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Method for detecting phlegm eliminating and cough relieving granules

A technology for removing phlegm and relieving cough and a detection method, which is applied in the detection of an expectorant and relieving cough preparation, and the field of fingerprint detection of expectorant and cough granules, can solve the requirements that are not suitable for quality control of traditional Chinese medicine, difficult to control product quality, and detect specificity. Insufficient and other problems to achieve the effect of avoiding product forgery, advanced methods, and monitoring stability

Active Publication Date: 2010-11-17
HUACHENG PHARMA FACTORY GAUNGZHOU +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality standard of Qutan Zhike Granules is recorded in the tenth volume of Chinese Medicine Prescriptions in Drug Standards of the Ministry of Health of the People's Republic of China, standard number: WS 3 -B-2001-95, there are only TLC identification tests for Rhododendron japonica, Daphne genkwa, and Kansui, without content determination items, the detection specificity is insufficient, and it is difficult to control product quality
[0003] The composition of traditional Chinese medicine is complex, and using a certain composition as a control index is no longer suitable for the requirements of quality control of traditional Chinese medicine
At present, there is no relevant report on the fingerprint detection method of Qutan Zhike Granules

Method used

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  • Method for detecting phlegm eliminating and cough relieving granules
  • Method for detecting phlegm eliminating and cough relieving granules
  • Method for detecting phlegm eliminating and cough relieving granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Determination of Qutanzhike Granules HPLC Fingerprint

[0024] 1 Instruments and reagents

[0025] 1.1 Instrument: Dionex high performance liquid chromatography (ASI-100 autosampler, ATH-585 column thermostat, P680 quaternary gradient pump, PDA-100 detector); chromatographic column: Hypersil BDS C 18 (4.6mm×250mm, 5μm).

[0026] 1.2 Test drug: 12 batches of finished products of expectorant and cough granules and corresponding semi-finished liquid extracts were provided by Guangzhou Huacheng Pharmaceutical Factory. The methanol used in the liquid chromatography in the experiment is chromatographically pure, the rest of the reagents used are analytically pure, and the water is ultrapure water. Hyperoside, quercetin, luteolin, quercetin, apigenin, genkwain and other reference substances were all provided by China National Institute for the Control of Pharmaceutical and Biological Products.

[0027] 2 Methods and Results

[0028] 2.1 Preparation of the test so...

Embodiment 2

[0056] Example 2 Detection of Quphlegm and Zhike Granules by HPLC Fingerprint Spectrum

[0057] 1 Apparatus and reference drug: same as Example 1.

[0058] 2 methods:

[0059] 2.1 The method for the test solution: the same as in Example 1.

[0060] Weigh 20090308, 20090309, 20090311, 20090312, 20091003, 20091004, 20091005, 20091006, 20091007, 20091104, 20091105, 20091108 twelve batches of expectorant and cough granules, according to the preparation method of the test solution.

[0061] In the actual detection process, it is not required to prepare a mixed reference solution of hyperin, quercetin, luteolin, quercetin, apigenin, and genkwain every time.

[0062] 2.2 High Performance Liquid Chromatography and Analysis Method: Same as Example 1.

[0063] 2.3 The embodiment of the repeatability test of different batches:

[0064] During the experiment, 12 batches of Qutan Zhike Granules were tested, and the results showed that the similarity coefficients of the 12 batches of Qu...

Embodiment 3

[0067] Example 3 Detection of Sugar-Free Quphlegm and Zhike Granules by High Performance Liquid Chromatography

[0068] The sugar-free type Qutanzhike granule with batch number 20090408 was tested according to the method of Example 2, and the result was similar to that of Example 2, with a similarity of 0.958.

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Abstract

The invention relates to a method for detecting phlegm eliminating and cough relieving granules. The method comprises the following steps of: preparing test sample solution, namely precisely weighing the phlegm eliminating and cough relieving granules, extracting the phlegm eliminating and cough relieving granules by using methanol, filtering the extracted phlegm eliminating and cough relieving granules, evaporating a proper amount the filtrate to dryness, purifying the filtrate and preparing the test sample solution of the phlegm eliminating and cough relieving granules by using the methanol; and detecting and comparing a finger-print characteristic peak of the high performance liquid chromatogram of the test sample solution by using a high performance liquid chromatography gradient elution method, wherein a total number of 19 characteristic peaks are obtained, and 6 chemical components are confirmed in the peak. By the detection method, a finger-print for the phlegm eliminating and cough relieving granules is obtained, the quality of the semi-finished product and finished product of liquid extract is effectively and comprehensively monitored according to the presence of a shared peak in the finger-print and the characteristic peaks, the stability of the production process is monitored and the quality is stable, uniform and controllable. Moreover, by the detection method, the cough relieving and sputum elimination granules, other preparations (capsules for example) of the same prescription (components of a medicament), the semi-finished products of the liquid extracts of the preparations and the like can be detected, and quality is controlled and anti-forgery work is performed.

Description

【Technical field】 [0001] The present invention relates to a detection method of expectorant and cough granules and its application in detection of expectorant and cough preparations, in particular to a fingerprint detection method of expectorant and cough granules and its application in detection of expectorant and cough preparations, belonging to Pharmaceutical analysis technology field. 【Background technique】 [0002] Phlegm and cough granule is a compound preparation of traditional Chinese medicine. It is made of Codonopsis pilosula, Shuipinxia, ​​genkwa (made with vinegar), Gansui (made with vinegar), rhododendron azalea, and alum. For chronic bronchitis and bronchitis combined with emphysema, pulmonary heart disease caused by excessive phlegm, cough, wheezing, etc., there are also expectorant and cough capsules for the same prescription on the market. The quality standard of Qutanzhike Granules is recorded in the tenth volume of Chinese Medicine Prescriptions in Drug S...

Claims

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Application Information

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IPC IPC(8): A61K36/8888G01N30/86A61P11/00A61P11/10A61P11/14A61K33/06
Inventor 王晓东苏薇薇郑文燕邝裕兴彭维沈艺陈军
Owner HUACHENG PHARMA FACTORY GAUNGZHOU
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