CN1714819A - Medicinal composition for treating coronary heart disease - Google Patents

Medicinal composition for treating coronary heart disease Download PDF

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Publication number
CN1714819A
CN1714819A CN 200410019827 CN200410019827A CN1714819A CN 1714819 A CN1714819 A CN 1714819A CN 200410019827 CN200410019827 CN 200410019827 CN 200410019827 A CN200410019827 A CN 200410019827A CN 1714819 A CN1714819 A CN 1714819A
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China
Prior art keywords
pharmaceutical composition
borneolum syntheticum
amount
salviae miltiorrhizae
composition according
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CN 200410019827
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CN100404041C (en
Inventor
杨悦武
闫希军
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Tasly Pharmaceutical Group Co Ltd
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Tianjin Tasly Pharmaceutical Co Ltd
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Priority to CNB2004100198273A priority Critical patent/CN100404041C/en
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Abstract

The present invention relates to coronary heart disease treating medicine composition, and is especially one kind of medicine composition prepared with Chinese herbal medicine material and through special extraction process and other technological process. Specifically, the medicine composition is prepared with notoginseng, red sage and borneol, and through alkali extraction, concentration, alcohol precipitation, and adding supplementary material.

Description

A kind of pharmaceutical composition for the treatment of coronary heart disease
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of coronary heart disease, refer to that especially a kind of is the pharmaceutical composition that the special extracting method of prepared using is made through special process with the Chinese herbal medicine.
Background technology
Along with the rejuvenation of growth in the living standard, world population aging and morbidity colony, cardiovascular and cerebrovascular vessel patient increases year by year, has become the second largest disease of harm humans health.Angina pectoris is a kind of caused by the temporary transient ischemia of cardiac muscle, anoxia, serves as the clinical syndrome of main performance with ictal chest pain or chest discomfort.Angina pectoris is meant because coronary atherosclerosis or spasm cause myocardial ischemia, the caused angina pectoris of anoxia, accounts for 90% of patient with angina pectoris.
The anginal method of treatment is based on blood vessel dilating, reduction blood viscosity, antiplatelet aggregation, anticoagulation at present.Traditional Western medicine of using is nitrate, nitrous acid ester, beta-receptor resistance preparation, calcium antagonist etc., but all has bigger toxic and side effects, should not take for a long time, mostly is symptomatic treatment and course of disease progress is not had bigger effect.For example take and occur jumping pain, palpitating speed in feeling of fullness in the head, the head behind the nitroglycerin sometimes, even faint and [, find again in recent years to cause severe hypotension [referring to contemporary Chinese medical journal 1997 referring to new pharmacology [the 14th edition) 264 page]; 7 (4): 42; Shaanxi medical journal 1996; 25 (5): 315], easily produce toleration [referring to southern nursing magazine 1996; 3 (5): 7-9] etc. problem has hindered its application clinically.
Though the anginal Chinese patent medicine of many treatments is also arranged, wherein ball, loose, cream, pellet, decoction becomes old historical already, the modern seldom uses.There are preparations such as common compound Salviae Miltiorrhizae tablet and capsule to sell in the market, but conventional tablet, capsule manufacture technology are more backward, active constituent content is low, no quality control standard, need be oral through gastrointestinal absorption, go into blood at liver generation first pass effect post-absorption, bioavailability is low, absorb slowly, can not be fit to the need of angina pectoris patient's first aid.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition with efficient, quick-acting, long lasting treatment coronary heart disease.
Another object of the present invention has provided the pharmacological action of aforementioned pharmaceutical compositions.
The present invention is implemented by following scheme:
Get Radix Salviae Miltiorrhizae, Radix Notoginseng and the Borneolum Syntheticum medical material of pulverizing; With Radix Salviae Miltiorrhizae and pseudo-ginseng and an amount of alkali, extracting in water filters, merging filtrate, and filtrate is suitably concentrated; Add ethanol and carry out precipitate with ethanol in concentrated solution, leave standstill, supernatant reclaims ethanol, is condensed into extractum; With gained extractum and Borneolum Syntheticum and adjuvant mixed evenly after, make preparation.
