硫酸阿托品眼用胶体溶液的制备及质量考察

目的制备硫酸阿托品眼用胶体溶液。方法用卡波姆-940作增稠剂,制备硫酸阿托品眼用胶体溶液,建立酸碱度、卫生学、含量测定等质控方法,进行制剂稳定性试验,体外释放试验及刺激性实验。结果pH为4.5~5.5,硫酸阿托品平均回收率为99.6%,RSD=0.89%(n=6),其他各项检查均符合眼用制剂的有关规定。结论本制剂制备工艺简单,性质稳定,质量可控,适于医院制剂。

Preparation and quality inspect of atropine sulfate ophthalmic gel solution

OBJECTIVE To prepare atropine sulfate ophthalmic gel solution.METHODS The gel solution in which carbomer-940 was taken as a increase viscosity was prepared.The quality control methods for acidity and alkalinity,hygienic,determination etc were established.The test of stability,release in vitro and stimulation were carried out. RESULTS The pH value was 4.5~5.5.the average recovery was 99.6%,RSD=0.89%(n=6).Other tests accorded standards of ophthalmic preparation.CONCLUSION The gel solution was easily able to prepared by the above-stated method.Quality was steady and can be controlled.It was suitable for hospital preparation.