经方化裁射麻汤煮散工艺优化与质量标准研究

Study on Process Optimization and Quality Standard of Shematang Boiling Powder by Modified Classical Prescription

目的:优化射麻汤煮散工艺,并建立煮散内控标准。方法:应用正交试验(工艺粉碎度、煎煮时间、加水量)优化煎煮工艺,采用薄层色谱法(TLC)定性鉴别煮散中的射干和麻黄,采用高效液相色谱法(HPLC)定量考察煮散中的盐酸麻黄碱和盐酸伪麻黄碱。结果:优选的工艺条件为饮片粉碎过40目筛,加12倍量水,煎煮5 min;建立射干和麻黄的TLC鉴别方法,色谱斑点清晰,分离度好;含测分析显示,盐酸麻黄碱在0.0862~0.8616μg内呈良好线性关系(r=0.9998),平均回收率为101.19%,RSD=2.50%;盐酸伪麻黄碱在0.0408~0.4076μg内呈良好线性关系(r=0.9994),平均回收率为100.39%,RSD=2.59%。结论:优化的射麻汤煮散工艺合理稳定,质量控制方法简单,准确度高,重现性好,可有效控制射麻汤煮散的质量。

Objective To optimize the process of Shematang boiling powder,and to establish the Internal control standards of boiling powder.MethodsOrthogonal test was used to optimize the extraction process.Thin-layer chromatography(TLC)was used for the qualitative identification of Belamcandae Rhizoma and Ephedrae Herba in the boiling powder,and High-performance liquid chromatography(HPLC)was used for the Quantitative investigation of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride.Results The optimal process conditions was as follows:the medicinal pieces are crushed and passed through a 40-mesh sieve,add 12 times the amount of water,and decocted for 5 minutes;established TLC method of Belamcandae Rhizoma and Ephedrae Herba showed that chromatographic spots were clear with good resolution;the study of content determination showed that the linear range of Ephedrine hydrochloride was 0.0862-0.8616μg(r=0.9998)which indicated the linearity of this method was all right.The average recovery of them were 101.19%and the RSD=2.50%;the linear range of Pseudoephedrine Hydrochloride was 0.0408-0.4076μg(r=0.9994)which indicated the linearity of this method was all right.The average recovery of them were 100.39%and the RSD=2.59%.Conclusion The optimized technology of Shematang boiling powder is reasonable and stable,the quality control method is simple and has good accuracy and repeatability,and can be effectively used for the quality control of Shematang boiling powder.