小儿外用健脾散质量标准研究  

Study on Quality Standards of Children's External Spleen-invigorating Powder

作　　者：叶慧[1] Ye Hui(Taizhou Institute for Food and Drug Control,Taizhou 225300,China)

机构地区：[1]泰州市食品药品检验所,山东泰州225300

出　　处：《亚太传统医药》2018年第10期59-61,共3页Asia-Pacific Traditional Medicine

摘　　要：目的:提高和完善小儿外用健脾散的质量标准。方法:采用薄层色谱法对方中丁香、肉桂、山柰进行定性鉴别;采用中国药典附录方法对浸出物进行测定;采用HPLC法测定肉桂中桂皮醛的含量,色谱条件:色谱柱为Waters Symmetry C_(18)柱(150mm×4.6mm,3.5μm),流动相为乙腈-水(35∶75),柱温为35℃,流速为1.0mL·min^(-1),检测波长290nm。结果:薄层鉴别色谱斑点清晰,分离度较好。HPLC显示桂皮醛在20.32～254μg范围内呈现良好的线性关系(r=1.0),平均回收率为101.5%,RSD为1.3%(n=6)。结论:该方法操作简便、准确,专属性强,重复性好,可用于小儿外用健脾散的质量控制。Objective. To improve the quality standard of children＇s external use spleen-invigorating powder. Methods. Qualitation discrimination of Flos Caryophylli, Cinnamon and Kaempferia galanga, in this prescription were identified by TLC. The extractive was determined according to Appendix method in Chinese Pharmacopoeia. HPLC was performed to determine the contents of cinnamaldehyde. It was performed on column of Waters Symmetry ODS column（150mm×4. 6mm, 3.5μm）with mobile phase of acetonitrilewater （35 ： 75）. in linear gradient elution mode at the flow rate of 1.0 mL · min^-1 ,the detection wavelength of 290 nm,the column temperature of 35℃. Results ： TLC spots were clear and well-separated. The HPLC experiment results showed the good linearities in the range of 20.32 - 254μg （r = 1.0） for cinnamaldehyde, and the average recovery rate was 101.5 %, and RSD was 1.3 % （ n = 6）. Conclusion ： This method was convenient, accurate, with strong incificity and reproducibility, and suitable for the quality control of the Xiaoer external use spleen-invigorating powder.

关 键 词：小儿外用健脾散 桂皮醛 质量标准 薄层法定性鉴别 高效液相色谱 定量分析 

分 类 号：R289.5[医药卫生—方剂学]