李军山 李雪利 高杰 高晗 张肖建 孙福仁

摘要  目的：对蛇床子饮片进行标准汤剂制备，并研究其质量标准。方法：按照中药配方颗粒质量控制与标准制定技术要求中的相关规定，对15批产自不同地区的蛇床子饮片进行标准汤剂制备，对其主含成分蛇床子素进行含量测定，计算15批标汤的出膏率及蛇床子素的含量转移率，并对高效液相色谱法（HPLC）特征图谱进行方法建立。结果：蛇床子素转移率为3.35% ～6.09%，出膏率为14.10% ～19.93%。对特征谱图中的8个特征峰中的5个色谱峰进行了指认。结论：蛇床子饮片标准汤剂符合中药配方颗粒质量控制与标准制定技术要求中的相关规定，测定方法精密度、稳定性和重复性良好，可以为蛇床子配方颗粒的质量控制提供参考。

关键词  蛇床子;蛇床子素;标准汤剂;转移率;出膏率;含量测定;特征图谱;中药化学

Study on Quality Standard of Standard Decoction of Based on Shechuangzi Formula Granules

LI Junshan1，2，LI Xueli1，GAO Jie1，GAO Han1，ZHANG Xiaoian1，SUN Furen1

（1 Shineway Pharmaceutical Group Co.，Ltd.，Shijiazhuang 051430，China; 2 TCM Formula Granule Engineering Technology Research Center of Hebei，Shijiazhuang 050091，China）

Abstract Objective： To prepare the standard Shechuangzi Decoction Pieces and study its quality standard. Methods： According to the relevant provisions of the technical requirements for the quality control and standard formulation of Chinese medicine formula granules，a total of 15 batches of Shechuangzi Decoction Pieces from different origins were prepared for standard decoction.The content of osthole in its main component was determined，the cream extraction rate and the content transfer rate of osthole in 15 batches of standard decoction were calculated，and the HPLC characteristic map method was developed. Results： By analyzing the determination results of 15 batches of standard decoction of Shechuangzi Decoction Pieces，the transfer rate of osthole ranged from 3.35% to 6.09%.The extraction rate was 14.10%-19.93%.A HPLC characteristic atlas analysis was established，and 5 chromatographic peaks were identified from 8 characteristic peaks in characteristic atlas. Conclusion： The standard decoction of Shechuang zi Decoction Pieces meets the relevant regulations in the technical requirements for quality control and standard formulation of Chinese medicine formula granules.The determination method has good precision，stability and repeatability，and can provide reference for the quality control of the Shechuangzi Formula Granules

Keywords  Fructus Cnidii; Osthole; Standard decoction; Transfer rate; Extraction rate; Determination of content; Characteristic chromatograms; Chemistry of Chinese medicine

中圖分类号：R283 文献标识码：A  doi： 10.3969/j.issn.1673-7202.2020.14.005

蛇床子为伞形科植物蛇床 Cnidium monnieri （L.）Cuss.的干燥成熟果实，又名蛇米（《本经》）、蛇珠（《吴普本草》）、蛇床仁（《药性论》）、野茴香（江西《草药手册》）等。始载于《神农本草经》，列为上品[1-2]，李时珍谓：“蛇虺喜卧子下食其子，故有蛇床、蛇粟诸名”。香豆素类成分为蛇床子的主要药效成分，其中蛇床子素含量最高，约占总香豆素的60%，其他香豆素类成分有水合橙皮内酯、花椒毒素、花椒毒酚、欧芹属素乙、佛手柑内酯、白芷素等。用于阴痒带下，湿疹瘙痒，湿痹腰痛，肾虚阳痿，宫冷不孕。用量3～10 g，外用适量，多煎汤熏洗，或研末调敷[3-5]。研究表明，蛇床子对中枢神经系统、心血管系统、内分泌系统、免疫系统等均具有好的作用，常用于治疗外科、妇科、皮肤等方面的疾病[6]。……