Zhu Chang-Yu, Zuo Hui-Ying, Li Hong-Lin, Tong Rong-Sheng
Department of Pharmacy, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital, Chengdu, Sichuan Province, China.
Personalized Drug Therapy Key Laboratory of Sichuan Province, School of Medicine, University of Electronic Science and Technology of China, Chengdu, Sichuan Province, China.
Front Pharmacol. 2024 Jan 8;14:1265945. doi: 10.3389/fphar.2023.1265945. eCollection 2023.
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. 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). 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. 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.
目的是系统比较药物与各种密闭静脉输液容器的相容性，为选择相对优质的输液容器提供参考，并提高临床实践中患者的用药安全性。本研究考察了中国市场上四种常用临床注射剂（头孢他啶、泮托拉唑钠、盐酸氨溴索、依达拉奉）与三种代表性的预先装有输液（0.9%氯化钠或5%葡萄糖）的密闭静脉输液容器（非PVC输液袋、直立式聚丙烯输液袋、内密封聚丙烯输液袋）的相容性。采用光阻法测定各种输液容器中输液及输液稀释化学注射剂的微粒数。在每种容器中用输液稀释四种注射剂后的0、2和6小时，检测溶液的pH值，并通过目视检查检查物理性质。同时，采用高效液相色谱法（HPLC）评估药物浓度。对于输液或输液稀释的注射剂，在某些情况下，非PVC输液袋中的微粒数明显高于其他两种袋子。与所有输液容器中的输液相比，输液稀释注射剂中的微粒数显著增加，尤其是小尺寸微粒。但在试验期间，所有输液容器中稀释输液溶液的pH值、物理性质和药物浓度几乎保持不变。本研究中包括的密闭静脉输液容器与四种注射剂均具有良好的相容性。此外，中国制造商生产的密闭输液容器已达到国际质量标准。特别是，静脉药物混合配制过程需要优化，以减少总体微粒污染物。
