旋光法快速测定乳糖含量的研究  

Investigation on the rapid determination of lactose content by polarimetry

作　　者：赵浩东 周小华 赵恂 朱林 施海蔚 黄青 袁耀佐 ZHAO Haodong;ZHOU Xiaohua;ZHAO Xun;ZHU Lin;SHI Haiwei;HUANG Qing;YUAN Yaozuo(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China;NMPA Key Laboratory for Impurity Profile of Chemical Drugs,Nanjing 210019,China)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019 [2]国家药品监督管理局化学药品杂质谱研究重点实验室,南京210019

出　　处：《中国药品标准》2024年第5期512-516,共5页Drug Standards of China

基　　金：2023年国家药品评价性抽验资助国药监药管([2023]2号);江苏省药品监督管理局2023年药品监管科学科研计划项目(202302,202313)。

摘　　要：目的:建立一种快速测定乳糖(C_(12)H_(22)O_(11))含量的方法。方法:采用乳糖精制品测得纯品乳糖的比旋度值[α]^(20)_(D),计算得到校正系数,将测得样品的旋光度值,乘以校正系数得到供试品中乳糖的质量(g),即可计算得到乳糖的含量。并对新建立的旋光法与法定检验方法(HPLC-RID法)测定乳糖含量的等效性进行了研究。结果:所建立的方法在0.05~0.20 g·mL^(-1)范围内与旋光度呈良好的线性关系(r=1.0000)、重现性[RSD=0.07%(n=6)]。旋光度法测得的141批乳糖含量与法检结果比较,同批样品间相对偏差均不大于1.0%。单因素方差分析检验结果也显示,两组数据无显著性差异(Sig.>0.05)。结论:本法与《中国药典》2020年版四部中HPLC-RID法性能相当,同时,可降低测试成本,缩短测试时间,满足质量控制需求。Objective:To established a rapid method for the determination of lactose(C_(12)H_(22)O_(11))content.Methods:The specific rotation([α]^(20)_(D))of pure lactose was measured with lactose extract product,and the correction coefficient was calculated.The measured rotatory value of the sample was multiplied by the correction coefficient to obtain the mass(g)of lactose in the test product,and the lactose content was calculated.The equivalence of the newly established polarimetric method and the legal test method(HPLC-RID method)for the determination of lactose content was studied.Results:The linear relation of established method was excellent with the range of 0.05-0.20 g·mL^(-1)(r=1.0000)and the method also had good reproducibility(RSD=0.07%(n=6)).The lactose content of 141 batches samples measured by polarimetry was compared with the results determined by official analytical procedure,and the results showed the relative deviation between the same batches was less than 1.0%.The results of one-way ANOVA also showed that there was no significant difference between two groups(Sig.>0.05).Conclusion:The performance of polarimetry is comparable to HPLC-RID in the Chinese Pharmacopoeia 2020 VolⅣ.Meanwhile,the polarimetry can reduce the test cost,shorten the test time and meet the requirements of the quality control.

关 键 词：乳糖含量 快速测定 旋光法 等效性研究 质量控制 

分 类 号：R921.2[医药卫生—药学]