光纤药物溶出度实时测定仪监测苯丙氨酯片的溶出度  

Dissolution monitoring of phenporbamate tablets by fiber-optic medicine dissolution process real time test system

作　　者：蒋洁 刘庄蔚 朱健萍 卢日刚 梁秋霞 JIANG Jie(Department of chemical medicine administration,Guangxi institute for food and drug control,Nanning 530021,China)

机构地区：[1]广西食品药品检验所化药室,广西南宁530021

出　　处：《药物评价研究》2018年第9期1653-1656,共4页Drug Evaluation Research

基　　金：广西食品药品安全科研项目(KY2017-03)

摘　　要：目的建立考察苯丙氨酯片溶出过程的方法,比较不同厂家的生产工艺及质量。方法以对照品法,利用FODT-601FX光纤药物溶出度实时测定仪实时监测苯丙氨酯片的溶出过程,并采用相似因子(f2)对溶出曲线进行一致性评价。结果选择0.5 mm探头,260 nm为测定波长,苯丙氨酯浓度在20~130μg/m L与吸光度具有良好的线性关系,r=0.999 9。考察了市售的5个厂家(A^E厂)11个批次的苯丙氨酯产品在水中的溶出曲线,除D厂外各批次苯丙氨酯片的溶出度检查结果均符合日本橙皮书的规定,但各厂家苯丙氨酯片的溶出曲线存在一定差异,选取样品C1作为参比制剂,有A、C2、C3、E样品的溶出曲线与C1相似(50≤f2≤100),而B、D厂样品的溶出曲线与C1明显不同(f2<50)。结论光纤法溶出度能客观反映苯丙氨酯片溶出全过程,监测的5个厂家生产的苯丙氨酯片存在药品溶出过程不相似以及部分厂家内在质量差异较大的问题。Objective To compare the differences in intrinsic qualities of products by observing dissolving-out process of phenporbamate tablets from different manufacturers. Methods The fiber-optic real-time dissolution detector was used and conditions adopted for dissolution were in accordance with detecting conditions of phenporbamate tablets dissolution, and similar factor method（f2） was also used to evaluate differences of dissolution values of different manufacturer＇s phenporbamate tablets. ResultsPhenporbamate tablets was monitored at light path 0.5 mm and wave length 260 nm, and its absorbability was better with concentration at range of 20—130 μg/m L, r = 0.999 9. Phenporbamate tablets from 11 different batches and 5 different manufacturers（A—E） conformed to the national drug standards（except D）, but differences were found in the dissolution curves of those drugs. C1 was used as the reference preparation, only samples A, C2, C3 and E had similar dissolution process with C1＇s dissolution process（50≤f2≤100）. However, both samples B and D had clear differences in their dissolution when compared to the dissolution process of C1（f2 50）. Conclusion Fiber optic dissolution test system can objectively reflect the whole dissolving process of phenporbamate tablets.

关 键 词：光纤药物溶出度 苯丙氨酯片 相似因子 质量控制 实时监控 

分 类 号：R917[医药卫生—药物分析学]