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目的:研究2种盐酸甲氯芬酯胶囊在中国健康志愿者体内的生物等效性。方法:18名健康男性志愿者随机分为2组,分别单剂量交叉口服盐酸甲氯芬酯胶囊受试制剂或参比制剂200mg。于服药前0h和服药后0.33、0.67、1、1.5、2、2.5、3、4、6、8、10、14、24h时抽取静脉血,采用高效液相色谱法测定血浆中对氯苯氧乙酸的浓度。通过DASVer2.0软件计算主要药动学参数,评价2制剂的生物等效性。结果:盐酸甲氯芬酯受试制剂与参比制剂的药动学参数分别为:tma(x2.11±0.37)、(2.06±0.34)h,cmax(12.56±2.85)、(12.78±2.84)μg·mL-1,t1/(25.81±2.68)、(6.00±2.14)h,AUC0～2(434.11±7.89)、(34.12±7.99)μg·h·mL-1,AUC0～∞(34.83±7.68)、(34.79±7.97)μg·h·mL-1。以AUC0～24计算,受试制剂对参比制剂的相对生物利用度为(100.7±11.7)%。结论:2种盐酸甲氯芬酯胶囊在中国健康志愿者体内具有生物等效性。
Objective: To study the bioequivalence of two kinds of meclofenoxate capsules in Chinese healthy volunteers. Methods: Eighteen healthy male volunteers were randomly divided into two groups. One single oral dose of meclofenoxate hydrochloride capsule or 200mg of the reference preparation was used respectively. Venous blood was drawn at 0 h before taking the drug and at 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 14 and 24 h after taking the medicine. Acetic acid concentration. The main pharmacokinetic parameters were calculated by DASVer2.0 software to evaluate the bioequivalence of 2 preparations. Results: The pharmacokinetic parameters of meclofenoxate hydrochloride and reference drug were as follows: tma (x2.11 ± 0.37), (2.06 ± 0.34) h, cmax (12.56 ± 2.85), (12.78 ± 2.84) AUC0 ~ 2 (34.83 ± 7.68), AUC0 ~ (34.83 ± 7.68), AUC0 ~ 2 (434.11 ± 7.89), (34.12 ± 7.99) μg · h · mL- ), (34.79 ± 7.97) μg · h · mL-1. The relative bioavailability of the test formulation to the reference formulation was (100.7 ± 11.7)%, calculated as AUC0-24. Conclusion: Two kinds of meclofenoxate capsules are bioequivalent in Chinese healthy volunteers.