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

A cardiovascular and cerebrovascular disease and composition technology, applied in cardiovascular system diseases, drug combinations, blood diseases, etc., can solve the problems of poor quality controllability, low extraction purity, traditional preparation process, etc., to achieve quality controllable, guaranteed Clinical efficacy, high purity 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, single Danshen preparations such as Danshen injection have been recognized in the treatment of cardiovascular and cerebrovascular diseases, but due to the traditional preparation process, low extraction purity, and relatively poor quality controllability, the clinical application of Danshen preparations has been restricted. To a large extent, the applicant has carried out in-depth research, using the effective parts of salvianolic acid with better curative effect in the treatment of cardiovascular and cerebrovascular diseases, and combining it with troxerutin to study and screen the effective parts of salvianolic acid The optimal compatibility ratio between the site and troxerutin, further research on the formulation and stability of the preparation, and then provide a new medication option for patients

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Embodiment 1 of the present invention: troxerutin 10g salvia phenolic acid 100g

[0058] Take troxerutin and salvianolic acid and add water for injection, stir to dissolve, filter, add 0.5% (W / V) activated carbon after the filtrate is boiled, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH value of the filtrate to 5.0 ~6.5, 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 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, raise the temperature to 30°C, and keep for 2 hours to obtain a lyophilized aseptic block containing 1 part of troxerutin and 10 parts of salvianolic acid....

Embodiment 2

[0059] Embodiment 2 of the present invention: troxerutin 10g salvianolic acid 1g

[0060] Take troxerutin, salvianolic acid, add water for injection and stir to dissolve, filter, adjust the pH value of the filtrate to 5.0-7.0, add 0.5% activated carbon for needles, boil for adsorption, remove carbon, fine filter, add filtrate Water for injection to the specified amount, refrigerated at 4°C overnight, coarsely filtered, finely filtered, divided into ampoules, sterilized, and divided into small volumes containing 1 part of troxerutin and 0.1 part of salvianolic acid Injection or concentrated solution for injection.

Embodiment 3

[0061] Embodiment 3 of the present invention: troxerutin 10g salvia phenolic acid 50g

[0062] Take troxerutin and salvianolic acid, 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 0.4% activated carbon for needles by volume, boil, and keep boiling slightly for 30 minutes. Slightly cold filter, 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 full amount, subpackage, sterilize, and then contain 1 part Troxerutin and 5 parts salvianolic acid in dextrose or sodium chloride intravenous infusion.

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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 total savianolic acid 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 coronary disease, angina pectoris, myocardial infarction, myocardial ischemia, pulmonary heart disease, arteriosclerosis, cerebral thrombus, myocardial and cerebral infarction, apoplexy after-effect, thrombotic phlebitis, capillary vessel hemorrhage, liver and kidney syndrome. The preparation of the invention has the advantages of high purity, ensured constituents, controllable quality, improved treatment effect, 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, cerebral thrombosis, senile dementia, etc. have become the number one killer of human health, and have become one of the main causes of population death in many countries; according to surveys, the incidence rate has been increasing year by year in recent years. And there is a continuous trend of rejuvenation, and the number of middle-aged and young patients continues to increase. Cardiovascular and cerebrovascular diseases have become common and frequently-occurring diseases that endanger the health of our people. At present, the treatment drugs are mainly concentrated in pure Chinese medicine preparations and Western medicines. Th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/53A61K31/343A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P13/12A61P11/00G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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