盐酸左氧氟沙星胶囊人体药物动力学与生物利用度研究

目的: 研究盐酸左氧氟沙星胶囊健康人体的药物动力学与生物利用度。方法: 高效液相色谱(HPLC)法测定20名健康受试者单剂量口服两种盐酸左氧氟沙星胶囊(受试制剂和参比制剂)的药时数值,以DAS1.0软件拟合其药动学参数,用方差分析和双侧t检验法检验其等效性。结果: 受试制剂与参比制剂的药动学参数分别为:t_1/2(5.24±1.58) h和(5.50±2.05) h,C_max(2.75±0.61) mg/L和(2.55±0.61) mg/L,T_max(0.99±0.56) h和(1.05±0.54) h,AUC_0-24(21.53±3.36) mg·L-1·h-1和(20.61±3.67) mg·L-1·h-1,AUC_0-∞(23.87±3.92) mg·L-1·h-1和AUC_0-∞(23.05±4.45) mg·L-1·h-1。受试制剂的相对生物利用度为(108.82±30.75)%。结论: 两种不同厂家的盐酸左氧氟沙星胶囊具有生物等效性。

The pharmacokinetics and relative bioavailability of levofloxacin hydrochloride capsule in healthy volunteers

Objective: This study was designed to characterize the ultrastructure of the coccoid Helicobacter pylori(H. pylori) forms in the tissues of carcinoma.Methods: Transmission electron microscopy(TEM) technique was used to examine the structure of coccoid H. pylori in 4 cases of gastric carcinoma and 2 cases of esophageal carcinoma.Results: It was found that the coccoid H. pylori were scattered in cancer nest and cancer interspace,some of which enterded cancer cells,macrophages and other cells.The coccoid H. pylori appeared to be similar to the L-forms of other bacteria with varying cell shape and size,different cytoplasmic electron densities and defects in cell wall.Two types of coccoid H. pylori could be distinguished in the tissues of carcinoma by TEM.Type A was smaller with higher electron density in the cytoplasma,and flagellation on the cell membrane,suggesting that it could be viable.However,the type B was larger with lower electron density in the cytoplasma,and no flagellation on the cell membrane,suggesting that it could be a degenerative form.Conclusions: The coccoid forms of H.pulori still have certain degree of viability,thus they may play an important role in the transmission of H. pylori,the relapse of H. pylori related disease after treatment and the development of the related carcinoma.