药品说明书应当规范化

来源 :中国药学杂志 | 被引量 : 0次 | 上传用户:nbf1smt
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药品说明书是医药供应部门向医药卫生人员和人民群众宣传介绍药品、指导合理用药并普及医药知识的主要依据,药厂不仅应对药品质量负责,而且应对药品说明书是否符合要求负责。国家医药管理局和卫生部1981年11月联合发的《有关医药产品包装问题的通知》中明确规定:药品包装须注明药品的品名、规格、主要成分、含量(除保密品种外)、主治(作用、能)、用法、用量、禁忌、毒副作用、注意事项、装量等内容。标签、盒袋版面较小、难以印全的,应由说明书详细介绍,不得缺项,并将说明书根据药品大、中,小包装情况,每一份药品须附一张装入盒、箱内,以保证用药安全有效。但有的药厂并未认真执行。笔者看了1982年后各地出厂的药品350余种,其中在盒、箱内都未附说明书的占60%以上,虽有说明书或以标签、盒袋文字代替说明书但内容缺项的也占60%以上,多数是对注意事项和毒副作用等不予重视。如江苏常州、宜兴、江都药厂生产的复方降压片,瓶贴文字中连主要成分都没有(也未附说明书),有的医生为了是 The drug specification is the main basis for the pharmaceutical supply department to promote the introduction of pharmaceuticals to the medical and health personnel and the public, and to guide the rational use of medicines and to popularize the medical knowledge. The pharmaceutical factory is not only responsible for the quality of the medicines, but also responsible for whether the pharmaceutical specifications meet the requirements. State Pharmaceutical Administration and the Ministry of Health in November 1981 jointly issued the “Notice on the packaging of pharmaceutical products,” clearly states: drug packaging must indicate the name of the drug, specifications, the main ingredients, content (except confidential varieties), attending (Role, can), usage, dosage, taboo, side effects, precautions, loading and so on. Labeling, small bagging layout, difficult to print the whole, should be described in detail in the manual, not missing items, and the instructions according to the drug in the medium and small packages, each drug must be accompanied by a box, box , To ensure safe and effective medication. However, some pharmaceutical companies did not implement it carefully. I saw after 1982 more than 350 kinds of drugs manufactured around the factory, of which boxes, boxes are not attached to the manual accounted for more than 60%, although the manual or labels, bags of text instead of manual but also lack of content also accounted for 60 % Or more, most of the attention and toxicity and other neglect. Such as Jiangsu Changzhou, Yixing, Jiangdu pharmaceutical production of compound antihypertensive tablets, bottles of text even with no main ingredients (also without instructions), and some doctors in order to
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