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| 丹桂香颗粒的质量标准研究 | |
| 引用本文： | 王坤,张桂菊,王宏.丹桂香颗粒的质量标准研究[J].中国药事,2011,25(4):349-351,372. |
| 作者姓名： | 王坤 张桂菊 王宏 |
| 作者单位： | 1. 山东省药品检验所,济南,250101 2. 山东中医药大学 3. 山东,科伦药业有限公司 |
| 基金项目： | 2010年版《中国药典》起草品种课题 |
| 摘 要： | 目的完善丹桂香颗粒的质量标准,以控制药品质量。方法采用HPLC-ELSD法,色谱柱为迪马Kromasil C18;流动相为乙腈-水(32∶68);流速为1.0mL.min-1;漂移管温度为60℃。结果黄芪甲苷进样量在1.245~12.45μg范围内,积分值的对数与进样量的对数线性关系良好,r=0.9999,平均回收率99.2%,RSD为1.48%。结论本方法操作简单、结果准确,能够有效地控制丹桂香颗粒的质量。 |
| 关 键 词： | 丹桂香颗粒 HPLC-ELSD 黄芪甲苷 |
Study on Quality Standards of Danguixiang Granules |
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| Wang Kun,Zhang Guiju,Wang Hong.Study on Quality Standards of Danguixiang Granules[J].Chinese Pharmaceutical Affairs,2011,25(4):349-351,372. | |
| Authors: | Wang Kun Zhang Guiju Wang Hong |
| Institution: | Wang Kun,Zhang Guiju1 and Wang Hong2(Shandong Institute for Drug Contro1,Jinan 250101,2Shandong University of TCM,3Shandong Ke Lun Limited Company of Medicines and Chemical Reagents) |
| Abstract: | Objective To improve the quality standard of Danguixiang Granules.Methods HPLC-ELSD was used to determine directly astragaloside on Kromasil C18 column.Using acetonitrile-water（32 ∶68） as mobile phase,the flow rate was 1.0mL ·min-1.The temperature of drift tube for ELSD was 60℃.Results Good linear relation of logA with logW was achieved when the sample size of astragaloside at 1.245～12.45μg,r=0.9999.The average recovery of astragaloside was 99.2%,RSD was 1.48%.Conclusion The method is simple,accurate and reproducible.It can be used as the quality control method of Danguixiang Granules. |
| Keywords: | HPLC-ELSD |
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