舒乳凝胶的质量标准研究

Quality Standard for Shuru Gel(舒乳凝胶)

目的：建立舒乳凝胶的质量控制方法 。方法：采用TLC法对方中丁香、胡椒进行定性鉴别。采用HPLC法测定桂皮醛含量,流动相为乙腈-水（35：75）,检测波长为290 nm。结果：TLC分离效果好,斑点清晰,阴性对照无干扰。桂皮醛在0.01464-0.0732μg,线性关系良好（r=0.99995）,平均回收率95.76%。结论：该方法简便准确,重复性好,能用于该产品的质量控制。

Objective： To establish a method for quality control of Shuru Gel （舒乳凝胶）. Methods： Caryophyllata Flos, Piperis Fruetus were identified by TLC. The content of einnamic aldehyde was determined by HPLC method with the mobile phase consisting of acetonitrile and water （35：75） and the detection wavelength was set at 290 nm. Results： TLC spots were clear and the blank test showed no interference. The linear range of cinnamic aldehyde was 0.01464～0.0732 μg, r=0.99995. The average recovery was 95.76%. Conclusion： The method for quality control is accurate and reliable, and can be used to control the quality of this preparation effectively.