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

A technology of cardiovascular and cerebrovascular diseases and compositions, which is applied in the direction of cardiovascular system diseases, drug combinations, blood diseases, etc., can solve the problems of inapplicable long-term administration, short half-life of administration, and affecting the therapeutic effect, etc., to achieve inhibition of platelet aggregation, Overcoming large fluctuations in curative effect and ensuring the effect of clinical curative effect

Inactive Publication Date: 2007-05-30
BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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  • 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: Clinical findings show that Erigeron breviscapus preparations such as Erigeron breviscapus injection have definite curative effect, but the bioavailability of common oral preparations of existing preparations is low, and the number of daily doses is high, and the half-life of common injection preparations is short and eliminated rapidly in the body At the same time, the curative effect has a certain fluctuation; Troxerutin can inhibit platelet aggregation and prevent thrombosis, etc. It is mainly used for ischemic cerebrovascular diseases (such as cerebral thrombosis, cerebral embolism), thrombophlebitis, central Diseases such as retinitis and edema caused by increased vascular permeability; but because troxerutin has certain side effects, its clinical use is limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 of the present invention: troxerutin 10g scutellaria scutellaria total flavonoids 50g

[0057] Take troxerutin and breviscapine total flavonoids, add water for injection, stir to dissolve, filter, add 0.5% (W / V) activated carbon for needles to the filtrate after boiling, keep boiling slightly for 30 minutes, filter slightly cold, adjust the pH of the filtrate value to 6.5-8.0, boil, refrigerate (4°C) overnight, coarse filter, fine filter; make 120mg / ml solution with mannitol and water for injection, mix with the above filtrate, filter, add water for injection to the specified amount, Subpackaging, freeze-drying, pre-freezing temperature -45°C, pre-freezing time 10h; start vacuuming, and raise the temperature to -40°C, keep for 8h; then raise the temperature to -35°C, keep for 8h; heat up to -25°C, keep for 8h Raise the temperature to -15°C and keep for 5h; raise the temperature to 0°C and keep for 5h; raise the temperature to 10°C and keep for 2h; raise the...

Embodiment 2

[0058] Example 2 of the present invention: troxerutin 3g total flavonoids of scutellaria breviscapine 6g

[0059] Take troxerutin and breviscapine total flavonoids, add appropriate amount of water for injection and stir to dissolve them, filter, add 5mol / L sodium hydroxide solution to the filtrate to adjust the pH value to 6.5-8.0, add 0.5% (W / V) Use activated carbon for activated needles, boil for adsorption, remove carbon, fine filter, add water for injection to the specified amount of filtrate, refrigerate overnight at 4°C, coarse filter, fine filter, divide into ampoules, sterilize, divide into bottles, and obtain A small-volume injection or a concentrated solution for injection containing 1 part of troxerutin and 2 parts of total flavonoids of breviscapine.

Embodiment 3

[0060] Example 3 of the present invention: Troxerutin 10g Total Flavonoids of Erigeron breviscapine 1g

[0061] Take troxerutin and add water for injection, stir to dissolve, and prepare the liquid for later use; take the total flavonoids of Erigeron breviscapine, add appropriate amount of water for injection to dissolve, and make the liquid for later use; combine the two liquids above, and add a prescribed amount of glucose or chloride Sodium, after mixing and dissolving, 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, refrigerate overnight at 4 °C, crude 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 troxerutin and 0.1 part of breviscapine total flavonoids.

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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 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, senile dementia, angina pectoris caused by coronary disease, myocardial infarction, auricular fibrillation, viral myocarditis, pulmonary heart disease, retina venous clogging, thrombotic phlebitis, capillary vessel hemorrhage, hepatorenal syndrome, diabetes and complications. The preparation of the invention has the advantages of high purity, ensured constituents, controllable quality, improved curative 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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IPC IPC(8): A61K36/28A61K31/7048A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02A61P1/16A61P13/12A61P3/10A61P25/28A61P25/00A61P31/12G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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