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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, applied in cardiovascular system diseases, drug combinations, blood diseases, etc., can solve problems such as difficult quality assurance, difficult control of hygienic indicators, and increased capillary resistance

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

And current treatment medicine mainly concentrates on two aspects of pure Chinese medicine preparation and Western medicine, and Western medicine side effect is bigger; Although pure Chinese medicine preparation has little toxic and side effects, their onset of effect is slower, affects therapeutic effect; In view of these situations, look for better, Compatibility is simple, the therapeutic effect is ideal, and the effective therapeutic drug with little side effect has become the problem that people urgently need to solve.
[0003] According to a large number of literatures, safflower, as a traditional Chinese medicine, has anti-thrombosis, inhibits platelet aggregation, anti-myocardial ischemia, can treat or prevent cardiovascular and cerebrovascular diseases, and has been widely favored by people in the pharmaceutical industry; Using medicinal materials as medicine is not only difficult to guarantee the quality, the dosage is large, but also the hygienic indicators are difficult to control; troxerutin can inhibit platelet aggregation, prevent thrombosis, and at the same time resist vascular damage caused by 5-hydroxytryptamine and bradykinin , increase capillary resistance, reduce capillary permeability, and prevent edema caused by increased vascular permeability; mainly used for ischemic cerebrovascular diseases (such as cerebral thrombosis, cerebral embolism), thrombophlebitis, Diseases such as central retinitis, edema caused by increased vascular permeability; but because troxerutin has certain side effects, it is limited in clinical use; for this reason, the inventor adopts the effective part of total flavonoids of safflower to be directly used as medicine , combined with troxerutin to investigate its molding process and medicinal effect, and at the same time to study the optimal ratio range of safflower total flavonoids and troxerutin, so as to provide the possibility for the wider application of safflower preparations and troxerutin preparations , and at the same time provide patients with a safer and more effective pharmaceutical preparation with small fluctuations in curative effect and less toxic and side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] Embodiment 1 of the present invention: troxerutin 10g safflower total flavonoids 30g

[0059] Take troxerutin, safflower total flavonoids and water for injection, stir to dissolve, filter, add 0.6% (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 6.5 ~8.0, boil, refrigerate (4°C) overnight, coarse filter, fine filter; make 120mg / ml solution of mannitol and water for injection, 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 sterile block for injection containing 3 parts of safflower total flavonoids and 1 part o...

Embodiment 2

[0060] Embodiment 2 of the present invention: troxerutin 10g safflower total flavonoids 1g

[0061] Take troxerutin and safflower total flavonoids and add water for injection, stir to dissolve, filter, adjust the pH value of the filtrate to 6.5-8.0, add 0.6% 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 volumes containing 0.1 part of safflower total flavonoids and 1 part of troxerutin Injection or concentrated solution for injection.

Embodiment 3

[0062] Embodiment 3 of the present invention: troxerutin 5g safflower total flavonoids 25g

[0063] Take troxerutin and safflower total flavonoids, add an appropriate amount of water for injection to dissolve, add a specified amount of glucose or sodium chloride to the liquid medicine, mix and dissolve, add 0.6% activated carbon for needles according to volume, boil, keep boiling slightly for 30 minutes, Cold filtration, add water for injection to the filtrate to an appropriate amount, adjust the pH value to 6.5-8.0, boil, refrigerate overnight at 4°C, coarse filter, fine filter, add water for injection to the full amount, subpackage, and sterilize to obtain 1 part of koji Creutin and 5 servings of safflower total flavonoids in dextrose or sodium chloride intravenously.

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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 Troxerutin and safflower 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 hemorrhage, cerebral infarction, angina pectoris caused by coronary disease, vasculitis, arrhythmia, pulmonary heart disease, thrombotic phlebitis, capillary vessel hemorrhage, hyperlipemia, diabetic circumferential neuropathy, cervical vertebra diseases, fatty liver and edema.

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. And current treatment medicine mainly concentrates on two aspects of pure Chinese medicine preparation and Western medicine, and Western medicine side effect is bigger; Although pure Chinese m...

Claims

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Application Information

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IPC IPC(8): A61K36/286A61K31/7048A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/06A61P9/00A61P7/02A61P7/10A61P1/16A61P3/10A61P27/16A61P43/00G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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