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目的建立测定b型流感嗜血杆菌结合疫苗中蔗糖含量的旋光法,并对方法进行验证。方法建立旋光法,检测b型流感嗜血杆菌结合疫苗中的蔗糖含量,并对方法进行专属性、线性范围、重复性、准确性、耐用性和稳定性验证。结果 b型流感嗜血杆菌结合疫苗中其他组分对蔗糖旋光度无干扰;蔗糖浓度在2~10 mg/ml范围内与旋光度具有良好的线性关系(r=0.999 998);重复测定供试品溶液6次,相对标准偏差(RSD)为0.46%;低、中、高浓度的供试品平均回收率分别为99.18%、99.14%、98.95%;温度在10~30℃范围内对旋光度无明显影响;样品于20℃放置5 h内旋光度无明显变化。结论建立了旋光法检测b型流感嗜血杆菌结合疫苗中蔗糖含量的方法,该方法操作简单快速,在确定的限度范围内具有较好的专属性、重复性、准确性、耐用性和稳定性。
Objective To establish an optical rotation method for determination of sucrose content in Haemophilus influenzae type b conjugate vaccine and to verify the method. Methods The optical rotation method was used to detect the content of sucrose in the Haemophilus influenzae type b conjugate vaccine. The specificity, linear range, reproducibility, accuracy, durability and stability of the method were verified. Results The other components of the Haemophilus influenzae type b conjugate vaccine did not interfere with the optical rotation of sucrose. The sucrose concentration had a good linear relationship with the optical rotation in the range of 2 ~ 10 mg / ml (r = 0.999 998) The relative standard deviation (RSD) was 0.46%. The average recoveries of low, medium and high concentration samples were 99.18%, 99.14% and 98.95%, respectively. The relative standard deviations No significant effect; sample at 20 ℃ placed within 5 h no significant changes in optical rotation. Conclusion The method for determining sucrose content in Haemophilus influenzae type b conjugate vaccine by optical rotation is established. The method is simple, rapid, and has good specificity, repeatability, accuracy, durability and stability within the defined limits .