奥硝唑胶囊的工艺研究和质量一致性评价  

Preparation of Ornidazole Capsules and Evaluation of Quality Consistency

作　　者：曹义海 顾林 李静 邹梅娟[1] CAO Yi-hai;GU Lin;LI Jing;ZOU Mei-juan(Shenyang Pharmaceutical University,Shenyang Liaoning 110016;Yangtze Pharmaceutical Group Nanjing Hailing Pharmaceutical Co.,Ltd.,Nanjing Jiangsu 210049,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]扬子江药业集团南京海陵药业有限公司,江苏南京210049

出　　处：《泰州职业技术学院学报》2023年第2期93-96,共4页Journal of Taizhou Polytechnic College

摘　　要：目的开发奥硝唑胶囊,并对其进行体外质量一致性评价。方法以奥硝唑片原研制剂为对照药品,单因素实验考察影响奥硝唑溶出度的处方因素及制备工艺参数,从而确定最佳处方和制备工艺,并测定自制片和原研药在4种溶出介质的溶出过程,采用相似因子(f2)法对两者的溶解曲线进行相似性评价。结果3批奥硝唑胶囊仿制药在磷酸盐缓冲液(pH6.8)、水、pH1.2盐酸溶液、p H4.5醋酸盐溶液中15 min内溶出大于85%。结论以溶出度为主要考察指标,通过单因素实验开发的奥硝唑胶囊仿制药与原研药体外溶出具有一致性,质量符合要求。Objective To develop Ornidazole capsules and evaluate their quality consistency.Methods Ornidazole tablets were used as the reference drug.In order to determine the best formulation and the best preparation processing,the single factor experiments were applied to determining the best formulation and the best preparation processing.And dissolution test was used as the evaluation index in the single factor experiments.Meanwhile the dissolubility of generic Ornidazole capsules and original preparation were investigated in four different media to evaluate the similarity of dissolution by calculating similar factor(f2).Results The dissolution was above 85% of three batches of generic Valsartan Tablets in the phosphate buffer(pH 6.8),water,hydrochloric acid solution(pH 1.2),and acetate buffer solution(pH 4.5).Conclusion The f2 similarity factor results indicate a similarity in the reference drug and generic Valsartan Tablets which were developed by single factor experiments,which means the quality of genetic Ornidazole capsules is qualified.

关 键 词：奥硝唑 溶出曲线 质量一致性研究 

分 类 号：R95[医药卫生—药学]