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作 者:李萍萍 陈一鸣 颜士茹 张瑞卿 张海毅 都红芳 LI Pingping;CHEN Yiming;YAN Shiru;ZHANG Ruiqing;ZHANG Haiyi;DU Hongfang(Health and Wellness Department,Weihai Vocational College,Shandong Weihai 264200;Weihai Rensheng Pharmaceutical Group Co.,Ltd.,Shandong Weihai 264200)
机构地区:[1]威海职业学院康养学院,山东威海264200 [2]威海人生药业有限公司,山东威海264200
出 处:《生物化工》2021年第5期21-24,共4页Biological Chemical Engineering
基 金:山东省重点研发计划(重大科技创新工程)项目(2019YYSP014);“十三五”国家海洋经济创新发展示范威海市海洋经济创新发展示范城市产业链协同创新类项目。
摘 要:以《中华人民共和国药典》(以下简称《中国药典》)为依据,建立岩藻多糖硫酸基检测方法,并进行方法学验证。该方法线性关系良好,硫酸根离子在0~200 mg/L浓度范围内与峰面积呈现良好的线性关系,线性方程为y=76926x+107499(n=5),相关系数R^(2)=0.9999;精密度试验RSD值小于1.0%;重复性试验RSD值在2.0%以内;准确度试验加标回收率均在96%~101%范围内,平均回收率为98.8%,RSD值为1.7%。3批岩藻多糖原料药平均硫酸基含量15.25%。本法精密度和准确度均符合药典相关规定,可应用于岩藻多糖原料药硫酸基含量的检测。The determination method of fucoidan sulfate groups is developed based on Pharmacopeia of the People's Republic of China(2020)and the methodological validation of fucoidan sulfate groups is made.The results showed that there was a good linear relationship between sulfate ion and peak area in the concentration range of 0~200 mg/L,the linear equation was y=76926x+107499(n=5),the correlation coefficient R^(2)=0.9999.RSD value of the precision test was below 1.0% and RSD value of the reproducibility test was within 2.0%.The accuracy in measurement was 96%~101%.The average recovery rate as 98.8% and RSD value was 1.7%.The average content of sulfate groups in fucoidan of 3 batches was 15.25%.Therefore,the established method can be applied for the determination of sulfate groups of fucoidan active pharmaceutical ingredient.
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