化橘红中展青霉素含量测定方法的建立
R917; 目的 建立一种测定化橘红药材中展青霉素含量的方法.方法 采用高效液相色谱-串联三重四极杆质谱联用(HPLC-MS/MS)法.化橘红样品粉末加水溶散后经果胶酶酶解,用乙腈高速匀浆提取,提取液依次经无水硫酸镁-无水醋酸钠(4:1,m/m)混合粉末分散固相萃取和SHIMSEN 228型固相净化柱净化后,采用岛津Shim-pack XR-ODS色谱柱、水-乙腈流动相、电喷雾离子源、负离子扫描、多反应监测模式测定,以基质标准曲线校正、外标法定量.结果 展青霉素的检测质量浓度在5～200 ng/mL范围内与峰面积成良好的线性关系(r=0.9996);精密度、重复性、稳定性(12 h)试验的RS...
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| Published in | 中国药房 Vol. 33; no. 23; pp. 2936 - 2939 |
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| Main Authors | , , , , , |
| Format | Journal Article |
| Language | Chinese |
| Published |
广州市药品检验所/国家药品监督管理局中成药质量评价重点实验室,广州 510160%广州市香雪制药股份有限公司,广州 510525
2022
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| Subjects | |
| Online Access | Get full text |
| ISSN | 1001-0408 |
| DOI | 10.6039/j.issn.1001-0408.2022.23.23 |
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| Abstract | R917; 目的 建立一种测定化橘红药材中展青霉素含量的方法.方法 采用高效液相色谱-串联三重四极杆质谱联用(HPLC-MS/MS)法.化橘红样品粉末加水溶散后经果胶酶酶解,用乙腈高速匀浆提取,提取液依次经无水硫酸镁-无水醋酸钠(4:1,m/m)混合粉末分散固相萃取和SHIMSEN 228型固相净化柱净化后,采用岛津Shim-pack XR-ODS色谱柱、水-乙腈流动相、电喷雾离子源、负离子扫描、多反应监测模式测定,以基质标准曲线校正、外标法定量.结果 展青霉素的检测质量浓度在5～200 ng/mL范围内与峰面积成良好的线性关系(r=0.9996);精密度、重复性、稳定性(12 h)试验的RSD均小于6％;低、中、高3种浓度加样量的平均加样回收率分别为83.90％、92.08％、92.21％(RSD分别为11.09％、5.53％、1.75％);定量限为6μg/kg,检出限为3μg/kg.20批样品均未检出展青霉素.结论 所建方法可实现对化橘红中展青霉素的快速筛查和准确定量,可为化橘红的安全性研究和质量控制提供实验依据和方法. |
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| AbstractList | R917; 目的 建立一种测定化橘红药材中展青霉素含量的方法.方法 采用高效液相色谱-串联三重四极杆质谱联用(HPLC-MS/MS)法.化橘红样品粉末加水溶散后经果胶酶酶解,用乙腈高速匀浆提取,提取液依次经无水硫酸镁-无水醋酸钠(4:1,m/m)混合粉末分散固相萃取和SHIMSEN 228型固相净化柱净化后,采用岛津Shim-pack XR-ODS色谱柱、水-乙腈流动相、电喷雾离子源、负离子扫描、多反应监测模式测定,以基质标准曲线校正、外标法定量.结果 展青霉素的检测质量浓度在5～200 ng/mL范围内与峰面积成良好的线性关系(r=0.9996);精密度、重复性、稳定性(12 h)试验的RSD均小于6％;低、中、高3种浓度加样量的平均加样回收率分别为83.90％、92.08％、92.21％(RSD分别为11.09％、5.53％、1.75％);定量限为6μg/kg,检出限为3μg/kg.20批样品均未检出展青霉素.结论 所建方法可实现对化橘红中展青霉素的快速筛查和准确定量,可为化橘红的安全性研究和质量控制提供实验依据和方法. |
| Author | 顾利红 栗建明 侯惠婵 谢思敏 王艳慧 陈俊妃 |
| AuthorAffiliation | 广州市药品检验所/国家药品监督管理局中成药质量评价重点实验室,广州 510160%广州市香雪制药股份有限公司,广州 510525 |
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| Author_FL | XIE Simin GU Lihong CHEN Junfei HOU Huichan LI Jianming WANG Yanhui |
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| Keywords | 含量测定 安全用药 化橘红 展青霉素 高效液相色谱-串联三重四极杆质谱联用 |
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