复方磺胺米隆凝胶的制备及质量控制

Preparation and quality control of compound mafenide gel

目的：建立复方磺胺米隆凝胶制备及质量控制方法。方法：以醋酸磺胺米隆和盐酸迭克罗宁为主药，以羧甲基纤维钠和甘油为基质，制备水溶性凝胶，以紫外分光光度法测定含量。结果：凝胶pH6．0～7．0，其他各项检查均符合有关规定，醋酸磺胺米隆平均回收率为99．49％，RSD为0．84％；盐酸达克罗宁回收率为100．2％，RSD为0．84％。结论：该制剂制备工艺简单，性质稳定，质量可控。

OBJECTIVE To establish a method for preparation and quality, control of the compound mafenide gel. METHODS The gel was prepared by taking mafenide acetate and dyclonine hydrochloride as main components, carboxymethylcellulose sodium and glycerol as base material. The contents were detrmened whith UV spectrophotometry. RNSULTS The gel pH value was 6. 0 - 7. 1）, other tests accord with the requirements of gel. The average.recovery of mafenide acetate was 99. 49%, RSD= 0. 97 % ;and the recoaery of dyclonine hydrochloride was 100. 2 %, RSD = 0. 84%. CONCLUSION The preparation of the gel is simple. The gel is Stable and its quality can be controlled.