基于体外溶出评价方法对硝苯地平缓释片(Ι)一致性评价研究  

Study on the Consistency Evaluation of Nifedipine Extended-release Tablets(Ι)Based on Dissolution Evaluation Method in Vitro

作　　者：牟聪[1] 徐有坤 吴青青 Mu Cong;Xu Youkun;Wu Qingqing(National Key Laboratory of Complex Drug Formulations for Overcoming Delivery Barriers,Yangtze River Pharmaceutical(Group)Co.,Ltd.,Taizhou 225300,China;Yangtze River Pharmaceutical Group Jiangsu Pharmaceutical Co.,Ltd,Taizhou 225300,China)

机构地区：[1]扬子江药业集团有限公司克服递药屏障高端制剂全国重点实验室,江苏泰州225300 [2]扬子江药业集团江苏制药股份有限公司,江苏泰州225300

出　　处：《山东化工》2024年第5期34-37,40,共5页Shandong Chemical Industry

摘　　要：建立硝苯地平缓释片(Ⅰ)体外溶出评价方法,以原研制剂为参比,评价本公司一致性研究前后的自研制剂(以下简称自制1、自制2),为质量一致性提供依据。选取0.3%吐温80的不同pH值(pH值1.0,pH值4.0,pH值6.8,水)溶液为溶出介质,采用高效液相色谱法考察0.25,0.5,1,2,3,10,12 h的释放度,从而建立体外溶出曲线方法,并进行了方法学验证,最后采用相似因子法(f_(2))将自研制剂与参比进行比较。结果表明,建立的本品体外溶出曲线方法的专属性、线性、精密度、准确度、滤膜吸附、溶液稳定性各项指标均符合要求;自制1与参比溶出行为不一致且f_(2)小于50,调整处方工艺后,自制2与参比体外溶出行为一致,且f_(2)均大于50。本品建立的体外溶出评价方法准确可靠,自制1与参比体外溶出不一致;自制2与参比溶出曲线相似,体外溶出一致。The evaluation method of in vitro dissolution of nifedipine sustained-release tablets(Ι)was established,and the self-developed drugs before and after the consistency study of the company were evaluated with the original drugs as the reference(Hereinafter referred to as self-developed drugs 1,self-developed drugs 2),so as to provide the basis for quality consistency.0.3%Tween 80 solution with different pH values(pH value 1.0,pH value 4.0,pH value 6.8,water)was selected as the dissolution medium,the release rates of 0.25,0.5,1,2,3,10,12 hours were investigated by HPLC,and the dissolution curve method was established in vitro,and the methodology was verified,finally,the similarity factor method(f_(2))was used to compare the self-developed drugs with the reference.The results showed that the specificity,linearity,precision,accuracy,filtration membrane adsorption and solution stability of the established in vitro dissolution curve method met the requirements;self-developed drugs 1 is inconsistent with the reference dissolution behavior and f_(2)is less than 50,after adjusting the prescription technology,self-developed drugs 2 is consistent with the reference dissolution behavior in vitro,and f_(2)is greater than 50.The evaluation method of in vitro dissolution established by this product is accurate and reliable,and the self-developed drugs 1 is inconsistent with the reference in vitro dissolution;the self-developed drugs 2 was similar to the reference dissolution curve,and the in vitro dissolution was consistent.

关 键 词：硝苯地平缓释片(Ι) 体外溶出 仿制药一致性评价 相似因子法 

分 类 号：TQ460.7[化学工程—制药化工] R927.1[医药卫生—药学]