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目的分析我国上市的药品说明书中群体药动学应用状况,探讨我国药品研发中群体药动学研究的现状。方法 在药品说明书数据库软件《新编临床用药参考》中进行关键词检索,并对检索结果进行汇总分析。结果 截至2012年3月在《新编临床用药参考》收载的10 000余份我国化药制剂与生物制品说明书中检索到18份药品说明书(10个药品通用名品种)包含群体药动学研究资料,这些资料显示了体重、年龄、性别等因素对药物体内过程的影响。结论药品说明书中的群体药动学研究资料体现了该方法在分析变异因素的能力和优势,对于药物剂量的调整有重要意义,但药品说明书中对具体方法和数据类型缺乏具体的描述;检出结果远低于国外研究的数量,我国药品研发中药代动力学研究的水平和生产厂家对药品说明书的重视程度均亟待提高。
Objective To analyze the application status of population pharmacokinetics in Chinese pharmaceuticals listed in China and to explore the current status of population pharmacokinetics in pharmaceutical research and development in China. Methods The keyword search was carried out in the “New Clinical Drug Reference” of the drug specification database software, and the search results were summarized and analyzed. Results As of March 2012, 18 copies of the drug manual (10 generic drug names) were retrieved from the over 10,000 instructions of our country for pharmaceutical preparations and biologicals contained in the “New Clinical Drug Reference” contained in the Pharmacokinetic Study of Population Data, these data show the body weight, age, gender and other factors on the process of drug effects. Conclusion The pharmacokinetic data of group pharmacopoeia in the drug specification embody the ability and advantage of this method in analyzing the variation factors, which is of great significance for the adjustment of drug dosage. However, there is no specific description of the specific methods and data types in the drug instruction manual. The result is much lower than the number of foreign studies. The level of research on pharmacokinetics of Chinese medicines in drug research and development and the importance attached by manufacturers to the pharmaceutical instructions need to be improved urgently.