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评估用不同稳定剂稳定并用各种稀释剂复溶的减毒活骆驼痘疫苗的稳定性。

Evaluation of stability of live attenuated camelpox vaccine stabilized with different stabilizers and reconstituted with various diluents.

作者信息

Prabhu M, Bhanuprakash V, Venkatesan G, Yogisharadhya R, Bora D P, Balamurugan V

机构信息

Division of Virology, Indian Veterinary Research Institute, Mukteswar 263138, Nainital (Distt) Uttarakhand, India; Sheep Breeding Research Station, Tamil Nadu Veterinary and Animal Sciences University, Sandynallah 643 237, Tamil Nadu, India.

Division of Virology, Indian Veterinary Research Institute, Mukteswar 263138, Nainital (Distt) Uttarakhand, India; FMD Laboratory, Indian Veterinary Research Institute, H A Farm, Hebbal, Bangalore 560 024, Karnataka, India.

出版信息

Biologicals. 2014 May;42(3):169-75. doi: 10.1016/j.biologicals.2014.02.001. Epub 2014 Mar 21.

Abstract

In this study, thermostability of a Vero cell attenuated live camelpox vaccine under conventional lyophilization conditions has been evaluated. Three stabilizers were used separately for freeze-drying the vaccine and the stability of the vaccine, both in freeze-dried and reconstituted forms at different temperatures was assessed. The study revealed that the camelpox vaccine lyophilized with TAA stabilizer found superior with a shelf life of 44 months, 227 days, 22 days and 20 days at 4, 25, 37 and 45 °C, respectively followed by LS stabilizer. In terms of half-life, TAA stabilizer proved better followed by LS and BUGS stabilizers at all temperatures except at 25 °C in which LS found relatively superior. Among the four diluents viz. 1x PBS (phosphate buffered saline, pH 7.4), 0.85% NaCl, distilled water and 1 M MgSO4, PBS was a better diluent followed by 0.85% NaCl. Both the diluents maintained the infectivity titer more than the minimum effective dose (3 log10TCID50 with a maximum titre of 6.53 log10TCID50 in both the diluents) for 60 h at 37 and 45 °C. However, 1 M MgSO4 found less suitable for camelpox vaccine dilution. The study indicates that the TAA and 1× PBS are the choice of stabilizer and diluent, respectively for camelpox vaccine.

摘要

在本研究中,评估了一种Vero细胞减毒活骆驼痘疫苗在常规冻干条件下的热稳定性。分别使用三种稳定剂对疫苗进行冻干,并评估了冻干和复溶形式的疫苗在不同温度下的稳定性。研究表明,用TAA稳定剂冻干的骆驼痘疫苗表现更优,在4、25、37和45℃下的保质期分别为44个月、227天、22天和20天,其次是LS稳定剂。就半衰期而言,除了在25℃时LS相对更优外,在所有温度下TAA稳定剂都表现更好,其次是LS和BUGS稳定剂。在四种稀释剂即1x PBS(磷酸盐缓冲盐水,pH 7.4)、0.85% NaCl、蒸馏水和1 M MgSO4中,PBS是较好的稀释剂,其次是0.85% NaCl。在37和45℃下,这两种稀释剂在60小时内维持的感染性滴度均高于最低有效剂量(3 log10TCID50,两种稀释剂中的最大滴度均为6.53 log10TCID50)。然而,1 M MgSO4不太适合用于骆驼痘疫苗的稀释。该研究表明,TAA和1× PBS分别是骆驼痘疫苗的稳定剂和稀释剂的选择。

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