桔贝合剂质量标准研究

Investigation of Quality Standard for Jubei Mixture

目的建立桔贝合剂的质量控制标准。方法用薄层色谱(TLC)法鉴别方中的浙贝母和枇杷叶,用高效液相色谱(HPLC)法测定制剂的黄芩苷含量。结果TLC法专属性强,黄芩苷进样量线性范围为0.02002～0.6006μg,r=0.9999(n=5),平均回收率为99.78%,RSD为1.30%(n=6)。结论定性定量方法简便、准确,重现性好,可作为桔贝合剂的质量控制标准。

Objective To establish the quality standard of Jubei Mixture. Methods To identify Bulbus Fritillariae Thunbergii and loquat leaf by TLC. Baicalin was determined by HPLC. Results The characteristic of identification by TLC was distinct and highly specific, the linear range of baicalin was 0. 020 02 -0. 600 6 μg, r=0. 999 9（ n =5）, the average recovery rate was 99.78%, RSD = 1.30% （ n =6）. Conclusion The method is easy to operate with accurate result and good reproducibility. It can be used effectively for the quality control of the preparation.