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CN1742986A - Guanxi-shengmai preparation and new preparing method - Google Patents

Guanxi-shengmai preparation and new preparing method Download PDF

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Publication number
CN1742986A
CN1742986A CN 200510105337 CN200510105337A CN1742986A CN 1742986 A CN1742986 A CN 1742986A CN 200510105337 CN200510105337 CN 200510105337 CN 200510105337 A CN200510105337 A CN 200510105337A CN 1742986 A CN1742986 A CN 1742986A
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preparation
radix
active component
parts
soft capsule
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Chinese (zh)
Inventor
刘露
严轶东
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Beijing Fukangren Bio Pharm Tech Co Ltd
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Priority to CN 200510105337 priority Critical patent/CN1742986A/en
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Abstract

The prescription of Chinese medicine Guanxin Shengmai preparation for curing palpitation, shortness of breath, oppressed feeling in the precordial region, spontaneous sweating, weak or irregular pulse due to insufficiency of the heart-qi, coronary heart disease, angina pectoris and arrhythmia is formed from 7 Chinese medicinal materials of ginseng, ophiopogon tuber, schisandra berry, salvia root, red peony root, curcuma tuber and notoginseng powder. Said invention also provides its preparation method, and said preparation can be made into the dosage forms of dripping pills and soft capsule, etc.

Description

' Guanxin Shengmai ' for treating coronary heart disease and new preparation method
Technical field:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, particularly a kind of treatment deficiency of heart-QI, the painstaking effort stasis of blood the moon that causes a little less than the deficiency of heart-yin, shortness of breath and palpitation is uncomfortable in chestly had a pain, unconsciously sweat and tire, faint pulse knot generation; Coronary heart disease, angina pectoris, ARR Chinese medicine preparation prescription and preparation technology thereof.
Background technology:
Aged coronary heart disease patient is many promptly to form the disease of " blood stasis " with " heart kidney qi (sun) void; the puckery or yang deficiency of deficiency of vital energy blood agitates the blood vessels unable and cause stasis of blood plug ", and clinical the lighter shows as angina pectoris attacks, and weight person shows as acute myocardial infarction, should be in the treatment with supplementing QI for promoting the production of body fluid, blood circulation and channel invigorating is its fundamental law.
Radix Ginseng strongly invigorating primordial QI among the we, invigorating the spleen to benefit the lung promotes the production of body fluid, the Fructus Alpiniae Oxyphyllae of calming the nerves; Radix Ophiopogonis YIN nourishing and the production of body fluid promoting, lung moistening clears away heart-fire; The Fructus Schisandrae Chinensis convergence is astringent or styptic treatment for spontaneous sweating, supplementing QI for promoting the production of body fluid, kidney calming.Chinese medicine prepared preparation after changing extraction process in side's is easy to dissolving and absorption than elite and thick putting that ordinary pill more can collect medicine, and curative effect is fast, and administration time is short, and therefore, curative effect is better.
The purpose of this invention is to provide a kind of therapeutic domain wide, easily accept, easily absorb, the preparation technology of efficient, low dosage, the Chinese medicine dripping pills that has no side effect, soft capsule, granule, chewable tablet, capsule, tablet, pill, its pill that makes can be used for curing mainly deficiency of heart-QI, the weak painstaking effort stasis of blood the moon that rises of deficiency of heart-yin, shortness of breath and palpitation, uncomfortable in chestly have a pain, unconsciously sweat and tire, faint pulse is tied generation; Coronary heart disease, angina pectoris, arrhythmia.
