谷氨酰胺胶囊在健康人体的生物等效性研究

Bioequivalence of glutamine capsules in healthy volunteers

目的研究中国健康受试者单次口服谷氨酰胺胶囊的人体生物等效性。方法将36名男性健康受试者随机分为2组,分别单剂量口服试验药或参比药4.0 g,洗脱1周后,交叉给药,用高效液相色谱与二级质谱联用(HPLC-MS/MS)方法测定血药浓度,计算两者的主要药代动力学参数和相对生物利用度。结果口服试验药和参比药后,血浆中谷氨酰胺主要药动学参数如下:tmax分别为(0.69±0.66)和(0.66±0.33)h,Cmax分别为(127.80±53.48)和(123.10±40.42)μg·m L-1,以AUC0→∞计算,试验药相对生物利用度为(99.96±39.92)%。结论试验药与参比药在健康受试者体内生物作用等效。

Objective To study the bioequivalence of glutamine cap-sules in healthy volunteers.Methods Thirty-six healthy male volun-teers were divided randomly into two groups.Subjects received respec-tively a single dose of 4.0 g test or reference drug, and cross were administered with the other drug after one -week washout period.LC-MS/MS were adopted to determine the plasma concentrations of glutamine capsules and the main pharmacokinetic parameters and relative bioavailability of both capsules.Results After receiving the test and the reference drugs, the pharmacokinetic parameters of glutamine were as follows： tmax were （0.69 ±0.66）, （0.66 ±0.33） h, and Cmax were （127.80 ±53.48 ） , （ 123.10 ±40.42 ）μg·mL^-1 , respectively.The relative bioavailability of the test drug was （ 99.96 ± 39.92 ）%.Conclusion The test and reference drug of glutamine were bioequivalent in healthy volunteers.