CN104510857B - A kind of Chinese medicinal effective-part composition for blood fat reducing and preparation thereof - Google Patents
A kind of Chinese medicinal effective-part composition for blood fat reducing and preparation thereof Download PDFInfo
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Abstract
The present invention relates to a kind of Chinese medicine composition for blood fat reducing and preparation thereof, be specifically related to the effective ingredient in Chinese such as Radix Puerariae for lipid-lowering therapy, belong to the field of Chinese medicines.Its Radix Puerariae total flavones, the Fructus Crataegi total flavones of 10% ~ 50%, Rhizoma Alismatis total triterpene alcohol, the fleece-flower root total stilbene glucoside of 10% ~ 50% and Radix Angelicae Sinensis volatile oil of 10% ~ 50% of 10% ~ 50% being 10% ~ 50% by percentage by weight forms.Pharmaceutical composition of the present invention can be prepared into suitable pharmaceutical preparation for lipid-lowering therapy with pharmaceutically acceptable adjuvant, as required as oral formulations, ejection preparation etc.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition for blood fat reducing and preparation thereof, be specifically related to the effective ingredient in Chinese such as Radix Puerariae for lipid-lowering therapy, belong to the field of Chinese medicines.
Background technology
Hyperlipemia is divided into former and the large class of secondary two clinically, is the result of lipid and lipoprotein metabolism disorder in numerous disease.Particularly hyperlipemia causes atherosclerosis, and cause cardiovascular and cerebrovascular vessel unexpected, the state of an illness is dangerous, prognosis mala.At present, all there is larger side effect in blood fat reducing chemical drugs conventional clinically, and life-time service, some drugs can be large because of gastrointestinal reaction, the consequences such as initiation fat soluble vitamin absorption is bad.In addition, because the individual variation of crowd is comparatively large, also bigger difference is existed with reaction to the curative effect of medicine.So, along with the development of the combination of Chinese and Western medicine and deepening continuously to Chinese medicine research, according to Traditional Chinese Medicine theory, in conjunction with contemporary Chinese medicine research achievement, dialectically to combine with differential diagnosis of diseases, select suitable drug matching application, be beneficial to long-term taking, side reaction is little, simultaneously the new type natural compound Chinese medicinal preparation of the balance of scalable human body body function, to treatment hyperlipemia, prevention cardiovascular and cerebrovascular disease and senile pathological changes important in inhibiting.
Ge Shan blood-fat-lowering granule comes from the clinical experience side for many years of Anhui Province famous physician Mr. Gao Daofan.Prescription is made up of Radix Puerariae, Fructus Crataegi (parched), Rhizoma Alismatis, Radix Polygoni Multiflori Preparata and Radix Angelicae Sinensis five kinds of Chinese medicine, and the percentage by weight of each taste Chinese medicine of this compound recipe is the Radix Puerariae of 32%, the Fructus Crataegi of 32%, the Rhizoma Alismatis of 15%, the Radix Polygoni Multiflori of 13% and the Radix Angelicae Sinensis of 8%.Be mainly used in the hyperlipemia that various inducement causes clinically, the features such as have rapid-action, curative effect is high, and side effect is little.But the many existence of this compound treatment hyperlipemia use inconvenience, dosage is large, complicated component, effective site are indefinite, the material base playing curative effect in compound recipe is unclear, and there is the problems such as certain untoward reaction, therefore necessaryly under the guidance of Chinese medical theory, develop that a kind of active substance is clear and definite, determined curative effect, side effect is little and take the pharmaceutical composition for the treatment of blood fat reducing easily.
Summary of the invention
An object of the present invention is to provide a kind of Chinese medicinal effective-part composition for blood fat reducing, its Radix Puerariae total flavones, the Fructus Crataegi total flavones of 10% ~ 50%, Rhizoma Alismatis total triterpene alcohol, the fleece-flower root total stilbene glucoside of 10% ~ 50% and Radix Angelicae Sinensis volatile oil of 10% ~ 50% of 10% ~ 50% being 10% ~ 50% by percentage by weight forms.
