中国防痨杂志
中國防癆雜誌
중국방로잡지
BULLETIN OF THE CHINESE ANTITUBERCULOSIS ASSOCIATION
2001年
1期
49-51
,共3页
张雅珍%付秋如%余苏娟%许纯兰
張雅珍%付鞦如%餘囌娟%許純蘭
장아진%부추여%여소연%허순란
结素纯蛋白衍化物%卡介苗%稳定性
結素純蛋白衍化物%卡介苗%穩定性
결소순단백연화물%잡개묘%은정성
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。
目的 瞭解國產結素純蛋白衍化物(PPD)的穩定性。方法 選擇卡介苗免疫嬰兒1 506人，用效期內PPD為對照品，以冰箱2～8℃、60℃30分鐘後冰箱2～8℃、36.7℃恆溫箱、室內常溫四種方法保存的PPD作雙臂對照試驗，觀察三年，在不同溫度下對PPD活性敏度的影響。結果 各組PPD在上述嬰兒身上引起的遲髮變態反應，其暘性率和反應硬結均徑與效期內對照品PPD比較，除冰箱2～8℃保存組無差異(P＞0.05)外，其餘三組差異非常顯著(P＜0.001)。結論 國產PPD質量穩定安全性良好，隻要確保冰箱保存，有效期可攷慮延長至三年。
목적 료해국산결소순단백연화물(PPD)적은정성。방법 선택잡개묘면역영인1 506인，용효기내PPD위대조품，이빙상2～8℃、60℃30분종후빙상2～8℃、36.7℃항온상、실내상온사충방법보존적PPD작쌍비대조시험，관찰삼년，재불동온도하대PPD활성민도적영향。결과 각조PPD재상술영인신상인기적지발변태반응，기양성솔화반응경결균경여효기내대조품PPD비교，제빙상2～8℃보존조무차이(P＞0.05)외，기여삼조차이비상현저(P＜0.001)。결론 국산PPD질량은정안전성량호，지요학보빙상보존，유효기가고필연장지삼년。
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.
