add 8 times of amounts of 70% edible ethanol and extract secondary, each 2 hours; Extracting solution is evaporated to does not have the alcohol flavor, and spray drying gets Fructus Crataegi extract; The extracting degreasing Semen sojae atricolor is ground into coarse powder, extracts 2 times in 44-65 ℃ with the 60-80% edible ethanol, each 2 hours, reclaim edible ethanol, the gained syrup passes through 100 in 65 ℃, the ultrafilter membrane of 000 molecular weight, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; Get the Rhizoma Alismatis decoction pieces, be ground into coarse powder, cold water soak is extracted with 80% edible ethanol then, reclaims edible ethanol, spray drying.It is an amount of to add dextrin, and mix homogeneously is standby, and cysteine is pulverized, crossed 80 mesh sieves, mixes with vitamin C and calcium pantothenate, and Rhizoma Alismatis extract mixes with adjuvant, crosses 40 mesh sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively.The PEG-6000 of fine powder adding 1% and 3% microcrystalline Cellulose, mixing is granulated, and with the magnesium stearate mixing of granule and 0.5%, compacting is in blocks, every heavy 0.3g.Oral, a twice-daily, once two.
Embodiment 5:
Fructus Crataegi extract 83g wolfberry fruit extract 60g Rhizoma Alismatis extract 30g soybean extract 20g
Vitamin C 35g L-cysteine 30g vitamin B
61.5g calcium pantothenate 1.25g
Folic acid 80mg vitamin B
122mg
With Fructus Crataegi extract, wolfberry fruit extract, Rhizoma Alismatis extract, that soybean extract adds dextrin is an amount of; mix homogeneously; standby; 80 mesh sieves are pulverized, crossed to cysteine; mix with vitamin C and calcium pantothenate; Rhizoma Alismatis extract mixes with adjuvant, crosses 40 mesh sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively.The fine powder that sieves is added mix homogeneously in the blending tank.After the fine powder of mix homogeneously pack with the double-layer plastic bag, keep in the sealing bucket.Mixed powder fully-automatic capsule filling machine filled capsules is filled 0.3 gram medicated powder for every, makes 1000, and is oral, a twice-daily, once two.
Embodiment 6:
Fructus Crataegi extract 63g wolfberry fruit extract 70g Rhizoma Alismatis extract 20g soybean extract 25g
Catergen 0g L-cysteine 20g vitamin B
62g calcium pantothenate 2g
Folic acid 100mg vitamin B
122mg
With Fructus Crataegi extract, wolfberry fruit extract, Rhizoma Alismatis extract, that soybean extract adds dextrin is an amount of; mix homogeneously; standby; 80 mesh sieves are pulverized, crossed to cysteine; mix with vitamin C and calcium pantothenate; Rhizoma Alismatis extract mixes with adjuvant, crosses 40 mesh sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively.The PEG-6000 of fine powder adding 1% and 3% microcrystalline Cellulose, mixing is granulated, and with the magnesium stearate mixing of granule and 0.5%, compacting is in blocks, every heavy 0.3g.Oral, a twice-daily, once two.
Claims (10)
1, a kind of pharmaceutical composition is characterized in that this pharmaceutical composition made by following raw material medicaments:
Soybean extract 5-40 weight portion wolfberry fruit extract 15-120 weight portion
L-cysteine 10-60 weight portion.
2, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:
Soybean extract 10-30 weight portion wolfberry fruit extract 30-90 weight portion
L-cysteine 15-45 weight portion.
3, pharmaceutical composition as claimed in claim 1 is characterized in that this pharmaceutical composition made by following raw material medicaments:
Soybean extract 5-40 weight portion wolfberry fruit extract 15-120 weight portion
L-cysteine 10-60 weight portion Fructus Crataegi extract 20-160 weight portion
Rhizoma Alismatis extract 10-60 weight portion vitamin C 10-60 weight portion
Vitamin B
60.5-4 weight portion calcium pantothenate 0.5-4 weight portion
Folic acid 0.02-0.4 weight portion vitamin B
120.001-0.005 weight portion.
4, pharmaceutical composition as claimed in claim 3 is characterized in that this pharmaceutical composition made by following raw material medicaments:
Soybean extract 10-30 weight portion wolfberry fruit extract 30-90 weight portion
L-cysteine 15-45 weight portion Fructus Crataegi extract 40-120 weight portion
Rhizoma Alismatis extract 15-45 weight portion vitamin C 15-45 weight portion
Vitamin B
61-2 weight portion calcium pantothenate 1-2 weight portion
Folic acid 0.05-0.15 weight portion vitamin B
120.002-0.003 weight portion.
5, pharmaceutical composition as claimed in claim 4 is characterized in that this pharmaceutical composition made by following raw material medicaments:
Fructus Crataegi extract 83 weight portion wolfberry fruit extracts 60 weight portions
Rhizoma Alismatis extract 30 weight portion soybean extract 20 weight portions
Vitamin C 35 weight portion L-cysteine 30 weight portions
Vitamin B
61.5 weight portion calcium pantothenate 1.25 weight portions
Folic acid 0.1 weight portion vitamin B
120.0025 weight portion.
6,, it is characterized in that this pharmaceutical composition also can add excipient and make clinical acceptable forms as claim 1,2,3,4 or 5 described pharmaceutical compositions.