Summary of the invention:
The present invention relates to a kind of prescription and preparation technology thereof of Chinese medicine preparation, it is characterized in that, the preparation of per 1000 dosage units is made up of following proportion raw material and adjuvant:
1.5~70 parts of 4.5~209 parts of 4.5~209 parts of Fructus Schisandrae Chinensis Radix Ophiopogonis of Radix Ginseng (processed with vinegar)
39~1837 parts of 6~279 portions of Radix Curcumaes of 7~348 parts of Radix Paeoniae Rubra of Radix Salviae Miltiorrhizae
0.3~14 part of Radix Notoginseng powder
Preferably:
3 parts of 9 parts of 9 parts of Fructus Schisandrae Chinensis Radix Ophiopogonis of Radix Ginseng (processed with vinegar)
79 parts of 12 portions of Radix Curcumaes of 15 parts of Radix Paeoniae Rubra of Radix Salviae Miltiorrhizae
0.6 part of Radix Notoginseng powder
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of soft capsule preparations, granule 1000g etc. also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50-1000 taking dose,, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether as granule.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The raw material of Chinese medicine of said ratio extracts processing through new technology of the present invention, obtain the active constituents of medicine of preparation of the present invention, add suitable excipient as required and make suitable medicinal any dosage form, said preparation can be drop pill, soft capsule, granule, chewable tablet, tablet, capsule or pill.
The above new technology of the present invention may further comprise the steps:
Method a:
(1) get Radix Ginseng, Radix Notoginseng decocts with water twice, each 3h, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.2 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill and makes precipitation, get supernatant, filter, decolouring, destaining solution reclaims ethanol, be concentrated into relative density and be the clear paste of 1.2 (60 ℃), standby;
(2) get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:
(1) get recipe quantity 1/4~3/4 Radix Ginseng, Radix Notoginseng, the extraction solvent load is 13 times of medical material amount, and concentration of alcohol is 30%, extracts 70 ℃ of temperature, 40 minutes heat time heating times.Extract with alcohol heating reflux, reuse n-butanol extraction or purification by macroporous resin extract 2 times with method, 3 parts of balancing runs, promptly; Remaining Radix Notoginseng and Radix Ginseng powder are broken into fine powder, and be standby;
(2) extraction of all the other medical materials is the same.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
The active constituents of medicine of the preparation of the present invention that above method obtains can be prepared into preparation of the present invention through further processing.
Preparation of the present invention, different dosage form method difference below is the preparation method of several preferred dosage form.
(1) preparation of drop pill
Drop pill of the present invention, wherein the ratio of active component and adjuvant is 1: 0.5~10, and preferred ratio is 1: 2~4, and most preferred ratio is 1: 3.The above adjuvant be specially molecular weight polyethylene glycol between 400 to 10000 Polyethylene Glycol and their mixture, as PEG400 (PEG400), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture, or other suitable other auxiliary elements such as glycerol, gelatin or stearic acid sodium etc. of making drop pill.
Following steps are taked in the preparation of drop pill of the present invention:
1. be ready to following raw material: active component, adjuvant and/or other inactive ingredients;
2. with the above-mentioned raw materials mix homogeneously;
3. add the transconversion into heat material, move into the drip irrigation of drop pill machine, medicinal liquid splashes in the liquid sub liquid paraffin by water dropper, removes liquid paraffin, selects ball, promptly.
(2) preparation of soft capsule
Soft capsule preparation of the present invention is that active component and pharmaceutically useful organic solvent and the material of making soft capsule shell are formed.Organic solvent wherein is selected from PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, the material of wherein making soft capsule shell is gelatin or arabic gum, water, plasticizer and antiseptic, the weight ratio of gelatin or arabic gum and plasticizer is 1.0: 0.4~1.0 in the soft capsule shell, and the weight ratio of gelatin and water is 1.0: 0.8~1.2.Wherein the weight proportion between active component and the pharmaceutically useful organic solvent is: the content of active component is 50mg-500mg in every soft capsule.
The preparation method of preparation of the present invention, through following steps,
A. get gelatin, glycerol, pure water adds thermosol, adds an amount of antiseptic, preparation rubber;
B. get active component and be dissolved in organic solvent, add suitable quantity of water, be prepared into soft capsule through encapsulating machine.
(3) preparation process of granule is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
(4) preparation method of chewable tablet is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, and drying, tabletting promptly gets chewable tablet.
Filler described in granule, capsule, pill, the chewable tablet preparation is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.; Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture; Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
Following data declaration beneficial effect of the present invention by experiment:
In order to prove the Clinical feasibility that changes after the technology, we have carried out its main pharmacodynamics, toxicologic study to this medicine, observe its therapeutical effect, and the clinical experimental basis that provides is provided.
