Effect of storage temperature on the stability of measles, mumps and rubella combined attenuated live vaccine
10.13200/j.cnki.cjb.004733
- VernacularTitle:储存温度对麻腮风联合减毒活疫苗成品稳定性的影响
- Author:
Xuena DU
- Publication Type:Journal Article
- Keywords:
Measles,mumps and rubella combined attenuated live vaccine(MMR);
Storage temperature;
Accelerated stability;
Long-term stability;
Viral titer
- From:
Chinese Journal of Biologicals
2026;39(07):769-776
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo evaluate the stability of the measles,mumps and rubella combined attenuated live vaccine(MMR)under different storage temperatures, thereby providing data support for its storage and transportation.MethodsThree batches of vaccine samples were stored under conditions of(25 ± 2),(37 ± 2),(45 ± 2) and(5 ± 3) ℃, respectively. Samples were taken at different time points to assay viral titer, moisture content, pH value, and osmotic pressure. The assay results were subjected to trend analysis and statistical analysis to evaluate the accelerated stability and long-term stability of the vaccine.ResultsAfter storage for up to 3 months at(25 ± 2) ℃, 5 weeks at(37 ± 2) ℃, 7 days at(45 ± 2) ℃, and 24 months at(5 ± 3) ℃, the moisture content, pH value, and osmotic pressure all met the enterprise specifications. After storage for 2 months at(25 ± 2) ℃, 2 weeks at(37 ± 2) ℃, and 3 days at(45 ± 2) ℃, the mumps virus titer had decreased below the qualified lower limit(4. 8 lgCCID_(50)/mL). After 24 months of storage at(5 ± 3) ℃, the viral titers of all three batches of vaccines met the enterprise requirements.ConclusionThe MMR vaccine demonstrates varying allowable storage times under different conditions. It exhibits good stability when stored under refrigerated conditions for 24 months, providing data support for the established enterprise shelf life of 18 months.
