赵丽娜 籍学伟 王玉华

【摘 要】 目的：建立蒙成药小儿清肺八味丸的质量控制方法。方法：采用薄层色谱法对小儿清肺八味丸中红花、麦冬、拳参、人工牛黄、胡黄连进行定性鉴别;采用高效液相色谱法测定胡黄连中胡黄连苷Ⅰ和胡黄连苷Ⅱ的含量。结果：薄层鉴别方法专属性强，特征斑点清晰，阴性对照无干扰;胡黄连苷Ⅰ在3.8～76μg/mL范围内与峰面积呈良好线性关系（r=0.9999），平均回收率为99.71%，RSD为1.03%;胡黄连苷Ⅱ在8.4～168μg/mL范围内与峰面积呈良好线性关系（r=0.9999），平均回收率为103.30%，RSD为1.95%。结论：所建立的定性、定量分析方法简便、准确、灵敏度高，可用于小儿清肺八味丸的质量控制。

【关键词】 小儿清肺八味丸;薄层色谱法;高效液相色谱法

【中图分类号】R917 【文献标志码】 A 【文章编号】1007-8517（2020）3-0027-06

Abstract：Objective To establish the quality control method of Xiaoer Qingfei Bawei Pills.Methods Carthami flos、Ophiopogonis radix、Bistortae rhizoma、Bovis calculus artifactus and Picrorhizae rhizoma in Xiaoer Qingfei Bawei Pills were identified by TLC.The contents of Picroside Ⅰ and Picroside Ⅱ in Picrorhizae rhizoma were determined by HPLC.Results The identification method was exclusive.The TLC spots were fairly clear，and the blank test showed no interference.The picroside Ⅰ showed a good linearity in the range of 3.8～76μg/mL（r=0.9999）.The average recovery was 99.71%，and RSD was 1.03%.The Picroside Ⅱ showed a good linearity in the range of 8.4～168μg/mL（r=0.9999）.The average recovery was 103.30%，and RSD was 1.95%.Conclusion The established qualitative and quantitative methods are simple、accurate and sensitive， which can be used in the quality control of Xiaoer Qingfei Bawei Pills.

Keywords：Xiaoer Qingfei Bawei Pills;TLC;HPLC

蒙成藥小儿清肺八味丸（蒙名：胡勒森竹岗-8）收载于《卫生部药品标准》蒙药分册第63页[1]，是蒙医常用儿科用药，由天竺黄、北沙参、红花、胡黄连、牛黄、拳参、檀香、麦冬八味药材制成，具有清肺热、止咳定喘的功效，用于小儿肺热、发烧、咳嗽、气促、瘟疫热盛等症。小儿清肺八味丸现行质量标准只收载了【性状】及【检查】项，无【鉴别】和【含量测定】项，现行标准水平低且不完善。为提高现行质量标准，该实验采用TLC法和HPLC法分别对小儿清肺八味丸薄层色谱鉴别方法和含量测定方法进行研究，并建立红花、麦冬[2]、拳参、人工牛黄、胡黄连[3]等五味药材的薄层鉴别方法及高效液相色谱测定胡黄连化学成分的含量测定方法。

1 仪器与材料

1.1 仪器 戴安U-3000型高效液相色谱……