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Quality testing method for compound paracetamol and amantadine hydrochloride granules

A technology of compound acetaminophen and its quality detection method, which is applied in the field of quality detection of compound acetaminophen granules, can solve the problems of large amount of samples to be detected, large errors, and low accuracy, and achieve high accuracy and heavy weight. Good performance and guaranteed clinical efficacy

Inactive Publication Date: 2013-01-16
葵花药业集团(衡水)得菲尔有限公司
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Problems solved by technology

[0003] At present, in the quality standards of cold medicines that are widely favored by patients in the market, such as compound acetaminophen tablets, etc., the quality detection methods generally have problems of low accuracy and large errors. For example, the detection of caffeine content uniformity, the general The method is to use the titration method to detect, the accuracy rate is only 80-90%, and the error is relatively large. In addition, the general method for the detection of artificial bezoar is to measure the content of bilirubin or bile acid by ultraviolet spectrophotometry, and there is also an accuracy rate. low problem, moreover, in the general application of high performance liquid chromatography to detect the content, the amount of the sample to be tested needs to be used more, and the trace sample cannot be detected accurately, thus providing a method with high accuracy and reproducibility Good performance, and the quality detection method that can detect trace samples has strong practical significance

Method used

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Embodiment Construction

[0040] The present invention will be described in detail below so that those skilled in the art can implement it after referring to this specification.

[0041] A kind of quality detection method of compound phenamine granule, wherein said compound phenamine granule is made of paracetamol 250g, amantadine hydrochloride 100g, caffeine 15g, chlorpheniramine maleate 2g, artificial Calculus Calculus 10g, add appropriate amount of auxiliary material and make 1000 bags; Wherein said quality measurement mainly comprises utilizing thin-layer chromatography to the quality identification of described compound acetaminophen granules, utilizing high performance liquid chromatography acetaminophen, adamantane hydrochloride Amine, caffeine, chlorpheniramine maleate, content uniformity determination and content determination of artificial bezoar, and dissolution determination, wherein the content determination of artificial bezoar is realized by measuring the bilirubin content by high perform...

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Abstract

The invention discloses a quality testing method for compound paracetamol and amantadine hydrochloride granules. The method mainly comprises the steps of appraising the quality of the compound paracetamol and amantadine hydrochloride granules by using a thin layer chromatography method, performing content uniformity measuring and content measuring for acetaminophen, amantadine hydrochloride, caffeine, chlorpheniramine maleate and artificial bezoar by using a liquid chromatography method, measuring the dissolution rate, and measuring the content of bilirubin to achieve the artificial bezoar content measuring. The quality testing method of micro samples of the compound paracetamol and amantadine hydrochloride granules is built, researches on appraisal, content measuring and content uniformity measuring of the compound paracetamol and amantadine hydrochloride granules are achieved, the accuracy is high, good in reproducibility, and the quality of the compound paracetamol and amantadine hydrochloride granules can be controlled comprehensively and effectively, so that clinical effects of the preparation are guaranteed.

Description

technical field [0001] The invention relates to a quality detection method of medicines, in particular to a quality detection method of compound acetaminophen granules. Background technique [0002] Flu is the disease that is caused by virus or bacterium, is a kind of self-healing disease, is divided into common cold and influenza generally. The common cold, called "cold" by traditional Chinese medicine, is a common respiratory disease caused by a variety of viruses, 30%-50% of which are caused by a certain serotype of rhinovirus. Though common cold is mainly in early winter, in any season, as can taking place in spring, summer, the Causative virus of the flu of Various Seasonals is not just the same yet. Influenza is an acute respiratory infectious disease caused by influenza virus. Virus is present in patient's respiratory tract, gives others through droplet infection when patient's cough, sneeze. [0003] At present, in the quality standards of cold medicines that are ...

Claims

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Application Information

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IPC IPC(8): G01N30/90G01N30/02G01N30/06
Inventor 李洪建邢耘
Owner 葵花药业集团(衡水)得菲尔有限公司
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