注射剂常用包装形式研究使用进展  

Research progress on use of common packaging forms of injections

作　　者：王敏[1] 周苏萍[1] 张帅[1] 王伯阳 储藏 WANG Min;ZHOU Suping;ZHANG Shuai;WANG Boyang;CHU Cang(Administration for Drug and Instrument Supervision and Inspection of PLAJLSF,Beijing 100071,China)

机构地区：[1]中国人民解放军联勤保障部队药品仪器监督检验总站,北京100071

出　　处：《药学实践与服务》2023年第9期528-533,571,共7页Journal of Pharmaceutical Practice and Service

摘　　要：目的为不同注射剂准确选用合适包装形式提供理论参考和现实依据。方法从注射剂常用包装形式的原材料入手,解析不同包装形式的特点和技术要求;介绍现阶段国家药品监督管理局药品审评中心药包材的登记数据,对注射剂不同包装形式的研究使用进展进行综述。结果对于单次用量小、价格便宜的药物可选择安瓿或注射剂瓶包装;粉针剂通常选用注射剂瓶包装;抢救药品、贵重药品可选用预灌封类注射器;对于需长期注射给药的慢性病治疗药物(如胰岛素),或某些用于急救的注射剂,可选用患者可自行注射的笔式注射器包装;对于某些偏酸或偏碱的药物宜选用中性玻璃包装或塑料类包装。结论药品生产企业应根据药物的理化性质、包装原材料性能、相容性试验结果、生产成本和携带使用方便性等多方面因素,综合考虑选择适合的包装形式,以确保药品质量和安全有效。Objective To provide theoretical reference and practical basis for accurately choosing the suitable packaging forms for different Injections.Methods Based on the raw materials in the common packaging forms of injections,the research and application progress on different packaging forms for injections were reviewed by analyzing the characteristics and technical requirements of different packaging forms,and the current registration information of pharmaceutical packaging materials in the Center for Drug Evaluation,NMPA were introduced.Results For preparations with small single-dose and low-cost,the ampoules or injection vials could be chosen.Powder injections are usually packaged in injection vials.For rescue medicines and valuable medicines,the pre-filled syringes could be chosen.For chronic disease treatment drugs(such as insulin)that require long-term injection,or some injections for emergency use,a pen-type syringe package that patients can inject themselves could be used.Neutral glass packaging or plastic packaging should be used for some acidic or alkaline.Conclusion The drug manufacturers should comprehensively consider the physicochemical properties of drugs,the performance of packaging raw materials,compatibility test results,price-cost,and convenience in carrying and use when choosing the appropriate packaging form to ensure the quality,safety,and effectivity of drugs.

关 键 词：注射剂 包装形式 研究进展 

分 类 号：TQ460.69[化学工程—制药化工]