1, to the influence of mice normal pressure anoxia enduring
Get 40 of mices, body weight 18~20g, male and female half and half, evenly be divided into 4 groups at random, gavage 1. 2. extractum and of extractum, technology of technology respectively with the normal saline of volume, administration every day 1 time, successive administration 7 days, 1 treated animal was irritated the propranolol suspension in the 7th day in addition, respectively at 1h after the administration, mice was put into the 250ml port grinding bottle that the 10g sodica calx is housed, close plug, put 1 of mice for every bottle, record is put into the close plug of bottle back to the time that mouse breathing stops, and the results are shown in Table 1.
2, to influence with mice normal pressure anoxia enduring behind the ISOP
Mice specification, grouping and administration are all the same, every Mus lumbar injection isoprenaline 10mg/kg immediately after last 1 administration after 15 minutes divides mice and puts into the 250ml port grinding bottle that the 10g sodica calx is housed, and is airtight, the record mice time-to-live, the results are shown in Table 1
3, the influence that the mice sodium nitrite is poisoned
Get 30 of body weight 18~20g mices, male and female half and half, evenly be divided into 3 groups at random, gavage 1. 2. extractum and of extractum, technology of technology respectively with the normal saline of volume, administration every day 1 time, successive administration 7 days, 1h after last 1 administration, lumbar injection sodium nitrite 20mg/kg is an index with the respiratory arrest immediately, the mice time-to-live respectively organized in record, the results are shown in Table 1.
The influence (branch) of table 1 pair mice hypoxia-bearing capability (x ± s)
Group Number of animals (only) Dosage (g/kg) The normal pressure anoxia enduring time-to-live With the anoxia enduring time-to-live behind the ISOP With the time-to-live behind the sodium nitrite
Normal saline propranolol group technology is 2. extractum of extract process 1. 10 10 10 10 - 0.04 0.21 0.29 25.18±1.86 31.03±1.02 * 31.00±0.82 * 27.60±1.31 * 18.40±0.87 24.15±1.45 * 24.05±1.34 * 22.30±1.09 * 15.75±0.92 - 17.62±0.94 * 16.58±0.51 *
Annotate: compare with the normal saline group *P<0.01
Can find out that extractum group and propranolol group all can obviously improve normal mouse and with mice normal pressure hypoxia-bearing capability (P<0.01) behind the ISOP from last table, the extractum group still can obviously prolong with behind the sodium nitrite during mice survival (P<0.01).
5, pituitrin is caused the influence of rat heart muscle ischemia
Get 200g left and right sides rat, survey normal ECG before the experiment earlier, select 50 of the normal persons of electrocardiogram, male and female half and half, evenly be divided into 5 groups at random, irritate 1. extractum of stomach technology respectively, technology is extractum 2., the FUFANG DANSHEN PIAN suspension reaches with volume normal saline (2 groups), administration every day 1 time, successive administration 7 days.Except that 1 group of normal saline group is not done the blank to pituitrin, all the other 4 groups all after administration the every caudal vein of 1h inject pituitrin lu/kg, in 10 seconds, annotated, traced 15 seconds then immediately, 30 seconds, 1 minute, 3 minutes, 5 minutes, 15 minutes ∏ lead electrocardiogram.With the J point, the variation of S-T field offset and T ripple the results are shown in Table 2 as the index of judging myocardial ischemia.
The influence of rat heart muscle ischemia due to the table 2 pair pituitrin (unit, only)
Group Number of animals Dosage (g/kg) Cardiac muscle is the ischemic animal number not The myocardial ischemia number of animals Ischemia rate (%)
Blank group model group compound Salviae Miltiorrhizae group technology is 2. extractum of extract process 1. 10 10 10 10 10 - - 5 0.10 0.14 10 0 6 8 7 0 10 4 2 3 0 100 40 20 30
Can find out that from table 2 model group myocardial ischemia animal occurrence rate illustrates the success of modeling type apparently higher than the blank group.Than extractum group myocardial ischemia animal occurrence rate is significantly reduced with model group.
6, toxicological study
Acute toxicity test shows that rat oral gavage extract of the present invention fails to measure LD 50
Long term toxicity test: rat grouping, extract of the present invention is irritated stomach, every day three times, connect and annotate 90d, the result, administration group rat and control rats movable, search for food, drinking-water, body weight and multinomial observation indexs such as substantial viscera pathologic finding and histopathology detect, result of the test is not all found any toxicity; Hemogram and hepatic and renal function index and the equal no significant difference of matched group.
