Department of Pharmacy, West China Second University Hospital of Sichuan University, Chengdu, People's Republic of China.
Evidence-Based Pharmacy Center, West China Second University Hospital of Sichuan University, Chengdu, People's Republic of China.
Drug Des Devel Ther. 2022 May 12;16:1433-1440. doi: 10.2147/DDDT.S363634. eCollection 2022.
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.
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 The compatible solutions were withdrawn at certain time intervals (0, 0.5, 1, 2, 4, 6 hours) after mixing and tested by description, insoluble particles detection, pH determination and high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.
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.
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.
小儿电解质补充注射液主要用于补充热量和体液，在儿科中常用。为了确保儿童安全和合理用药，其与常用临床药物如抗生素的配伍和稳定性鲜有报道。本研究旨在考察小儿电解质补充注射液与十种常用临床药物混合后的物理化学稳定性。
根据临床药物浓度，将小儿电解质补充注射液与十种药物混合。混合后在特定时间间隔（0、0.5、1、2、4、6 小时）抽取混合溶液，通过描述、不溶性颗粒检测、pH 值测定和高效液相色谱（HPLC）测定活性成分来评估物理化学相容性。
混合时外观无明显变化。此外，在制备后 6 小时内，pH 值均符合各药物质量标准要求，除注射用美洛西林钠外，不溶性颗粒（≥10μm 和≥25μm）数量也符合《中国药典》（2020 年版）的要求。在 6 小时内，混合物中初始浓度的百分比至少保持在 97%。
在 25°C 避光条件下，小儿电解质补充注射液在 6 小时内与十种常用临床药物稳定。不推荐将注射用美洛西林钠与小儿电解质补充注射液混合，因为其不溶性颗粒超过标准。