In the present invention further embodiment, the percentage by weight of described compositions be preferably 20% ~ 40% Radix Puerariae total flavones, 20% ~ 40% Fructus Crataegi total flavones, 10% ~ 30% Rhizoma Alismatis total triterpene alcohol, the fleece-flower root total stilbene glucoside of 20% ~ 40% and the Radix Angelicae Sinensis volatile oil of 10% ~ 30%.
Effective ingredient in Chinese extract of the present invention can obtain by prior art, also can the specific method of the present invention be prepared.
1) preparation of Radix Puerariae total flavones: 1kg Herba Gelsemii Elegantis decoction pieces respectively with 10 times amount and 8 times of water gagings for solvent decocts each extraction 30min, filter, merging filtrate, be concentrated into 6L, add the chitosan solution 900ml of 1%, hold over night, centrifugal, filtrate is concentrated into 500ml, upper D101 macroporous resin column, post ratio of height to diameter is 1:5, resin demand 2L, with the remove impurity of 4L deionized water eluting, using 4L70% ethanol elution, it is dry that eluent reclaims ethanol, obtains Radix Puerariae total flavones, yield 7.5% (see patent documentation CN03115538).
2) preparation of Fructus Crataegi total flavones:
Fructus Crataegi 1000g, adds 5 times of 80% soak with ethanol 30min, reflux, extract, 2 times, each 1 hour.Merge extractive liquid, is evaporated to 0.77-0.83g medical material/ml, and concentrated solution is put into freezer and spent the night (4 DEG C), centrifugal supernatant.Macroporous adsorbent resin ADS-17 (polystyrene hydrogen bond type polarity) on supernatant, washing discards 7 times of column volumes, and 15% ethanol elution discards, then collects 5 times of column volumes with 30% ethanol elution.Eluent concentrating under reduced pressure obtains Fructus Crataegi total flavones, yield 1.34%, purity 87.5%.(see patent documentation CN200610013121).
3) preparation of Rhizoma Alismatis total triterpene alcohol: Rhizoma Alismatis 80% ethanol water of 8 times amount is extracted 3 times, each extraction 2 hours, filters merging filtrate, be recycled to 1/4 volume, low temperature places 12 hours, filters, and supernatant reclaims 1/3 (proportion 1.07) of decompression original volume.Said extracted liquid directly uses D101 resin column, first slough assorted with 50% ethanol aqueous wash, elute soln amount is about 3 times of retention volume, then the ethanol water eluting of 90% is used, collect eluent, concentrated, spraying dry and get final product, yield is 3.2% (see patent documentation CN200610154797)
4) preparation of fleece-flower root total stilbene glucoside: by Radix Polygoni Multiflori 60 order powder with after 5 times amount (w/w) 60% soak with ethanol 30 minutes (min), be placed in microwave oven, use power 280w, 30 second time filtered after extracting, residue identical multiple ethanol and microwave condition repeat extraction 2 times again, merge the filtrate of 3 times, be the extracting solution (see patent documentation CN200710039534) containing total stilbene glucoside.
5) preparation of Radix Angelicae Sinensis volatile oil: get dry Radix Angelicae Sinensis medical material 500g, pulverized 40 mesh sieves, the Radix Angelicae Sinensis medicinal powder after sieving is inserted supercritical CO
2extractor; Adjustment CO
2flow is 20m
3/ h, extracting pressure 20MPa, extraction temperature 35 DEG C; Pressure 4MPa is resolved in adjustment, resolution temperature 20 DEG C; Adopt dehydrated alcohol as entrainer, its consumption accounts for 5% of feeding quantity; Dynamic extraction 30min.Collect extract, vacuum volatilizes dehydrated alcohol; Gained pale yellow transparent grease and described Radix Angelicae Sinensis volatile oil (see patent documentation CN200910201870).
