| 刘桂珍1 刘纪青2 廖朝峰1 周国波1.肾衰康浓缩丸质量标准研究[J].现代生物医学进展英文版,2011,11(14):2767-2769. |
| 肾衰康浓缩丸质量标准研究 |
| Study on Quality Standard of Shenshuaikang Concentrated Pill |
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| DOI： |
| 中文关键词: 肾衰康浓缩丸 黄芪甲苷 HPLC-ELSD 丹参 大黄 TLC 质量标准 |
| 英文关键词: Shenshuaikang Concentrated Pill Astragaloside IV HPLC-ELSD Salviae Miltiorrhizae Radis et Rhizoma Rhei Radis
et Rhizoma TLC Quality standards |
| 基金项目: |
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| 中文摘要: |
| 目的：建立肾衰康浓缩丸质量控制方法。方法：采用TLC 鉴别肾衰康浓缩丸中大黄、丹参；采用HPLC-ELSD 对制剂中黄芪
甲苷进行含量测定，流动相为乙腈- 水（30:70），流速：1 mL/min，柱温：28℃，漂移管温度：42℃，氮气：355kPa。结果：大黄、丹参的
TLC 鉴别斑点清晰、专属性强；黄芪甲苷在1.0μg-10.0μg 之间呈良好的线性关系（r=0.9997，n=5），平均回收率为99.81％，RSD 为
1.73%（n=6）。结论：所建立的方法简便准确、专属性强、重现性好，可作为控制肾衰康浓缩丸质量的方法。 |
| 英文摘要: |
| Objective: To establish the quality standard of Shenshuaikang concentrated pill. Methods: Salviae Miltiorrhizae Radis
et Rhizoma, Rhei Radis et Rhizoma were identified by TLC. The content of Astragaloside IV was determined by HPLC. Hypersil-C18
column was used(4.6 mm×150 mm,5μm).The mobile phase was consisted of acetonitrile-water (30:70). The flow rate was 1.0 ml/min,
and column temperature was at 28℃,The evaporation temperature was 42℃,Pressure of Nitrogen gas was 355kPa. Results: The spots on
TLC plates were clear without interference. The linearity range of Astragaloside IV was 1.0μg～10.0μg,(r = 0. 9997,n =5). The average
recovery of Astragaloside IV was 99.81% , and RSD was 1.73% ( n = 6). Conclusions: This method is accurate, reliable and reproducible,
which can be used for the quality control of Shenshuaikang Concentrated Pill. |
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