摘要
目的制备利拉萘酯乳膏并进行质量控制及稳定性研究。方法以利拉萘酯为主药制备乳膏剂,以高效液相色谱法测定主药含量及有关物质;对3批样品进行初步稳定性试验。结果所制制剂为乳白色乳膏,鉴别、检查项符合相关规定;利拉萘酯质量浓度范围在38.52～192.6μg/mL范围内与峰面积线性关系良好,平均回收率为100.08%,RSD=0.32%;初步稳定性试验中各指标均未见明显变化。结论该制剂工艺简单,质量可控,在阴凉处保存性质稳定。
Objective To prepare Liranaftate Cream and to conduct quality control and stability research of it .Methods To prepare liranaftate cream with raw material .HPLC was used to detect the content and related compunds of liranaftate.The stress testing,accelerated testing of 3 batches were carried out.Results Preparation was white cream.Its identification and test are in line with the related specification.The linear range of liranaftate were 38.52-192.6μg/mL with an average recovery of 100.08%（RSD=0.32%）.The quality of Liranaftate Cream was in line with product quality standard in stress testing.There was no obvious change stress testing,Conclusion The preparation is simple,controllable and stable in cool place.
出处
《中国药业》
CAS
2012年第23期24-26,共3页
China Pharmaceuticals
关键词
利拉萘酯乳膏
制备
质量控制
稳定性
Lianaftate Cream
preparaton
quality control
stability