Concrete steps are as follows:
1. get a certain amount of Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, standby;
2. will add an amount of alkali in above-mentioned Radix Salviae Miltiorrhizae, the Radix Notoginseng, heating extraction 2~4 times, each amount of water is 4~8 times of medical material amount, leach cooking liquid filters, merging filtrate, it is 1.10~1.30 (80 ± 5 ℃) that filtrate is concentrated into relative density;
3. add 95% ethanol in above-mentioned steps 2 described concentrated solutions, making determining alcohol is 50~85%, leaves standstill 4~24 hours, and supernatant filters, filtrate recycling ethanol, and the simmer down to relative density is the extractum of 1.15~1.45 (55~60 ℃);
With gained extractum and aforementioned proportion Borneolum Syntheticum and adjuvant mixed evenly after, make preparation.
Wherein, each medicine described in the step 1, its formulation ratio is (in a weight percentage):
Radix Salviae Miltiorrhizae 20%~97%, Radix Notoginseng 2%~80%, Borneolum Syntheticum 0.2%~3%;
Best proportioning is (in a weight percentage):
Radix Salviae Miltiorrhizae 82.87%, Radix Notoginseng 16.21%, Borneolum Syntheticum 0.92%;
The described alkali of step 2 is sodium carbonate, sodium bicarbonate, is preferably sodium bicarbonate, and addition is 1.0%~3.0% of a medical material amount, and is preferred 1.4%~1.9%, and the best is 1.81%; Extraction time is preferably 2 times, and for the first time amount of water is 4 times of medical material amount, extracts 2 hours, and the second time, amount of water was 3 times of medical material amount, extracted 1 hour; Filtrate is concentrated into relative density 1.20 (75 ± 1 ℃); Add the high concentration ethanol precipitation in the step 3, make to contain alcohol and reach 65%~70%, optium concentration is 68%; Be 8~12 hours quiescent time, and the best is 10 hours; Concentrating and reclaiming ethanol to relative density is 1.35~1.40 (55~60 ℃), and the best is 1.38 (55~60 ℃); Can make acceptable dosage form on any one pharmaceutics in the step 4, wherein preferred dosage form is a drop pill, and it is shaped as reddish brown-brownish black round bead shape, and size evenly.
The drop pill preparation method of medicine of the present invention be mainly with above-mentioned gained extractum and Borneolum Syntheticum and adjuvant mixed evenly after, add the transconversion into heat material, move into dripping jar of drop pill machine, medicine liquid droplet is removed liquid paraffin to cryogenic liquid paraffin, select ball.
Wherein: adjuvant is a Polyethylene Glycol-6000, and 53~58 ℃ of its condensation points, addition are extractum and Borneolum Syntheticum weight 2~6 times, and preferred 2~4 times, the best is 3 times; Changing the material temperature is 60~100 ℃, and optimum temperature is 85 ℃; The temperature of liquid paraffin is 0~10 ℃, and the best is 5~10 ℃; Ball heavily is 5~50mg/ grain, diameter 1.95~4.29mm.
The present invention utilizes modern special extraction process and high-tech Quality Control means, improves content of effective and quality control standard, really guarantees the safety and the effectiveness of medicine.Preferred dosage form drop pill of the present invention can be given full play to the dosage form advantage.Drop pill can be referred to as solid solution, and medicine is dispersed in the substrate with molecularity, forms uniform solid dispersion, and is can the bonding dosed administration accurate; Drug microparticles is embedded in the substrate, tight, and secluding air has increased stability of drug; After medicine and the substrate congruent melting medicine is dispersed in the substrate, condensation forms superfine crystallization, helps dissolving and absorbs, and brings into play curative effect rapidly, improves bioavailability, reduces side effect; Medicine is avoided first pass effect through sublingual administration, the bioavailability height; The effective ingredient oral transmucosal absorbs directly into blood, and the performance curative effect can reach quick-acting purposes.
Below by to the zooperal elaboration of invention drug regimen, the beneficial effect that it is used is described in pharmacy.
Protective effect to the Ischemia and Reperfusion in vivo in Rats myocardial damage
This research and inquirement pharmaceutical composition of the present invention is to the Ischemia and Reperfusion in vivo in Rats myocardial damage, the especially influence of apoptosis of cardiac muscle.
1. animal model: Wistar strain male rat, open chest anesthetized is kept breathing, around left coronary artery, and carries out ligation between left auricle and pulmonary conus.
