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目的:预防输液微粒的远期危害,阐明监管过度输液的预防医学意义。方法:通过各国最新版药典,比较各国对注射剂不溶性微粒限度要求,并与输液微粒、大气PM2.5进行对比;在举证了乙肝病毒传播途径在我国的历史教训后,阐述过度输液远期危害还有未知领域。结果:《中国药典》(2015年版)注射剂不溶性微粒的限定与《美国药典》(USP8)、《日本药局方》(JP16)、《英国药典》(BP2015)、《欧洲药典》(EP8.0)一致;输液微粒在组成成分上比大气PM2.5更复杂、检测更难、危害性更大。结论:国家卫生主管部门应重视输液微粒所致远期危害,制定监管过度输液远期危害的策略和措施。
Objective: To prevent the long-term damage caused by transfusion particles and to clarify the preventive medical significance of over-transfusion. Methods: Through the latest edition of the Pharmacopoeia in each country, comparing the requirements of insoluble particles in injections in various countries, compared with the transfusion particles and atmospheric PM2.5; after proving the historical lesson of hepatitis B virus transmission in our country, expounded the long- There are unknown areas. Results: The definition of insoluble particulates in the Chinese Pharmacopoeia (2015 Edition) was similar to those of the United States Pharmacopeia (USP8), JP16, BP2015, EP8.0 ); Injectable particles in the composition of more than atmospheric PM2.5 more complex, more difficult to detect, more harmful. Conclusion: National health authorities should pay attention to the long-term damage caused by fluid particles and formulate strategies and measures to monitor the long-term harm of infusion.