硝酸甘油贴膜的含量均匀度和体外释放度测定
硝酸甘油,,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,1仪器与试药,2方法与结果,3讨论,参考文献
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。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
Content uniformity and controlled release characteristics of nitroglycerin transdermal delivery systems in vitro
WEI Xuefang
(Guangdong Provincial Center for Drug Evaluation and Certification，Guangzhou 510080, China)
Abstract 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 C18 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 C1 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 ......
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