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药物溶出试验中桨法的改进及效果初步评价

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桨法装置通常用于药品研发和质量控制,但由于产品落入溶出杯中的沉降位置可能会改变容器底部药物崩解的扩散范围,故经常受到可重复性和准确性问题的影响,可能无法准确反映药物的释放特性.为了得到更高的重复性,采用在传统桨法装置的半球形玻璃容器底部添加辅助珠的方式来改良桨法装置.另外,辅助珠的大小可根据不同药物的溶出行为进行选择.以恩他卡朋(1)片、达格列净(2)片和克拉霉素(3)片作为模型药物对改良桨法装置、传统溶出杯和尖峰溶出杯进行考察.结果表明,改良桨法装置除了可以根据药物灵活地选择相应的辅助珠外,其获得的药物释放曲线的重复性也更好,有利于批次间或实验室间溶出曲线的比较.
Improvement and Preliminary Evaluation of Paddle Method in Drug Dissolution Test
The paddle apparatus is commonly used in both research and development(R&D)and quality control.However,because the settling position of the product after falling into the dissolution vessel may change the diffusion range of drug disintegration at the bottom of the vessel,it is often affected by the problems of reproducibility and accuracy,which may not reflect the drug release characteristics precisely.To achieve better reproducibility,the new modified paddle apparatus was improved by adding auxiliary beads at the bottom of the glass vessel of the paddle apparatus.In addition,the size of the auxiliary beads can be selected according to the dissolution behaviors of different drugs.In this study,entacapone(1)tablets,dapagliflozin(2)tablets and clarithromycin(3)tablets were used as model drugs to Investigate the effects of the improved paddle apparatus,traditional vessel and apex vessel.The results indicated that the improved paddle dissolution vessel could not only select the corresponding auxiliary beads more flexibly according to the drugs,but also obtain better reproducibility of the drug release curves,which was beneficial to the comparison of dissolution results between batches or laboratories.

dissolution apparatuspaddle methodentacaponedapagliflozinclarithromycindissolution curvereproducibilityauxiliary bead

李琰、吴恒乾、王正平、李素叶、韩军

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聊城大学生物制药研究院,山东聊城 252059

济南大学化学化工学院,山东济南 250022

聊城高新生物技术有限公司,山东聊城 252059

山东中医药大学药物研究院,山东济南 250355

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溶出装置 桨法 恩他卡朋 达格列净 克拉霉素 溶出曲线 可重复性 辅助珠

国家"重大新药创制"科技重大专项山东省泰山学者研究基金资助项目山东省抗体药物创新创业共同体重大科技项目

2017ZX09201003-013319190201GTT2111-CYDW-033

2024

10.16522/j.cnki.cjph.2024.10.011

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子：0.487
ISSN：1001-8255
年,卷(期)：2024.55(10)
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