光纤传感过程分析评价不同厂家非洛地平缓释片体外生物等效性  

In vitroevaluation of bioequiavailability of Felodipine Sustained-Release Tablets from different manufactures by fiber-optic dissolution test

作　　者：刘洋[1] 李新霞[1] 郑立民[1] 李莉[1] 耿东升[2] 

机构地区：[1]新疆医科大学药学院,乌鲁木齐830011 [2]新疆军区联勤部药品仪器检验所,乌鲁木齐830063

出　　处：《西北药学杂志》2012年第2期152-154,共3页Northwest Pharmaceutical Journal

基　　金：新疆维吾尔自治区高技术发展项目(200910107);新疆维吾尔自治区自然科学基金(编号:2011211A041)

摘　　要：目的采用光纤传感药物溶出度实时测定仪测定非洛地平缓释片释放度,用f2评价软件比较3个厂家的非洛地平缓释片释放曲线相似性。方法按照部颁标准非洛地平缓释片溶出度测定法第二法的装置,转速200r.min-1,以4g.L-1十六烷基三甲基溴化铵磷酸盐缓冲液(pH6.5)500mL为溶出介质。选用5mm探头,365和420nm双波长进行测定。结果 12粒非洛地平缓释片在1,4和7h的释放度,A厂产品均值分别为9.10%,52.1%,78.7%;RSD分别为15.9%,7.36%,5.58%;B厂产品均值分别为14.0%,63.4%,96.5%;RSD分别为32.1%,23.6%和14.2%;C厂产品均值分别为12.1%,49.4%和80.5%;RSD分别为35.3%,28.0%和22.4%。结论按释放度标准3个厂家的片剂均不合格,且B厂和C厂12粒药的释放度一致性不符合进行f2因子评价的条件。Objective To monitor the release rate of Felodipine Sustained-Release Tablets with fiber-optic dissolution test （FODT）, and to employ f2 factor to compare the similarity of Felodipine Sustained-Release Tablets dissolution curve. Methods Apparatus 2 with the paddle rotation of 200 r · min-1 ,4 g · L-l hexadecyltrimethylammonium bromide phosphate buffer （ pH6.5） 500 mL as dissolution medium was used. With a probe of 5 mm path, the detect wavelength was 365 nm and the reference wavelength was 420 nm. Results The accumulated release of Felodipine Extended-Release Tablets A at 1,4 and 7 h were 9.10 %, 52.1% and 78.7 %, respectively;RSD were 15.9% ,7.36% ,and 5.58% ,respectively;Factory B were 14.0%, 63.4% ,and 96.5%, respectively; RSD were 32.1% ,23.6% and 14.2%, respectively; Factory C were 12. 1%, 49.4%, and 80.5 %, respectively; RSD were 35.3%, 28.0% and 22.4%, respectively. Conclusion Felodipine Sustained-Release Tablets from three manufacturers are all disqualification. The consistency of dissolution profile of B and C is poor,it does not meet the conditions of the f2 factor evaluation.

关 键 词：非洛地平缓释片 光纤传感药物溶出度实时测定仪 F2因子 体外生物等效性 

分 类 号：R944[医药卫生—药剂学]