国产结核菌素纯蛋白衍化物稳定性观察

摘要

Objective　To evaluate the stablity of homemade PPD.Methods　Prepare 1 506 babies immuned from BCG.Use PPD in useful-life as contrast of four groups of PPD which is stored in four condition:2～8℃ in refrigeratory;60℃ keeped as long as 30 minutes then 2～8℃ in refrigeratory;36℃in the constant temperature box;room temprature.Test the 4 kinds of PPD on both arms of the babies,and watch them for three years to find out how much that different temprature affects PPD's sensitivity.Results　Noting the positive ratio and induration pattern of the delayed allergic reaction on the babies with the test PPD then compare them to te PPD which in useful-life.The result comes out:the group of in 2～8℃ refrigeration is normal (P＞0.05) but other three groups show remarkable different (P＜0.01).Conclusion　Homemade PPD owns steady quality and nice safety,if stored in 2～8℃ condition PPD suseful-life can be delay to 3 years considerable.%目的　了解国产结素纯蛋白衍化物(PPD)的稳定性。方法　选择卡介苗免疫婴儿1 506人，用效期内PPD为对照品，以冰箱2～8℃、60℃30分钟后冰箱2～8℃、36.7℃恒温箱、室内常温四种方法保存的PPD作双臂对照试验，观察三年，在不同温度下对PPD活性敏度的影响。结果　各组PPD在上述婴儿身上引起的迟发变态反应，其阳性率和反应硬结均径与效期内对照品PPD比较，除冰箱2～8℃保存组无差异(P＞0.05)外，其余三组差异非常显著(P＜0.001)。结论　国产PPD质量稳定安全性良好，只要确保冰箱保存，有效期可考虑延长至三年。