蒙成药小儿清肺八味丸的质量控制方法研究

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。

Quality Control of Mongolia Drug Xiaoer Qingfei Bawei Pills

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 PicrosideⅠand PicrosideⅡin 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 picrosideⅠshowed 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 PicrosideⅡshowed 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.