人用狂犬病疫苗pH值质量分析

Quality Analysis of pH Value of Rabies Vaccine for Human Use

目的:了解人用狂犬病疫苗pH值质控现状,为做好人用狂犬病疫苗质量评价提供数据支持。方法:采用《中华人民共和国药典》三部pH值测定法,对国内15家企业人用狂犬病疫苗进行测定,每批疫苗测3次;对测得的结果进行趋势分析;并对人用狂犬病疫苗pH值质量控制进行讨论。结果与结论:测定结果显示,有14家企业的42批疫苗pH值在7.41~7.63,1家企业3批疫苗pH值在7.68~7.73;15家企业45批疫苗pH平均值为7.51,均在7.2~8.0的合格范围。不同病毒类疫苗的pH值标准各不相同,但对狂犬病毒而言,pH值在7.2~8.0之间能保持较好的生物学活性,因此适宜的pH值对维持狂犬病疫苗的安全、有效至关重要。

Objective:To understand the pH value quality control status of rabies vaccine for human use,and to provide data support for quality evaluation of rabies vaccine for human use.Methods:Rabies vaccines for human use from 15 domestic enterprises were determined with the pH measurement method in Part Ⅲ of the Chinese Pharmacopoeia,and each batch of vaccine was determined three times.Trend analysis was conducted on the measured results and pH value of rabies vaccine for human use quality control was discussed.Results and Conclusion:Determination results show that the pH value of 42 batches of rabies vaccine from 14 enterprises was 7.41-7.63,and that of 3 batches of vaccines from one enterprise was 7.68-7.73.The averaged pH value of 45batches of vaccines from 15 enterprises was 7.51,which was within the qualifi ed range of 7.2-8.0.The pH value standard for dif ferent viral vaccines vary,but for rabies virus,the pH value between 7.2 and 8.0 can maintain good biological activity.Therefore,an appropriate pH value is very important for maintaining the safety and ef fectiveness of rabies vaccine.