Author:
Zhu Chang-yu,Zuo Hui-ying,Li Hong-lin,Tong Rong-sheng
Abstract
Objective: The aim was to systematically compare the drug compatibility with various closed intravenous (i.v.) infusion containers, to provide a reference for selecting a relatively superior infusion container and improve the medication safety for patients in clinical practice.Methods: The compatibility of four commonly used clinical injections (ceftazidime, pantoprazole sodium, ambroxol hydrochloride, edaravone) with three representative closed i. v. infusion containers (non-PVC infusion bags, upright polypropylene infusion bags, inner sealed polypropylene infusion bags) prefilled with infusion fluids (0.9% sodium chloride or 5% dextrose) in the Chinese market were investigated in this study. The particle counts of both infusion fluids and diluted chemical injections by infusion fluids in various infusion containers were determined by the light obscuration method. At 0, 2 and 6 h after four injections following dilution with infusion fluids in each container, the pH of the solutions was detected, and the physical properties were examined by visual inspection. Meanwhile, the drug concentrations were assessed by high performance liquid chromatography (HPLC).Results: As for either infusion fluids or diluted injections by infusion fluids, the particle counts in non-PVC infusion bags were significantly greater than those in the other two bags under some circumstances. The particle counts in diluted injections by infusion fluids increased dramatically compared with those in infusion fluids in all infusion containers, especially for the small-size particles. But pH, physical properties and drug concentrations of diluted infusion solutions in all infusion containers remained nearly unchanged over the test period.Conclusion: Closed i. v. infusion containers included in this study are all well-compatible with four injections. Moreover, the closed infusion containers produced by Chinese manufacturers have met the international quality standard. Particularly, the intravenous admixture preparation process needs to be optimized to reduce the overall particulate contaminants.
Reference27 articles.
1. ASHP guidelines on compounding sterile preparations;American Society of Health System Pharmacists;Am. J. Health Syst. Pharm.,2014
2. Conducting clinical risk assessments for visible particulate matter in parenteral preparations;Ayres;PDA J. Pharm. Sci. Technol.,2018
3. Policy suggestions on procurement of basic infusion against the background of volume procurement;Cui;Asian J. Soc. Pharm.,2020
4. Compatibility and stability of Imexon in infusion devices and its in vitro biocompatibility;den Brok;Anticancer Drugs,2005
5. Analysis of particulate matter in liquid-finished dosage forms;Duchek;PDA J. Pharm. Sci. Technol.,2018
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献