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Pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, preparation process and quality control method thereof

A technology for cardiovascular and cerebrovascular diseases and compositions, which can be applied to cardiovascular system diseases, drug combinations, blood diseases, etc., and can solve the problems of unreliable product quality stability and safety, inability to act quickly, and low bioavailability, etc. Achieve the effects of inhibiting platelet aggregation, overcoming large fluctuations in curative effect, and improving curative effect

Inactive Publication Date: 2007-05-30
BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, a large number of Chinese and Western medicines have been released, but because Western medicines have no absolute advantage in cardiovascular and cerebrovascular diseases and have relatively large side effects, and Chinese medicine injections can have adverse consequences on the human body due to other impurities produced during the process of extracting active ingredients. Produced without strict quality control methods, the quality stability and safety of the obtained products are unreliable. Although the oral preparations of traditional Chinese medicines have a wide variety of options and are available, due to their low bioavailability and long course of treatment, they cannot Rapid onset of effect, so the research and development of drugs with definite curative effect, no adverse reactions, and effective control of the quality of preparations has become a new hot spot for people

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1 of the present invention: troxerutin 10g total ginsenosides 50g

[0042] Take troxerutin, total ginsenosides and water for injection, stir to dissolve, filter, add 0.2% (W / V) activated carbon to the filtrate after boiling, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH value of the filtrate to 6.0~ 7.0, boil, refrigerate (4°C) overnight, coarse filter, fine filter; add mannitol and water for injection to make a 120mg / ml solution, mix with the above filtrate, filter, add water for injection to the full amount, subpackage, freeze-dry , pre-freezing temperature -45°C, pre-freezing time 10h; start vacuuming, and raise the temperature to -40°C, keep for 8h; then raise the temperature to -35°C, keep for 8h; heat up to -25°C, keep for 8h; ℃, keep 5h; warm up to 0°C, keep 5h; warm up to 10°C, keep 2h; warm up to 20°C, keep 2h; warm up to 30°C, keep 2h, that is, it contains 5 parts of total ginsenosides and 1 part of Quke Rutin in sterile...

Embodiment 2

[0043] Embodiment 2 of the present invention: troxerutin 10g ginseng stem and leaf total saponins 5g

[0044] Take troxerutin and total saponins from ginseng stems and leaves, add an appropriate amount of water for injection, put it on a water bath, heat to dissolve, add 0.5% activated carbon for needles according to volume, boil, keep slightly boiling for 20 minutes, filter slightly cold, add water for injection to the filtrate to an appropriate amount , adjust the pH value to 5.5-7.0, add polysorbate 80 to dissolve, boil, refrigerate overnight at 4°C, add water for injection to the specified amount, coarse filter, fine filter, pack into ampoules, seal and sterilize, that is, the content of 0.5 1 part total saponins of ginseng stems and leaves and 1 part troxerutin small water needle.

Embodiment 3

[0045] Embodiment 3 of the present invention: troxerutin 10g total ginsenosides 100g

[0046] Take troxerutin and total ginsenosides, add an appropriate amount of water for injection to dissolve, filter, add a specified amount of glucose or sodium chloride to the filtrate, mix and dissolve, add 0.1% activated carbon for needles according to volume, boil, keep boiling slightly for 40min, Cold filtration, add water for injection to the filtrate to an appropriate amount, adjust the pH value to 5.5-7.0, boil, refrigerate overnight at 4°C, coarse filter, fine filter, add water for injection to the specified amount, subpackage, sterilize, and then it contains 1 part Troxerutin and dextrose or sodium chloride intravenous infusion of 10 parts of total ginsenosides.

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Abstract

The invention provides a pharmaceutical composition for treating cardiovascular and cerebrovascular diseases and its preparing process, wherein Troxerutin and ginsenosides or significant parts of ginsenoside of stems and leaves are employed in combination to obtain injection preparations and pharmacologically allowable dose forms such as oral administration preparations. The composite preparation is mainly used for treating myocardial ischemia, coronary disease, angina pectoris, heart failure, ischemic stroke, cerebral thrombus, apoplexy after-effect, thrombotic phlebitis, capillary vessel hemorrhage, hepatorenal syndrome, pulmonary heart disease, climacteric metancholia, the preparation of the invention has the advantages of high purity, ensured constituents, controllable quality, and assured curative effect.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, a preparation method and a quality control method thereof, and belongs to the technical field of medicines. technical background [0002] Cardiovascular and cerebrovascular diseases, such as coronary heart disease, myocardial infarction, and thromboembolic cerebrovascular disease are a major chronic disease that threatens the healthy population of the world, and there is a gradual upward trend in recent years. According to the report of the World Health Organization, one out of every three deaths in the world dies from cardiovascular and cerebrovascular diseases, and the mortality rate is still increasing. Cardiovascular and cerebrovascular diseases have attracted extensive attention from the medical circles at home and abroad. So far, a large number of Chinese and Western medicines have been released, but because Western medicines have no ab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/258A61K31/704A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P13/12A61P11/00A61P15/14A61P25/00G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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