美洛昔康咀嚼片的生物等效性研究

Study on bioequivalence of Meloxicam Chewable Tablets

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 investigate in vivo pharmacokinetics and bioequivalence of Meloxicam Chewable Tablets in healthyBeagle＇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 plasmaconcentration of meloxicam was determinated by RP-HPLC. The 3P97 software was adopted to calculate the pharmacokineticparameters and evaluate the bioequivalence of two preparations. Results The area under the curves （AUCo96 h） of the testingtablets and innovator tablets were （2.85±0.64）and（2.79±0.48）μg/m L·h,T_（max）vs（4.33±0.65）and（4.16±0.71）h,C_（max）was（0.091±0.017）and（0.086±0.021）μg/m L,t_（1/2）was（26.08±3.64）和（26.94±4.21）h. After the double unilateral t test, there was no statistical significance in the difference of lnAUC and lnCmax between thetesting tablets and innovator tablets. Conclusion The testing tablets and innovator tablets are bioequivalent. The relativebioavailability of generic tablet is （98.0_ 9.76）%.