Quality inspection method of traditional Chinese medicine composition twenty-five-ingredient lung disease preparation

A quality inspection method and composition technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of reducing toxic components, the original standard needs to be improved, and the safety of medicine can not be guaranteed.

Active Publication Date: 2012-10-24
JINHE TIBETAN MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tiebendhammer and Bangga in Ershiwuweifeibing Capsules contain aconitine and other alkaloids, which have high pharmacological activity and medicinal value, but also have strong toxicity
Although the toxic components are significantly reduced after processing, the safety of medicinal use cannot be guaranteed.
The original quality standard of Ershiwuweifeibing Capsules included the TLC identification of oleanactone, oleanolic acid, cholic

Method used

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  • Quality inspection method of traditional Chinese medicine composition twenty-five-ingredient lung disease preparation
  • Quality inspection method of traditional Chinese medicine composition twenty-five-ingredient lung disease preparation
  • Quality inspection method of traditional Chinese medicine composition twenty-five-ingredient lung disease preparation

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0114] Experimental example 1: limit check of aconitine

[0115] 1. Instruments, reagents and test samples

[0116] Instruments: L-2100 Hitachi High Performance Liquid Chromatograph; AuW220D Shimadzu Electronic Analytical Balance.

[0117] Reference substance: aconitine reference substance (National Institute for the Control of Pharmaceutical and Biological Products) batch number: MUST-11031101.

[0118] Sample: Erwuwei Feibing Capsules (provided by Qinghai Jinhe Tibetan Medicine Co., Ltd.), batch numbers: 20110901, 20110902, 20110903.

[0119] 2. Selection of detection wavelength

[0120] Take aconitine reference substance solution and scan in the wavelength range of 190~400nm. Aconitine has maximum absorption at 235nm wavelength, so 235nm is selected as the detection wavelength according to the ultraviolet absorption spectrum.

[0121] 3. Mobile phase selection

[0122] The study found that aconitine can achieve good chromatographic separation effect when the methanol-wa...

experiment example 2

[0168] Experimental Example 2: Content Determination Experiment of Hydroxysafflower Yellow A

[0169] 1. Instruments, reagents and test samples

[0170] Instrument: L-2100 Hitachi high performance liquid chromatograph; Shimadzu AuW220D electronic balance.

[0171] Reference substance: hydroxysafflower yellow A reference substance (National Institute for the Identification of Pharmaceutical and Biological Products), batch number: 111637-200905.

[0172] Sample: Erwuwei Feibing Capsules (provided by Qinghai Jinhe Tibetan Medicine Co., Ltd.), batch numbers: 20110901, 20110902, 20110903.

[0173] 2. Selection of detection wavelength

[0174] Take hydroxysafflower yellow A reference substance solution and scan in the wavelength range of 190~500nm. Hydroxysafflower yellow A has the maximum absorption at 403nm wavelength, so 403nm is selected as the detection wavelength according to the ultraviolet absorption spectrum.

[0175] 3. Mobile phase selection

[0176] The study found t...

experiment example 3

[0221] Experimental Example 3: Content Determination Experiment of Swertiamarin

[0222] 1. Instruments, reagents and test samples

[0223] Instrument: L-2100 Hitachi high performance liquid chromatograph; Shimadzu AuW220D electronic balance.

[0224] Reference substance: swertiamarin reference substance (National Institute for the Identification of Pharmaceutical and Biological Products), batch number: 0785-200203.

[0225] Sample: Erwuwei Feibing Capsules (provided by Qinghai Jinhe Tibetan Medicine Co., Ltd.), batch numbers: 20110901, 20110902, 20110903.

[0226] 2. Selection of detection wavelength

[0227] Take the swertiamarin reference substance solution and scan it in the wavelength range of 190~400nm. The swertiamarin has the maximum absorption at the wavelength of 243nm, so 243nm is selected as the detection wavelength according to the ultraviolet absorption spectrum.

[0228] 3. Mobile phase selection

[0229] The study found that swertiamarin can achieve good ch...

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Abstract

The invention discloses a quality inspection method of a traditional Chinese medicine composition twenty-five-ingredient lung disease capsule and a preparation thereof. On the basis of the primary standard, high-performance liquid chromatography (HPLC) is additionally used to perform limit test to aconitine in the twenty-five-ingredient lung disease capsule, and simultaneously the high-performance liquid chromatography (HPLC) is adopted to perform quantitative detection to active ingredients of hydroxysafflor yellow A, swertiamarin and cholic acid, as well as differentiation to fructus terminaliae billericae, sandalwood, kummel, Baxiaga and licorice root. The method improves the product quality, and ensures that the preparation can guarantee the drug use safety and the effectiveness while curing diseases.

Description

technical field [0001] The invention relates to a quality detection method of a traditional Chinese medicine composition preparation, in particular to a quality detection method of a Chinese medicine composition twenty-five-flavor lung disease preparation. Background technique [0002] Twenty-five Flavors of Lung Disease Capsule was first recorded in the "Supplement to the Secrets of Tibetan Medicine" written by Sangjie Gyatso. It has a history of clinical application for nearly 300 years and is a good medicine for treating lung diseases in Tibetan medicine. It is recorded in the national standard part of the local standard of Chinese patent medicine, standard number: WS-11380 (ZD-1380)-2002. Twenty-five flavors of lung disease capsules are composed of 25 herbs such as sandalwood, hanging wood, travertine, safflower, grape, licorice, iron rod hammer, bangga, myrobalan, hairy myrobalan, emblica, and bezoar. Eliminates heat and inflammation, relieves lungs and resolves phlegm...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/90
Inventor 孙泰俊刘玉芹孙绪丁马宏伟张本永
Owner JINHE TIBETAN MEDICINE
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