Another object of the present invention is to provide a kind of pharmaceutical preparation containing described Chinese medicinal effective-part composition, pharmaceutical composition of the present invention can be prepared into suitable pharmaceutical preparation for lipid-lowering therapy with pharmaceutically acceptable adjuvant, as required as oral formulations, ejection preparation etc.
Described pharmaceutical preparation is preferably oral formulations, and described oral formulations is selected from tablet, capsule, slow releasing tablet, pill, granule, dispersible tablet, powder.Adjuvant selected by described oral formulations is selected from starch, pregelatinized Starch, starch slurry, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, Polyethylene Glycol (PEG), sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, mannitol, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose, polyvinylpyrrolidone (PVP), crospolyvinylpyrrolidone, magnesium stearate, Pulvis Talci, micropowder silica gel, aspartame, orange flavor, sodium bicarbonate, sodium carbonate, one or more in enteric coating powder.The adjuvant used of above-mentioned preparation and preparation method all can adopt the adjuvant of its routine and preparation method to obtain.
The present invention also provides the purposes of described Chinese medicinal effective-part composition, and namely this Chinese medicinal effective-part composition is for the preparation of the application in lipid-lowering therapy.In described medical usage, aforementioned pharmaceutical compositions can be prepared into suitable pharmaceutical preparation to facilitate medication according to the animal state of an illness and agents area, this is within the technical scope of those skilled in the art's grasp.Such as, will be applied on the person to the therapeutic scheme of mice dysmenorrhea, all medicines can be converted by the effective dose of this medicine to mice to the effective dose of people, and this is apparent for the person of ordinary skill of the art.
The present invention is by carrying out Chinese medicine of the five flavours refining thus obtaining corresponding effective ingredient in Chinese, by a large amount of animal and clinical trial, the proportioning between each effective ingredient in Chinese is optimized, thus greatly improve curative effect, and take safe and reliable, toxic and side effects is low.
Detailed description of the invention
Further will illustrate the present invention below.It is pointed out that following explanation is only illustrating the technical scheme that application claims is protected, any restriction not to these technical schemes.The content that protection scope of the present invention is recorded with appended claims is as the criterion.
The preparation of each taste effective ingredient in Chinese of embodiment 1
1) preparation of Radix Puerariae total flavones: 1kg Herba Gelsemii Elegantis decoction pieces respectively with 10 times amount and 8 times of water gagings for solvent decocts each extraction 30min, filter, merging filtrate, be concentrated into 6L, add the chitosan solution 900ml of 1%, hold over night, centrifugal, filtrate is concentrated into 500ml, upper D101 macroporous resin column, post ratio of height to diameter is 1:5, resin demand 2L, with the remove impurity of 4L deionized water eluting, using 4L70% ethanol elution, it is dry that eluent reclaims ethanol, obtains Radix Puerariae total flavones, yield 7.5% (see patent documentation CN03115538).
2) preparation of Fructus Crataegi total flavones:
Fructus Crataegi 1kg, adds 5 times of 80% soak with ethanol 30min, reflux, extract, 2 times, each 1 hour.Merge extractive liquid, is evaporated to 0.77-0.83g medical material/ml, and concentrated solution is put into freezer and spent the night (4 DEG C), centrifugal supernatant.Macroporous adsorbent resin ADS-17 (polystyrene hydrogen bond type polarity) on supernatant, washing discards 7 times of column volumes, and 15% ethanol elution discards, then collects 5 times of column volumes with 30% ethanol elution.Eluent concentrating under reduced pressure obtains Fructus Crataegi total flavones, yield 1.34%, purity 87.5%.(see patent documentation CN200610013121).
