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Development of the chromatographic fingerprint of herbal preparations Shuang-Huang-Lian oral liquid.

机译:中药双黄连口服液色谱指纹图谱的研制。

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摘要

A simple, reliable and reproducible method, based on high performance liquid chromatography (HPLC), for developing chromatographic fingerprint of complex herbal medicine Shuang-Huang-Lian (SHL) oral liquid was described. Ten batches of SHL obtained from different pharmaceutical factories were used to establish the fingerprint. In addition, the contents of baicalin and chlorogenic acid, which are two marker constituents in the preparations, were also determined. Chromatographic fingerprint, together with the contents of the markers were applied for quality control of SHL. SHL comprises three kinds of medicinal herbs: Fols Lonicerae, Radix Scutellariae and Fructus Forsythiae. According to State Food and Drug Administration (SFDA) requirement, the chromatographic fingerprints of Fols Lonicerae, Radix Scutellariae and Fructus Forsythiae, the raw materials of SHL preparations, were also established. The data of fingerprints of SHL and its raw herbs established by HPLC were all processed with two kinds of mathematic methods including correlation coefficient and cosine value of vectorial angle to validate their similarities. In conclusion, fingerprints of Radix Scutellariae, Fols Lonicerae and Fructus Forsythiae are suitable for identification, differentiation of their geographic origins and quality control. The similarity of 10 batches of SHL oral liquid was more than 0.988, which showed the preparations from different pharmaceutical factories were consistent.
机译:描述了一种基于高效液相色谱(HPLC)的简单,可靠且可重现的方法,用于开发复杂草药双黄连(SHL)口服液的色谱指纹图谱。从不同制药厂获得的十批SHL用于建立指纹。此外,还测定了制剂中两个标志物成分黄ical苷和绿原酸的含量。色谱指纹图谱和标记物的含量一起用于SHL的质量控制。 SHL包括三种药草:金银花,黄cut和连翘。根据国家食品药品监督管理局(SFDA)的要求,还建立了SHL制剂原料药金银花,黄cut和连翘的色谱指纹图谱。 HPLC建立的SHL及其生药指纹图谱数据均采用相关系数和矢量角余弦值两种数学方法进行处理,以验证其相似性。总之,黄S,金银花和连翘的指纹图谱适用于鉴定,区分其地理起源和质量控制。 10批次SHL口服液的相似度均大于0.988,表明不同制药厂的制剂是一致的。

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