硝酸甘油贴膜的含量均匀度和体外释放度测定  

Content uniformity and controlled release characteristics of nitroglycerin transdermal delivery systems in vitro

作　　者：魏雪芳[1] 

机构地区：[1]广东省药品审评认证中心,广东广州510080

出　　处：《广东药学院学报》2005年第1期34-36,38,共4页Academic Journal of Guangdong College of Pharmacy

摘　　要：目的测定硝酸甘油贴膜的含量均匀度和体外释放度.方法采用高效液相色谱法,用SUNTEK KROMASIL C18柱,以ψ(甲醇:水)=60:40为流动相,流速1.0 mL·min-1,检测波长220 nm,测定硝酸甘油贴膜的含量均匀度.采用高效液相色谱法,用大连依利特C1柱,以ψ(甲醇:水)=25:75,每1 000 mL中含醋酸铵386 mg为流动相,流速1.25 mL·min-1,检测波长214 nm,用浆法溶出装置,测定硝酸甘油贴膜2、4、6、12、24 h 累积释放量. 结果 2个规格各3个批号供试品每片含硝酸甘油均为标示量的88%～102%,且2、4、6、12、24 h硝酸甘油平均释放量分别为1.09、1.49、1.88 、3.12、4.91 mg(16 mg/片,释出率5 mg/24 h)和2.0、3.3 、4.3、6.6、10.3 mg(32 mg/片,释出率10 mg/24 h).结论两种测定方法简便、稳定、准确,能有效地反映硝酸甘油贴膜的质量.Objective To determine the content uniformity and controlled release characteristics of transdermal nitroglycerin in vitro. Methods The content uniformity was measured by HPLC on SUNTEK KROMASIL C 18 column with methanol and water(60∶40, v/v) as mobile phase at a flow rate of 1.0 mL/min under the wavelength of 220 nm. A Hypersil C 1 column was employed together with a mobile phase of methanol-water(25∶75, v/v) containing ammonium acetate (386 mg/L) at a flow rate of 1.25 mL/min, and UV detection was performed at 214 nm to determine the content release of nitroglycerin at 2, 4, 6, 12 and 24 h with the paddle method. Results The contents of nitroglycerin in 3 test batches ranged from 88% to 102% of labelled amount. The amounts of released nitroglycerin were 1.09, 1.49, 1.88, 3.12 and 4.91 mg(16 mg /patch,designed to release 5 mg of nitroglycerin over 24 h)and 2.0, 3.3, 4.3,6.0 and 10.3 mg(32 mg /patch,designed to release 10 mg of nitroglycerin over 24 h )at 2, 4, 6, 12 and 24 h , respectively. Conclusion These detection methods are convenient,stable and reliable for the quality control of nitroglycerin transdermal delivery systems.

关 键 词：硝酸甘油 硝酸甘油贴膜 含量均匀度 释放度 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]