白斑乳膏(Ⅰ)的制备与质量控制

The preparation and quality control of Leukoplakia Cream( Ⅰ)

目的制备白斑乳膏(Ⅰ)并建立质量控制标准。方法乳化法制备白斑乳膏(Ⅰ),采用HPLC梯度洗脱,测定四种主要成分的含量。结果该乳膏外观性状、微生物限度检查、稳定性等均符合相关要求,盐酸达克罗宁、黄芩苷、维生素E、己烯雌酚在各自线性范围内与峰面积呈良好的线性关系,平均加样回收率:盐酸达克罗宁为100.42%,RSD为0.77%,黄芩苷为100.49%,RSD为0.68%,维生素E为100.46%,RSD为0.85%,己烯雌酚为100.06%,RSD为0.82%。结论本制剂工艺简单,所得制剂性质稳定,质量可控,质量测定方法简便、快捷、准确。

Objective To Prepare Leukoplakia Cream （I） and to establish its quality control method. Methods Emulsion process was used to compound Leukoplakia Cream （I）. HPLC method was developed to detetxuine the compounds of Leukoplakia Cream （I）. Results The quality of cream was eligible in appearance properties,microbial limit,and stability. As for Dyclonine hydrochloride, baicalin, diethylstilbestrol, vitamin E, their concentration and peak area displayed good linear relationship. The average recovery rates ： dy clonine hydrochloride was 100. 42% , RSD was 0. 77% ;baicalin was 100. 49% , RSD was 0. 68% ; diethylstilbestrol was 100. 06% , RSD was 0. 82% ,vitamin E was 100. 46% ,and RSD was 0. 85%. Conclusion The preparation process is simple. The quality of the prepa ration is controllable,and the properU is stable. The method of content determination is also simple, rapid and accurate.