乳酸依沙吖啶凝胶的制备及质量控制

Preparation and Quality Control of Ethacridine Lactate Gel

目的研究乳酸依沙吖啶凝胶制备及质量控制方法。方法用卡波姆为主要基质制备乳酸依沙吖啶凝胶,采用紫外分光光度法在362nm波长处测定主药含量。结果含量测定方法平均回收率为100.32%,RSD=0.37%,样品卫生学检查符合规定,凝胶稳定无变化。结论该制剂制备工艺简单,质量可靠。

Objective To develop a gel of ethacridine and the methods of quality control. Methods Using carbomer as the gel strome, the gel of ethaeridine lactate was developed. Results In the test of content, the average recovery rate was 100.32% and RSD=0.37%, It qualified the standard through the hygienieal test, After going through the eentrifugation in high speed, no change in the gel was found. Conclusion The gel can be easily developed, The quality is able to be controlled.