黄芩乳膏制备工艺及质量标准研究

目的确定黄芩乳膏的最佳制备工艺和质量标准。方法采用正交设计法,以所制乳膏外观及高速离心后油层高度为考察指标,对黄芩乳膏的制备工艺进行优选,并采用薄层色谱法以及HPLC对黄芩乳膏进行定性定量鉴别。结果以搅拌方式为变速(混相成乳时以720 r/min搅拌,继以120 r/min搅拌),油相与水相比为30:70;成相温度为90℃为最佳条件。黄芩苷进样浓度在15.81~252.96μg/mL(r=1.0000)范围内线性良好,平均回收率为101.1%,RSD为1.1%(n=6)。结论所确定的制备工艺合理,质量控制较全面。

Preparation and Quality Control of Scutellaria Cream

Objective Determine the best preparation process on Scutellaria cream and quality standards.Methods Optimize the preparation process by using the orthogonal design method and the appearance of the reservoir height of the indexes after high-speed centrifugal cream,and using TLC and HPLC method to evaluate its qualitative and quantitative identification.Results The best conditions are variable speed（when mixed with milk to 720 r/min mixing complementary to each other,then mixing by 120r/min）,the oil phase and water was compared to 30：70;into phase temperature of 90 ℃.Baicalin has good linearity when concentration in the range of 15.81~252.96 μg/mL（r=1.0000）,the average recovery was 101.1%,RSD of 1.1%（n=6）.Conclusion The preparation process was reasonable and the quality control more comprehensive.