论文部分内容阅读
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 study its quality control and stability. Methods: The clindamycin phosphate was used as the main drug to prepare the cream. The main drug content was determined by high performance liquid chromatography. The three batches of samples were tested under high temperature, light, acceleration and long-term stability. Results: The preparation was milky white cream, identification, check items meet the relevant requirements; linear range of clindamycin phosphate detection concentration was 0.192 ~ 0.960mg · mL- (1r = 0.9998), the average recovery was 99.9%, RSD = 0.68%. During the high temperature and accelerated tests, the content of related substances increased and the main drug content decreased. No significant changes were observed in the light and long-term stability test. Conclusion: The preparation process is simple, quality control, preservation in the shade of a stable nature.