摘要
目的 :为满足临床需要而研制的一种抗真菌制剂。方法 :将酮康唑制成酊剂 ,建立了酸碱度、卫生学、含量测定等质控方法 ,并进行了刺激性和稳定性方面考察。结果 :pH值为 7.1～ 7.3,卫生学检查符合规定 ,含量测定平均回收率为 10 0 .5 2 % ,RSD =0 .81% ,刺激性较小 ,稳定性较好。结论 :本制剂制备工艺简便 ,质控方法准确可靠 ,性质稳定 。
OJBECTIVE:To prepare a ketoconazole for the clinical use.METHODS:Ketoconazole were made into an anti fungi preparation,The quality control methods were established,inculding acid-base scale,hygienics,assaying and so on.The preparation was gone through irritation test and stability test.RESULTS:The pH value is 7.1～7.3.which adapts the standard of the hygienical test. The average rate of recovery for assay is 100.5% and RSD=0.81%.It has smaller irritation and govd stability.CONCLUSIONS:The preparation method is simple and the quality control is accurate It is a useful preparation for the clinical.
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2001年第2期156-158,共3页
Chinese Journal of Modern Applied Pharmacy
关键词
酮康唑酊剂
制备
质量控制
抗真菌药
the ketoconazole tincture,preparation method,quality control