The blood vessel irritation of this medicine, allergy and hemolytic test all are negative.
In sum, preparation of the present invention, dropping pill formulation particularly of the present invention and soft capsule preparation are a kind of good treatment deficiency of heart-QI, the painstaking effort stasis of blood the moon that causes a little less than the deficiency of heart-yin, and shortness of breath and palpitation is uncomfortable in chestly had a pain, unconsciously sweat and tire, faint pulse knot generation; Coronary heart disease, angina pectoris, ARR medicine, and change preparation technology can obviously strengthen its supplementing QI for promoting the production of body fluid, clinical efficacies such as blood circulation and channel invigorating, its hypotoxicity in addition, therefore prolonged application safety, be worth clinical application.
The specific embodiment:
Further specify the present invention by the following examples, include but not limited to the following example.
Embodiment 1:
The preparation method of drop pill of the present invention:
Prescription:
Radix Ginseng 42g 42g Radix Ophiopogonis Fructus Schisandrae Chinensis (processed with vinegar) 14g
Radix Salviae Miltiorrhizae 70g Radix Paeoniae Rubra 56g Radix Curcumae 367g
Radix Notoginseng powder 2.8g PEG400 110g
Make 1000 balls
Preparation method:
Get Radix Ginseng, Radix Notoginseng decocts with water twice, each 3h, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.2 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill and makes precipitation, get supernatant, filter, decolouring, destaining solution reclaims ethanol, be concentrated into relative density and be the clear paste of 1.2 (60 ℃), standby; Get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.With above-mentioned extract obtained, the PEG400 that adds recipe quantity puts into the vessel in heating dissolving, and jolting makes and dissolves into uniform solution, inserts in the fluid reservoir.Keep 80 ℃ the system of dripping temperature, and a control speed, condensed fluid is a liquid paraffin, drips system promptly.
Embodiment 2:
Preparation of soft capsule method of the present invention:
Prescription:
Radix Ginseng 209g 209g Radix Ophiopogonis Fructus Schisandrae Chinensis (processed with vinegar) 70g
Radix Salviae Miltiorrhizae 348g Radix Paeoniae Rubra 279g Radix Curcumae 1837g
Radix Notoginseng powder 14g PEG400 630g
Make 1000 balls
Preparation method:
Get Radix Ginseng, Radix Notoginseng decocts with water twice, each 3h, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.2 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill and makes precipitation, get supernatant, filter, decolouring, destaining solution reclaims ethanol, be concentrated into relative density and be the clear paste of 1.2 (60 ℃), standby; Get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.With above-mentioned extract obtained, add an amount of PEG400 mixing and pulverizing, add the PEG400 of surplus then, promptly get medicinal liquid.It is standby in addition to join gelatin solution by certain prescription.The condition that control is suitable splashes in the coolant (liquid paraffin), promptly.
Embodiment 3:
The preparation method of granule of the present invention:
Prescription:
Radix Ginseng 165g 165g Radix Ophiopogonis Fructus Schisandrae Chinensis (processed with vinegar) 55g
Radix Salviae Miltiorrhizae 276g Radix Paeoniae Rubra 221g Radix Curcumae 1456g
Radix Notoginseng powder 11g
Make 1000g
Preparation method:
Get recipe quantity 1/4 Radix Ginseng, Radix Notoginseng, the extraction solvent load is 13 times of medical material amount, and concentration of alcohol is 30%, extracts 70 ℃ of temperature, 40 minutes heat time heating times.Extract with alcohol heating reflux, reuse n-butanol extraction or purification by macroporous resin extract 2 times with method, 3 parts of balancing runs, promptly; Remaining Radix Notoginseng and Radix Ginseng powder are broken into fine powder, and be standby; Get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.With above-mentioned medicated powder and adding aspartame 5.0g, dextrin 420.0g, to granulate, drying sprays into essence 5.0g, promptly gets granule 1000g.
