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Quality control method of fructus xanthil dripping pills for treating rhinitis

A quality control method and technology of cocklebur, which can be applied to medical preparations containing active ingredients, measuring devices, pharmaceutical formulas, etc., and can solve the problems of inaccurate and reliable quality control of cocklebur rhinitis dripping pills, non-compliance, etc.

Active Publication Date: 2010-02-17
四川字库山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since drug quality issues are closely related to human health, the requirements for drug quality control are getting higher and higher, and safety and efficacy are equally important; The control method is not accurate and reliable enough for the quality control of cocklebur rhinitis dripping pills, does not meet the needs of modern medicine development, and needs to be further improved

Method used

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  • Quality control method of fructus xanthil dripping pills for treating rhinitis
  • Quality control method of fructus xanthil dripping pills for treating rhinitis
  • Quality control method of fructus xanthil dripping pills for treating rhinitis

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Effect test

Embodiment 1

[0109] The present embodiment is: using the method of the present invention to treat 10 batches of cocklebur rhinitis dripping pills (batch numbers: 041201, 041202, 041203, 041204, 041205, 041206, 041207, 041208, 041209, 041210, all produced by Sichuan Hebang Sunshine Pharmaceutical Co., Ltd. Provided by the company) to measure the content of baicalin, the specific method is as follows:

[0110] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel is used as filler; methanol-water-phosphoric acid (47:53:0.2, volume ratio) solution is used as mobile phase, flow rate is 1ml / min; detection wavelength is 280nm ; Column temperature: 40°C. The number of theoretical plates calculated based on the baicalin peak is not less than 2500.

[0111] Preparation of reference substance solution: Accurately weigh an appropriate amount of baicalin reference substance, add 50% methanol to make a solution containing about 45 μg of baicalin per 1 ml, and obtain...

Embodiment 2

[0117] The present embodiment is: using the method of the present invention to treat 10 batches of cocklebur rhinitis dripping pills (batch numbers: 041201, 041202, 041203, 041204, 041205, 041206, 041207, 041208, 041209, 041210, all produced by Sichuan Hebang Sunshine Pharmaceutical Co., Ltd. Provided by the company) for TLC identification, the specific method is as follows:

[0118] (1), Scutellaria baicalensis and Angelica dahurica TLC identification:

[0119] A, preparation of test solution:

[0120] Take 5g of Xanthium rhinitis dropping pills, add 20ml of dilute hydrochloric acid with a concentration of 10% by mass, heat and reflux for extraction for 1 hour, let cool, filter, and shake the filtrate with diethyl ether to extract twice, 20ml each time, the aqueous solution is used for later use, and combined Diethyl ether extract, washed with water to neutral, evaporated to dryness, the residue was dissolved in 1ml of ethanol, as need testing solution I;

[0121] Get the n...

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Abstract

The invention discloses a quality control method of fructus xanthil dripping pills for treating rhinitis. In the method, a high performance liquid chromatography is used to measure the the content ofscutelloside, and octadecyl silane bonded silica gel is used as a filling agent; a methanol-water-phosphoric acid solution in volume ratio of 47:53:0.2 is used as a mobile phase at the rate of 1ml / min; the wave length for testing is 280 nm; the column temperature is 40 DEG C; a reference substance solution and a test sample solution are respectively and precisely absorbed and injected into a liquid chromatograph for the measurement; and the calculation is carried out according to the measurement result to obtain the content of the scutelloside in the fructus xanthil dripping pills for treatingrhinitis. The quality control method provides a method for measuring the content of the scutelloside in the fructus xanthil dripping pills for treating rhinitis, so that the quality control on the fructus xanthil dripping pills for treating rhinitis is more accurate and efficient, thereby providing convenience for ensuring the clinical efficacy. The method for measuring the content has the advantages of simple operation and accurate result as well as high precision, repetitiveness, stability and the like.

Description

technical field [0001] The invention belongs to the technical field of quality control of pharmaceutical preparations, in particular to a quality control method of cocklebur rhinitis dropping pills. Background technique [0002] Xanthizi rhinitis dripping pill is a new dosage form drug modified from Xanthium rhinitis capsule. Xanthium Rhinitis Capsules are recorded in the fourteenth volume of the Ministry of Health's drug standards for traditional Chinese medicine prescriptions. Chronic rhinitis, sinusitis, allergic rhinitis, etc. [0003] Xanthium Rhinitis Capsules are made of Xanthium extract powder 180g, gypsum extract powder 1.76g, Angelica dahurica extract powder 62.1g, borneol 30g, magnolia flower volatile oil 4ml, menthol 15g, magnolia flower extract powder 72.2g, Scutellaria baicalensis Extract powder 25.3g is a capsule preparation made from raw materials. The preparation method is: in addition to the volatile oil of magnolia flower, mix borneol, menthol and approp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/575G01N30/36G01N30/90A61P11/02A61K31/045A61K33/06
Inventor 刘文旭肖华张悦宋波伍江蓉
Owner 四川字库山制药有限公司
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