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药品说明书是药品质量管理的主要内容之一,内容应完整、正确。《药品管理法》第十章第三十七条规定:标签或者说明书必须注明药品的品名、规格、生产企业、批准文号、产品批号、主要成份、适应症、用法、用量、禁忌、不良反应和注意事项。 笔者查了西药和中成药300个品种,发现有的药厂的药品标签说明书记载的项目中存在着一些问题,主要表现在以下几个方面。
Drug instruction manual is one of the main contents of drug quality management, the content should be complete and correct. Article 37 of Chapter 10 of the Drug Administration Law stipulates that the label or the specification must indicate the name, specifications, manufacturer, approval number, product lot number, main ingredient, indications, usage, dosage, contraindication, and defect of the drug Reaction and precautions. I checked the western medicine and proprietary Chinese medicines 300 varieties and found that some of the items listed in the pharmaceutical label instructions of the pharmaceutical companies, there are some problems, mainly in the following areas.