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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 is applied in the direction of cardiovascular system diseases, drug combinations, and testing of pharmaceutical preparations, etc. It can solve the problems of product quality stability and safety fluctuations, large dosage of oral Chinese medicine, and low bioavailability , to achieve the effect of overcoming large fluctuations in curative effect, stabilizing drug safety, 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

However, western medicine has great side effects, and at the same time, it does not have the absolute advantage of antibiotics in the treatment of cardiovascular and cerebrovascular diseases. However, traditional Chinese medicine has a long course of treatment and slow onset of action. In the process of extracting active ingredients, other impurities produced may have adverse consequences on the human body. If there is no strict quality control method in production, the quality stability and safety fluctuations of the obtained products are also relatively high. Large, while some oral Chinese medicines take a large amount and have low bioavailability, so it is difficult to satisfy the choice of doctors and patients to the maximum extent

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Embodiment 1 of the present invention: dipyridamole 10g Panax notoginseng total saponins 500g

[0060] Take dipyridamole, add water for injection, add 5% citric acid and stir to dissolve, and use the liquid for later use; take total saponins of Panax notoginseng and add water for injection, stir to dissolve, filter, and use the filtrate for later use; combine the above two liquids, After boiling, add 0.5% (W / V) activated carbon, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH value of the filtrate to 5.5-6.5, boil, refrigerate (4°C) overnight, coarse filter, fine filter; Add water for injection to prepare a 100mg / ml solution, mix with the above filtrate, filter, add water for injection to the specified amount, sub-package, freeze-dry, pre-freeze at -45°C, and pre-freeze for 10 hours; start vacuuming and heat up Heat up to -40°C and keep for 8h; heat up to -35°C and keep for 8h; heat up to -25°C and keep for 8h; heat up to -15°C and keep for 5h;...

Embodiment 2

[0061] Embodiment 2 of the present invention: dipyridamole 1g Panax notoginseng total saponins 20g

[0062] Take dipyridamole, add water for injection, add 0.5% tartaric acid and stir to dissolve it, and prepare the liquid for later use; take total saponins of Panax notoginseng, add appropriate amount of water for injection and stir to dissolve, and prepare the liquid for later use; Add 0.5% activated carbon for needles, boil, keep boiling slightly for 20 minutes, filter slightly cold, add an appropriate amount of water for injection to the filtrate, adjust the pH value to 5.5-7.0, boil, refrigerate at 4°C overnight, add water for injection to the full amount, coarsely filter, Finely filter, pack into ampoules, seal and sterilize to obtain 20 parts of Panax notoginseng saponins and 1 part of dipyridamole small-volume injection or concentrated solution for injection.

Embodiment 3

[0063] Embodiment 3 of the present invention: dipyridamole 30g Panax notoginseng total saponins 450g

[0064] Take dipyridamole, add water for injection, add 0.65% tartaric acid and stir to dissolve it, and prepare the liquid for later use; take total saponins of Panax notoginseng, add an appropriate amount of water for injection to dissolve, and prepare the liquid for later use; combine the above two medicinal liquids, and add a prescribed amount of glucose Or sodium chloride, after mixing and dissolving, add 0.3% activated carbon for needles according to the volume, boil, keep boiling slightly for 30 minutes, filter slightly cold, add water for injection to the filtrate to an appropriate amount, adjust the pH value to 5.5-7.0, boil, and refrigerate at 4°C Overnight, coarse filtration, fine filtration, add water for injection to the full amount, subpackage, and sterilize to obtain glucose or sodium chloride intravenous infusion containing 1 part of dipyridamole and 15 parts of...

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PUM

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Abstract

The invention provides a pharmaceutical composition for treating cardiovascular and cerebrovascular diseases, its preparing process and quality control method, wherein Dipyridamole and Notoginsen triterpenes significant parts are employed in combination to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating apoplexy hemiplegia, chest pain, angina pectoris caused by coronary disease, cardiac functional insufficiency, cerebral hemorrhage sequelae, liver and kidney syndrome. The preparation of the invention has the advantages of high purity, ensured constituents, controllable quality, wider range of safely, and less fluctuation of treatment effects.

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. The death rate of cardiovascular and cerebrovascular diseases is an important indicator to measure the quality of life of a country or region, residents, and health care. With the advent of a well-off life and changes in dietary patterns, residents' desire for longevity and healthy survival continues to increase. In order to prevent and control the occurrence of cardiovascular and cerebrovascular diseases, it has become a major trend to...

Claims

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Application Information

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IPC IPC(8): A61K36/258A61K31/704A61K31/519A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P1/16A61P13/12G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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