摘要
目的:制备克林霉素磷酸酯乳膏并进行质量控制及稳定性研究。方法:以克林霉素磷酸酯为主药制备乳膏剂,以高效液相色谱法测定主药含量;对3批样品进行高温、光照、加速和长期稳定性试验。结果:所制制剂为乳白色乳膏,鉴别、检查项符合相关规定;克林霉素磷酸酯检测浓度线性范围为0.192～0.960mg·mL-(1r=0.9998),平均回收率为99.9%,RSD=0.68%;在高温和加速试验中有关物质含量升高、主药含量降低,在光照和长期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 clindamycin phosphate cream and to conduct quality control and stability research of it.METHODS： The cream was prepared with clindamycin phosphate as principal component and HPLC was used to detect the content of principal component.Thermal test,light test,accelerated stability test and long-term stability test of 3 batches of samples were carried out.RESULTS： Preparation was white cream.Its identification and test are in line with the related specification.The linear range of clindamycin phosphate were 0.192～0.960 mg·mL-1 （r=0.999 8） with an average recovery of 99.9% （RSD=0.68%）.The content of principal component was increased while then content of relevant substance were decreased in thermal test and accelerated stability test.There was no obvious change in light test and long-term stability test.CONCLUSION： The preparation is simple,controllable and stable in cool place.
出处
《中国药房》
CAS
CSCD
北大核心
2010年第21期1979-1981,共3页
China Pharmacy
关键词
克林霉素磷酸酯乳膏
制备
质量控制
稳定性
Clindamycin phosphate cream
Preparation
Quality control
Stability
