Objective  To evaluate the stability of oral rotavirus active vaccine. Methods  Three consecutive batches of oral rotavirus vaccine produced by Lanzhou Institute of Biological Products Co., Ltd.(Lanzhou Compamy) were selected.The virus titer was tested at 0 d and 7 d after stored in 37 ℃ for thermal stability ,all items were tested at 0，1，2，3 month after stored in 25 ℃ for accelerated test ,and all items were tested at 0，3，6，9，12，15，18 month after stored in 2-8 ℃ for long-term stability test. Results  Oral rotavirus vaccine was stored in 37 ℃ for 7 d, and the thermal stability met the standard(virus titer ≥5.5 lg 50% cell culture infectious dose per ml and decreased of virus titer ≤1.0 lg).The samples were stored in 25 ℃ for 3 months, and all test results met the standard. The samples were stored in 2-8 ℃ for 18 months, and all test results met the standard. Conclusion  The quality of oral rotavirus active vaccine produced by Lanzhou Company is stable.

Rotavirus is the main pathogen that causes infantile diarrhea worldwide. Rotavirus vaccine is the most economical and effective prevention method against infection, which has greatly alleviated the disease burden caused by rotavirus. However, the currently marketed vaccines are live attenuated vaccines, which have risks of toxicity reversion and intestinal adverse reactions. Therefore, the optimized traditional live attenuated vaccine, inactivated vaccine, virus-like particles and other subunit vaccines have become potential candidate vaccines, thus improving the safety and effectiveness of the rotavirus vaccine. This article summarizes the current status of the main marketed rotavirus vaccines and the research status of new vaccines entering clinical trials, so as to lay a foundation for the subsequent vaccine development.