Abstract
Objective To observe the stability of measles and rubella combined vaccine, live (MR vaccine). Methods Seventeen batches of MR vaccines produced by Beijing Institute of Biological Products Co., Ltd. (BIBP) in 2012—2017 were stored at (5±3) °C, and according to the enterprise registration standard and the requirements of Chinese pharmacopoeia (2010 or 2015 edition, volume Ⅲ), the related tests were carried out in 0, 9, 12, 18 and 24 months, respectively.At the same time, the main quality indicators of 3 batches each of MR vacccines produced in new and old workshops were compared. Results The virus titer decreased gradually with the extension of the storage time. The measles and rubella virus titers were 3.9-4.8 and 4.0-4.8 lg 50% cell culture infective dose (CCID50)/ml, respectively, and all virus titer droping in thermal stability test was not higher than 1.0 lgCCID50/ml. The moisture was all not higher than 3.0%. The results of other indicators were in compliance with the registration standard and pharmacopoeia requirements. There was no difference between the quality of vaccines produced in new and old workshops. Conclusion The quality of MR vaccine produced by BIBP is stable. Key words: Measles vaccine; Rubella vaccine; Vaccines, combined; Quality control
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