本文選題：國家參考品 + 人血白蛋白　； 參考：《中國藥學雜志》2017年06期

【摘要】：目的制備首批人血白蛋白國家參考品,用于人血白蛋白產品放行、批簽發(fā)或注冊檢驗等質量控制工作。方法選擇經檢驗合格的人血白蛋白產品作為原料進行合并、除菌、分裝。制備后按照2015年版《中國藥典》三部人血白蛋白各論初步選定7個檢驗項目,包括:蛋白質含量(凱式定氮)、辛酸鈉含量測定、多聚體含量、pH測定、吸光度測定、鈉離子含量、鋁離子含量,在11家實驗室進行協作標定,同時進行穩(wěn)定性監(jiān)測。結果依據11家實驗室協作標定結果確立該批國家參考品的參考值范圍分別為:蛋白質含量(193.30±5.08)g·L~(-1);辛酸鈉含量(0.162 4±0.009 2)mmol·g(Pro)~(-1);多聚體含量(2.72±0.29)%(HPLC-SEC);pH值(6.71±0.08)[測定溫度(22±3)℃];吸光度(0.030±0.005);鈉離子含量(134.9±23.6)mmol·L~(-1);鋁離子含量協作標定范圍為(88.4±30.5)μg·L~(-1),但鋁離子含量項目在穩(wěn)定性監(jiān)測過程中出現明顯上升趨勢,因此該項目不納入參考品最終發(fā)布的標定項目。結論該批人血白蛋白參考品符合相關要求,可以作為國家參考品發(fā)放。有利于人血白蛋白產品的質量控制。
[Abstract]:Objective to prepare the first batch of human serum albumin (HSA) reference material for quality control, such as release, batch issuance or registration inspection. Methods the qualified human serum albumin product was selected as raw material to be combined, sterilized and partitioned. After preparation, according to the 2015 edition of the Chinese Pharmacopoeia, seven tests were preliminarily selected for each of the three parts of human serum albumin, including: protein content, sodium octanoate content, pH determination, absorbance determination, sodium ion content, Aluminum ion content was calibrated in 11 laboratories and stability monitoring was carried out at the same time. Results according to the calibration results of 11 laboratories, the reference ranges of the national reference materials were determined as follows: protein content was 193.30 鹵5.08g / L ~ (-1), sodium octanoate was 0.162 4 鹵0.009 2)mmol / g ~ (-1) ~ (-1), pH value of HPLC-SECU was 6.71 鹵0.08) [determination temperature was 22 鹵3 鈩僝, sodium ion content was 0.030 鹵5 ~ (-1) 鈩，

本文編號：1780318