2. method: rat is divided into 5 groups at random: 1. sham operated rats (sham-operated control), normal saline is irritated stomach, 1ml/ days, totally 4 days; 2. myocardial ischemia-reperfusion group (M-IR), it is the same to irritate the stomach method; 3. pharmaceutical composition I group of the present invention (DSPI) was dissolved in the 1ml normal saline with 150ml/kg/ days, irritated stomach (method is the same); 4. pharmaceutical composition II group of the present invention (DSPII), with 300ml/kg/ days, the same DSPI of all the other methods; 5. pharmaceutical composition III group of the present invention (DSPIII), with 450ml/kg/ days, the same DSPI of all the other methods.
Testing index:
2.1 myocardial infarct size is measured: ligation left coronary artery once more before the sacrifice of animal, take out after injecting 1% her Wen orchid in the ventricle, with the PBS rinsing, freezing 1h.After removing unnecessary tissue, the 30min that in 1%TTC, dyes (37 ℃).With weight method calculating myocardium ischemia hazardous area (she does not dye the district by the Wen orchid), infarcted region (TTC does not dye the district).
2.2 cardiomyocyte apoptosis cell in-situ marker detection and analysis: each heart get 3 different parts section each 1, press duPT breach end-labelling (TdT-mediateflourescein-duTP nick end labeling, TUNEL) DNA3 ' in the labelling cardiomyocyte apoptosis nucleus-OH end of the band fluorescence of end deoxyribonucleic acid transferase (TdT enzyme) mediation.Select 5 visuals field, in 300 myocardial cell of each visual field counting positive cell number with the shared percentage ratio of average computation positive cell number as the apoptosis of cardiac muscle positivity index (apoptotic index, AI)
3. result
3.1 the variation of myocardial infarct size: sham-operation 7h does not see the myocardial infarction phenomenon; Myocardial infarction was obvious after myocardial ischemia 1h poured into 6h again; Pharmaceutical composition of the present invention (DSP) can dwindle the ischemia-reperfusion myocardial infarct size, and increases with dosage, and myocardial infarct size dwindles and significantly sees Table 1.
Table 1 is respectively organized the variation of myocardial infarct size
Group Infarcted region weight/left ventricular mass (%) Infarcted region weight/hazardous area weight (%)
The Sham-control group 0 0
The M-IR group 41.8±7.9 63.2±8.6
Pharmaceutical composition I group of the present invention 34.6±7.2 **△ 55.7±8.4 *
Pharmaceutical composition II group of the present invention 27.1±6.5 **△ 47.3±7.7 **△
Pharmaceutical composition III group of the present invention 19.4±6.1 **△△◇ 38.9±7.5 **△△◇
Annotate: compare with the M-IR group, *P<0.05, *P<0.01; Compare with the I group, P<0.05, △ △P<0.01; Compare with the II group, P<0.05.
3.2 the change of cardiomyocyte apoptosis cell: relatively large DSP can obviously reduce ischemia-reperfusion cardiac cellular apoptosis quantity, and AI descends along with the increase of DSP dosage, sees Table 2.2.
Table 2 is respectively organized the variation of apoptosis of cardiac muscle cell quantity
Group The example number Myocardial cell AI (%)
The Sham-control group 10 0.82±0.47
The M-IR group 10 22.76±13.17
Pharmaceutical composition I group of the present invention 10 20.93±13.25 *
Pharmaceutical composition II group of the present invention 10 16.28±11.96 *△◇
Annotate: compare with the Sham-control group, *P<0.01; Compare with the M-IR group, P<0.05, △ △P<0.01; Compare with the I group, P<0.05, ◇ ◇P<0.01; Compare with the II group, P<0.05
Conclusion: studies show that originally pharmaceutical composition of the present invention can obviously dwindle the myocardial infarct size of myocardial reperfusion rat, show that further pharmaceutical composition of the present invention pours into the myocardium cell necrosis variation again to ischemic myocardial cells good protective action is arranged.
The specific embodiment
The embodiment that enumerates the preparation aspect below further describes the present invention, and this embodiment only is used to the present invention is described and the present invention is not limited.
