盐酸哌甲酯双相控释渗透泵片释放度测定方法的建立  

Establishment of Drug Release Determination Method for Methylphenidate Hydrochloride Bipolar Controlled Release Osmotic Pump Tablets

作　　者：夏琼琼[1,2] 刘辉[1] 何佩芳 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070 [2]湖北中医药大学药学院

出　　处：《中国药师》2016年第2期226-230,共5页China Pharmacist

基　　金：国家"十二五"重大新药创制科技重大专项经费资助课题(编号:2013ZX09J13109-05C)

摘　　要：目的:建立盐酸哌甲酯双相控释渗透泵片释放度的测定条件和释放度的测定方法。方法:采用HPLC法测定盐酸哌甲酯双相控释渗透泵片的释放度,色谱条件:Diamonsil C_(18)(250 mm×4.6 mm,5μm)为色谱柱,流动相为0.02 mol·L^(-1)磷酸二氢钾溶液(用1%磷酸溶液调节p H为3.0)∶乙腈=70∶30,检测波长为220 nm,流速为1.0 ml·min^(-1),柱温为35℃,进样量为20μl;考察释放介质、不同释放装置和转速对盐酸哌甲酯双相控释渗透泵片释放度的影响。结果:建立的释放量测定方法在1.0~24.0μg·ml^(-1)线性关系良好,r=0.999 5,平均回收率为100.5%,RSD为1.58%(n=6);以900 ml p H 3.0磷酸盐缓冲溶液作为释放介质,转速为50 r·min^(-1),加沉降篮的释放条件下,本品在0~2 h内快速释放,2~10 h符合零级释放,释药方程为Q=5.505t+44.221(r=0.994 5)。结论:本方法简便、准确、可靠,可用于盐酸哌甲酯双相控释渗透泵片释放度的质量控制。Objective： To establish the drug release determination conditions and method for methylphenidate hydrochloride bipolar controlled release osmotic pump tablets. Methods： The drug release of the tablets was determined by HPLC using a Diamonsil C18 （250 mm ×4.6 mm, 5 μm） column with acetonitrile-KH2PO4 （0.02 mol · L-1 ,and pH was adjusted to 3.0 by 1% H3PO4solution） （30： 70） as the mobile phase at a flow rate of 1 ml · min-1 , the column temperature was 35 ℃ and the injection volume was 20 μl. The effects of release medium, release apparatus and rotation speed on the release of methylphenidate hydrochloride bipolar controlled release osmotic pump tablets were studied as well. Results： The established drug release determination method had a good linear relationship within the range of 1.0-24.0 μg · ml- 1 （ r = 0.999 5） , and the average recovery was 100.5% （RSD = 1.58% , n = 6）. Under the conditions of 900 ml pH 3.0 phosphate buffer solution as the release medium and the rotation speed of 50 r ·main- 1, the drug was quickly released in 0-2h, and then the release behavior was complied with a zero-level model in vitro in 2-10h with the release equation of Q = 5.505t ＋ 44.221 （ r = 0. 994 5 ）. Conclusion： The method is simple, accurate and reliable, and suitable for the quality control of methylphenidate hydrochloride bipolar controlled release osmotic pump tablets.

关 键 词：盐酸哌甲酯 双相控释渗透泵片 高效液相色谱 释放度 质量控制 

分 类 号：R944.9[医药卫生—药剂学]