中文摘要：

目的：建立客观评价蛇胆陈皮制剂中蛇胆汁质量的分析方法,对130批蛇胆陈皮制剂中蛇胆汁的质量进行分析与综合评价,为其质量控制提供参考。方法：采用薄层色谱法对蛇胆陈皮制剂中的蛇胆汁进行薄层鉴别;并采用高效液相色谱-蒸发先散射检测（HPLC-ELSD）法对蛇胆陈皮制剂中牛磺胆酸的含量进行测定。结果：建立的薄层鉴别方法专属性较强,蛇胆汁的斑点信息较丰富;采用HPLC-ELSD法测定蛇胆陈皮制剂中牛磺胆酸的含量,精密度、准确性、专属性及方法重复性均良好;含量测定结果显示不同批次蛇胆陈皮制剂中牛磺胆酸的含量差异较大,不同企业的蛇胆陈皮制剂产品质量存在差异。结论：所建立的质量分析方法为蛇胆陈皮制剂中蛇胆汁的质量控制提供了科学依据。

英文摘要：

OBJECTIVE To establish methods for the quality evaluation of snake bile in130 batches of Shedan Chenpi Preparation,and provide a reference for quality control.METHODS Snake bile in Shedan Chenpi Preparation was identified by TLC and the contents of taurocholic acid in Shedan Chenpi Preparation were determined by HPLC-ELSD.RESULTS The TLC identification method was specific,and the information of snake was abundant.The HPLC-ELSD method for taurocholic acid test had good precision,accuracy,specificity and reproducibility.The compositions of volatile compounds in different dosage forms were similar,while the relative contents were quite different.The contents of costunolide and dehydrocostuslactone in Shedan Chenpi preparation were different.The results showed that the content of taurocholic acid was different in different batches of Shedan Chenpi Preparation or different manufacturers.CONCLUSION The established method can provide a guidance for quality control of snake bile in Shedan Chenpi Preparation.