新加香薷颗粒制备及质量标准研究

Study on the preparation and quality standard of Elsholtzia supplements

目的优化新加香薷颗粒剂制备工艺,并进行新加香薷颗粒质量控制研究。方法经方义衍化、古代煎煮方法对提取工艺进行研究,采用高效液相色谱法建立尊古煎煮新加香薷饮指纹图谱,并优选出新加香薷饮最佳提取工艺,建立处方含量测定方法;优选其制剂工艺参数,随后采用TLC法、HPLC法对其进行质量控制。结果新加香薷颗粒的最优提取工艺为:加水量为12倍,提取次数为3次,每次提取时间为1h。新加香薷颗粒的最佳制剂工艺为:以糊精为辅料,浸膏与辅料的比例为1∶1.2,85%乙醇为润湿剂,干燥温度为50~60℃。初步建立了新加香薷颗粒的质量标准,其方法简易可行。结论建立了新加香薷饮古法煎煮汤剂的指纹图谱,得出新加香薷颗粒的最优提取工艺和最佳制剂工艺,初步建立了新加香薷颗粒的质量标准。

Objective Optimisation of the preparation process of Elsholtzia sp.granules and quality control study of Elsholtzia sp.granules.Methods The extraction process was investigated by the derivation of the formulae and ancient decoction methods,and the fingerprints of the Zungu decoction of Elsholtzia sp.were established by high performance liquid chromatography(HPLC).The optimal extraction process of Elsholtzia sp.was optimised,and a method for the determination of the content of the prescriptions was established;the parameters of the preparation process were preferred,and then the quality control was carried out by the TLC method and the HPLC method.Results The optimal extraction process of Elsholtzria sp.granules was as follows:the amount of water added was 12 times,the number of extraction times was 3,and the extraction time was 1 h.The optimal preparation process of Elsholtzia sp.granules was as follows:dextrin was used as excipient,and the ratio of the maceration paste to the excipient was 1∶1.2;85% ethanol was used as a wetting agent,and the drying temperature was 50~60℃.The results were as follows.The quality standard of Elsholtzia sp.granules was initially established,and the method was simple and feasible.Conclusion The fingerprints of the ancient decoction of Elsholtzia sp.nobilis drink were established,the optimal extraction process and the optimal preparation process of Elsholtzia sp.nobilis granules were derived,and the quality standard of Elsholtzia sp.nobilis granules was preliminarily established.