Embodiment 4:
The preparation method of chewable tablet of the present invention:
Prescription:
Radix Ginseng 105g 105g Radix Ophiopogonis Fructus Schisandrae Chinensis (processed with vinegar) 35g
Radix Salviae Miltiorrhizae 175g Radix Paeoniae Rubra 140g Radix Curcumae 920g
Radix Notoginseng powder 7g
Make 1000
Preparation method:
Get recipe quantity 1/4 Radix Ginseng, Radix Notoginseng, the extraction solvent load is 13 times of medical material amount, and concentration of alcohol is 30%, extracts 70 ℃ of temperature, 40 minutes heat time heating times.Extract with alcohol heating reflux, reuse n-butanol extraction or purification by macroporous resin extract 2 times with method, 3 parts of balancing runs, promptly; Remaining Radix Notoginseng and Radix Ginseng powder are broken into fine powder, and be standby; Get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.With above-mentioned medicated powder and add aspartame 3.0g, mannitol 140.0g, granulation, drying adds magnesium stearate 3.0g, mixing, and tabletting promptly gets 1000 of chewable tablet.

Claims (10)

1, a kind of Chinese medicine composition is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
1.5~70 parts of 4.5~209 parts of 4.5~209 parts of Fructus Schisandrae Chinensis Radix Ophiopogonis of Radix Ginseng (processed with vinegar)
39~1837 parts of 6~279 portions of Radix Curcumaes of 7~348 parts of Radix Paeoniae Rubra of Radix Salviae Miltiorrhizae
0.3~14 part of Radix Notoginseng powder
2, the compound preparation of claim 1 is characterized in that per 1000 dosage units are made by the following weight proportion raw material:
3 parts of 9 parts of 9 parts of Fructus Schisandrae Chinensis Radix Ophiopogonis of Radix Ginseng (processed with vinegar)
79 parts of 12 portions of Radix Curcumaes of 15 parts of Radix Paeoniae Rubra of Radix Salviae Miltiorrhizae
0.6 part of Radix Notoginseng powder
3, claim 1 or any one Chinese medicine preparation of 2 are drop pill, soft capsule, granule, chewable tablet, tablet, capsule or pill.
4, the Chinese medicine preparation of claim 3 through described raw material is extracted processing, obtains active component, adds suitable adjuvant as required and makes.
5, the Chinese medicine preparation of claim 4 is characterized in that, described active component prepares through following steps:
Method a:(technology 1.)
(1) get Radix Ginseng, Radix Notoginseng decocts with water twice, each 3h, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.2 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill and makes precipitation, get supernatant, filter, decolouring, destaining solution reclaims ethanol, be concentrated into relative density and be the clear paste of 1.2 (60 ℃), standby;
(2) get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.
Above extract lumps together the active constituents of medicine into preparation of the present invention; This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:(technology 2.)
(1) get recipe quantity 1/4~3/4 Radix Ginseng, Radix Notoginseng, the extraction solvent load is 13 times of medical material amount, and concentration of alcohol is 30%, extracts 70 ℃ of temperature, 40 minutes heat time heating times.Extract with alcohol heating reflux, reuse n-butanol extraction or purification by macroporous resin extract 2 times with method, 3 parts of balancing runs, promptly; Remaining Radix Notoginseng and Radix Ginseng powder are broken into fine powder, and be standby;
(2) extraction of all the other medical materials is the same.
Above extract lumps together the active constituents of medicine into preparation of the present invention.This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
6, the Chinese medicine preparation of claim 5, it is characterized in that: described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60-115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, coolant temperature is-and 10-5 ℃.
7, the Chinese medicine preparation of claim 5 is characterized in that: described soft capsule, and its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg-200mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
8, the Chinese medicine preparation of claim 5 is characterized in that:
The preparation process of granule is as follows: with above-mentioned extract obtained, add a certain amount of correctives, filler, lubricant, granulate, promptly get granule.
The preparation method of chewable tablet is as follows: with above-mentioned extract obtained, adds a certain amount of correctives, filler, lubricant, granulates, and drying, tabletting promptly gets chewable tablet.
