药品溶出度测定中的影响因素分析

17　吴小林.临床上利福平与格列齐特的相互作用.国外医药・抗生素分册,2004,25(2):96

18　N iem i M,Backman J T,Neuvonen M,et al.Effects of rifa mp in on the phar macokinetics and phar macodyna m ics of glyburide and gli p izide.Clin Phar macol Ther,2001,69(6):400

19　N iem iM,Kivist K T,Backman J T,et al.Effect of rifa mp icin on the phar macokinetics and phar macodyna m ics of gli m ep iride.B r J Clin Phar2 macol,2000,50(6):591

20　Park J Y,Ki m K A,KangM H,et al.Effect of rifa mp in on the phar ma2 cokinetics of r osiglitaz one in healthy subjects.Clin Phar macol Ther.

2004,75(3):157

21　Scheen AJ.D rug-drug and f ood-drug phar macokinetic interacti ons with ne w insulinotr op ic agents repaglinide and nateglinide.Clin Phar ma2 cokinet,2007,46(2):93

22　Kyrklund C,Backman J T,Kivist¨

o K T,et al.R ifa mp in greatly reduces p las ma si m vastatin and si m vastatin acid concentrati ons.Clin Phar macol Ther,2000,68(6):592

23　Scri p ture C D,Pieper J A.Clinical phar macokinetics of fluvastatin.Clin Phar macokinet,2001,40(4):263

24　Lau Y Y,Okochi H,Huang Y,et al.Phar macokinetics of at orvastatin and its hydr oxy metabolites in rats and the effects of concom itant rifa mp i2 cin single doses:relevance of first-pass effect fr om hepatic up take trans porters,and intestinal and hepatic metabolis m.D rug Metabolis m and D is positi on,2006,34(7):1175

25　R idtitid W,Wongna wa M,Mahatthanatrakul W.et al.R ifa mp in

markedly decreases p las ma concentrati ons of p raziquantel in healthy vol2 unteers.Clin Phar macol Ther,2002,72(5):505

26　N ijland H M,Ruslam i R,Sur ot o A J.et al.R ifa mp icin reduces p las ma concentrati ons of moxifl oxacin in patients with tubercul osis.Clin I nfect

D is,2007,45(8):1001

27　Gebhart B C,Barker B C,Marke witz B A et al.Decreased serum lin2 ez olid levels in a critically ill patient receiving concom itant linezolid and rifa mp in.Phar macotherapy,2007,27(3):476

28　R ibera E,Azuaje C,Lopez R M et al.par macokinetic interacti on be2 t w een rifa mp icin and the once-daily combinati on of saquinavir and l ow -dose rit onavir in H I V-infected patients with tubercul osis.J Anti m i2 cr ob Chemother,2007,59(4):690

29　Justesen U S,Andersen A B,Klitgaard N A,et al.Phar macokinetic in2 teracti on bet w een rifa mp in and the combinati on of indinavir and l ow-dose rit onavir in H I V-infected patients.Clin I nfect D is,2004,38(3): 426

30　郭婕,罗鹃,朱珠.抗肿瘤新药———舒尼替尼.中国药学杂志,2007, 42(13):1037

31　D ickins on B D,A lt m an R D,N ielsen N H,et al.D rug interacti ons be2 t w een oral contracep tives and antibi otics.Obstet Gynecol,2001,98

(5):853

32　Machavara m K K,Gundu J,Ya m saniM R.Effect of ket oconaz ole and rif2

a mp icin on the phar macokinetics of ranitidine in healthy human volun2

teer:a possible r ole of P-glycop r otein.D rug Metabol D rug I nteract, 2006,22(1):47

药品溶出度测定中的影响因素分析3

唐素芳

(天津市药品检验所,天津　300070)

摘　要　为保证溶出度测定数据的客观性和准确性,本文分析了溶出度测定中的影响因素,从溶出仪的调试与校正、溶出介质的配制与脱气、取样过程、胶囊壳的干扰和过滤材料的吸附等方面对溶出度测定结果的偏离进行纠正。

关键词　药品,溶出度测定,影响因素

中图分类号:R927.1 文献标识码:A 文章编号:100625687(2009)0120072203

溶出度测定法是将某种固体制剂的一定量分别置于溶出仪的转篮(或溶出杯)中,在(37.0±0.5)℃恒温下,在规定的转速和溶出介质中依法操作,在规定时间内取样并测定其溶出量[1]。溶出度检查作为评价药品质量的一个重要指标,模拟口服固体制剂在胃肠道环境中的崩解和溶出,其重要性不言而喻。

在多年的工作实践中,笔者检验的绝大多数药品均能达到溶出度的要求,也有部分药品溶出度测定结果不符合规定,这其中多为药品本身的质量问题,但也有测定方法存在的问题,致使测定结果偏离。分析溶出度测定偏离的原因,有针对性地予以纠正,对实际工作具有十分重要的指导意义。为保证溶出度测定数据的客观性、准确性和科学性,本文综述了溶出度测定过程中的常见问题和解决办法。

1　仪器因素

111　溶出仪的调试　在溶出度测定前,必须检查溶出仪的稳定性、转速和温度等是否符合要求。①仪器运转时,整套装置应保持平稳,不能产生明显的晃动或振动(包括仪器装置所处的环境)。②转轴应在中心孔并保持垂直状态,旋转应平稳无颤动,仪器应处于良好

27天津药学　Tianjin　Phar macy　2009年　第21卷第1期3收稿日期:2008203204