双黄解毒乳膏质量标准研究

Quality Standard of Shuanghuang Jiedu Cream

目的:建立双黄解毒乳膏的质量标准。方法:采用薄层色谱法对制剂中的黄芩和关黄柏进行定性鉴别;采用高效液相色谱法对制剂中的黄芩苷含量进行定量分析。结果:定性鉴别方法能同时鉴别黄芩、关黄柏,专属性强,分离度好。黄芩苷进样浓度在80.0～400.0μg·mL-1范围内与峰面积积分值呈良好线性关系(r=0.9998);平均回收率为97.3%,RSD=1.3%(n=9)。结论:所建标准可用于双黄解毒乳膏的质量控制。

OBJECTIVE： To establish the quality standard of Shuanghuang jiedu cream. METHODS： Scutellaria baicalensis and Phellodendron chinensis were identified qualitatively by TLC and the content of baicalin was determined by HPLC. RESULTS： The qualitative identification can be used to identify S. baicalensis and P. chinensis simultaneously. It is specific and well separated. The linear range of baicalin were 80.0 μg·mL-1 and 400.0 μg·mL-1（r=0.999 8）with an average recovery of 97.3% （RSD=1.3%,n=9）. CONCLUSION： Established method be used for the quality control of Shuanghuang jiedu cream.