Hongxin Shen,1– 3 Yuzhi Fu,1– 3 Ying Chen,1– 3 Wenxing Xia,1– 3 Zhi-Jun Jia,1– 4 Qin Yu,3,5 Lingli Zhang,1– 3 Lu Han1– 3 1Department of Pharmacy, West China Second University Hospital of Sichuan University, Chengdu, People’s Republic of China; 2Evidence-Based Pharmacy Center, West China Second University Hospital of Sichuan University, Chengdu, People’s Republic of China; 3Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, People’s Republic of China; 4West China School of Pharmacy, Sichuan University, Chengdu, People’s Republic of China; 5Institute of Drug Clinical Trial GCP, West China Second University Hospital, Sichuan University, Chengdu, People’s Republic of ChinaCorrespondence: Lu Han, West China Second University Hospital, Sichuan University, No. 20, Third Section, Renmin South Road, Chengdu, Sichuan, 610041, People’s Republic of China, Email luhan830301@sina.comObjective: Pediatric electrolyte supplements injection is mainly used to supplement heat and body fluid, and commonly used in pediatrics. Its compatibility and stability with common clinical drugs such as antibiotics was rarely reported to ensure the children’s safety and the rational use of drugs. The aim of the present study was to investigate physical and chemical stability of pediatric electrolyte supplements injection mixed with ten commonly used clinical drugs.Methods: According to clinical drug concentration, we mix the pediatric electrolyte supplements injection mixed with ten drugs. The compatible solutions were withdrawn at certain time intervals (0, 0.5, 1, 2, 4, 6 hours) after mixing and tested by description, insoluble particles detection, pH determination and high performance liquid chromatography (HPLC) assay of active ingredient as measures of physicochemical compatibility.Results: No obvious appearance changes were observed when mixing. Furthermore, over the 6 hours post-preparation period the pH values were within the requirements of each drug quality standard and the number of insoluble particles (≥ 10 and ≥ 25μm) met requirements of Chinese Pharmacopeia (Edition 2020) except for mezlocillin sodium for injection. The percentages of the initial concentrations maintained at a minimum of 97% in the mixtures within 6 hours.Conclusions: Nine commonly used clinical drugs remained stable in the pediatric electrolyte supplements injection for 6 hours at 25°C and avoiding from light. Mezlocillin sodium for injection was not recommended to be combined with electrolyte supplement injection for children because its insoluble particles exceed the standard.Keywords: compatibility, stability, pediatric electrolyte supplements injection
