中成药说明书现状调查

Investigation on the Instructions of Chinese Patent Medicines

通过对87份中成药说明书进行项目分析,对中成药说明书的现状进行调查,为其修订提供建议。调查发现目前中成药说明书普遍存在缺少药代动力学、老年患者用药、儿童用药、孕妇及哺期妇女用药等重要项目的描述,不良反应、药物相互作用等项目叙述不清晰,未对中药药性进行介绍。中成药说明书仍需规范化管理并体现中医药特色。

The current status of the instructions of Chinese patent medicines was investigated through the item analysis of 87 instructions of Chinese patent medicines, and suggestions were thus provided for the further revision. The survey showed that the common problems existing in the instructions of Chinese patent medicines were characterized by the absence of some important items such as pharmacokinetics, medications in elderly and children patients and medications in pregnant and lactation women; in addition, the descriptions of adverse drug reactions and drug interaction were unclear and the property of traditional Chinese medicines was not introduced.It is necessary to further standardize the instructions of Chinese patent medicines, which should embody the characteristics of traditional Chinese Medicines.