古代经典名方泻白散基准样品制备工艺研究

Study on the Preparation Technology of Material Benchmark of Xiebai San

通过试验考察,确定古代经典名方泻白散基准样品的制备工艺,为进一步研究开发其复方制剂提供依据。方法:采用超高效液相色谱法建立含量测定方法,以出膏率、浸出物以及有效成分地骨皮乙素、桑皮苷A、甘草苷和甘草酸含量作为评价指标,确定最佳制备工艺,并验证其稳定性与可行性。结果:通过试验考察了饮片粒度、煎煮容器材质、浸泡时间、煎煮时间对出膏率、浸出物和有效成分含量的影响,最终确定制备工艺为:取炒桑白皮2.95 g、地骨皮2.95 g和炒甘草0.30 g,粉碎过10目筛,加入粳米2 g,置陶瓷锅中,加水300 mL,浸泡30 min,200 W煎煮30 min,至煎液约180 mL,过滤,即得泻白散基准样品,并通过工艺验证证明了制备工艺的稳定性和可行性。结论:通过试验考察,确定泻白散的现代化制备工艺并进行了工艺验证,为复方制剂的制备研究提供了科学依据。

Objective:The experimental investigation was conducted to determine the preparation process of the benchmark sample of the ancient classical formula Xiebai San,which provides the basis for further development of the compound preparation application.Methods:The content determination method was established by UPLC,and the content of paste yield,leachate and the active ingredients kukoamine B,mulberry A,glycyrrhizin,glycyrrhizic acid were used as evaluation indexes to determine the best preparation process and to verify its stability and feasibility.Results:The effects of particle size,decoction vessel material,soaking time and decoction time on the rate of paste,leachate content and active component content were investigated,and the preparation process was finally determined as follows:take 2.95g of fried Cortex Mori,2.95g of Cortex Lycii and 0.30 g of fried Glycyrrhizae Radix et Rhizoma,crushed and passed through 10 mesh sieve,add 2g of Japonica rice,put in a ceramic pot,add 300mL of water,soak for 30min,200W The decoction was boiled for 30min until the decoction was about 180mL,filtered,and the baseline sample of Xiebai San was obtained.The stability and feasibility of the preparation process were also proved by process verification.Conclusion:Through experimental investigation,the modernized preparation process of Xiebai San was determined and the process validation was carried out to provide a scientific basis for the research and development of the compound preparation.