Quality control method of compound platycodon grandiflorus ephedrine syrup (II)

Abstract

The invention discloses a quality control method of compound platycodon grandiflorus ephedrine syrup (II). The problems of an existing quality detection method of related reagents of the compound platycodon grandiflorus ephedrine syrup (II) are improved, thin-layer identification of ephedrine hydrochloride and platycodon grandiflorus are mainly added, a headspace capillary gas chromatographic method is adopted for content measurement of menthol and ethyl alcohol, an HPLC method is adopted for content measurement of the ephedrine hydrochloride, and a nitrogen determination method is adopted forcontent measurement of ammonium chloride. The quality control method is reasonable in design, accurate, reliable, high in specificity and easy to operate, a novel quality control standard of the compound platycodon grandiflorus ephedrine syrup (II) is built according to the quality control method and can help to effectively control the medicine quality and improve the quality level of medicine inthe steps such as production, circulation and usage of the compound platycodon grandiflorus ephedrine syrup (II), it is guaranteed that the production technology is controllable and the clinical application is safe, and reliable guarantee is provided for the stable and precise product therapeutic effect.

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 (II). Background technique [0002] Compound Platycodon grandiflorum ephedrine syrup (II) (Part II) used to be called children's cough syrup, children's cough syrup, children's cough syrup, children's cough syrup, children's cough syrup, children's cough, etc. The current standard is "National Drugs "Standards" local standards for chemicals have been upgraded to the 14th volume of national standards. Chengdu Century Huayang Pharmaceutical Co., Ltd. was first approved to go public in China in 1981. In 1982, many enterprises obtained approval numbers. At present, there are 7 domestic production enterprises with 7 approval numbers. [0003] There are gaps in the current standard testing items for Compound Bellflower Ephedrine Syrup (II), and there are no relevant preparation method descri...

AI Technical Summary

Problems solved by technology

[0003] There are gaps in the current standard testing items for Compound Bellflower Ephedrine Syrup (II), and there are no relevant preparation method descriptions or requirements for Chinese medicine extracts such as Bellflower Liquid Extract and Fennel Water; there is a lack of identification and content control items for Bellflower Liquid Extract , there is no specific requirement on the content of menthol, sucrose, and preservatives; the assay method of ephedrine hydrochloride is UV method, and the pretreatment method is loaded down with trivial details, and the specificity of the method is poor

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.

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