对乙酰氨基酚片仿制药与原研药的溶出度一致性评价

Consistency Evaluation of Dissolution of Generic and Original Preparations of Paracetamol Tablet

建立对乙酰氨基酚片溶出曲线的测定方法,并评价仿制药与原研药的质量一致性.采用紫外—可见分光光度法,检测波长为243 nm,以水、pH 1.2的盐酸溶液、pH 5.8的磷酸盐缓冲液、pH 6.8的磷酸盐缓冲液为溶出介质,溶出介质体积为900 m L,采用桨法(50 r/min),分别考察对乙酰氨基酚片仿制药与原研药的溶出度,并通过计算相似因子(f2)来评价其溶出曲线的相似性.实验结果表明,4批次原研药和6批次仿制药在水、pH1.2盐酸溶液、pH 5.8磷酸盐缓冲液、pH 6.8磷酸盐缓冲液4种溶出介质中10 min时溶出均大于85%,均为非常快速溶出,相似性好.实验结果显示,该方法适用于对乙酰氨基酚片溶出曲线的测定,对乙酰氨基酚片仿制药与原研药的体外溶出曲线具有相似性,其质量一致性较好.

The paper aims to establish a determination method for the dissolution curves of Paracetamol tablet,and evaluate the quality consistency of its generic and original preparation.UV spectrometry is performed with the column of 243 nm,the dissolution media of Hydrochloric solution(pH1.2),the phosphate buffer solution(pH5.8),phosphate buffer solution(pH6.8)and water,the volume of dissolution medium 900 mL,and the rotation speed 50 r/min in paddle method.Then the dissolution of generic and original preparation of Paracetamol tablet is detected,and the similarity of dissolution curve is evaluated by calculating the similarity factor(f2).The results show that the dissolution rates of four batches of original preparation and six batches of generic preparation are larger than 85%in four dissolution media,including water,pH1.2 hydrochloric acid solution,pH5.8 phosphate buffer and pH6.8 phosphate buffer for 10 minutes.All of them dissolve very quickly and have good similarity.It is thus concluded that the method is suitable for the dissolution determination of Paracetamol tablet;meanwhile,the in vitro dissolution curves of generic and original preparations of Paracetamol tablet show similarity,so the quality consistency is good.