Bioequivalence Study Of Iodizedlecithin In Healthy Volunteers By GC

ObjectiveThe purpose of population pharmacokinetics of cyclosporine in clinical was to elucidated the dynamic change law of absorption,distribution,metabolism,excretion in vivo.It was an essential component of acknowledge between people and drug,and was the foundation of dosage schedule in clinical.To established a reasonable method of separation,purification and quantitative analysis was the key of pharmaceutical analysis because the components of biological sample was complicated and the contents of determinand was low.A gas phase chromatography was developed to studied iodizedlecithin in vivo,and to clarified the discipline of pharmacokinetics in healthy chinese.It provided some scientific references for safety usage and apropriate use.MethodThe operation was carried on 18 healthy male subjects using double- preparation double-cycle random cross matching design.Subjects eated on a light diet foe dinner and fast at 21 in the evening.Subjects tookj drug hollowlly using 250 mL purified water in the morning on next day,and uniform standard diet was supplied(using salt and vegetables lack of iodine).There were a doctor and two nurses measured heart rate and blood pressure,and recorded dealed with the untoward effect.There were also first aid equipment to guarantee the safety of subjects.A GC method was used to deternined iodizedlecithin using OV-1701(50 m×0.53 mm) column vaporizer temperature was 230℃,column temperature was 105℃, detector temperature was 260℃.Nitrogen was used as supporting gas,and the flow speed was 10 mL/min.ResultsThe linear range of iodizedlecithin was 0.04-0.4μg/mL and the recovery was 74.98-86.91%.The LOQ and LOD of iodizedlecithin was 0.02μg/mL,0.04μg/mL, respectively.Samples were stable in 30 days under refrigeration.The pharmacokinetics parameters after oral administration iodizedlecithin 9 mg were as follows:T_max(1.028±0.19),(1.028±0.19) h;C_max(2.72±0.87),(2.56±0.92)μg/mL;T_1/2ke(34.41±13.6),(42.85±27.79) h;AUC_0-t(18.29±4.34),(17.39±4.72)μg.h/mL;AUC_0-∞(44.99±17.25).The relative bioavailability of iodizedlecithin was (106.7±13.3)%calculated by AUC_0-t,and(102.8±32.9%) calculated by AUC_0-∞.ConclusionsThe method is found accurate,sensitive and reproducible.It can be used for the determination of the contents of iodizedlecithin in vivo.The two preparation was found to be bioequivalen.