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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, which is applied in cardiovascular system diseases, drug combinations, blood diseases, etc., can solve the problems of short half-life of administration, unsuitable for long-term administration, and many times of daily administration, so as to overcome the fluctuation of curative effect. Large, inhibiting platelet aggregation, reducing blood viscosity

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 therapeutic drugs are mainly concentrated in pure Chinese medicine preparations and western medicines. Although the formulas of western medicines are relatively simple and can relieve symptoms quickly, they are not suitable for long-term administration due to certain toxic and side effects, and the curative effect is relatively poor; Although pure traditional Chinese medicine preparations have less toxic and side effects, their onset of effect is relatively slow. Although some injection preparations are widely used in the treatment of acute and severe diseases and have achieved certain curative effects, the quality of the preparations often affects the therapeutic effect. Oral preparations of traditional Chinese medicine Although there are many varieties and relatively complete indications, the low bioavailability has brought inconvenience to some patients; therefore, combining the overall concept of traditional Chinese medicine, the principle of consolidating the root and the characteristics of the disease, the combination of Chinese and Western medicine has become the direction of people's initial research.
According to a large number of literatures, the total flavonoids of Erigeron breviscapus has antithrombotic properties, inhibits platelet aggregation, and resists myocardial ischemia. It is mainly used clinically for occlusive cerebrovascular diseases, coronary heart disease, angina pectoris, vasculitis, paralysis after stroke and other cardiovascular and cerebrovascular diseases. Treatment of diseases; dipyridamole has the functions of inhibiting platelet aggregation and antithrombosis, and is widely used in the treatment of cardiovascular and cerebrovascular diseases such as myocardial ischemia, coronary heart disease, angina pectoris, and cerebral thrombosis. The curative effect of Xin injection is definite, but the bioavailability of the common oral preparations of the existing preparations is low, and the number of daily doses is high, the half-life of the common injection preparations is short, the elimination is rapid in the body, and the curative effect has certain fluctuations. Adverse reactions, not suitable for long-term use; In view of these circumstances, it is an urgent problem to find effective therapeutic drugs that are better, simple in compatibility, ideal in therapeutic effect, and less toxic and side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Example 1 of the present invention: dipyridamole 10g total flavonoids of Erigeron breviscapine 50g

[0058] Take dipyridamole, add 0.5% tartaric acid or citric acid and stir to dissolve; take breviscapine total flavonoids and add water for injection and stir to dissolve, mix and shake the two solutions, filter, add 0.5% (W / V) with activated carbon for needles, kept boiling slightly for 30 minutes, filtered slightly cold, adjusted the pH value of the filtrate to 6.5-8.0, boiled, refrigerated (4°C) overnight, coarsely filtered, finely filtered; Mannitol was prepared by adding water for injection 120mg / 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, Keep the temperature for 8h; then raise the temperature to -35°C, keep for 8h; raise the temperature to -25°C, keep for 8h; raise the temperature to -15°C, keep for...

Embodiment 2

[0059] Example 2 of the present invention: dipyridamole 1g scutellaria total flavonoids 1g

[0060] Take dipyridamole, add 0.5% tartaric acid or citric acid and stir to dissolve; take breviscapine total flavonoids, add appropriate amount of water for injection and stir to dissolve, mix the two medicines evenly, add 5mol / L sodium hydroxide solution Adjust the pH value to 6.0-8.0, add 0.5% (W / V) activated carbon for needles, boil for adsorption, remove carbon, fine filter, add water for injection to the filtrate to the specified amount, refrigerate overnight at 4 °C, coarse filter, fine filter Filter, pack into ampoules, sterilize, and pack to obtain a small-volume injection or a concentrated solution for injection containing 1 part of dipyridamole and 1 part of breviscapine total flavonoids.

Embodiment 3

[0061] Example 3 of the present invention: dipyridamole 10g total flavonoids of Erigeron breviscapine 500g

[0062] Take dipyridamole, add water for injection, add 0.5% tartaric acid and stir to dissolve it, and prepare the liquid medicine for later use; take total flavonoids of Asarum breviscapine, add appropriate amount of water for injection, and dissolve the medicine liquid for later use; combine the above two medicinal liquids, and add a specified amount of Glucose or sodium chloride, mix and dissolve, add 0.5% 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 6.0-8.0, boil, 4°C Refrigerate overnight, coarsely filter, finely filter, 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 50 parts of breviscap...

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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 significant parts of herba erigerontis flavones are employed in combination to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating cerebral thrombus, cerebral infarction, cerebral hemorrhage, hemiplegia, senile dementia, angina pectoris caused by coronary disease, myocardial infarction, auricular fibrillation, viral myocarditis, pulmonary heart disease, retina venous clogging, hepatorenal syndrome, diabetes and complications. 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, angina pectoris, arrhythmia, cerebral thrombosis, stroke, etc. have become one of the important factors threatening human health. According to the survey, the incidence rate has been increasing in recent years, and there is a trend of younger people. The number of middle-aged and young patients is increasing. Cardiovascular and cerebrovascular diseases have become common and frequently-occurring diseases that endanger the health of our people. At present, the therapeutic drugs are mainly concentrated in pure Chinese medicine preparations and western medicines. Although the formulas of western medicines are relatively simple and can ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/28A61K31/7048A61K31/519A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P13/12A61P31/12A61P25/28G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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