Present Status Analysis Of Pharmaceutical Excipients In China,Comparative Analysis Of Pharmaceutical Excipients Regulation About USA,EURO,Japan And China And Countermeasures Discussion About Chinese Pharmaceutical Excipients Regulation

In order to get comprehensive and accurate information about pharmaceutical excipients' regulation of USA, EURO, Japan and China, to get comprehensive and accurate information about Manufacturing and Using of Pharmaceutical Excipients in China and to provide advice for Chinese pharmaceutical excipient regulation. This research' s objects are four countries' regulation of pharmaceutical excipients, the manufacturing and using of pharmaceutical excipients in China and all pharmaceutical excipients approved by all provinces of China. Make comparative analysis about pharmaceutical excipient' s regulation of the four countries; Investigation is made on pharmaceutical factories of 11 provinces of China, the items include name, function, dosage, specification, original etc; Investigation is also made on all excipients approved by every province of China, the items include name, function, dosage, specification, original documents for approved etc.The results show as follows: the regulation of pharmaceutical excipients must be different from active pharmaceutical ingredients; Compare to other countries, the regulations of China are not comprehensive and systemic, the main problems are: the requirements for specification of pharmaceutical excipients are not exact and reasonable; the definition, classification and some requirement of pharmaceutical excipients don' t accord with pharmaceutical development; the number of pharmaceutical excipients embodied by pharmacopeia is too small to satisfy the requirement of pharmaceutical industry, and the classification of pharmaceutical excipients by pharmacopeia is not comprehensive; the information of pharmaceutical excipients in drug application is too simple; the absence of regulation of pharmaceutical excipients' manufacture and service, the manufacturers of pharmaceutical excipients are variety: in China, the manufacturers of pharmaceutical excipients include pharmaceutical industry, specific pharmaceutical excipients industry, chemical industry, the foodstuff industry etc. and the most pharmaceutical excipients manufacturers are chemical industry and the foodstuff industry; the specification of pharmaceutical excipients are variety: the specification of pharmaceutical excipients used in China include compulsive standard issued by SFDA, GB standard, HB standard etc, the specificationsof most pharmaceutical excipients used in China are GB standard, HB standard. The absence of new pharmaceutical excipients: there are not novel new excipients in markets, the new pharmaceutical excipients in markets are coprocessed excipients; there are great gap between the specification of pharmaceutical excipients pharmaceutical foreign and domestic. By these researches, specific suggestions are proposed on regulation of pharmaceutical excipients.