文章摘要
赵悦,张营,杜益,严菲,孟长虹,汪玉馨,陆益红.雷贝拉唑钠肠溶片的溶出度研究及方法学验证[J].药学与临床研究,2022,30(1):25~30
雷贝拉唑钠肠溶片的溶出度研究及方法学验证
Dissolution Study and Method Validation of Rabeprazole Sodium Enteric-coated Tablets
投稿时间：2021-05-28  修订日期：2022-02-16
DOI：
中文关键词: 雷贝拉唑钠肠溶片  溶出度  紫外分光光度法  等吸收点-双波长吸收差值法  方法学验证
英文关键词: Rabeprazole sodium enteric-coated tablets  Dissolution  UV spectrophotometry  Isosorbent point-dual wavelength absorption difference method  Method validation
基金项目:化学药品关键质量溶出曲线监控技术应用研究与风险评估（202022）
作者单位邮编
赵悦 徐州医科大学 210019
张营 中国人民解放军联勤保障部队第988医院 
杜益 浙江省中医院药剂科 
严菲 江苏省食品药品监督检验研究院 
孟长虹 江苏省食品药品监督检验研究院 
汪玉馨 江苏省食品药品监督检验研究院 
陆益红 江苏省食品药品监督检验研究院 210019
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中文摘要:
      目的：针对雷贝拉唑钠肠溶片在偏中性介质中不稳定及存在辅料干扰的情况，建立适宜的溶出度测定方法，考察雷贝拉唑钠肠溶片参比制剂及不同厂家仿制药的溶出度，并对该测定方法进行方法学验证。方法：利用紫外分光光度计，采用等吸收点-双波长吸收差值法测定参比制剂及国内A、B两个厂家仿制药在pH 1.2、pH 6.0、pH 6.8、水4种溶出介质中的溶出度，溶出方法为桨法，溶出介质体积为900 mL，转速为50 r·min-1。结果：通过方法学验证，表明紫外分光光度法-等吸收点-双波长吸收差值法准确可靠，能测定出雷贝拉唑钠肠溶片的累积溶出量。结论：建立的溶出度测定方法适用于雷贝拉唑钠肠溶片溶出曲线的评估，可用于该产品的质量控制。
英文摘要:
      Objective: Aiming at instability and excipients interference of rabeprazole sodium enteric-coated tablets in partial neutral media, this paper was designed to establish a suitable method for the determination of dissolution of rabeprazole sodium enteric-coated tablets from different manufacturers, and to validate this determination method. Methods: The dissolutions of the reference listed drug(RLD) and generic drugs A, B from two domestic manufacturers in four dissolution media of pH 1.2, pH 6.0, pH 6.8 and water were determined by an isosorbent point-dual wavelength absorption difference method using a UV spectrophotometer. Paddle method was used at rate of 50 r·min-1 and the volume of the dissolution media was 900 mL. Results: The isosorbent point-dual wavelength absorption difference method by UV spectrophotometry was validated as accurate and reliable in determining the cumulative dissolution of rabeprazole sodium enteric-coated tablets. Conclusion: The established dissolution method is suitable for the evaluation of the dissolution curve of rabeprazole sodium enteric-coated tablets and can be used for the quality control of this product.
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