不同包装形式基础输液生产质量内控标准调查研究

目的:考查不同包装形式基础输液的生产质量内控标准。方法:通过调研问卷调查7家基础输液生产企业关于细菌内毒素、不溶性微粒、漏液率、组合盖穿刺落屑的企业标准,并与国家标准/行业标准进行对照。结果:不同包装形式基础输液在细菌内毒素、不溶性微粒、漏液率、胶塞穿刺落屑四个方面的生产质量标准较国家标准/行业标准均有不同程度的提高。结论:生产企业的内控标准均较国家标准/行业标准更为严格,各类材料和包装形式的基础输液产品在保证临床用药安全、便捷等方面发挥了重要作用,建议将不同包装形式的技术、材料成本与药品安全性、使用便捷性挂钩,这对鼓励创新、促进公平竞争十分重要。

Investigation and research on internal control standard of basic intravenous infusion production quality in different packaging forms

OBJECTIVE To investigate the internal control standard of production quality of basic infusion with different packaging forms.METHODS The enterprise standards of bacterial endotoxin,insoluble particles,leakage rate,chip dropping of combined cap in 7 manufacturing enterprises were investigated through the questionnaire survey and compared with the national standards/trade standards.RESULTS Compared with the national standard/industry standard,the production quality standards of different packaging forms of basic infusion in four aspects of bacterial endotoxin,insoluble particles,leakage rate and chip dropping of combined cap were improved to different extents compared with national standards/industrial standards.CONCLUSION The internal control standards of manufacturers are stricter than those of national standards/industry standards.Various materials and basic infusion products in packaging form play an important role in ensuring the safety and convenience of clinical medication.It is recommended to link the technology and material costs of different packaging forms with drug safety and convenience of use,which is very important to encourage innovation and promote fair competition.