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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 problems such as poor quality controllability, limited application of astragalus preparations, and large fluctuation range of clinical curative effect, so as to achieve quality control , To ensure the stability of the clinical curative effect and overcome the effect of large fluctuations in the 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

At present, the single flavor of Astragalus membranaceus preparations are all used as medicinal materials. Due to the influence of many factors such as the quality of medicinal materials, extraction routes, refining processes, etc., the fluctuation range of clinical curative effect is relatively large, and the quality controllability is relatively poor; therefore, Astragalus membranaceus preparations The clinical application has been limited to a large extent, and the majority of patients also suffer from the lack of safe and effective drug treatment.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] Embodiment 1 of the present invention: dipyridamole 1g astragalus total saponins 100g

[0062] Take dipyridamole, add water for injection, add tartaric acid and stir to dissolve, and use the liquid for later use; take total saponins of astragalus, add water for injection, stir to dissolve, filter, and use the filtrate for later use; combine the above two liquids, boil and add 0.5 % (W / V) of activated carbon, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH value of the filtrate to 5.5-7.0, boil, refrigerate (4°C) overnight, filter coarsely and finely; add mannitol to water for injection to prepare Make a 100mg / ml solution, mix with the above filtrate, filter, add water for injection to the specified amount, subpackage, freeze-dry, pre-freeze at -45°C, and pre-freeze for 10 hours; start vacuuming and heat up to -40°C , kept for 8 hours; and within 12 to 72 hours, the temperature was gradually raised to 10°C with a differential gradient, kept for ...

Embodiment 2

[0063] Embodiment 2 of the present invention: dipyridamole 1g astragalus total saponins 50g

[0064] Take dipyridamole, add water for injection, add 0.5% tartaric acid and stir to dissolve it, and prepare the medicinal solution; take total astragalus saponins, add appropriate amount of water for injection and stir to dissolve, and prepare the medicinal solution; mix the above two medicinal solutions, and add according to volume 0.5% activated carbon for needles, boiled, kept at a slight boil for 20 minutes, filtered slightly cold, added an appropriate amount of water for injection to the filtrate, adjusted the pH value to 5.5-7.0, boiled, refrigerated at 4°C overnight, added water for injection to the full amount, coarsely filtered, refined Filter, pack into ampoules, seal and sterilize to obtain 50 parts of total astragalus saponins and 1 part of dipyridamole small-volume injection or concentrated solution for injection.

Embodiment 3

[0065] Embodiment 3 of the present invention: dipyridamole 30g astragalus total saponins 60g

[0066] Take dipyridamole, add water for injection, add 0.65% tartaric acid and stir to dissolve it, and prepare the medicinal solution; take total astragalus saponins, add appropriate amount of water for injection to dissolve, and prepare the medicinal solution; combine the above two medicinal solutions, and add a prescribed amount of glucose or Sodium chloride, mix and dissolve, 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 overnight at 4°C , 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 2 parts of total astragalus saponins.

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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 one or several of astragalus root saponins, and astragalus root polysaccharides to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating viral myocarditis, cardiac functional insufficiency, angina pectoris caused by coronary disease, cerebral thrombus, cerebral apoplexy, apoplexy after-effect and hepatitis. 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] Among the causes of human death, about 17 million people die from cardiovascular and cerebrovascular diseases in the world every year, accounting for more than 50% of the total death toll, ranking first; among human diseases, the recurrence rate of cardiovascular and cerebrovascular diseases is as high as 87% , ranking first; in human diseases, the disability rate of cardiovascular and cerebrovascular diseases is as high as 50%, ranking first. This grim fact has been highly concerned by all walks of life. There are already a lot of western medicines. Chemical medicines are used to control symptoms and have definite curative effects. Poor in nature, either the curative effect of consolidating the root is we...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/481A61K31/715A61K31/519A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P31/14G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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