药品说明书是指导临床用药和患者自我药疗的主要依据,经国家药品监督管理局审核批准的药品说明书是药品的法定文件,其内容不得自行修改。2001年6月22日,国家药品监督管理局下发“药品说明书规范细则(暂行)”的通知 (以下称规范),对化学药品、中药的说明书内容、格式进行了较为详尽的规范要求。自规范实施后,药品说明书内容得 Drug instructions is to guide the clinical medication and patients with self-medication the main basis for approval by the State Drug Administration Pharmaceutical Manual is a statutory drug documents, the content shall not be modified. On June 22, 2001, the State Drug Administration issued the “Specifications (Specification) of Specifications for Pharmaceutical Specification” (hereinafter referred to as the “Specification”), which made detailed specification requirements for the content and format of instructions for chemicals and Chinese medicines. Since the implementation of the norms, the contents of the drug instructions too