3) preparation of Rhizoma Alismatis total triterpene alcohol: Rhizoma Alismatis 1kg 80% ethanol water of 8 times amount is extracted 3 times, each extraction 2 hours, filters merging filtrate, be recycled to 1/4 volume, low temperature places 12 hours, filters, and supernatant reclaims 1/3 (proportion 1.07) of decompression original volume.Said extracted liquid directly uses D101 resin column, first slough assorted with 50% ethanol aqueous wash, elute soln amount is about 3 times of retention volume, then the ethanol water eluting of 90% is used, collect eluent, concentrated, spraying dry and get final product, yield is 3.2% (see patent documentation CN200610154797)
4) preparation of fleece-flower root total stilbene glucoside: by 1kg Radix Polygoni Multiflori 60 order powder with after 5 times amount (w/w) 60% soak with ethanol 30 minutes (min), be placed in microwave oven, use power 280w, 30 second time filtered after extracting, residue identical multiple ethanol and microwave condition repeat extraction 2 times again, merge the filtrate of 3 times, be the extracting solution (see patent documentation CN200710039534) containing total stilbene glucoside.
5) preparation of Radix Angelicae Sinensis volatile oil: get dry Radix Angelicae Sinensis medical material 500g, pulverized 40 mesh sieves, the Radix Angelicae Sinensis medicinal powder after sieving is inserted supercritical CO
2extractor; Adjustment CO
2flow is 20m
3/ h, extracting pressure 20MPa, extraction temperature 35 DEG C; Pressure 4MPa is resolved in adjustment, resolution temperature 20 DEG C; Adopt dehydrated alcohol as entrainer, its consumption accounts for 5% of feeding quantity; Dynamic extraction 30min.Collect extract, vacuum volatilizes dehydrated alcohol; Gained pale yellow transparent grease and described Radix Angelicae Sinensis volatile oil (see patent documentation CN200910201870).
Embodiment 2 Chinese medicinal effective-part composition is to the lipid of feeding high lipid food rat
Add lumbar injection VD3 by high lipid food and oralbumin excites inflammatory reaction, set up rat AS model.Modeling time 1 first quarter moon.Concrete steps are as follows: after rat adaptability feeds one week, random packet (often organizing 8), be respectively blank group of (normalstate, NS), model group and each administration group, NS group rat gives normal diet, and other groups give high lipid food (containing 1% cholesterol, 0.2% Fel Sus domestica salt, 10% Adeps Sus domestica, 10% yolk powder, 78.8% normal feedstuff).After grouping, except NS group, other group rat disposable celiac injections VD
36O ten thousand IU/kg, NS group gives isopyknic normal saline; Next day carries out immunologic injury (by oralbumin with physiological saline solution to rat, get egg protein solution and the Split completely of equivalent, stable water-in-oil type antigen Emulsion is made, with antigen Emulsion (3mg/kg) at the subcutaneous multi-point injection of rat back after mixing; With egg protein solution (2.5mg/kg) lumbar injection challenge after 3 weeks, 1 time weekly, continuous 3 weeks; NS group gives the normal saline of equivalent by identical approach.Observe rat drinking-water, body weight, outward appearance, activity.Modeling is after 8 weeks, and oral administration gavage gives respective components and medicine (dosage is 100mg/kg), NS and MS group gives isopyknic 0.5%CMC-Na, administration time one month.Fasting 12h after doomsday administration, 20% urethane anesthesia, abdominal aortic blood, blood is divided into anticoagulation and non-anticoagulation two kinds to collect, 4 DEG C standing after, centrifugal (4 DEG C, 3000rpm) lOmin, getting serum and blood, to fill subpackage for subsequent use.Cut to abdominal aortic bifurcation place downwards from aortic arch root simultaneously, peel off connective tissue, longitudinally cut open, clean with cold normal saline flushing, perusal tunica intima situation, is fixed in 4% paraformaldehyde solution, and standby pathology detection is used.
