Objective To optimize the preparation procedure of the Juhong Tanke effervescent tablets for the stability of preparation. Methods The collapse time was used as the index to evaluate the technologies based on orthogonal test ,in which the proportion between the citricacid and the sodium bicarbonate,the granulating methods and the total of the acid-base were considered as three main technology factors. Results The optimum procedure condition was A1B1C2 ,which were with the proportion of 1:1,encapsulated by polyethylene glycol and 37% of the acid-base in total amount. Conclusion The new procedure is superior to the traditional procedure,and it is reliable and efficient to improve the stability.

本文按照时间的顺序回顾了我国药品注册审批制度的历史进程,主要通过对历次新药注册审批管理相关法规的解析来阐明我国对药品注册管理的发展思路,可以看到我国对药品注册管理的标准在不断地提高,药品注册管理在一步步地走向规范法、法制化和国际化。

目的 观察金振口服液对Vero E6细胞内SARS相关冠状病毒的抑制作用.方法 取一定量的SARS相关冠状病毒BJ-01株加入培养好的Vero E6细胞中,置37℃、5%CO2培养箱吸附2 h,吸出病毒液,再分别加入不同浓度的药物稀释液,在同样条件下培养4～5 d,观察细胞病变情况.结果 金振口服液抑制冠状病毒半数有效浓度(IC50)为2.0μg/mL,治疗指数(TI)为35,,结论金振口服液对SARS病毒有较好的抑制作用.

逍遥软胶囊是由《中华人民共和国药典》1995年版收载的中成药逍遥丸改剂型而来,主要由柴胡、当归、白芍、白术、茯苓等中药组成,具有疏肝健脾、养血调经之功效,用于肝气不舒、胸肋疼痛、头晕目眩、食欲减退、月经不调.白芍为方中的主要组份,故采用HPLC法测定逍遥软胶囊中芍药苷的含量,结果准确可靠,可作为逍遥软胶囊的质量控制方法.