摘要:枸橼酸他莫昔芬是目前临床上，应用最广泛的抗刺激素治疗乳腺癌的药物，国内已有13个厂家的品种上市销售。目前，枸橼酸他莫昔芬片的体外溶出试验，已作为体外评价样品质量以及判断药物疗效的有效药学研究手段。本论文以药物溶出为主开展对枸橼酸他莫昔芬体外溶出度的考察。77534

  目的：考察来自相同厂家不同批次的枸橼酸他莫昔芬的体外溶出，并作出相应的质量评价，提出工艺改进建议。

  方法：采用中国药典2015年版中规定的桨法进行了溶出试验，采用紫外分光光度法对溶出样品进行了测定，并用吸收系数法计算他莫昔芬浓度，从而确立了枸橼酸他莫昔芬片体外溶出试验的方法。首先通过原研片在四种不同介质中的溶出，初步确定在各个溶出介质中药品达到完全溶出所需要的时间，从而为三批仿制药的溶出试验奠定基础。在37℃，50（转/分钟）条件下，对一批原研制剂（阿斯利康，枸橼酸他莫昔芬片，10mg）以及三批上市仿制药（复旦复华，枸橼酸他莫昔芬片，10mg）分别在水、pH1。2、pH3。0、pH6。8四种溶出介质中进行了溶出试验。从而确定在水、pH1。2、pH6。8中达到“溶出上限”所需时间为6h，在pH3。0中所需时间为2h。并对两种制剂在四种介质中的溶出曲线进行了比对，采用f2进行了溶出曲线的一致性评价。

  结果与结论：三批上市仿制药的体外溶出度均达到药典所规定的要求，但任存在一定的溶出差异。对于存在的溶出差异，应给予关注发现问题所在，调整工艺提高药品质量。

毕业论文关键词： 枸橼酸他莫昔芬片；体外溶出；一致性评价；溶出曲线

Study on dissolution curve of tamoxifen citrate tablets

Abstract:Tamoxifen citrate is currently the most widely used anti-irritant hormone treatment of breast cancer drugs, domestic manufacturers have 13 varieties of sales。 At present, the in vitro dissolution test of tamoxifen citrate tablets has been used as an effective pHarmacological means to evaluate the quality of samples and determine the efficacy of drugs。 In this paper, the dissolution of tamoxifen citrate in vitro was investigated。

 OBJECTIVE: To investigate the in vitro dissolution of tamoxifen citrate from different batches of the same manufacturers, and to make corresponding quality evaluation。

 Methods: The dissolution test was carried out by using the paddle method specified in the Chinese pHarmacopoeia 2015 edition。 The dissolution test was determined by ultraviolet spectropHotometry, and tamoxifen concentration was calculated by absorption coefficient method。 The tamoxifen citrate In vitro dissolution test method。 First of all, through the original research in four different media dissolution, the initial determination of the dissolution medium in the drug to complete the time required for complete dissolution, so as to lay the foundation for the three batches of generic drug dissolution experiments。 A series of original preparations (AstraZeneca, tamoxifen citrate tablets, 10 mg) and three batches of generic drugs (Fudan Fuhua, tamoxel citrate) at 37 ° C, 50 (rpm) Xifen tablets, 10mg) were eluted in water, pH1。2, pH3。0, pH6。8 four dissolution media。 The time required to reach the "dissolution limit" in water, pH1。2 and pH6。8 was determined to be 6h, and the time required in pH3。0 was 2h。 The dissolution curves of the two formulations were compared in four media。 The consistency of the dissolution curves was evaluated by f2。

 RESULTS AND CONCLUSION: The dissolution of the three batches of generic drugs was in accordance with the requirements of the pHarmacopoeia, but there was a certain dissolution difference。 For the existence of the dissolution of the difference should be given attention to find the problem, adjust the process to improve drug quality。