Embodiment 1
1. prescription consumption
Radix Salviae Miltiorrhizae 41.06g Radix Notoginseng 8.03g Borneolum Syntheticum 0.46g
Adjuvant Polyethylene Glycol-6000 18g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 0.89g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.20 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 68%, leaves standstill 10 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.38 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 85 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 85~90 ℃ with Polyethylene Glycol-6000 18g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
1. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.
The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.
Embodiment 2
1. prescription consumption
Radix Salviae Miltiorrhizae 31.12g Radix Notoginseng 9.21g Borneolum Syntheticum 0.50g
Adjuvant Polyethylene Glycol-6000 20g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 0.40g sodium bicarbonate, add 2 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 8 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.10 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 50%, leaves standstill 8 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.35 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 60 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with Polyethylene Glycol-6000 20g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.
Embodiment 3
1. prescription consumption
Radix Salviae Miltiorrhizae 31.12g Radix Notoginseng 9.21g Borneolum Syntheticum 0.50g
Adjuvant Polyethylene Glycol-6000 20g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 0.40g sodium carbonate, add 2 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 8 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.10 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 50%, leaves standstill 8 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.35 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 60 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with Polyethylene Glycol-6000 20g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.
Embodiment 4
1. prescription consumption
Radix Salviae Miltiorrhizae 59.36g Radix Notoginseng 6.38g Borneolum Syntheticum 0.34g
Adjuvant Polyethylene Glycol-6000 21g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 1.97g sodium bicarbonate, add 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 5 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.10 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 85%, leaves standstill 8 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.40 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 100 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with Polyethylene Glycol-6000 20g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.
Embodiment 5
1. prescription consumption
Radix Salviae Miltiorrhizae 59.36g Radix Notoginseng 6.38g Borneolum Syntheticum 0.34g
Adjuvant Polyethylene Glycol-6000 21g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 1.97g sodium carbonate, add 5 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 5 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.10 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 85%, leaves standstill 8 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.40 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 100 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 90 ℃ with Polyethylene Glycol-6000 20g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.
Embodiment 6
1. prescription consumption
Radix Salviae Miltiorrhizae 10g Radix Notoginseng 38.5g Borneolum Syntheticum 1.5g
Adjuvant Polyethylene Glycol-6000 18g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 0.89g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.20 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 68%, leaves standstill 10 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.38 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 85 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 85~90 ℃ with Polyethylene Glycol-6000 18g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.
The product ball heavily is 25mg ± 15%/grain, diameter 3.34415%mm.
Embodiment 7
1. prescription consumption
Radix Salviae Miltiorrhizae 15g Radix Notoginseng 34g Borneolum Syntheticum 1g
Adjuvant Polyethylene Glycol-6000 18g
Make 1000 drop pill
2. the extraction of Radix Salviae Miltiorrhizae, Radix Notoginseng
Learn from else's experience the Radix Salviae Miltiorrhizae, pseudo-ginseng of coarse pulverization to extraction pot, add the 0.89g sodium bicarbonate, add 4 times of water gagings, decocted 2 hours, filter, filtering residue carries out extraction second time, adds 4 times of water gagings, decocted 1 hour, and filtration, filtering residue discards, merging filtrate.Filtrate decompression is concentrated into relative density 1.20 (75 ± 1 ℃), slowly adds 95% ethanol, makes medicinal liquid contain determining alcohol 68%, leaves standstill 10 hours.Get the supernatant of medicinal liquid behind the precipitate with ethanol, filter, filtrate recycling ethanol, the simmer down to relative density is the extractum of 1.38 (55~60 ℃).
3. the preparation of product
Get above-mentioned extractum and Borneolum Syntheticum, evenly be heated to 85 ℃ of temperature, change material after 20~120 minutes, move in the dropping-pill machine jar that jar temperature remains on 85~90 ℃ with Polyethylene Glycol-6000 18g is mixed.In ℃ liquid paraffin of medicine liquid droplet to 7~8, take out drop pill, oil removing, screen cloth selects ball, promptly.
4. the feature of product
The product character is reddish brown-brownish black round bead shape, and size is even, color and luster is consistent, gas perfume (or spice), bitter in the mouth.
The product ball heavily is 25mg ± 15%/grain, diameter 3.34 ± 15%mm.

