CAJ | 학술논문

目的：：研究甲钴胺在健康人体内的药动学和生物等效性。方法：采用自身交叉三周期的实验设计,19名健康受试者分别口服两种甲钴胺制剂1.5 mg后,采用化学发光微粒子免疫法测定血清中甲钴胺的浓度,DAS 3.0软件计算药动学参数,进行等效性评价。结果：受试制剂和参比制剂的甲钴胺药动学参数：tmax分别为(4.2±1.9) h和(4.4±2.4) h,Cmax分别为(322.0±145.4) ng·L-1和(282.2±108.1) ng·L-1,t1/2分别为(19.2±5.3)h和(20.0±6.3)h,AUC0-72分别为(6769.1±2169.4) ng·h· L-1和(6400.6±1921.5) ng · h · L-1, AUC0-∞分别为(7334.2±2376.5) ng · h · L-1和(6992.4±2076.1) ng·h·L-1,受试制剂的相对生物利用度F(0-72)为105.9%±13.2%,F(0-∞)为104.9%±12.6%。结论：本试验建立的血清甲钴胺浓度测试方法简便、准确,两种制剂生物等效。
목적：：연구갑고알재건강인체내적약동학화생물등효성。방법：채용자신교차삼주기적실험설계,19명건강수시자분별구복량충갑고알제제1.5 mg후,채용화학발광미입자면역법측정혈청중갑고알적농도,DAS 3.0연건계산약동학삼수,진행등효성평개。결과：수시제제화삼비제제적갑고알약동학삼수：tmax분별위(4.2±1.9) h화(4.4±2.4) h,Cmax분별위(322.0±145.4) ng·L-1화(282.2±108.1) ng·L-1,t1/2분별위(19.2±5.3)h화(20.0±6.3)h,AUC0-72분별위(6769.1±2169.4) ng·h· L-1화(6400.6±1921.5) ng · h · L-1, AUC0-∞분별위(7334.2±2376.5) ng · h · L-1화(6992.4±2076.1) ng·h·L-1,수시제제적상대생물이용도F(0-72)위105.9%±13.2%,F(0-∞)위104.9%±12.6%。결론：본시험건립적혈청갑고알농도측시방법간편、준학,량충제제생물등효。
Objective:To develop a chemiluminescent microparticle immunoassay ( CMIA) method for the determination of meco-balamin in human serum to investigate the pharmacokinetics and bioequivalence of mecobalamin. Methods:A single oral dose of two kinds of mecobalamin was given to 19 healthy volunteers in a randomized three-period crossover study. The concentrations of mecobal-amin in serum were assayed by CMIA, the main pharmacokinetic parameters were analyzed by DAS 3. 0 software, and the bioequiva-lence was evaluated. Results: The main pharmacokinetic parameters of test and reference mecobalamin tablets were as follows: tmax were (4.2 ±1.9)h and (4.4 ±2.4)h,Cmax were (322.0 ±145.4) ng·L-1 and (282.2 ±108.1) ng·L-1,t1/2 were (19.2 ±5.3) h and (20.0 ±6.3)h,AUC0-72 were (6 769.1 ±2 169.4) ng·h·L-1 and (6 400.6 ±1 921.5) ng·h·L-1. F(0-72) and F(0-∞) of the test tablets was 105. 9% ± 13. 2% and 104. 9% ± 12. 6%,respectively. Conclusion:The method is simple and precise. The two tablets are bioequivalent.