Effective ingredient in Chinese composition situation in each administration group
| ％ | Group 1 | Group 2 | Group 3 | Group 4 |
| Radix Puerariae total flavones | 10 | 20 | 30 | 15 |
| Fructus Crataegi total flavones | 10 | 20 | 30 | 25 |
| Rhizoma Alismatis total triterpene alcohol | 10 | 20 | 15 | 10 |
| Fleece-flower root total stilbene glucoside | 20 | 20 | 15 | 30 |
| Radix Angelicae Sinensis volatile oil | 50 | 20 | 10 | 20 |
Comparative example 1 its preparation method is see embodiment in patent documentation CN03108971 1 (dosage 100mg/kg)
Comparative example 2 its preparation method is see embodiment in patent documentation CN03108971 1 (dosage 500mg/kg)
Result:
(1) each administration group is on the impact of Serum Lipids in Experimental HypercholesterolemicRats, specifically sees the following form:
| TC(mmol/L) | TG(mmol/L) | LDL-C(mmol/L) | HDL-C(mmol/L) | |
| Matched group | 1.3±0.2 | 0.15±0.03 | 0.19±0.02 | 1.0±0.1 |
| Model group | 2.6±0.3 | 0.56±0.05 | 0.61±0.05 | 0.9±0.2 |
| Group 1 | 1.8±0.2 | 0.36±0.05 | 0.38±0.03 | 1.2±0.2 |
| Group 2 | 1.5±0.4 | 0.23±0.03 | 0.26±0.03 | 1.3±0.3 |
| Group 3 | 1.6±0.3 | 0.28±0.04 | 0.31±0.04 | 1.3±0.2 |
| Group 4 | 1.4±0.4 | 0.17±0.02 | 0.22±0.03 | 1.4±0.3 |
| Comparative example 1 | 2.5±0.3 | 0.55±0.05 | 0.62±0.05 | 1.0±0.2 |
| Comparative example 2 | 2.2±0.3 | 0.51±0.04 | 0.59±0.04 | 1.1±0.2 |
(2) administration group is on the impact of Antioxidant Indexes in serum, specific as follows:
| SOD(U/L) | MDA(mmol/L) | |
| Matched group | 237±18 | 3.7±0.4 |
| Model group | 173±14 | 6.8±0.7 |
| Group 1 | 210±19 | 4.2±0.6 |
| Group 2 | 223±17 | 4.0±0.5 |
| Group 3 | 221±18 | 4.1±0.4 |
| Group 4 | 239±16 | 3.8±0.5 |
| Comparative example 1 | 176±19 | 6.5±0.5 |
| Comparative example 2 | 181±18 | 6.4±0.4 |
(3) administration group is on the impact of the inner skin cell function factor in serum, specific as follows:
(4) administration group is on the impact of inflammatory factor in serum, specific as follows:
| CRP(ng/L) | IL-1b(ng/mL) | |
| Matched group | 5.1±0.4 | 0.32±0.04 |
| Model group | 9.3±0.5 | 0.53±0.05 |
| Group 1 | 7.1±0.4 | 0.43±0.05 |
| Group 2 | 6.5±0.5 | 0.39±0.03 |
| Group 3 | 6.6±0.2 | 0.37±0.04 |
| Group 4 | 5.5±0.4 | 0.34±0.03 |
| Comparative example 1 | 8.7±0.5 | 0.49±0.04 |
| Comparative example 2 | 8.9±0.4 | 0.47±0.05 |
(5) administration group is on the impact of rat aorta inner membrance-media thickness (IMT), specific as follows:
| IMT(μm) | |
| Matched group | 92±8 |
| Model group | 163±12 |
| Group 1 | 121±9 |
| Group 2 | 113±8 |
| Group 3 | 118±9 |
| Group 4 | 95±7 |
| Comparative example 1 | 157±11 |
| Comparative example 2 | 158±12 |
Embodiment 3 Chinese medicinal effective-part composition is on the impact suppressing Caco-2 Cell uptake cholesterol
Caco-2 cell is inoculated in 12 hole Transwell culture plates, by the DMEM culture medium containing 10% hyclone, 1% dual anti-(penicillin 100U/ml, streptomycin 100 μ g/ml), 1% non essential amino acid, in 37 DEG C, 5%CO
2after cultivating 21d in incubator, cell forms monolayer closely, measures its resistance and verifies its effectiveness.Before experiment, changing degrease serum fresh culture and adding final concentration is respectively 100 μ g/L drug incubation cell 24h.DMEM culture medium is as blank group (Control group).After adding [14C]-cholesterol micro-sol solution continuation incubated cell 2h again, inhale and abandon culture fluid, the cold PBS of cell washes 3 times, every hole adds 0.5ml0.1mol/LNaOH peptic cell, get 0.1ml cell dissociation buffer, add scintillation solution, measure flicker value with liquid scintillation counter.With the protein concentration of the determination of protein concentration kit detection cell Digestive system of Bio-Rad company, Caco-2 cellular cholesterol absorbability represents with the amount (dpm/mgprotein) of [the 14C]-cholesterol of cell pyrolysis liquid every milligram protein uptake.The dosage of comparative example 1 and 2 is respectively 100 μ g/L and 500 μ g/L
