张关敏 赵冰清 张艳华

[摘要] 目的 对3个不同厂家所生产的盐酸昂丹司琼片体外溶出度进行了考察，为临床用药提供参考。 方法 根据《中华人民共和国药典》（2010版）中盐酸昂丹司琼片的溶出度实验项下要求，采用浆法测定溶出度，紫外-可见分光光度法测定吸光度，对照品法计算溶液中盐酸昂丹司琼浓度。利用Excel软件计算累积溶出百分率及溶出参数，并进行比较分析。 结果 3个厂家盐酸昂丹司琼片的体外溶出度均符合药典规定，但各自间存在一定差异。 结论 不同厂家盐酸昂丹司琼片的溶出情况存在一定差异。

[关键词] 盐酸昂丹司琼片；溶出度；溶出参数

[中图分类号] R917???[文献标识码] B???[文章编号] 2095-0616（2012）15-37-04

Study on the dissolution of ondansetron hydrochloride tablets of different manufacturers

ZHANG?Guanmin??ZHAO?Bingqing??ZHANG?Yanhua

Peking University Cancer Hospital and Institute,Pharmaceutical Department of Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education), Beijing 100142, China

[Abstract] Objective To investigate the dissolution of ondansetron hydrochloride tablets of 3 different manufacturers. Methods The dissolution test was carried out by paddle method in Chinese Pharmacopoeia 2010 edition, and the absorbance of ondansetron hydrochloride solution was measured by UV spectrometry, then the concentration of ondansetron hydrochloride was calculated according to the absorbance of standard reference. Cumulative dissolution percentage as well as dissolution parameters was calculated using Excel software. Results The dissolution performance of ondansetron hydrochloride tablets in 3 different manufacturers all reached the Chinese Pharmacopoeia requirements, but there are some differences between each brand. Conclusion Attentions should be paid in the clinical use of ondansetron hydrochloride tablets because of the differences dissolution patterns between different manufacturers.

[Key words] Ondansetron hydrochloride tablet;Dissolution;Dissolution parameters

化疗是肿瘤治疗的重要手段之一，化疗药物可通过刺激胃肠道黏膜，引起黏膜损伤，黏膜上的嗜铬细胞释放5-HT，与5-HT3受体结合产生神经冲动并传入呕吐中枢导致呕吐。恶心、呕吐为化疗后严重的不良反应，严重影响了患者的依从性。适当的止吐治疗可预防或减少与化疗有关的恶心、呕吐的频率和强度[1]。昂丹司琼为第一代高选择性5-HT3受体阻断剂，通过作用于迷走神经上的5-HT3受体，抑制迷走神经传入纤维的兴奋，阻断向呕吐中枢的传入冲动，抑制呕吐；为临床常用的止吐药物，用于细胞毒性药物化疗和放射治疗引起的恶心呕吐，还可用于预防和治疗手术后的恶心呕吐。

为考察不同厂家盐酸昂丹司琼片的产品质量，笔者根据《中华人民共和国药典》（2010版）中的方法，对3个厂家的产品进行体外溶出度实验，比较其溶出行为与溶出参数。……