滋益颗粒的工艺研究及质量标准的建立

Process Research and Quality Standards of Ziyi Granules

目的优选颗粒的提取工艺与制备工艺,初步建立该颗粒剂的质量标准及指纹图谱。方法采用水煎煮法对滋益汤进行提取,通过正交试验设计对煎煮时间、煎煮次数和加水量进行考察,优选滋益颗粒的提取工艺;以浸膏为原料,对辅料及粘合剂进行单因素考察。采用TLC对滋益颗粒进行定性鉴别。结果最佳提取工艺为处方药材加8倍水,提取2次,每次1 h。最佳制备工艺为干浸膏粉与糊精混合,以75%乙醇湿润,制粒;TLC图斑点清晰、重现性好、阴性无干扰。结论提取工艺合理、可行,薄层鉴别方法简单可靠,为该复方的开发利用提供试验依据。

Objective To optimize the extraction process and preparation process of the granules,and to establish the quality standard and fingerprint of the granules.Methods The extraction of Ziyi decoction was carried out by water decoction method.The boiling time,the number of boiling times and the amount of water added were investigated by orthogonal design.The extraction process of Ziyi granules was optimized.The extracts were used as raw materials and auxiliary materials.The adhesive was investigated by a single factor.The TLC was used to qualitatively identify the Ziyi granules.Results The optimaL extraction process was to add 8 times water to the prescription medicinal materials and extract 2 times for 1 hour each time.The best preparation process was that the dry extract powder was mixed with dextrin,wetted with 75%ethanol,and granulated;the TLC chart had clear spots,good reproducibility,and no negative interference.Conclusion The extraction process was reasonable and feasible,and the thin layer identification method was simple and reliable.which provided experimental basis for the development and utilization of the compound.