复方酸枣仁汤颗粒的制备与质量控制

Preparation and Test of Primary Stability of Ziziphus JuJuba Mill

目的:制备酸枣仁颗粒,建立质量控制标准。方法:优化制备工艺,采用薄层扫描法测定酸枣仁皂苷A,B的含量。结果:制备的酸枣仁颗粒成型性及溶化性均符合要求,含量测定方法准确可靠。初步稳定性考察结果表明该制剂较稳定。但在高湿条件下易吸湿,应在干燥条件下保存。结论:酸枣仁颗粒符合质量要求,质控方法简便、准确、可行。

Objective: To prepare the Ziziphus jujuba Mill(ZJM) granules, establish a quality control method, and conduct the primary investigations on its stability. Method: The technology of preparation was optinized, the quality standard of the content determination for jujuboside A,B was established by TLC scanning method. The primary investigation of ZJM granules stability was conducted. Result: The shaping ability and dissolvability of the prepared ZJM granules were in accord with the requirement. The content determining method was accurate and reliable. The result showed that this preparation was stable by the investigation of primary stability. Conclusion: The ZJM granules met the quality requirement and the method for quality control were simple, accurate and feasible. This granules were able to ABSorb moisture, so it must be preserved under dry condition.