Objective To preliminarily screen the preparation process of Feire Zhike Granules and establish the quality standards.Methods Using the L9(34)orthogonal design experimental method,the effects of soaking time,extraction time,and water addition on the transfer rate of baicalin and the yield of dry extract were investigated to optimize the optimal extraction process for Feire Zhike Granules.The types of excipients were investigated based on the evaluation indicators of soft material preparation,particle yield,angle of repose,and meltability,and the formulation molding process was optimized.Thin layer chromatography(TLC)was used to qualitatively identify Chenpi and Sangbaipi,and high-performance liquid chromatography(HPLC)was used to determine the content of baicalin in the granules.Results The optimal extraction process was as follows:soaking for 0.5 h,adding 8 times and 6 times of water,respectively,and heating and refluxing for 0.5/0.25 h,and the best excipient was dextrin.The TLC spots were clear,well separated,negative without interference,and highly specific.Baicalin showed a good linear relationship with peak area in the concentration range of 0.0075-0.75 μg/mL,with an average recovery rate of 99.137%,the average content of Baicalin in Feire Zhike Granules was 8.25 mg/g.Conclusion The process is stable and feasible,and the established TLC and HPLC methods are highly specific,sensitive,and reproducible,which will lay the foundation for subsequent research and development and quality control.
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