Objective To evaluate postprandial pharmacokinetics and bioequivalence of two preparations of cefdinir capsules in Chinese healthy volunteers. Methods In a two-way cross-over study, 24 healthy male volunteers were divided into two groups randomly and a single dose of cefdinir capsules of test and reference preparation were administered orally, respectively.The concentration in plasma was determined by LC-MS/MS. Pharmacokinetic parameters and bioequivalence were calculated and evaluated by DAS. Results The main pharmacokinetic parameters of test and reference were as follows: AUCt (4.35±1.09) μg??h??mL-1 and (4.12±1.22) μg??h??mL-1, AUC0-∞(4.53±1.12) and (4.53±1.73) μg??h??mL-1, t1/2 (1.74±0.29) h and (2.13±1.65) h, tmax(4.44±0.86) h and (4.54 ±1.16) h, Cmax(900±250) ng??mL-1 and (876±269) ng??mL-1 . Conclusion The test and reference preparation of cefdinir capsules are bioequivalent.

Objective:To evaluate the safety of cardiac catheterization intervention therapy and transthoracic small incision surgery in the occlusion bydomestic occluder under echocardiography guiding in patients with atrial septal defect (ASD).Methods:A total of 1 080 patients with ASD in the occlusion by domestic occluder were analyzed retrospectively,and the interventional treatment were performed in 734 cases through cardiac catheterization intervention therapy and 346 cases through transthoracic small incision surgery.The patients undergone cardiac catheterization intervention therapy were guided under the digital substraction angiography (DSA) and were monitored by transthoracic echocardiography (TTE) in the whole interventional process,and the efficacy was evaluated with TTE.The occlusion of transthoracic small incision surgery was guided under the transesophageal echocardiography (TEE),which was used to monitor the position of occluder and evaluate the efficacy immediately.Results:Two kinds of intervention in the occlusion by domestic occluder had achieved satisfactory results in patients with ASD.There was no statistically difference in the longest size of ASD between the 2 intervention methods,while there were statistically differences in the ratio between ASD longest diameter and atrial septal length,and the size of the occlusion,and the disparity between the size of the occluder and ASD longest diameter (D value),respectively (all P＜0.05).When the size of arithmetic mean of the ASD was ＜30 mm,the success rate of the 2 methods was both 100％.When the size of arithmetic mean of the ASD was ≥ 30 mm,the success rate was 100％ in the transthoracic small incision surgery and 50％ in the cardiac catheterization intervention therapy.Conclusion:Domestic occluder is safe.Compared with the imported one,its cost is lower.When the size of the defects is same,the occlusion is smaller in the transthoracic small incision surgery compared with that in the cardiac catheterization intervention therapy.When the size of arithmetic mean of the ASD is ≥ 30 mm,the success rate of the transthoracic small incision surgery is higher compared with the cardiac catheterization intervention therapy.When the cardiac catheterization intervention therapy fails,the transthoracic small incision surgery may be a better choice.