7, as claim 3,4 or 5 described preparation of drug combination methods, it is characterized in that this method is: get Fructus Lycii, add 6-10 and doubly measure purified water, boiled 1-3 hour, filter, add 4-6 again and doubly measure purified water, boiled 1-2 hour, merging filtrate concentrates, and spray drying gets wolfberry fruit extract; Get Fructus Crataegi, pulverize, add 50-80% edible ethanol 4-10 and doubly measure the extraction secondary, each 1-3 hour; Extracting solution is evaporated to does not have the alcohol flavor, and spray drying gets Fructus Crataegi extract; The extracting degreasing Semen sojae atricolor is pulverized, extract 2 times in 44-65 ℃ with the 50-80% edible ethanol, each 1-3 hour, reclaim edible ethanol, the gained syrup in 60-70 ℃ by ultrafilter membrane, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; Get the Rhizoma Alismatis decoction pieces, pulverize, cold water soak is extracted with the 50-85% edible ethanol then, reclaims edible ethanol, spray drying; It is an amount of to add dextrin, and mix homogeneously is standby; Cysteine is pulverized, sieved, mix with vitamin C and calcium pantothenate, Rhizoma Alismatis extract mixes with adjuvant, sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively; The fine powder that sieves is added mix homogeneously in the blending tank; At last directly or add pharmaceutically acceptable excipient and make clinical acceptable forms through conventional operation.
8, preparation of drug combination method as claimed in claim 7, the preparation method of its feature capsule is: get Fructus Lycii, add 8 times of amount purified water, boiled 2 hours, filter, add 5 times of amount purified water again, boiled 1.5 hours, merging filtrate is concentrated into 1/2 volume, and spray drying gets wolfberry fruit extract; Get Fructus Crataegi, be ground into coarse powder, add 8 times of amounts of 70% edible ethanol and extract secondary, each 2 hours; Extracting solution is evaporated to does not have the alcohol flavor, and spray drying gets Fructus Crataegi extract; The extracting degreasing Semen sojae atricolor is ground into coarse powder, extracts 2 times in 44-65 ℃ with the 60-80% edible ethanol, each 2 hours, reclaim edible ethanol, the gained syrup passes through 100 in 65 ℃, the ultrafilter membrane of 000 molecular weight, the filtrate reverse osmosis, reverse osmosis liquid concentrates the back spray drying and gets soybean extract; Get the Rhizoma Alismatis decoction pieces, be ground into coarse powder, cold water soak is extracted with 80% edible ethanol then, reclaims edible ethanol, spray drying; It is an amount of to add dextrin, and mix homogeneously is standby, and cysteine is pulverized, sieved, and mixes with vitamin C and calcium pantothenate, and Rhizoma Alismatis extract mixes with adjuvant, sieves on pelletizing machine, sieves Fructus Crataegi extract, wolfberry fruit extract and soybean extract more successively; The fine powder that sieves is added mix homogeneously in the blending tank; After the fine powder of mix homogeneously pack with the double-layer plastic bag, keep in the sealing bucket; Mixed powder fully-automatic capsule filling machine filled capsules gets capsule.
9, treat in preparation, prevent the medicine of chemical liver injury and chemical liver injury is had the health-care effect Application in Food as the described pharmaceutical composition of claim 1-5.
10, application as claimed in claim 9, it is characterized in that preparing have relieve the effect of alcohol, the medicine of anti-alcohol function and the application in the health food.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03122873 CN1257736C (en) | 2003-05-08 | 2003-05-08 | Sobering-up liver-protecting medicine composition for preventing chemical liver damage and its prepn process |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03122873 CN1257736C (en) | 2003-05-08 | 2003-05-08 | Sobering-up liver-protecting medicine composition for preventing chemical liver damage and its prepn process |
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| Publication Number | Publication Date |
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| CN1548050A true CN1548050A (en) | 2004-11-24 |
| CN1257736C CN1257736C (en) | 2006-05-31 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 03122873 Expired - Lifetime CN1257736C (en) | 2003-05-08 | 2003-05-08 | Sobering-up liver-protecting medicine composition for preventing chemical liver damage and its prepn process |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698879B (en) * | 2005-06-21 | 2010-08-11 | 蔺益民 | Product having sobering up and liver protecting functions and its preparation method and usage |
| CN115120634A (en) * | 2021-03-24 | 2022-09-30 | 中国科学院上海药物研究所 | Traditional Chinese medicine compound preparation for preventing and treating alcoholic liver injury and preparation method and application thereof |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2011051742A1 (en) * | 2009-10-28 | 2011-05-05 | Modutech S.A. | Preparation comprising amino acids and plants and its activity in the alcohol detoxification |
-
2003
- 2003-05-08 CN CN 03122873 patent/CN1257736C/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1698879B (en) * | 2005-06-21 | 2010-08-11 | 蔺益民 | Product having sobering up and liver protecting functions and its preparation method and usage |
| CN115120634A (en) * | 2021-03-24 | 2022-09-30 | 中国科学院上海药物研究所 | Traditional Chinese medicine compound preparation for preventing and treating alcoholic liver injury and preparation method and application thereof |
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| Publication number | Publication date |
|---|---|
| CN1257736C (en) | 2006-05-31 |
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