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三种药物在环烯烃共聚物或聚丙烯制成的注射器中的吸附现象比较研究。

Comparative Study of Sorption Phenomena Between Three Medications and Syringes Made of Cyclic Olefin Copolymer or Polypropylene.

机构信息

Université Clermont Auvergne, CHU Clermont Ferrand, Clermont Auvergne INP, CNRS, ICCF, 63000, Clermont-Ferrand, France.

SCHOTT Pharma Schweiz AG, St. Josefen-Strasse 20, 9001, St Gallen, Switzerland.

出版信息

Pharm Res. 2024 Jan;41(1):51-62. doi: 10.1007/s11095-023-03633-7. Epub 2023 Nov 21.

Abstract

INTRODUCTION

Medical syringes are widely used in hospitals to store and administer drugs, and the contact time between the drugs and these syringes can vary from a few minutes to several weeks like for pharmaceutical preparations. The aim of this comparative study was to evaluate the potential sorption phenomena occurring between three drugs (paracetamol, diazepam and insulin aspart) and polypropylene syringes (PP) or syringes made of Cyclic Olefin Copolymer (COC).

MATERIALS AND METHODS

50 mL 3-part syringes made of either COC with crosslinked silicone on the barrel inner surface (COC-CLS) and a bromobutyl plunger seal, or PP lubricated with silicone oil (PP-SOL) with a polyisoprene plunger seal were used.

RESULTS

COC-CLS syringes induced less sorption of diazepam and insulin than PP-SOL syringes and the plunger seal material seemed to be the main cause of these interactions. An alkalinization of the medications in contact with the PP-SOL syringes was observed. It could be caused by leachable compounds and should be investigated further.

CONCLUSION

This work shows once again that it is essential to consider content-container interactions to help improve the safe use of parenteral drugs.

摘要

简介

医用注射器广泛用于医院储存和给药,药物与注射器的接触时间从几分钟到几周不等,具体取决于药物的种类,例如药物制剂。本对比研究旨在评估三种药物(对乙酰氨基酚、地西泮和门冬胰岛素)与聚丙烯(PP)注射器或环烯烃共聚物(COC)注射器之间可能发生的吸附现象。

材料与方法

使用了 50mL 三部分注射器,其筒身内表面由交联硅橡胶处理的 COC 制成,且柱塞密封为丁基溴橡胶,或由硅油润滑的 PP 制成,且柱塞密封为聚异戊二烯。

结果

COC-CLS 注射器对地西泮和胰岛素的吸附作用小于 PP-SOL 注射器,且柱塞密封材料似乎是导致这些相互作用的主要原因。与 PP-SOL 注射器接触的药物呈碱性,这可能是由可浸出化合物引起的,应进一步研究。

结论

这项工作再次表明,必须考虑药物与容器的相互作用,以帮助提高患者对肠外药物的安全使用。

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