【作者】 万梅玲； 魏志平； 曾缘缘； 姬怀雪； 邵珠民； 王艳；

【Author】 Wan Meiling,Wei Zhiping,WangYan,Zeng Yaunyuan, Shao Zhumin,JI Huaixue (Affiliated Hospital of Xuzhou Medical College ,1.Dept of Pharmacy,2.Department of Dermatology, Xuzhou 221002,Jiangsu,China)

【机构】 徐州医学院附属医院药剂科； 徐州医学院附属医院皮肤科；

【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。更多还原

【Abstract】 objective: To Prepare Dingben cream, and establish quality control method. Method: To make cream using hydrocortisone butyrate and diphenhydramine hydrochloride as the two main drugs. The content of Dingben cream was determined by HPLC, and the other quality standard was also established. Result: Dingben cream is stable and reliable. The average recovery of hydrocortisone butyrate was 98.77%, RSD was 1.01 % (n=6). The average 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.更多还原