9, the Chinese medicine preparation of claim 8 is characterized in that: described filler is selected from one or more the mixture in lactose, sucrose, dextrin, starch, microcrystalline Cellulose, mannitol, pregelatinized Starch, sorbitol, the xylitol etc.; Described correctives one of is selected from Rhizoma et radix valerianae, Fructus Pruni pseudocerasi, Fructus Vitis viniferae, Fructus Citri tangerinae, Fructus Citri Limoniae, Herba Menthae, Fructus Fragariae Ananssae, Fructus Musae, Fructus Ananadis comosi, honey peach essence, maltose alcohol, saccharin sodium, protein sugar, sucrose, aspartame, the stevioside or wherein several mixture; Suitable lubricant comprises wherein one or more such as magnesium stearate, Pulvis Talci, micropowder silica gel.
10, the preparation method of any one Chinese medicine preparation of claim 1-9 is characterized in that, the process following steps:
Described raw material of Chinese medicine is extracted processing, obtain active component, add suitable adjuvant and make.Wherein said active component prepares through following steps:
Method a:(technology 1.)
(1) get Radix Ginseng, Radix Notoginseng decocts with water twice, each 3h, collecting decoction, filter, filtrate is concentrated into the clear paste that relative density is 1.2 (60 ℃), adds ethanol and makes that to contain alcohol amount be 60%, leaves standstill and makes precipitation, get supernatant, filter, decolouring, destaining solution reclaims ethanol, be concentrated into relative density and be the clear paste of 1.2 (60 ℃), standby;
(2) get Radix Salviae Miltiorrhizae, Radix Ophiopogonis, Fructus Schisandrae Chinensis, Radix Curcumae, Radix Paeoniae Rubra and decoct with water secondary, 3 hours for the first time, 2 hours for the second time, collecting decoction filtered, and filtrate is condensed into thick paste.
Above extract lumps together the active constituents of medicine into preparation of the present invention.This active component is suitable for preparing drop pill of the present invention and soft capsule preparation.
Method b:(technology 2.)
(1) get recipe quantity 1/4~3/4 Radix Ginseng, Radix Notoginseng, the extraction solvent load is 13 times of medical material amount, and concentration of alcohol is 30%, extracts 70 ℃ of temperature, 40 minutes heat time heating times.Extract with alcohol heating reflux, reuse n-butanol extraction or purification by macroporous resin extract 2 times with method, 3 parts of balancing runs, promptly; Remaining Radix Notoginseng and Radix Ginseng powder are broken into fine powder, and be standby;
(2) extraction of all the other medical materials is the same.
Above extract lumps together the active constituents of medicine into preparation of the present invention.This active component is suitable for preparing other dosage forms except that drop pill and soft capsule preparation of the present invention.
Described drop pill, wherein the ratio of active component and adjuvant is 1: 0.5~10, described adjuvant be molecular weight between 400 to 10000 Polyethylene Glycol and their mixture, be selected from PEG400 (or 600), Macrogol 2000, Macrogol 4000, polyethylene glycol 6000 or their mixture.Its preparation method is: active constituents of medicine and proper auxiliary materials behind 60-115 ℃ of mix homogeneously, are regulated the water dropper size with control drop pill weight, are that the coolant system of dripping forms with dimethicone or liquid paraffin, coolant temperature is-and 10-5 ℃.
Described soft capsule, its content is made up of active component and suitable substrate, and wherein the content of active component is 50mg-500mg in every soft capsule; Substrate wherein is selected from wherein one or more of PEG400, Tween 80, glycerol, propylene glycol, isopropyl alcohol, dehydrogenation soybean oil, vegetable oil, aromatic oil, animal wet goods.Its preparation method is: with active constituents of medicine and proper auxiliary materials mix homogeneously, obtain uniform suspension and/or solution, regulate content weight, compacting, dry getting final product.
CN 200510105337 2005-09-23 2005-09-23 Guanxi-shengmai preparation and new preparing method Pending CN1742986A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101744993B (en) * 2008-12-05 2013-01-02 天津天士力之骄药业有限公司 Extraction method for ginseng, ophiopogon root and schisandra chinensis and preparation thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101744993B (en) * 2008-12-05 2013-01-02 天津天士力之骄药业有限公司 Extraction method for ginseng, ophiopogon root and schisandra chinensis and preparation thereof

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