Claims (15)

1. pharmaceutical composition for the treatment of coronary heart disease is characterized in that adopting following step to make:
1. get a certain amount of Radix Salviae Miltiorrhizae, Radix Notoginseng and Borneolum Syntheticum, standby;
2. will add an amount of alkali in above-mentioned Radix Salviae Miltiorrhizae, the Radix Notoginseng, heating extraction 2~4 times, each amount of water is 4~8 times of medical material amount, leach cooking liquid filters, merging filtrate, it is 1.10~1.30 (80 ± 5 ℃) that filtrate is concentrated into relative density;
3. add 95% ethanol in above-mentioned steps 2 described concentrated solutions, making determining alcohol is 50~85%, leaves standstill 4~24 hours, and supernatant filters, filtrate recycling ethanol, and the simmer down to relative density is the extractum of 1.15~1.45 (55~60 ℃);
With gained extractum and aforementioned proportion Borneolum Syntheticum and adjuvant mixed evenly after, make preparation.
2. according to the described pharmaceutical composition of claim 1, it is characterized in that the weight proportion of each raw material is in the step 1:
Radix Salviae Miltiorrhizae 20%~97%, Radix Notoginseng 2%~80%, Borneolum Syntheticum 0.2%~3%.
3. according to claim 1 or 2 described pharmaceutical compositions, it is characterized in that the weight proportion of each raw material is:
Radix Salviae Miltiorrhizae 82.87%, Radix Notoginseng 16.21%, Borneolum Syntheticum 0.92%.
4. pharmaceutical composition according to claim 1 is characterized in that the described alkali of step 2 is selected from sodium carbonate or sodium bicarbonate, and addition is 1.0%~3.0% of a medical material amount.
5. according to claim 1 or 4 described pharmaceutical compositions, it is characterized in that described alkali is sodium bicarbonate, addition is 1.81% of a medical material amount.
6. pharmaceutical composition according to claim 1, it is characterized in that the extraction time described in the step 2 is 2 times, for the first time the frame water yield is 4 times of medical material amount, and amount of water is 3 times of medical material amount for the second time, and filtrate concentrating is meant and is concentrated into relative density 1.20 (75 ± 1 ℃).
7. pharmaceutical composition according to claim 1 is characterized in that alcoholic acid addition described in the step 3 is to make the determining alcohol of precipitate with ethanol solution reach 50~85%.
8. according to claim 1 or 7 described pharmaceutical compositions, it is characterized in that described alcoholic acid addition is to make the determining alcohol of precipitate with ethanol solution reach 68%.
9. pharmaceutical composition according to claim 1 is characterized in that time of repose described in the step 2 is 10 hours, and the relative density of concentrated extract is 1.38 (55~60 ℃).
10. pharmaceutical composition according to claim 1 is characterized in that preparation described in the step 4 can be a said dosage form on any pharmaceutics.
11. pharmaceutical composition according to claim 10 is characterized in that preferred dosage form is a drop pill.
12. according to claim 1 or 11 described pharmaceutical compositions, the preparation method that it is characterized in that described drop pill is for after mixing gained extractum and Borneolum Syntheticum and adjuvant in claim 1 step 3 evenly, add the transconversion into heat material, move into the dropping-pill machine jar, medicine liquid droplet is to cryogenic liquid paraffin, remove liquid paraffin, select ball.
13. pharmaceutical composition according to claim 12 is characterized in that described adjuvant is a Polyethylene Glycol-6000, addition is extractum and Borneolum Syntheticum weight 2~6 times.
14. pharmaceutical composition according to claim 13, the addition that it is characterized in that described adjuvant Polyethylene Glycol-6000 are extractum and Borneolum Syntheticum weight 3 times.
