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[摘要]
目的 研究美洛昔康咀嚼片在比格犬体内的药动学和生物等效性。方法 12只健康成年比格犬随机分为2组,采用双周期交叉实验设计,分别口服测试片剂和参比片剂2 mg,用RP-HPLC方法测定血浆中美洛昔康的浓度,应用3P97软件计算药动学参数,并进行两种制剂的生物等效性评价。结果 测试片剂和参比片剂的AUC0~96 h分别为(2.85±0.64)和(2.79±0.48)μg/mL·h,Tmax分别为(4.33±0.65)和(4.16±0.71)h,Cmax分别为(0.091±0.017)和(0.086±0.021)μg/mL,t1/2分别为(26.08±3.64)和(26.94±4.21)h,两者的lnAUC和lnCmax经双单侧t检验证明差异无统计意义。结论 测试片剂与国外上市的参比片剂具有生物等效性,其平均相对生物利用度为(98.0±9.76)%。
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[Abstract]
Objective To investigate in vivo pharmacokinetics and bioequivalence of Meloxicam Chewable Tablets in healthy Beagle's dogs. Method Twelve healthy adult Beagle's dogs were randomized into two groups. Using the double-preparation, double-cycle, cross-over method and administering orally of testing and reference tablet (2 mg) respectively. The plasma concentration of meloxicam was determinated by RP-HPLC. The 3P97 software was adopted to calculate the pharmacokinetic parameters and evaluate the bioequivalence of two preparations. Results The area under the curves (AUC0-96 h) of the testing tablets and innovator tablets were (2.85±0.64) and (2.79±0.48) μg/mL·h. The peak time (Tmax) was (4.33±0.65) and (4.16±0.71) h. The peak concentration (Cmax) was (0.091±0.017) and (0.086±0.021) μg/mL. The half time (t1/2) was (26.08±3.64) and (26.94±4.21) h. After the double unilateral t test, there was no statistical significance in the difference of lnAUC and lnCmax between the testing tablets and innovator tablets. Conclusion The testing tablets and innovator tablets are bioequivalent. The relative bioavailability of generic tablet is (98.0±9.76)%.
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