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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 no absolute advantage in cardiovascular and cerebrovascular diseases, small fluctuation range of curative effect, large fluctuation of curative effect, etc., to ensure that Stable clinical curative effect, overcoming large fluctuations in curative effect, good formulation and stability

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

[0003] Modern studies have shown that angelica has strong anticoagulant and antithrombotic effects, anti-oxidation, anti-aging effects, protective effects on brain and kidney ischemic damage, anti-atherosclerosis effects, and can significantly inhibit platelet aggregation. It has anti-tumor, anti-injury, anti-pulmonary fibrosis, liver-protecting effects, analgesic and anti-convulsant effects on the central nervous system, prolonging sleep effects caused by pentobarbital, alleviating memory loss, etc. Inflammation and immune enhancement, etc., but at present, medicinal materials are mostly used as medicine, resulting in low bioavailability and large fluctuations in curative effect; troxerutin can inhibit the aggregation of red blood cells and platelets, prevent thrombosis, increase blood oxygen saturation, improve microcirculation, Promote new angiogenesis, increase cerebral blood flow, improve hemodynamic indicators, etc., but because it has no absolute advantage in cardiovascular and cerebrovascular diseases, and has certain side effects, its clinical use is limited; in view of the above situation, The present inventor adopts one or several kinds of angelica polysaccharides, angelica organic acids, and angelica volatile oils from the effective parts of angelica to be directly used as medicine, and is compatible with troxerutin to investigate its molding process and drug effect. The optimal ratio range of compatibility provides 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

[0067] Embodiment 1 of the present invention: troxerutin 20g angelica organic acid 80g

[0068] Take troxerutin, angelica organic acid 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 4.5~ 6.0, 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, subpackage, and 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 with a differential gradient within 12 to 72 hours, keep for 2h, and raise the temperature to 20°C ℃, keep for 2 hours, raise the temperature to 30 ℃, keep for 2 hours, and obtain the sterile block for injection.

Embodiment 2

[0069] Embodiment 2 of the present invention: troxerutin 80g angelica polysaccharide 20g

[0070] Take troxerutin, angelica polysaccharide and water for injection, stir to dissolve, filter, adjust the pH value of the filtrate to 4.5-6.0, add 0.5% 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, coarsely filter, finely filter, dispense into ampoules, sterilize, and dispense to obtain a small-volume injection or a concentrated solution for injection.

Embodiment 3

[0071] Embodiment 3 of the present invention: Troxerutin 50g Angelica volatile oil 50g

[0072] Take troxerutin and angelica volatile oil, according to the ratio of volatile oil: β-cyclodextrin: water 1ml: 7g: 70ml, add volatile oil to β-cyclodextrin saturated aqueous solution, add the anhydrous solution of volatile oil under stirring Ethanol solution, stirred at 45°C for 4 hours, refrigerated overnight, filtered with suction, dried, added appropriate amount of water for injection to dissolve, and used for later use; combine the above two liquids, add a specified amount of glucose or sodium chloride, mix and dissolve, and press the volume Add 1.0% activated carbon for needles, 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 4.5-6.0, boil, refrigerate at 4°C overnight, coarse filter, fine filter, add injection Make up to the full amount with water, subpackage, and steriliz...

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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 one or several of Chinese angelica polysaccharides, Chinese angelica organic acids and Chinese angelica volatile oil to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating coronary disease, angina pectoris, arrhythmia, cerebral thrombus, apoplexy, thrombotic phlebitis and capillary vessel hemorrhage.

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] At present, cardiovascular and cerebrovascular diseases have become the most important disease that affects the health of residents, and the number one killer that endangers human health, showing a worldwide distribution. In China, there are about 2.6 million people every year, and about 7,000 people die of cardiovascular and cerebrovascular diseases every day. The pressure from work, society, and life in modern society, coupled with irregular life, unscientific diet, and lack of exercise, have contributed to the increasing incidence of cardiovascular and cerebrovascular diseases among young and middle-aged people aged 30 to 40. The onset population tends to be younger, and the age span of onset is expandi...

Claims

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Application Information

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IPC IPC(8): A61K36/232A61K31/715A61K31/352A61K9/08A61K9/10A61K9/16A61K9/20A61K9/48A61K9/70A61P9/10A61P9/00A61P7/02
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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