Development and verification of modified Lowry method for protein content detection of Sabin strain inactivated poliovirus vaccine(Vero cells)
10.13200/j.cnki.cjb.004681
- VernacularTitle:Sabin株脊髓灰质炎灭活疫苗（Vero细胞）蛋白质含量检测改良Lowry法的建立及验证
- Author:
TANG Wei
1
Author Information
1. Wuhan Institute of Biological Products Co., Ltd., Wuhan 430207, Hubei Province, China
- Publication Type:Journal Article
- Keywords:
Protein content;
Sabin strain poliovirus;
Modified Lowry method;
Lowry2 method
- From:
Chinese Journal of Biologicals
2026;39(04):461-467
- CountryChina
- Language:Chinese
-
Abstract:
Objective To develop a modified Lowry method for the detection of protein content of Sabin strain inactivated poliovirus vaccine(sIPV)(Vero cells), and compare it with the Lowry2 method after verification.MethodsThe specificity,linear range, repeatability, intermediate precision, accuracy and robustness of the developed modified Lowry method were verified, and the detection results of protein content of sIPV typesⅠ,Ⅱand Ⅲ monovalent bulk solution and finished products were compared with those of Lowry2 method, and the applicability research of the modified Lowry method was conducted.ResultsThe total RSD of the detected protein content of the standard at the same concentration diluted with two diluents was 2. 1%. The protein content showed good linearity in the range of 0-50 μg/mL, R2 > 0. 99, and the recovery rates of30 μg protein were 101%-103%. The total RSDs of six repeated tests of sIPV typesⅠ,Ⅱand Ⅲ monovalent bulk solutions and finished products by different experimenters on the same equipment were 1. 2%, 0. 0%, 1. 9% and 2. 4%, and the total RSDs of six repeated tests by the same experimenter on different equipment were 1. 4%, 0. 0%, 1. 9% and 2. 4%, respectively.The recovery rates of spiked sIPV typesⅠ,Ⅱand Ⅲ monovalent bulk solutions and finished products were 96%-102%,99%-101%, 96%-101% and 100%-103%, respectively. After being placed at room temperature for 30 min and 50 min,the total RSDs of sIPV typesⅠ,Ⅱand Ⅲ monovalent bulk solutions and finished products were 2. 1%, 1. 1%, 2. 2% and2. 4%, respectively. The modified Lowry method was simpler in operation steps and had similar recovery rate with the Lowry2 method(F = 1. 655, P > 0. 05), and both could remove impurities in the sIPV vaccine. Samples from three batches of sIPV types Ⅰ, Ⅱ and Ⅲ monovalent bulk solutions and finished products for 12 times of applicability tests were all qualified.ConclusionThe modified Lowry method can be used to detect the protein content of sIPV(Vero cells) as an indicator of product effectiveness evaluation.
