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Quality control method of pinellia ternate syrup

A quality control method and technology of Pinellia Syrup, which can be used in measuring devices, instruments, scientific instruments, etc., and can solve problems such as multi-component content determination methods that have not yet seen detection results.

Pending Publication Date: 2020-10-27
广州白云山潘高寿药业股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] In the existing literature, there are many methods for determining the single component content of ephedrine or pseudoephedrine in traditional Chinese medicine preparations, such as Chen Jihai's "HPLC Method to Measure the Content of Ephedrine in Pinellia Syrup", Xu Yanli's "HPLC Determination of Hydrochloric Acid in Pinellia Cough Syrup" Ephedrine content", but there is no multi-component content determination method with better detection effect

Method used

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  • Quality control method of pinellia ternate syrup
  • Quality control method of pinellia ternate syrup
  • Quality control method of pinellia ternate syrup

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preparation example Construction

[0038] The preparation of need testing solution: get pinellia syrup sample, carry out distillation after adding sodium hydroxide aqueous solution, filter after collecting the distillate with hydrochloric acid aqueous solution, get continued filtrate and prepare need testing solution;

[0039] Preparation of reference substance solution: take ephedrine hydrochloride and pseudoephedrine hydrochloride as reference substances, add solvent to dissolve, and prepare reference substance solution;

[0040] Described need testing solution, reference substance solution inject liquid chromatograph and measure;

[0041] The mobile phase of the liquid chromatograph is: acetonitrile-0.3-0.7wt% phosphoric acid aqueous solution with a volume ratio of 3.5-7:93-96.5.

[0042] Ephedra is the monarch drug in the prescription of pinellia syrup, and ephedrine and pseudoephedrine are one of the important active ingredients of pinellia syrup, so choosing ephedrine and pseudoephedrine in ephedra as ind...

Embodiment 1

[0048] 1. Instruments and reagents

[0049] 1. Instrument

[0050] Agilent 1200 high performance liquid chromatography; VWD detector.

[0051] Chromatographic column: DIAMOND ODS C18 column (200×4.6mm, 5μm), column number: 99902.

[0052] 2. Reagents and materials

[0053] Pinellia syrup (batch numbers: N07004S, J05001, J10002, A08001), ephedra negative control samples (both produced and prepared by Guangzhou Baiyunshan Pan Gaoshou Pharmaceutical Co., Ltd.);

[0054] Ephedrine hydrochloride reference substance (batch number: 171241-200506) and pseudoephedrine hydrochloride reference substance (batch number: 171237-200304) both came from China Institute for the Control of Pharmaceutical and Biological Products.

[0055] Acetonitrile is chromatographically pure; water is ultrapure water, and other reagents are analytically pure (all produced and prepared by American Tiandi Company).

[0056] 2. Investigation of the preparation method of the test product

[0057] Three pre-exp...

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Abstract

The invention relates to a quality control method of pinellia ternate syrup. The method comprises the following steps of preparation of a test solution, taking a pinellia ternate syrup sample to be detected, adding a sodium hydroxide aqueous solution, distilling, collecting the distillate by using a hydrochloric acid aqueous solution, filtering, and taking the subsequent filtrate to prepare the test solution; preparing a reference substance solution, taking ephedrine hydrochloride and pseudoephedrine hydrochloride as reference substances, and adding a solvent for dissolving to prepare the reference substance solution; injecting the test solution and the reference solution into a liquid chromatograph for determination; wherein a mobile phase of the liquid chromatograph is an acetonitrile-0.3wt%-0.7 wt% phosphoric acid aqueous solution with the volume ratio of (3.5-7):(93-96.5). According to the method disclosed by the invention, a good separation effect of ephedrine hydrochloride and pseudoephedrine hydrochloride is realized, other substances are not interfered, and meanwhile, the method disclosed by the invention is strong in specificity, high in accuracy and good in reproducibility.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a quality control method for pinellia sinensis syrup. Background technique [0002] Pinellia Syrup is recorded in the "Drug Standards of the Ministry of Health Traditional Chinese Medicine Prescriptions (Volume 8)", the standard number is WS3-B-1527-93, and the prescription is composed of raw pinellia, ephedra, aster, platycodon grandiflora, polygala, loquat leaf Composed of 9 Chinese herbal medicines such as tangerine peel, licorice and peppermint oil, it has the function of relieving cough and reducing phlegm. It is clinically used to treat cough with excessive phlegm and bronchitis. Ephedra has the effects of sweating and dispelling cold, clearing the lungs and relieving asthma. It is one of the ministerial medicines in the prescription. The active ingredients are its extracts ephedrine and pseudoephedrine. [0003] In the ministerial standards, only physical and chemical methods...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8675G01N2030/065
Inventor 彭惠炫叶雪兰黄华娥侯勤
Owner 广州白云山潘高寿药业股份有限公司
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