| 摘要 |
[Objectives] To optimize the extraction and molding technology of Chengyin Mixture, an empirical prescription of Zhuang medicine, and to establish its quality control method. [Methods] An L₉(3⁴) orthogonal experimental design was adopted, with water addition amount, extraction time, and extraction times as investigative factors, and dry extract yield, transfer rate of forsythiaside, and transfer rate of chlorogenic acid as evaluation indices to optimize the process. Referring to the relevant methods specified in the Chinese Pharmacopoeia (2020 Edition), TLC identification and preparation inspections for Lonicerae Japonicae Flos, Forsythiae Fructus, and Glycyrrhizae Radix et Rhizoma were established. [Results] The optimal process was determined as follows: adding 10 times the amount of water, decocting twice, with one hour for each decoction. Validation tests showed that the mean dry extract yield was 24.24%, and the mean transfer rates of forsythiaside and chlorogenic acid were 71.86% and 69.48%, respectively, with all RSD values below 5%. TLC spots were clear with no negative interference. The properties, relative density, pH, filling volume, and microbial limits of three batches of pilot-scale samples all complied with the pharmacopoeia standards. [Conclusions] The optimized extraction process is stable and feasible, and the established quality standard is simple to operate and highly specific, which can be used for the quality control of Chengyin Mixture, providing a basis for its hospital preparation registration and standardized production. |
