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复方烟酸辛伐他汀双层缓释片的制备及Beagle犬体内药代动力学

周莉, 黎洪, 尹莉芳, 王莎, 陈西敬

周莉, 黎洪, 尹莉芳, 王莎, 陈西敬. 复方烟酸辛伐他汀双层缓释片的制备及Beagle犬体内药代动力学[J]. 中国药科大学学报, 2012, 43(6): 508-513.
引用本文: 周莉, 黎洪, 尹莉芳, 王莎, 陈西敬. 复方烟酸辛伐他汀双层缓释片的制备及Beagle犬体内药代动力学[J]. 中国药科大学学报, 2012, 43(6): 508-513.
ZHOU Li, LI Hong, YIN Li-fang, WANG Sha, CHEN Xi-jing. Preparation and pharmacokinetics of compound nicotinic acid extended-release and simvastatin immediate-release double-layer tablets[J]. Journal of China Pharmaceutical University, 2012, 43(6): 508-513.
Citation: ZHOU Li, LI Hong, YIN Li-fang, WANG Sha, CHEN Xi-jing. Preparation and pharmacokinetics of compound nicotinic acid extended-release and simvastatin immediate-release double-layer tablets[J]. Journal of China Pharmaceutical University, 2012, 43(6): 508-513.

复方烟酸辛伐他汀双层缓释片的制备及Beagle犬体内药代动力学

基金项目: 国家“重大新药创制”科技重大专项资助项目(No.2009ZX09310-004);教育部新世纪优秀人才支持计划资助项目(No.NCET-08-0846);中央高校基本科研业务费专项基金资助项目(No.JKZ2009009)

Preparation and pharmacokinetics of compound nicotinic acid extended-release and simvastatin immediate-release double-layer tablets

  • 摘要: 以烟酸和辛伐他汀为模型药物制备复方双层缓释片,并评价其体外释放特性。采用双周期双交叉给药方案,LC-MS/MS法同时测定自制制剂和市售制剂中烟酸和辛伐他汀的血药浓度,对6只Beagle犬进行了药代动力学和生物利用度的初步研究。自制制剂和市售制剂给药后烟酸的cmax分别为(6.43±0.80)和(6.38±0.47)μg/mL,tmax分别为(2.80±1.00)和(2.50±1.00)h,AUC分别为(30.16±4.51)和(27.49±4.04) μg·h/mL;辛伐他汀的cmax分别为(38.65±1.71)和(40.54±2.33)ng/mL,tmax均为(1.50±0.40)h,AUC分别为(118.76±11.83)和(115.76±5.46)ng·h/mL。结果表明两种制剂中烟酸和辛伐他汀的AUC,cmaxtmax都等效,说明自制制剂和市售制剂在Beagle犬体内具有生物等效性。
    Abstract: Compound nicotinic acid extended-release and simvastatin immediate-release double-layer tablets were developed and their in vitro release characteristics were evaluated.The LC-MS/MS method was established for the determination of the concentration of nicotinic acid and simvastatin in blood and investigate the pharmacokinetics and relative bioavailability in 6 Beagle dogs with the double-period and double-crossover dosage regimen.After oral administration of the test and reference tablets,cmax of nicotinic acid was (6.43±0.80) and (6.38±0.47) μg/mL; tmax was (2.80±1.00) and (2.50±1.00) h;AUC was (30.16±4.51) and (27.49±4.04) μg ·h/mL,respectively.cmax of simvastatin was (38.65±1.71) and (40.54±2.33) ng/mL; tmax was (1.50±0.40) and (1.50±0.40) h,AUC was (118.76±11.83) and (115.76±5.46) ng ·h/mL,respectively.Statistical analysis indicated that AUC,cmax and tmax of test preparations were equivalent to reference preparations.So it is bioequiavailability between the test and reference preparations in Beagle dogs.
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  • 刊出日期:  2012-12-24

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