Suppression ratio computing formula is: (matched group picked-up cholesterol amount-administration group picked-up cholesterol amount)/matched group picked-up cholesterol amount × 100%
Concrete outcome is as follows:
| Suppression ratio (%) | |
| Matched group | 100 |
| Group 1 | 68±6 |
| Group 2 | 53±5 |
| Group 3 | 58±6 |
| Group 4 | 45±5 |
| Comparative example 1 | 101±8 |
| Comparative example 2 | 98±5 |
Prepared by embodiment 4 tablet
Prescription
Preparation technology: Chinese medicinal effective-part composition and adjuvant were pulverized 80 mesh sieves respectively, Chinese medicinal effective-part composition is fully mixed with microcrystalline Cellulose, pregelatinized Starch and cross-linked carboxymethyl fiber sodium, 10% starch slurry soft material, 18 mesh sieves are granulated, dry at 60 DEG C, 16 mesh sieve granulate, add magnesium stearate, mixing, tabletting, the heavy 500mg of sheet.
Prepared by embodiment 5 granule
Prescription
Preparation technology: first Chinese medicinal effective-part composition is mixed homogeneously with beta-schardinger dextrin-, then add microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose, methylcellulose, sodium lauryl sulphate mix after crossing 16 mesh sieves, after mix homogeneously with orange flavor, aspartame again.Mixture 5% polyvidone ethanol is granulated, and dry, granulate, subpackage, to obtain final product.
Content of the present invention merely illustrates some claimed specific embodiments; one of them or more described technical characteristic can be combined with arbitrary one or more technical scheme in technical scheme; these technical schemes obtained through combination also in the application's protection domain, just as these technical schemes obtained through combination in the disclosure of invention concrete record.
Claims (5)
1. the Chinese medicinal effective-part composition for blood fat reducing, it is characterized in that, its Radix Puerariae total flavones, the Fructus Crataegi total flavones of 25%, Rhizoma Alismatis total triterpene alcohol, the fleece-flower root total stilbene glucoside of 30% and Radix Angelicae Sinensis volatile oil of 20% of 10% being 15% by percentage by weight forms.
2. the pharmaceutical preparation containing Chinese medicinal effective-part composition described in claim 1.
3. pharmaceutical preparation according to claim 2, described pharmaceutical preparation is oral formulations.
4. pharmaceutical preparation according to claim 3, is characterized in that, described oral formulations is selected from tablet, capsule, pill, granule, powder.
5. pharmaceutical preparation according to claim 4, it is characterized in that, adjuvant selected by described oral formulations is selected from starch, beta-schardinger dextrin-, carbomer, microcrystalline Cellulose, hydroxypropyl emthylcellulose, low-substituted hydroxypropyl cellulose, carboxymethylcellulose calcium, Polyethylene Glycol, sodium carboxymethyl cellulose, methylcellulose, ethyl cellulose, mannitol, sodium lauryl sulphate, cross-linking sodium carboxymethyl cellulose, lactose, polyvinylpyrrolidone, crospolyvinylpyrrolidone, magnesium stearate, Pulvis Talci, micropowder silica gel, aspartame, orange flavor, sodium bicarbonate, sodium carbonate, one or more in enteric coating powder.
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