| 愈创木酚甘油醚缓释微丸在Beagle犬内的药动学及生物等效性研究 |
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| 引用本文： | 熊龙启,陈庆华. 愈创木酚甘油醚缓释微丸在Beagle犬内的药动学及生物等效性研究[J]. 中国药学杂志, 2007, 42(20): 1574-1576 |
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| 作者姓名： | 熊龙启 陈庆华 |
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| 作者单位： | 上海医药工业研究院,上海,200437 |
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| 摘 要： | 目的探讨愈创木酚甘油醚缓释微丸在Beagle犬内的药动学特性和相对生物利用度,并计算其生物等效性。方法用反相HPLC测定动物血浆中愈创木酚甘油醚的浓度,计算愈创木酚甘油醚缓释微丸(受试制剂)及Mucinex?((参比制剂)药动学参数和相对生物利用度,并比较两制剂的生物等效性。结果口服受试制剂的主要药动学参数:AUC0-16为(20407.49±2120.62)μg·h·L-1;tmax为(0.92±0.36)h;ρmax为(3699.85±806.39)μg·L-1;Ke为(0.20±0.039)h-1;t1/2(Ke)为(3.58±0.64)h。受试制剂相对于参比制剂的平均相对生物利用度F-AUC0-16为(99.8±9.8)%,F-AUC0-inf为(101.6±10.1)%。结论愈创木酚甘油醚缓释微丸和进口愈创木酚甘油醚缓释片生物等效。
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| 关 键 词： | 愈创木酚甘油醚 缓释微丸 药动学 生物等效性 |
| 文章编号： | 1001-2494（2007）20-1574-03 |
| 收稿时间： | 2006-07-19; |
| 修稿时间： | 2006-07-19 |
Study on Pharmacokinetics of Guaifenesin Sustained Release Pellets in Beagle Dogs |
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| XIONG Long-qi,CHEN Qing-hua. Study on Pharmacokinetics of Guaifenesin Sustained Release Pellets in Beagle Dogs[J]. Chinese Pharmaceutical Journal, 2007, 42(20): 1574-1576 |
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| Authors: | XIONG Long-qi CHEN Qing-hua |
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| Affiliation: | Shanghai Institute of Pharmaceutical Industry, Shanghai 200437, China |
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| Abstract: | OBJECTIVE To study the pharmacokinetics of guaifenesin sustained release pellets in healthy beagle dogs and to evaluate the bioequivalence.METHODS The concentrations of guaifenesin in plasma were determined by RP-HPLC.The pharmacokinetic parameters were calculated and the relative bioequivalence was evaluated.RESULTS The main pharmacokinetic parameters of guaifenesin sustained release pellets were as follows:AUC0-16(20 407.49±2 120.62)μg·h·L-1;tmax(0.92±0.36)h;ρmax(3 699.85±806.39)mg·L-1;Ke(0.20±0.039)h-1;t1/2(Ke)(3.58±0.64)h,respectively.The relative bioavailability of AUC0-16 and AUC0-inf were(99.8±9.8)% and(101.6±10.1)%.CONSLUSION The reference and test formulations are bioequivalent. |
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| Keywords: | guaifenesin sustained release pellets pharmacokinetics bioequivalence |
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