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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, which is applied in the fields of cardiovascular system diseases, drug combinations, blood diseases, etc., and can solve the problems of cardiovascular and cerebrovascular diseases without antibiotics, hygienic indicators are difficult to control, and quality is difficult to guarantee.

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] The total flavonoids of hawthorn leaves are the main active ingredients of hawthorn leaves. A large number of studies have shown that the total flavonoids of hawthorn leaves can protect myocardial ischemia, inhibit platelet aggregation, scavenge free radicals, and enhance the body's immunity, especially in cardiovascular and cerebrovascular diseases. Diseases have broad development prospects, and have been favored by people in the pharmaceutical industry in recent years; but because most of them were used as medicines in the past, not only the quality was difficult to guarantee, the dosage was large, and the hygienic indicators were difficult to control; troxerutin has the ability to inhibit platelet aggregation, The effect of preventing thrombosis, but because there is no such absolute advantage as antibiotics in cardiovascular and cerebrovascular diseases, there are adverse reactions at the same time, so it is limited in clinical use; for this reason, the inventor uses the total flavonoids of the effective part of hawthorn leaves to be directly used as medicine. Compatibility with troxerutin to examine its molding process and medicinal effect, and at the same time in-depth research on the optimal ratio range of the total flavonoids of hawthorn leaves and troxerutin, to provide the possibility for wider application of hawthorn leaf preparations and troxerutin preparations, At the same time, provide patients with a safer and more effective pharmaceutical preparation with a small fluctuation range of curative effect and less toxic and side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 of the present invention: Troxerutin 6g Hawthorn Leaf Total Flavonoids 30g

[0057] Take troxerutin and total flavonoids of hawthorn leaves and add water for injection to dissolve, filter, add 0.5% (W / V) activated carbon to the filtrate after boiling, 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 sterile block for injection containing 5 parts of total flavonoids fr...

Embodiment 2

[0058] Embodiment 2 of the present invention: Troxerutin 10g Hawthorn Leaf Total Flavonoids 5g

[0059] Take troxerutin and total flavonoids from hawthorn leaves, add an appropriate amount of water for injection and stir to dissolve them, filter, add 0.5% activated carbon for needles to the filtrate according to volume, boil, keep slightly boiling for 20 minutes, filter slightly cold, add appropriate amount of water for injection to the filtrate , adjust the pH value to 5.0-7.0, boil, refrigerate overnight at 4°C, add water for injection to the full amount, coarsely filter, finely filter, divide into ampoules, seal and sterilize, that is, it contains 0.5 parts of total flavonoids of hawthorn leaves and 1 part Troxerutin small-volume injection or concentrated solution for injection.

Embodiment 3

[0060] Embodiment 3 of the present invention: Troxerutin 2g Hawthorn Leaf Total Flavonoids 30g

[0061] Take troxerutin and total flavonoids of hawthorn leaves, 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 0.6% activated carbon for needles according to 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 5.0-6.5, 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 15 servings of total flavonoids of hawthorn leaf in dextrose or sodium chloride intravenous infusion.

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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 haw leaves flavones are employed in combination to obtain various dose forms of injections and oral administration preparations. The composite preparation is mainly used for treating tightness and pain of the chest, palpitation and shortness of breath, coronary disease, angina pectoris, arrhythmia, cerebral apoplexy, cerebral thrombus, apoplexy after-effect, thrombotic phlebitis, capillary vessel hemorrhage. 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, myocardial infarction, and thromboembolic cerebrovascular disease are a major chronic disease that threatens healthy people in the world, and become the number one killer that threatens human health. According to my country's epidemiological survey, the incidence and mortality of cardiovascular and cerebrovascular diseases have been on the rise in recent decades, whether in rural areas or cities. In the 1950s and 1960s, cardiovascular disease and cerebrovascular disease ranked fifth and sixth among the causes of population death in my country, and rose to second and third respectively after 1975. Cardiovascular and cerebrovascular ...

Claims

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Application Information

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IPC IPC(8): A61K36/734A61K31/7048A61K31/352A61K9/08A61K9/10A61K9/14A61K9/16A61K9/19A61K9/20A61K9/48A61K9/70A61P9/10A61P9/06A61P9/00A61P7/02G01N30/02G01N33/15
Inventor 于文风
Owner BEIJING QI YUAN YI DE PHARMA RESEARCH CENTER
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