胃蛋白酶片比活与纯度的相关性研究  

Study on the Specific Activity and Purity Determination of Pepsin Tablets

作　　者：焦旭雯[1] 梁蔚阳[1] 蒋玉辉[1] JIAO Xu-wen;LIANG Wei-yang;JIANG Yu-hui(Guangdong Institute for Drug Control,NMPA Key Laboratory of Quality Control of Blood Product,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所、国家药品监督管理局血液制品质量控制重点实验室,广东广州510663

出　　处：《药物生物技术》2020年第6期527-531,共5页Pharmaceutical Biotechnology

基　　金：广东省药品监督管理局血液制品质量控制研究重点实验室(No.2019ZDZ23);广东省药品监督管理局科技引导扶持项目(No.2018YDB002);广东省医学科学技术研究基金项目(No.B2018130、B2018220)。

摘　　要：分别建立一种适用于胃蛋白酶片比活测定的方法以及HPLC纯度测定方法。采用凯氏定氮法测定胃蛋白酶片中的总蛋白质含量,再结合效价计算比活。纯度采用TSK gel Pheny1-5PW(75 mm×7.5 mm,10μm)色谱柱,以1.7 mol/L硫酸铵磷酸盐缓冲液(pH 7.0)和磷酸盐缓冲液(pH 7.0)为流动相进行梯度洗脱,体积流量为1.0 m L/min,检测波长为214 nm,柱温30℃。由凯氏定氮法得到的比活结果与采用HPLC法测得的纯度结果无相关性(rs=-0.232,P=0.1,n=5)。两种方法均可用于胃蛋白酶片的质量控制。比活或纯度检查项,可对企业低比活投料及原料来源稳定性进行有效监控。The methods for the specific activity and purity determination of Pepsin tablets were established.To determinate the total protein content of Pepsin tablets by Kjeldahl determination of nitrogen,the specific activity was calculated by potency and total protein content.The HPLC analysis of purity was performed on a TSK gel Pheny1-5 PW(75 mm × 7.5 mm,10 μm) column using gradient elution with mobile phase of 1.7 mol/L ammonium sulfate in phosphate buffer solution(pH 7.0) and 1.7 mol/L phosphate buffer solution(pH 7.0).The assay was carried out at a flow rate of 1.0 m L/min at 30 ° C with the UV detection at 214 nm.The specific activity of Pepsin tablets showed non-correlation with its purity(r_s=-0.232,P = 0.1,n = 5).Both two methods can be used for the quality control of Pepsin tablets.The specific activity or purity can effectively monitor the low specific feeding and stability of raw materials.

关 键 词：胃蛋白酶片 凯氏定氮法 高效液相色谱法 比活 纯度 

分 类 号：R917[医药卫生—药物分析学]