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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AUC_(0~96) h分别为(2.85±0.64)和(2.79±0.48)μg/m L·h,T_(max)分别为(4.33±0.65)和(4.16±0.71)h,C_(max)分别为(0.091±0.017)和(0.086±0.021)μg/m L,t_(1/2)分别为(26.08±3.64)和(26.94±4.21)h,两者的lnAUC和lnC_(max)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)%。
Objective To study the pharmacokinetics and bioequivalence of meloxicam chewable tablets in Beagle dogs. Methods Twelve healthy adult beagle dogs were randomly divided into two groups. The two-cycle crossover design was used. The test tablets and reference tablets were orally administered 2 mg orally. The concentration of meloxicam in plasma was determined by RP-HPLC. Pharmacokinetic parameters were calculated by the 3P97 software and bioequivalence was evaluated for both formulations. Results The AUC_ (0 ~ 96) h of test tablet and reference tablet were (2.85 ± 0.64) and (2.79 ± 0.48) μg / m L · h, respectively, and the T max were 4.33 ± 0.65 and 4.16 ± 0.71 h and C max were (0.091 ± 0.017) and (0.086 ± 0.021) μg / m L, respectively, and t 1/2 was 26.08 ± 3.64 and 26.94 ± 4.21 h respectively The lnAUC and lnC_ (max) by double unilateral t test showed no significant difference. Conclusion The test tablets are bioequivalent to the reference tablets marketed overseas, with an average relative bioavailability of (98.0 ± 9.76)%.