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1988年卫生部药政局共收到经省级初审,正式上报的中药新药89种,其中申请生产的34种、申请临床研究的55种。符合新药审批办法要求,予以批准生产和试生产的41种。分析申报审批材料可以看出中成药新药研究开发的一些动向。 1.申报的89种新药中,共有14个剂型。其中口服液及胶囊剂占很大比例。一些传统方剂,如十
In 1988, the Bureau of Pharmaceutical Affairs of the Ministry of Health received a total of 89 new Chinese herbal medicines that had been submitted to the provincial level for preliminary review, including 34 applications for production and 55 applications for clinical research. In compliance with the requirements of the new drug approval method, 41 kinds of approved production and trial production were approved. Analysis of the application materials for approval can show some trends in the research and development of new Chinese medicines. 1. Among the 89 new drugs declared, there are 14 dosage forms. Among them, oral liquids and capsules account for a large proportion. Some traditional prescriptions, such as ten