HPLC测定丹参护肤面膜丹酚酸B含量及局部刺激性研究

Determination of salvianolic acid B content in Danshen Hufu facial mask by HPLC and mucosal irritation research

目的:建立丹参护肤面膜的质量标准,并进行安全性评价。方法:采用高效液相色谱法测定制剂中丹酚酸B的含量;通过家兔皮肤刺激性试验和眼睛刺激性试验考察其安全性。结果:丹酚酸B在0.146～1.606μg范围内线性关系良好,r=0.9999,平均回收率为98.8%,RSD值为1.35%;本品皮肤刺激性和眼睛刺激性试验均显示无刺激性。结论:该含量测定方法操作简便,结果可靠,重现性好,可用以控制丹参护肤面膜的质量,本品安全无毒。

Objective:To establish quality standard for Danshen Hufu facial mask and evaluate the safety.Method:HPLC was used to determine the content of salvianolic acid B in preparation.Skin and eye reaction tests on rabbit were applied to evaluate the safety.Result:The good linear was obtained in the concentration range of 0.146μg ～1.606μg(r=0.9999).The average recovery rate was 99.8%,and RSD was 1.35%(n=9).The results showed that no irritation was found in rabbit skin and eye.Conclusion:The HPLC method is simple,reliable,repeatable,and can be used to control the quality of Danshen Hufu facial mask.The Danshen Hufu facial mask is safe for use.