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Published on: March 11, 2017
Compatibility and Stability of Ten Commonly Used Clinical Drugs in Pediatric Electrolyte Supplements Injection
Hongxin Shen1,2,3, Yuzhi Fu1,2,3, Ying Chen1,2,3
1Department of Pharmacy, West China Second University Hospital of Sichuan University, Chengdu, People's Republic of China.
Insights
Pediatric electrolyte supplements injection is stable with nine common drugs for 6 hours. Mezlocillin sodium is not recommended due to particle issues, ensuring pediatric patient safety.
Area of Science:
- Pediatric pharmacology
- Clinical pharmacy
- Drug compatibility studies
Background:
- Pediatric electrolyte supplements injection is crucial for fluid and heat balance in children.
- Limited data exists on the compatibility and stability of these injections with common antibiotics.
- Ensuring drug safety and rational use in pediatric patients is paramount.
Purpose of the Study:
- To evaluate the physical and chemical stability of pediatric electrolyte supplements injection when mixed with ten common clinical drugs.
- To assess the safety and efficacy of co-administered drugs in pediatric electrolyte solutions.
Main Methods:
- Pediatric electrolyte supplements injection was mixed with ten drugs at clinical concentrations.
- Physicochemical compatibility was assessed through visual inspection, insoluble particle counts, pH monitoring, and HPLC analysis over 6 hours.
- Testing adhered to Chinese Pharmacopeia (2020) standards.
Main Results:
- No significant changes in appearance were observed upon mixing.
- pH levels remained within acceptable ranges for all mixtures.
- Insoluble particle counts met standards for nine drugs; mezlocillin sodium exceeded limits.
- Active ingredient concentrations remained above 97% for all mixtures within 6 hours.
Conclusions:
- Nine common clinical drugs are stable in pediatric electrolyte supplements injection for 6 hours under standard conditions (25°C, protected from light).
- Mezlocillin sodium for injection is not recommended for co-administration due to exceeding insoluble particle standards.
- These findings support the safe and rational use of pediatric electrolyte supplements in combination with specific medications.
Objective:
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.
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