复方甘草片溶出度方法的建立和溶出曲线相似性评价  

Establishment of dissolution method and similarity evaluation of dissolution culves of compound licorice tablets

作　　者：周晓力[1] 曾月林 尹利辉[1] 陈华[1] ZHOU Xiao-li;ZENG Yue-lin;YIN Li-hui;CHEN Hua(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《药物分析杂志》2023年第2期280-288,共9页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:为了控制复方甘草片的质量,进一步评价其生产工艺,建立体外溶出实验方法及相关的HPLC检测方法。方法:溶出条件为桨法,转速为50 r·min^(-1),溶出介质为水,检测方法为HPLC法,以自身对照法进行溶出度计算。采用建立的溶出方法对3个厂家的复方甘草片中吗啡、磷酸可待因和甘草酸的溶出情况进行了考察,并用Weibull模型对溶出数据进行拟合。结果:通过比较拟合参数来评价各厂家的溶出情况,发现不同厂家之间的Weibull拟合参数有显着差异,说明各厂家的制剂工艺存在较大的区别;通过批间均一性比较,发现厂家A的生产工艺相对稳定,但其不同年份生产的样品存在一定的差异性。结论:采用建立的体外溶出实验方法对不同厂家的样品进行溶出曲线相似性评价,为复方甘草片的质量研究提供参考。Objective:To establish an in vitro dissolution test method in order to control the quality of compound licorice tablets,and further evaluate its production process.Methods:The dissolution conditions were the paddle method,the speed was 50 r·min^(-1),the dissolution medium was water,the detection method was the HPLC method,and the self-control method was used to calculate the dissolution.The established dissolution method was used to investigate the release of morphine,codeine phosphate and glycyrrhizic acid in compound licorice tablets from 3 companies.The Weibull model was used to fit the dissolution data.Results:The products from each company were evaluated by comparing the fitting parameters.There were significant differences between the Weibull fitting parameters of different manufacturers,indicating that there were a big difference in the preparation process of each manufacturer.Through the comparison of batch uniformity,it was found that the production process of manufacturer A was relatively stable,but there were certain differences in the samples produced in different years.Conclusion:An dissolution test method is established,and the method was used to evaluate the similarity of the dissolution curves of samples from different manufacturers,which provids a reference for the quality research of compound licorice tablets.

关 键 词：复方甘草片 吗啡 磷酸可待因 甘草酸 溶出度 溶出曲线 相似性 高相液相色谱法 

分 类 号：R917[医药卫生—药物分析学]