氨糖美辛肠溶片在健康受试者体内的生物等效性研究

Study on Bioequivalence of Glucosamine Indometacin Enteric-coated Tablets in Healthy Volunteers

目的:研究2种氨糖美辛肠溶片的人体生物等效性。方法:采用随机双交叉试验设计,20名男性健康受试者分别单剂量口服氨糖美辛肠溶片受试制剂与参比制剂1片后,用高效液相色谱法测定氨糖美辛的血药浓度,并用3p97程序对试验数据进行统计处理。结果:受试制剂与参比制剂的主要药动学参数分别为:tmax(3.36±0.87)、(3.11±0.79)h,cmax(5.91±1.60)、(6.01±1.10)mg/L,t1/2(7.46±1.97)、(7.51±2.64)h,AUC0-24h(17.36±4.04)、(16.09±3.08)mg·h/L,AUC0-∞(19.34±4.26)、(17.58±3.58)mg·h/L。受试制剂的相对生物利用度为(109.5±13.6)%。经统计学检验,2种制剂的AUC0-∞、cmax、t1/2、tmax差异均无统计学意义(P>0.05)。结论:2种氨糖美辛肠溶片具有生物等效性。

OBJECTIVE： To study the bioequivalence of 2 kinds of Glucosamine indometacin enteric-coated tablets in healthy volunteers. METHODS ： In randomized crossover design, 20 male healthy volunteers received single dose of test preparation or reference preparation （1 piece） of Glucosamine indometacin enteric-coated tablets orally. The blood concentration of glucosamine indometacin was determined by HPLC. The data were analyzed by 3p97 program. RESULTS ： Main pharmacokinetic parameters of test preparation and reference preparation were as follows： t_max were （3.36±0.87）h and （3.11 ± 0.79）h; C_max were （5.91 ± 1.60）mg/L and （6.01 ± 1.10）mg/L; t1/2 were （7.46 ± 1.97） h and （7.51 ± 2.64）h;AUC_0-24h were （17.36 ± 4.04）mg·h/L and（16.09 ± 3.08）mg·h/ L; AUC_0-∞ were （ 19.34 ± 4.26） mg· h/L and （ 17.58 ± 3.58） mg·h/L. The relative bioavailability of test preparation was （ 109.5±13.6）%. There was no statistical significance in AUC_0-∞ C_max and t_max between them （P〉0.05）. CONCLUSIONS： 2 kinds of Glucosamine indometacin enteric-coated tablets are bioequivalent.