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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 cardiovascular system diseases, drug combinations, blood diseases, etc., can solve the problems of product quality stability and safety fluctuations, large dosage of oral Chinese medicine, and low bioavailability, etc. To achieve the effect of overcoming large fluctuations in curative effect, stable drug safety, and improved 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

[0063] Embodiment 1 of the present invention: troxerutin 1g Panax notoginseng total saponins 20g

[0064] Take troxerutin, Panax notoginseng saponins and water for injection, stir to dissolve, filter, add 0.5% (W / V) activated carbon after the filtrate is boiled, keep slightly boiling 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 100mg / ml solution, mix with the above filtrate, filter, add water for injection to the specified amount, dispense, Freeze drying, pre-freezing temperature -45°C, pre-freezing time 10h; start vacuuming, and raise the temperature to -40°C, keep for 8h; and gradually increase the temperature to 10°C in 12 to 72 hours, keep for 2h, heat up to Keep at 20°C for 2 hours to obtain a sterile block for injection containing 20 parts of Panax notoginseng saponins and 1 part of troxerutin.

Embodiment 2

[0065] Embodiment 2 of the present invention: troxerutin 10g Panax notoginseng total saponins 5g

[0066] Take troxerutin and panax notoginseng saponins and add water for injection, stir to dissolve, filter, adjust the pH value of the filtrate to 6.0-7.0, add 0.5% activated carbon for needles, boil for adsorption, remove carbon, fine filter, add filtrate Water for injection to the specified amount, refrigerated overnight at 4°C, coarsely filtered, finely filtered, divided into ampoules, sterilized, and divided into small volume injections containing 0.5 parts of Panax notoginseng saponins and 1 part of troxerutin solution or concentrated solution for injection.

Embodiment 3

[0067] Embodiment 3 of the present invention: troxerutin 2g Panax notoginseng total saponins 10g

[0068] Take troxerutin and panax notoginseng saponins, add appropriate amount of water for injection and stir to dissolve them, filter, add a specified amount of glucose or sodium chloride to the filtrate, mix and dissolve, add 0.4% activated carbon for needles by volume, boil, Keep boiling slightly for 30 minutes, filter slightly cold, add water for injection to the appropriate amount of the filtrate, adjust the pH value to 6.0-7.0, boil, refrigerate at 4°C overnight, coarse filter, fine filter, add water for injection to the full amount, subpackage, sterilize, That is, an intravenous infusion of glucose or sodium chloride containing 1 part of troxerutin and 5 parts of Panax notoginseng saponins is obtained.

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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 Troxerutin 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, angina pectoris caused by coronary disease, cardiac functional insufficiency, cerebrovascular sequelae, thrombotic phlebitis, capillary vessel hemorrhage, 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): A61K36/258A61K31/704A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P31/14A61P13/12G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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