高效液相色谱法测定复方甘草酸苷胶囊甘氨酸与蛋氨酸含量及溶出度  

Determination of Content and Dissolution of Glycine and Methionine in Compound Glycyrrhizin Capsules by HPLC

作　　者：曾红霞 彭婷婷 程晨 郑金琪 ZENG Hongxia;PENG Tingting;CHENG Chen;ZHENG Jinqi(Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration,Department for Chemical Drug Control of Zhejiang Institute for Food and Drug Control,Hangzhou 310052,China)

机构地区：[1]国家药监局仿制药评价关键技术重点实验室,浙江省食品药品检验研究院化学药品检验所,杭州310052

出　　处：《医药导报》2023年第3期405-410,共6页Herald of Medicine

基　　金：浙江省药品监督管理局科技计划项目(2021020);浙江省公益技术研究项目(LGF19H300001)。

摘　　要：目的建立非衍生化的高效液相色谱(HPLC)法直接测定复方甘草酸苷胶囊中甘氨酸和蛋氨酸含量及溶出度。方法含量测定采用强酸性离子交换树脂为填充剂的SHIM-PACK AMINO-NA柱(6 mm×100 mm,5μm);流动相为0.3 mol·L^(-1)磷酸二氢钠-无水乙醇(95:5);检测波长205 nm;流速0.4 mL·min^(-1)。溶出度测定以水为溶出介质;篮法;转速100 r·min^(-1);45 min取样,取样后采用含量测定项下方法测定溶出量。结果含量测定项下甘氨酸平均回收率99.3%,RSD=0.7%;蛋氨酸平均回收率100.7%,RSD=0.2%;线性关系均良好。溶出度项下甘氨酸平均回收率99.7%,RSD=0.7%;蛋氨酸平均回收率100.3%,RSD=0.3%;溶出液在12 h内稳定;国内11批样品45 min平均溶出量均>90%。结论该方法简便、准确,绿色环保,可为下版《中华人民共和国药典》复方甘草酸苷胶囊标准修订中含量测定和溶出度方法提供科学依据。Objective To establish a non-derivative HPLC method for determining glycine and methionine in compound glycyrrhizin capsules directly.Methods Determination of content was measured using a SHIM-PACK AMINO-NA(6 mm×100 mm,5μm)column.The mobile phase was 0.3 mol·L^(-1)sodium dihydrogen phosphate-absolute ethyl alcohol(95:5).The detection wavelength was 205 nm.The flow rate was 0.4 mL·min^(-1).The dissolution medium of determination of dissolution was water.Rotating basket method was used with the speed of 100 r·min^(-1).The dissolution medium was taken and analyzed by HPLC under the content determination method at 45 min.Results The average recovery was 99.3%(RSD=0.7%)of glycine,100.7%(RSD=0.2%)of methionine,and the method for determination of glycine and methionine had good linearities.The average recovery was 99.7%(RSD=0.7%)of glycine and 100.3%(RSD=0.3%)of methionine.The solution stabilized within 12 hours.The average dissolution from eleven batches was>90%at 45 min.Conclusion The method is simple,accurate,and environmentally friendly.It provides a scientific basis for content and dissolution determination of compound glycyrrhizin capsules in the next revision of Pharmacopoeia of the People's Republic of China.

关 键 词：复方甘草酸苷胶囊 甘氨酸 蛋氨酸 含量测定 溶出度 

分 类 号：R286[医药卫生—中药学] R927.1[医药卫生—中医学]