目的 制定小儿清肺颗粒（茯苓、清半夏、川贝母、百部等）的质量标准。方法 采用薄层色谱法（TLC）法对小儿清肺颗粒中茯苓、川贝母进行定性鉴别；采用高效液相色谱-蒸发光散射法（HPLC-ELSD）对小儿清肺颗粒中川贝母的有效成分贝母辛和贝母素乙同时进行定量测定，采用Comatex C18色谱柱（250 mm×4.6 mm，5 μm），流动相为乙腈-0.02 %三乙胺水溶液，梯度洗脱，流速为1.0 mL·min-1，漂移管温度90 ℃，雾化室温度35 ℃，载气压力46.2 psi。结果 茯苓、川贝母的薄层斑点清晰，分离度好，专属性强，阴性对照无干扰。贝母辛在2.380～23.800 μg范围内，其进样质量的常用对数（X）与峰面积积分值的常用对数（Y）具有良好的线性关系（r=0.9996），平均加样回收率为99.6 %，RSD为0.20 %；贝母素乙在1.440～14.400 μg范围内，其进样质量的常用对数（X）与峰面积积分值的常用对数（Y）具有良好的线性关系（r=0.9997），平均加样回收率为99.4 %，RSD为0.43 %。结论 所建立的方法可靠、准确、专属性强，可用于小儿清肺颗粒的质量控制。

Objective To establish the quality standard for Xiao’er Qingfei Granules（mainly composed of Poria，Rhizoma Pinelliae，Bulbus Fritillariae Cirrhosae，Radix Stemonae）. Methods TLC was used for the qualitative identification of Poria and Bulbus Fritillariae Cirrhosae. HPLC-ELSD was used to simultaneously determine the contents of peimisine and peiminine in Xiao’er Qingfei Granules. The samples were separated on a Comatex C18（250 mm×4.6 mm，5 μm） column by gradient elution using acetonitrile-0.02 % triethylamine as the mobile phase with the flow rate of 1.0 mL·min-1. The temperature of the drift tube and atomizer chamber was 90 ℃ and 35 ℃，respectively，and the gas pressure was 46.2 psi. Results The developed TLC spots for Poria and Bulbus Fritillariae Cirrhosae were clear，separation was good and specific，and the negative test showed no interference. Peimisine showed a good linear relationship in the range of 2.380~ 23.800 μg（r=0.9996）. Its average recovery was 99.6 %，and RSD was 0.20 %. Peiminine showed a good linear relationship in the range of 1.440 ~ 14.400 μg（r=0.9997）. Its average recovery was 99.4 %，and RSD was 0.43 %. Conclusion The method is reliable，accurate and specific，and can be used for the quality control of Xiao’er Qingfei Granules.

R284.1