市售3种富马酸替诺福韦二吡呋酯片的主要质量比较

Main Quality Comparison of Tenofovirdisoproxil Fumarate Tables Produced by Different Manufacturers

目的:对市售的3厂家生产的富马酸替诺福韦二吡呋酯片的主要质量指标进行比较。方法:依据CFDA批准的该片质量标准,采用高效液相色谱法(HPLC-UV),选择苯基键合硅胶色谱柱(Inertsil Phenyl-3柱),使用梯度洗脱的方式测定该片的主药含量和有关物质;采用紫外-可见分光光度法测定溶出度。结果:3厂家(代号A、B、C)生产的片剂主药含量和有关物质均均符合标准要求;在0.01 mol·L^(-1)盐酸、0.1 mol·L^(-1)盐酸、pH 4.5醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和纯化水中,30 min内3个产品均完全溶出。国产品种B的主药含量最高,有关物质相对最低,C产品在20 min内溶出较慢。结论:3厂家测定批次的富马酸替诺福韦二吡呋酯片的主药含量、有关物质和溶出度均符合规定,B产品对主要质量指标的控制相对更为严格。

Objective： To compare the qualities of three products of tenofovirdisoproxil fumarate tables supplied by different manufactories. Methods： The content of tenofovirdisoproxil fumarate and related substances were determined by HPLC with an Inertsil Phenyl-3 column（gradient elution）, and the dissolution was determined by UV-Vis spectrophotometry. Results： The contents of all tenofovirdisoproxil fumarate tables were more than 90%. The contents of related substances of them were all lower than the limits specified in the standard of the State Food and Drug Administration, among which the domestic ＂Product B＂ had a more stringent control for the main content and the related substances. Complete dissolution was observed in 0.01 mol·L^（-1） HCl, 0.1 mol·L^（-1） HCl, pH4.5 acetate, pH6.8 phosphate buffer and purified water within 30 min for all of the tenofovirdisoproxil fumarate tables, and the slowest dissolution was found for ＂Product C＂ within 20 min. Conclusions： The main drug content, related substance and dissolution of tenofovirdisoproxil fumarate tables produced by different companies all comply with the quality standard, but there exist variations. It seems that the quality of domestic ＂Product B＂ was better.