论文部分内容阅读
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。
OBJECTIVE: To establish a method for the objective evaluation of the quality of snake bile in the preparation of snakebread and tangerine peel preparations, and to analyze and evaluate the quality of snake bile in 130 batches of snake-gall-dried tangerine peel preparations, providing a reference for its quality control. Methods: Thin-layer chromatography was used to identify the snake bile in the preparation of snake-gall-dried tangerine peel. The contents of taurocholic acid in snake gall-free dried tangerine peel preparations were determined by HPLC-ELSD . Results: The TLC identification method was more specific and had more abundant spots information in snake bile. The content, precision, accuracy, specificity and repeatability of taurocholic acid in snake gall-dried tangerine preparation were determined by HPLC-ELSD The content of taurocholic acid in different groups of snakebread and tangerine peel preparations were quite different, and the quality of products of snake gall and calafel preparations of different enterprises differed. Conclusion: The established method for quality analysis provides a scientific basis for the quality control of snake bile in the preparation of snake gall-free tangerine peel preparations.