【摘要】：目的建立測定23價肺炎球菌多糖疫苗的關(guān)鍵原輔材料—過氧化氫酶活性的方法,并進(jìn)行驗(yàn)證。方法分別采用高錳酸鉀滴定法和紫外分光光度法測定過氧化氫酶活性,并對紫外分光光度法進(jìn)行重復(fù)性、日間精密度、不同人員間精密度、耐用性、線性驗(yàn)證。結(jié)果兩批樣品重復(fù)測定6次結(jié)果的RSD均5%;兩批樣品兩名檢測人員3日內(nèi)的檢測結(jié)果以及兩批樣品不同工作日間的檢測結(jié)果差異均無統(tǒng)計(jì)學(xué)意義(P0.05),樣品日間和人員間檢測結(jié)果的RSD均5%;在20~30℃溫度范圍內(nèi)該方法耐用性良好,在p H 7.0~7.5范圍內(nèi)耐用性良好;該方法在樣品濃度為0.2~1.6μl/ml之間的線性關(guān)系良好。結(jié)論分光光度法重復(fù)性、日間精密度、不同人員間精密度良好,且操作簡便,結(jié)果可靠,適用于過氧化氫酶的質(zhì)量控制。
[Abstract]:Objective to establish a method for the determination of catalase activity of 23 valent pneumococcal polysaccharide vaccine. Methods the activity of catalase was determined by potassium permanganate titration and ultraviolet spectrophotometry, and the repeatability, day precision, durability and linearity of ultraviolet spectrophotometry were tested. Results the RSD of the two batches of samples were determined 6 times repeatedly. There was no significant difference in the results of the two batches of samples within 3 days and the two batches of samples between different working days (P0.05). The RSD of the test results of the two batches of samples during the day and between the people were 5. The method has good durability in the temperature range of 20 鈩，

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