国内7厂家红霉素肠溶片的溶出度一致性评价  

Consistency Evaluation of Dissolution of Erythromycin Enteric-coated Tablets from 7 Manufacturers in China

作　　者：张建伟 涂星 尹聪 陈家艺 侯远鑫 Zhang Jianwei;Tu Xin;Yin Cong;Chen Jiayi;Hou Yuanxin(Medical College of Hubei University for Nationalities, Enshi 445000, China;The University Hospital of Hubei University for Nationalities, Enshi 445000, China)

机构地区：[1]湖北民族学院医学院,湖北恩施445000 [2]湖北民族学院附属民大医院,湖北恩施445000

出　　处：《湖北民族学院学报（医学版）》2018年第2期4-7,共4页Journal of Hubei Minzu University(Medical Edition)

基　　金：湖北省教育科学规划重点课题(2016GA024)

摘　　要：目的评价国内7厂家仿制药红霉素肠溶片的溶出度一致性,为临床用药及剂型改进提供参考。方法以水、pH1.0盐酸溶液、pH6.8磷酸盐缓冲溶液为溶出介质,篮法,转速为100 r/min,溶出介质体积为900 m L,采用紫外分光光度法,检测波长482 nm,进行溶出度测定。通过相似因f2法评价仿制药与参比制剂的溶出曲线的相似性。结果 7厂家仿制药红霉素肠溶片在水和pH1.0酸性介质中均未见明显的裂隙或崩解,除E厂家外其他厂家的红霉素肠溶片在40 min时溶出限均超过80%,与参比制剂的相似性f_2值分别为98.02、68.09、80.62、93.24、90.00、68.99、68.09。结论 7厂家的红霉素肠溶片的溶出度均符合《中国药典》规定,与参比制剂的体外溶出行为具有相似性,其质量一致性较好,可代替原研药在临床使用。但依然有部分厂家的红霉素肠溶片存在溶出度限量不达标的问题,需要进行制剂工艺改进。Objective To evaluate the dissolution of erythromycin enteric-coated tablets in domestic manufacturers,and provide reference for clinical medication and dosage form improvement. Methods The water,pH1.0 hydrochloric acid solution and pH6. 8 phosphate buffer solution were used as the dissolution medium by basket method. The speed was 100 r/min and dissolution medium volume was 900 mL. The wavelength was 482 nm detected by UV spectrophotometry.The similarity of the dissolution profiles of the generic and reference formulations was evaluated by the similar f_2 method.Results The erythromycin enteric-coated tablets of 7 manufacturers of in water and pH1.0 acid medium were no obvious cracks or disintegration.In addition to E,when the erythromycin enteric-coated tablets of other manufacturers were in 40 min,the dissolution limit exceeded 80%.The similarity values f_2 of the reference formulation were 98. 02,68. 09,80. 62,93.24,90. 00,68. 99,and 68. 09,respectively. Conclusion The dissolution of erythromycin enteric-coated tablets in 7 manufacturers conforms to the provisions of the Chinese Pharmacopoeia and has similarity with the in vitro dissolution behaviors of the reference preparations.The consistency of the erythromycin enteric-tablets is good and can be used in place of the original study drug.But the dissolution limit of erythromycin enteric-coated tablets in some manufacturers is not up to the standard,and it needs to be improved.

关 键 词：红霉素肠溶片 仿制药 溶出曲线 溶出度 一致性评价 

分 类 号：R944[医药卫生—药剂学]