枸橼酸托法替布片的质量评价与生物等效性研究  

Quality evaluation and bioequivalence of Tofacitib citrate tablets

作　　者：和芳[1] 朱丽璇[1] 马莎[1] 俞娟[1] 左大辰 HE Fang;ZHU Lixuan;MA Sha;YU Juan;ZUO Dachen(First People′s Hospital of Yunnan Province,Kunming,Yunnan,650032 P.R.China)

机构地区：[1]云南省第一人民医院,云南昆明650032

出　　处：《华西药学杂志》2023年第1期17-20,共4页West China Journal of Pharmaceutical Sciences

基　　金：云南省基础研究计划昆医联合专项(202001AY070001-121)。

摘　　要：目的 探究国产与原研枸橼酸托法替布片的质量及两者生物利用度的差异,为国家药品集中采购政策提供参考。方法 对两厂家生产的枸橼酸托法替布片的质量标准进行对比,并比较其性状、UV、HPLC、有关物质、水分、溶出度、含量均匀度、含量、微生物限度等。以药品集采中标的国产样品(A厂)作为受试制剂,进口原研样品(B厂)作为参比制剂,分别在空腹和餐后条件下,开展两个厂家样品的人体生物等效性试验。结果 A厂产品的有关物质总和低于B厂,溶出度高于B厂家。其他指标如性状、水分、含量均匀度、含量、微生物限度等均符合质量标准,两厂家基本一致。生物等效性试验中,两厂产品的血药浓度曲线基本一致。结论 A、B两厂枸橼酸托法替布片的质量均在限度之内,但在有关物质、溶出度等方面,A厂更优于B厂。两厂家的产品生物等效,药品集采政策值得推广。OBJECTIVE To explore differences in the quality and bioavailability between domestic and original Tofacitib citrate tablets, so as to provide reference for the implementation of the centralized drug procurement policy organized by the country.METHODS The quality standards of Tofacitib citrate tablets produced by two manufacturers were compared.The characteristics, UV, HPLC,related substances, moisture, dissolution, content uniformity, content, and microbial limit were compared.Tofatib citrate tablets of manufacturer A,the new bid winning product after the implementation of the national drug centralized purchase policy, were taken as the test preparation, Tofacitib citrate tablets from manufacturer B were as the reference drug, and human bioequivalence tests were carried out under fasting and postprandial conditions.RESULTS The total amount of related substances in Tofacitib citrate tablets produced by manufacturer A was lower than that of manufacturer B,and the dissolution rate was higher than that of manufacturer B.Other indicators, such as characteristics, moisture, content uniformity, content, and microbial limit, were basically the same, which all met the quality standards.Comparative study on human bioequivalence showed that Tofacitib citrate tablets from two manufacturers were consistent in terms of safety and efficacy.CONCLUSION The quality of Tofacitib citrate tablets produced by both manufacturers A and B is within the limit, but manufacturer A is better than manufacturer B in terms of related substances and dissolution.Tofacitib citrate tablets produced by the two manufacturers are bioequivalent.The centralized drug purchase policy is worthy of popularization and application.

关 键 词：枸橼酸托法替布 质量对比 生物等效性 集中采购 血药浓度 生物利用度 有关物质 溶出度 

分 类 号：R94[医药卫生—药剂学]