奥美拉唑肠溶胶囊质量一致性评价

发布时间：2018-05-17 11:56

本文选题：奥美拉唑肠溶胶囊 + 溶出曲线　；参考：《中国药师》2016年10期

【摘要】：目的:建立奥美拉唑肠溶胶囊溶出曲线测定方法,考察参比制剂的释放行为,为该品种仿制药质量一致性评价工作提供理论依据。方法:采用中国药典2015年版四部0931第一法(篮法),分别考察释放介质的种类及奥美拉唑在不同介质中的溶解度和稳定性,考察不同处理方式对溶出液中主药的吸附影响,并对不同转速及紫外-分光光度法的方法学进行考察。结果:以p H 6.0磷酸盐缓冲液、p H 6.8磷酸盐缓冲液和水(含3%吐温80)为释放介质,介质体积为900 ml,转速为75 r·min~(-1),采用在线滤头过滤方式;奥美拉唑在三种释放介质中的溶解度分别为0.123,0.078,0.275 mg·ml~(-1),奥美拉唑在p H 6.0、p H6.8磷酸盐缓冲液、水(含3%吐温-80)中2 h分别降解44%、8%和14%,在水(含3%吐温-80)中6 h降解43%;奥美拉唑在三种释放介质中的线性范围分别为0.209 4~20.94,0.204 8~20.48,0.201 6~20.16μg·ml~(-1),平均回收率分别为99.3%(RSD=0.7%,n=12),99.7%(RSD=0.9%,n=12),99.5%(RSD=0.6%,n=12)。结论:建立的溶出曲线测定方法准确、可靠,可用于奥美拉唑肠溶胶囊的仿制药一致性评价。
[Abstract]:Objective: to establish a method for determination of the dissolution curve of omeprazole enteric capsules, and to investigate the release behavior of reference preparation, and to provide theoretical basis for the quality consistency evaluation of this generic drug. Methods: the Chinese Pharmacopoeia 2015 edition of four parts 0931 first method (basket method) was used to investigate the type of release medium, the solubility and stability of omeprazole in different media, and the effect of different treatment methods on the adsorption of main drug in the solution. The methodology of different rotational speed and UV-spectrophotometry was investigated. Results: the pH 6.0 phosphate buffer solution, pH 6.8 phosphate buffer solution and water (containing 3% Tween 80) were used as the release medium, the volume of the medium was 900 ml, and the rotational speed was 75 r 路min ~ (-1). The solubility of omeprazole in the three release media was 0.123n 0.078U 0.275 mg / ml ~ (-1), and omeprazole was used in pH 6.0 / H 6.8 phosphate buffer, respectively. Water (containing 3% Tween-80) degraded 440.8% and 14g in 2 h, and 43in 6 h in water (containing 3% Tween-80), and the linear range of omeprazole in the three release media was 0.209 420.940.208,20.40.201 620.16 渭 g ml-1, respectively. The average recovery was 99.3SD0.7n 127K and 99.5RSD0. 6%. Conclusion: the established method is accurate and reliable, and can be used to evaluate the consistency of omeprazole enteric-coated capsules.
【作者单位】：江苏省食品药品监督检验研究院;泰州市食品药品检验所;
【分类号】：R927

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