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目的对氢氧化铝佐剂吸附的无细胞百白破联合疫苗(diphtheria,tetanus and acellular pertussis combined vaccine,adsorbed,DTa P)成品中内毒素含量进行测定,确定将内毒素检查方法纳入2015版《中国药典》中百白破类疫苗质量标准的可行性和必要性。方法参考《中国药典》三部(2010版)附录ⅫE建立动态浊度法,测定解吸附前后DTa P中细菌内毒素含量,并进行标准曲线的可靠性及干扰试验验证。结果该方法在0.005~10 EU/ml范围内线性较好,r=-0.997 1。干扰试验样品回收率在50%~200%。实测样品内毒素值从低于检测限至433 EU/ml。不同厂家及同一厂家不同批次产品解吸附前后的内毒素测定值差异显著,CV值在36.9%~89.0%之间。结论该方法可靠性、线性、回收率、灵敏度均符合要求,为进一步制定DTa P相关质量标准提供参考。现有热原检测方法不能全面反映DTa P成品中内毒素水平,有必要将内毒素检测纳入DTa P质量标准,以更好地控制疫苗安全性。
Objective To determine the content of endotoxin in the finished product of diphtheria, tetheredus and acellular pertussis combined vaccine adsorbed by aluminum hydroxide adjuvant, and to determine the method of endotoxin test into the 2015 edition of “China Feasibility and Necessity of Quality Standard of Baibai Disability Vaccine in Pharmacopoeia. Methods Reference to the ”Chinese Pharmacopoeia" (2010 version) Appendix Ⅻ E established dynamic turbidity method to determine the DTa P before and after desorption bacterial endotoxin content, and the reliability of the standard curve and interference test validation. Results The method showed good linearity in the range of 0.005-10 EU / ml, r = -0.997 1. Interference test sample recovery rate of 50% to 200%. The measured sample endotoxin value from below the detection limit to 433 EU / ml. Different manufacturers and different manufacturers of the same batch products before and after desorption of endotoxin measured values significantly different, CV values ?? between 36.9% ~ 89.0%. Conclusion The reliability, linearity, recovery and sensitivity of the method meet the requirements and provide a reference for the further development of DTa P related quality standards. Existing pyrogen detection methods do not fully reflect endotoxin levels in finished DTa P products. It is necessary to include endotoxin testing in the DTa P quality standard to better control vaccine safety.