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Quality control method for compound platycodon grandiflorum ephedrine syrup

A quality control method, the technology of ephedrine syrup, applied in the direction of chemical method analysis, measuring devices, instruments, etc., can solve the problems of no reasonable and accurate indicators for product quality, difficulty in effectively controlling the quality of finished products, and huge impact of clinical treatment, etc., to ensure that Clinical use is safe, the curative effect is stable and accurate, and the effect of the production process is guaranteed

Inactive Publication Date: 2017-11-28
广西壮族自治区食品药品检验所
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Problems solved by technology

For this reason, the existing methods are difficult to effectively control the quality of finished products in production. There is no reasonable and accurate indicator to measure the quality of different batches of products, and it is impossible to ensure the efficacy of the products, which has a huge impact on clinical treatment.

Method used

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  • Quality control method for compound platycodon grandiflorum ephedrine syrup
  • Quality control method for compound platycodon grandiflorum ephedrine syrup
  • Quality control method for compound platycodon grandiflorum ephedrine syrup

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Embodiment Construction

[0030] Study on Quality Control Method of Compound Bellflower Ephedrine Syrup

[0031] This study selected 1 batch of samples produced by manufacturer 1; 4 batches of samples produced by manufacturer 2; 1 batch of samples produced by manufacturer 3, a total of 6 batches of compound bellflower ephedrine syrup.

[0032] TLC identification of Campanulaceae

[0033] The proposed method is as follows: Take 60ml of this product, shake and extract 3 times with ethyl acetate, 60ml each time, let stand and separate, combine the ethyl acetate layer, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution; Take another 1g of bellflower reference medicinal material, add methanol 50ml, ultrasonically extract for 30min, filter, take the filtrate and evaporate to dryness, add 60ml of water to dissolve the residue, start from "extraction by shaking with ethyl acetate 3 times", and prepare the bellflower reference medicinal material solution by the...

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Abstract

The invention discloses a quality control method for compound platycodon grandiflorum ephedrine syrup. According to the method, problems existing in the conventional compound platycodon grandiflorum ephedrine syrup related preparation quality detection method are improved, and the method mainly comprises the following steps: adding thin-layer chromatography of platycodon grandiflorum, polygala tenuifolia and ephedrine hydrochloride, determining the content of the ephedrine hydrochloride by adopting HPLC (High Performance Liquid Chromatography), and determining the ammonium chloride content by adopting nitrogen determination. The quality control method disclosed by the invention is reasonable in design, accurate, reliable, high in specificity and simple to operate, and then a novel quality control standard of the compound platycodon grandiflorum ephedrine syrup is established, so that the drug quality in production, circulation, usage and other links of the compound platycodon grandiflorum ephedrine syrup can be helped to be effectively controlled, the quality level is improved, the controllable production process is ensured, the clinical using safety is ensured, and a reliable guarantee is stably and exactly provided for curative effects of the product.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, and in particular relates to a quality control method of compound bellflower ephedrine syrup. Background technique [0002] Compound Platycodon grandiflorum ephedrine syrup (Part I) antitussive and expectorant medicine, once called Xinning cough syrup, was recorded in the local standard of Zhejiang Province in 1993, and the current standard is "National Drug Standards". Seven volumes. Hubei Shengtong Pharmaceutical Co., Ltd. was the first to obtain approval in China, and it was listed in China in 1981. In 1982, many enterprises obtained approval numbers. At present, there are 21 domestic production enterprises with 21 approval numbers. [0003] In view of the fact that the current standards are relatively old and there are many missing items, there is a lack of identification or content control methods for the main components of ephedrine hydrochloride, ammonium chloride, poly...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02G01N31/00
CPCG01N30/02G01N30/90G01N31/002
Inventor 卢日刚朱健萍赵庄谭菊英朱荣孙煜奉艳花杨娜
Owner 广西壮族自治区食品药品检验所
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