丁苯乳膏的制备与质量控制  

Preparation and quality control of Hydrocortisone Butyrate and Diphenhydramine Hydrochloride Cream

作　　者：万梅玲[1] 魏志平[2] 曾缘缘[1] 姬怀雪[1] 邵珠民[1] 王艳[1] 

机构地区：[1]徐州医学院附属医院药剂科,徐州221002 [2]徐州医学院附属医院皮肤科,徐州221002

出　　处：《海峡药学》2013年第10期10-12,共3页Strait Pharmaceutical Journal

摘　　要：目的制备丁苯乳膏,建立质量控制方法。方法以丁酸氢化可的松和盐酸苯海拉明为主药制成乳膏剂,采用高效液相色谱法测定两主药的含量,并建立相关质控标准。结果丁苯乳膏制剂稳定,质量可靠,丁酸氢化可的松的平均回收率为98.77%,RSD为1.01%(n=6);盐酸苯海拉明平均回收率为99.33%,RSD为0.68%(n=6)。结论该制剂制备工艺简单,质量稳定,质量控制方法准确可靠。OBJECTIVE To Prepare Dingben cream, and establish quality control method. METHODS Hy- drocortisone butyrate and diphenhydramine hydrochloride were used as the two main drugs to made cream and the content Dingben cream was determined by HPLC. Quality standard was established. RESULTS Dingben cream has stable and reliable. The average recovery of hydrocortisone butyrate was 98.77% ,RSD was 1.01% （n =6）. The av- erage recovery of diphenhydramine hydrochloride was 99. 33 %. RSD was 0. 68% （ n = 6）. CONCLUSION The design of the preparation is rational, and manufacturing technique is simple. The preparation quality is stable. The method of the quality control is accurate and reliable.

关 键 词：丁酸氢化可的松 盐酸苯海拉明 乳膏剂 制剂 质量控制 

分 类 号：TQ460.4[化学工程—制药化工] R927.11[医药卫生—药学]