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Quality control method of pharmaceutical composition for preventing and treating coronary heart disease

A quality control method and composition technology, which is applied in the direction of drug combination, pharmaceutical formula, cardiovascular system diseases, etc., can solve the problem of no quality control index, etc., and achieve the effect of preventing and treating angina pectoris

Inactive Publication Date: 2009-04-22
大连美罗中药厂有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the document "Determination of the Content of Chansu in Chanshe Jiuxin Pills by PHLC Method" (Spectral Laboratory, Issue 03, 2005), although the determination of the content of Chansu components is disclosed, there are no other quality control indicators

Method used

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  • Quality control method of pharmaceutical composition for preventing and treating coronary heart disease
  • Quality control method of pharmaceutical composition for preventing and treating coronary heart disease
  • Quality control method of pharmaceutical composition for preventing and treating coronary heart disease

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] Embodiment 1 The quality control method of pharmaceutical composition of the present invention

[0103] 【prescription】

[0104] Bezoar 100 parts Musk 10 parts Pearl 400 parts

[0105] Toad cake 100 parts Red ginseng 60 parts Panax notoginseng 300 parts

[0106] 100 parts of borneol, 100 parts of pig gall paste, 50 parts of ocher

[0107] Concentrated Buffalo Horn Powder 130 parts Danshen Extract 100 parts

[0108] 【Method】

[0109] (1) taking the bulk drug of the weight ratio for subsequent use;

[0110] (2) pearl, salvia miltiorrhiza extract and ocher are pulverized into the finest powder respectively;

[0111] (3) Red ginseng and Panax notoginseng are crushed and added to pig gall paste, mixed evenly, and crushed into the finest powder;

[0112] (4) Crush bezoar, musk, toad venom, buffalo horn concentrated powder and borneol into the finest powder, mix with the above-mentioned powders except ochre, sieve, mix well, pour water into pills, coat ochre, and dry, tha...

Embodiment 2

[0130] Embodiment 2 The quality control method of pharmaceutical composition of the present invention

[0131] Except the content in embodiment 1, also include following content:

[0132] TLC identification of toad venom:

[0133] Take 0.7g of the medicine of the present invention, grind it finely, add 1ml of chloroform, shake it, leave it for 1 hour, and use the supernatant as the test solution; take 0.05g of the reference medicinal material of toadstool, and make a solution of the reference medicinal material in the same way; Add chloroform to each 1ml containing 1mg of the reference substance of Dugenji and Cinobufaction base, respectively, as the reference substance solution; according to the thin-layer chromatography test in Appendix VI B of the Chinese Pharmacopoeia 2005 edition, absorb the above four 4 μl of each solution was spotted on the same silica gel G thin-layer plate, and cyclohexane: chloroform: acetone was used as a developing agent at a ratio of 4:3:3, and d...

Embodiment 3

[0146] Embodiment 3 The quality control method of pharmaceutical composition of the present invention

[0147] Except the content in embodiment 2, also include following content:

[0148] TLC identification of Salvia miltiorrhiza: take 3g of the drug powder of the present invention, add 10ml of ether, shake, place for 1 hour, filter, evaporate the filtrate to dryness, add 1ml of ethyl acetate to the residue to dissolve, and use it as the test solution; take another tanshinone II A reference substance, add ethyl acetate to make a solution containing 5mg per 1ml, as the reference substance solution; according to the thin-layer chromatography test in Appendix VI B of the Chinese Pharmacopoeia version in 2005, draw 5 μl of the reference substance solution and 10 μl of the test solution. , point respectively on the same silica gel G thin-layer plate, with benzene:ethyl acetate as 19:1 as developing agent, develop, take out, and dry; Spots of the same color; for TLC see figure 2 ...

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Abstract

The invention discloses a method for controlling the quality of a medicine composition for preventing coronary heart disease. The medicine composition comprises a composition prepared from bezoar, muskiness, pearl, toad venom, red ginseng, notoginseng, borneol, hyocholalic cream, ochre, concentrated powder of cornu bubali, a salvia miltiorrhiza extract and and so on, and a preparation thereof; the quality control method at least comprises character identification, microscopical identification and physicochemical identification; in addition, the quality control method also comprises the identification of thin-layer chromatography; the optimal quality control method also comprises content measuration, wherein the identification of thin-layer chromatography comprises the identification of thin layer chromatography carried out on any one or several of the borneol, the toad venom and salvia miltiorrhiza; the content measuration is carried out by measuring the content of index compositions of any one or several of the toad venom, the salvia miltiorrhiza, the red ginseng and the notoginseng; and the measuration method is a high-efficient liquid phase chromatography. The quality control method has wide range of quality control, simple and reliable method, easy operation and good sensitivity and repeatability, and can effectively ensure the curative effect and safe medication.

Description

technical field [0001] The invention relates to a quality control method of a pharmaceutical composition, in particular to a quality control method of a pharmaceutical composition for preventing and treating coronary heart disease. Background technique [0002] The pharmaceutical composition of the present invention is composed of drugs including bezoar, musk, pearl, toad venom, red ginseng, notoginseng, borneol, pig gall paste, ochre, buffalo horn concentrated powder, salvia miltiorrhiza extract, etc. Coronary artery, improve myocardial oxygen supply, enhance heart function, etc. It is used to treat angina pectoris, chest tightness, shortness of breath and vertigo caused by coronary heart disease, and has a good therapeutic effect clinically. [0003] Drugs should be safe, effective, and controllable, and perfect quality control standards can effectively guarantee the quality of drugs. Disclosed in the patent literature (publication number: CN1785240A) contains the drop pi...

Claims

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Application Information

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IPC IPC(8): A61K36/258A61P9/10G01N30/02G01N30/36G01N30/90A61K31/045A61K33/26A61K35/32A61K35/413A61K35/55A61K35/56A61K35/618
Inventor 张成海周文波陈心石桂芳姜伟李晓艳
Owner 大连美罗中药厂有限公司
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