一般项目:药品生产、销售(以《药品生产许可证》核定的范围和有效期为准);医疗器械的生产、销售(以《医疗器械生产许可证》核定的范围为准);预包装食品、保健食品和特殊医学用途配方食品的研发、生产、销售(凭有效许可证经营);第一类易制毒化学品生产、经营;医药技术开发、技术转让、技术服务、技术咨询;药品、食品检测服务;经营本企业自产产品及技术的出口业务;经营本企业生产、科研所需的原辅材料、机械设备、仪器仪表、零配件及技术的进口业务(国家限定公司经营和国家禁止进出口的商品除外);代理进出口(国家有专项审批规定的,未取得相关许可,不得经营);经营进料加工和“三来一补”业务++;药品委托生产(除依法须经批准的项目外,凭营业执照依法自主开展经营活动)
MicroRNAs(miRNAs) are involved in the pathophysiological processes of many diseases. Stably present in cells, tissues and blood, they can be used as potential markers of many diseases. They play an important role in the pathogenesis of liver fibrosis caused by various chronic liver diseases. It has been shown that miRNAs can participate in the process of liver fibrosis by targeting the down-regulation of liver fibrosis-related gene expression. In this review, we discuss the research progress on the role of miRNAs in liver fibrosis, with the hope of providing reference for diagnosis and molecularly targeted treatment.
Objective To study the pharmacokinetic characteristics of clobazam tablet in Chinese healthy subjects and evaluate the bioequivalence of test preparation(T)and reference preparation(R)under fasting or fed conditions.Methods A randomized,open-label,single-dose,two-period,two-way crossover bioequivalence trial was performed.34 healthy subjects were enrolled in fasting study and 30 in fed study.Each subjects received a single dose of T 20 mg or R 20 mg with a washout period of 28 days.Plasma concentrations of clobazam and its active metabolite,N-desmethylclobazam were determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS).The pharmacokinetic parameters of clobazam and N-desmethylclobazam were calculated by non-compartment model.Geometric mean values for the T/R ratios of clobazam's main pharmacokinetic parameters and their corresponding 90 percent confidence intervals(CI)were evaluated to assess bioequivalence of the two preparations.Results In fasting study,the 90 percent CI of the geometric mean values for the T/R ratios were 94.46 to 103.82 percent for Cmax,99.64 to 103.62 percent for AUC0-tand 99.39 to 103.51 percent for AUC0-∞,respectively.In fed study,the 90 percent CI of the geometric mean values for the T/R ratios of were 93.86 to 106.02 percent for Cmax,100.37 to 104.51 percent for AUC0-tand 100.71 to 104.63 percent for AUC0-∞,respectively.Conclusion In this study,the 90 percent CI of the geometric mean values of Cmax,AUC0-tand AUC0-∞ for T/R ratios were all within the acceptable bioequivalence limits of 80 to 125 percent for clobazam.Therefore two formulations were considered bioequivalent.