Abstract

Objective To develope new gelatin-free stabilizers in order to improve the safety of live attenuated varicella vaccine,Methods Based on the current stabilizer formula of live attenuated varicella vaccine,four new stabilizers (B,C,D,E formulas) were formulated by removing gelatin.Vaccines without gelatin (B,C,D,E vaccines) were prepared with the formulated gelatin-free stabilizers and compared with the current live attenuated varicella vaccine with gelatin (A vaccine as control).The optimized stabilizer formula was determined.Results After 7 days at 37 ℃,the relevant qualities of all vaccines conformed with the requirement of Registration Criteria of Live Attenuated Vaccine Varicella,and the virus titers of A,B,C,D,E vaccines were 3.6,3.5,3.3,3.3 and 3.3 lgPFU/0.5 ml,respectively,but the virus titers of C,D,E vaccines have dropped to critical value.After 24 months at 2-8 ℃,the virus titers of A,B,C,D,E vaccines were 3.4,3.4,3.2,3.0 and 2.8 lgPFU/0.5 ml,respectively.Among the four vaccines without gelatin,the virus titers of C,D,E vaccines have been below the requirement (3.3 lgPFU/0.5 ml),only B vaccine met the requirement and was the same as A vaccine.Conclusion The B formula stabilizer without gelatin has better protection for varicella virus. Key words: Chickenpox vaccine; Excipients; Stability

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