15. pharmaceutical composition according to claim 1 is characterized in that described step is as follows:
1. get weight proportion and be the medical material of Radix Salviae Miltiorrhizae 82.87%, Radix Notoginseng 16.21%, Borneolum Syntheticum 0.92%, standby;
2. an amount of sodium bicarbonate will be added in above-mentioned Radix Salviae Miltiorrhizae, the Radix Notoginseng, addition is 1.81% of a medical material amount, heating extraction 2 times, for the first time the frame water yield is 4 times of medical material amount, extracts 2 hours, and the second time, amount of water was 3 times of medical material amount, extracted 1 hour, leach cooking liquid filters, merging filtrate, and it is 1.20 (75 ± 1 ℃) that filtrate is concentrated into relative density;
3. add 95% ethanol in above-mentioned steps 3 described concentrated solutions, making determining alcohol is 68%, leaves standstill 10 hours, and supernatant filters, filtrate recycling ethanol, and the simmer down to relative density is the extractum of 1.38 (55~60 ℃);
With gained extractum and aforementioned proportion Borneolum Syntheticum and adjuvant mixed evenly after, add Polyethylene Glycol-6000, mix homogeneously is heated to 85 ℃, changes material, moves in the drop pill machine, in the liquid paraffin of medicine liquid droplet to 7~8 ℃, takes out drop pill, oil removing obtains product.
CNB2004100198273A 2004-06-30 2004-06-30 Medicinal composition for treating coronary heart disease Expired - Lifetime CN100404041C (en)

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Application Number Priority Date Filing Date Title
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CN100404041C CN100404041C (en) 2008-07-23

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CN102028746A (en) * 2009-09-29 2011-04-27 天津天士力现代中药资源有限公司 Drug for treating coronary heart disease and extraction method
CN102028743A (en) * 2009-09-29 2011-04-27 天津天士力现代中药资源有限公司 Medicament for treating coronary heart disease and preparation method thereof
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CN102028746A (en) * 2009-09-29 2011-04-27 天津天士力现代中药资源有限公司 Drug for treating coronary heart disease and extraction method
CN102028743A (en) * 2009-09-29 2011-04-27 天津天士力现代中药资源有限公司 Medicament for treating coronary heart disease and preparation method thereof
CN102028740A (en) * 2009-09-29 2011-04-27 天津天士力现代中药资源有限公司 Medicament for treating coronary heart disease and preparation process thereof
CN102028743B (en) * 2009-09-29 2014-12-24 天津天士力现代中药资源有限公司 Medicament for treating coronary heart disease and preparation method thereof
CN102028746B (en) * 2009-09-29 2014-12-24 天津天士力现代中药资源有限公司 Drug for treating coronary heart disease and extraction method
CN103068398A (en) * 2010-08-06 2013-04-24 天士力制药集团股份有限公司 Use of salvia miltiorrhiza composition in preparing drugs for secondary prevention of coronary heart disease
CN103068398B (en) * 2010-08-06 2015-08-19 天士力制药集团股份有限公司 Red sage root composition is for the preparation of the purposes in the medicine of Coronary heart disease
WO2015003659A1 (en) * 2013-07-11 2015-01-15 天士力制药集团股份有限公司 Traditional chinese medicine composition, and preparation and application thereof
CN104274520A (en) * 2013-07-11 2015-01-14 天士力制药集团股份有限公司 Traditional Chinese medicine (TCM) composition and preparation thereof
CN104274518A (en) * 2013-07-11 2015-01-14 天士力制药集团股份有限公司 Traditional Chinese medicine (TCM) composition and preparation
CN104274520B (en) * 2013-07-11 2018-04-27 天士力医药集团股份有限公司 A kind of Chinese medicine composition and its preparation
US9999630B2 (en) 2013-07-11 2018-06-19 Tasly Pharmaceutical Group Co., Ltd. Traditional chinese medicine composition, and preparation and application thereof
CN104274518B (en) * 2013-07-11 2018-08-03 天士力医药集团股份有限公司 A kind of Chinese medicine composition and preparation
EA034217B1 (en) * 2013-07-11 2020-01-17 Тасли Фармасьютикал Груп Ко., Лтд. Traditional chinese medicine composition, pharmaceutical preparation and micro drop pill thereof, preparation method for the micro drop pill and use of the composition
US11013694B2 (en) 2013-07-11 2021-05-25 Tasly Pharmaceutical Group Co., Ltd. Formulation of a micro drop pill and the preparation method thereof
USRE49035E1 (en) 2013-07-11 2022-04-19 Tasly Pharmaceutical Group Co., Ltd. Traditional Chinese medicine composition, and preparation and application thereof
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US10626077B2 (en) 2013-08-29 2020-04-21 Tasly Pharmaceutical Group Co., Ltd. Salvianolic acid compound T, preparation method therefor, and use thereof

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