国产布洛芬片溶出曲线考察及质量评价  

Study on dissolution curve and quality evaluation of domestic ibuprofen tablets

作　　者：栾晓娇 杨俊 杨广雪 温美强 程刚[1] LUAN Xiaojiao;YANG Jun;YANG Guangxue;WEN Meiqiang;CHENG Gang(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2021年第4期335-341,共7页Journal of Shenyang Pharmaceutical University

摘　　要：目的考察国内9个厂家生产的布洛芬片与参比制剂(商品名:Motrin?IB)的体外溶出度、有关物质及标识百分含量,为控制国产布洛芬片的质量提供依据。方法采用高效液相色谱法测定布洛芬片在纯化水、pH 1.2氯化钠盐酸溶液、pH 5.5磷酸盐缓冲液和pH 7.2磷酸盐缓冲液4种溶出介质中的溶出度,并用f2相似因子法评价溶出曲线的相似性。同时测定各厂家布洛芬片的有关物质含量及标示百分含量,比较其与参比制剂的差异。结果 9个厂家生产的布洛芬片与参比制剂在4种溶出介质中的溶出行为均不相似,其中G与H的杂质J及总杂超限,各厂家制剂的标示百分含量均符合要求。结论国产的布洛芬片与参比制剂的溶出行为存在显著性差异,且有杂质超限行为,临床应用时应加以注意。厂家应严格控制药物的溶出速率及有关物质含量,缩短与进口制剂质量间的差距。Objective Investigating the dissolution, related substances and content of ibuprofen tablets from 9 manufacturers and reference(trade name: Motrin? IB),to provide a basis for controlling the quality of domestic ibuprofen tablets.Methods The dissolution rate of tablets in 4 kinds of dissolution media(purified water, pH 1.2 sodium chloride hydrochloric acid solution, pH 5.5 phosphate buffer solution and pH 7.2 phosphate buffer solution) were determined by high performance liquid chromatography, and f2 similarity factor was used to evaluate the similarity of the dissolution profiles.The percentage of related substances and the contents of the ibuprofen tablets were measured to compare the differences between domestic tablets and reference.Results There were no similarity of dissolution behaviors among preparations produced by 9 manufacturers and reference in 4 kinds of dissolution media.However, the percentage of impurity J and total impurities from G and H were over the limit, the contents of preparations from all manufacturers conformed to the regulations.Conclusion There is a significant difference in the dissolution behavior of domestic tablets and reference, and there are impurities over-limit behavior, which should be paid attention to in clinical application.Manufacturers should strictly control the dissolution rate of drugs and related substances, and shorten the gap with the quality of imported preparations.

关 键 词：布洛芬片 溶出度 f_(2)相似因子法 有关物质 

分 类 号：R94[医药卫生—药剂学]