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作 者:赵跃东[1] 陈丹阳[1] 王晴[1] 韩文杰[1] 张旗[1] 雷海民[1] 李强[1]
出 处:《国际中医中药杂志》2016年第5期433-435,共3页International Journal of Traditional Chinese Medicine
基 金:北京中医药大学科研创新团队.中药先导化合物发现与开发创新团队项目(2011-CXTD-15)
摘 要:目的动态分析黄芪注射液制备过程,验证其现行工艺的合理性及存在的问题。方法采用现行部颁标准制备黄芪注射液,对其主要流程进行固体量测定;色谱柱为AgilentZORBAXSB.C18(250mm×4.6mm,5μm),流动相为乙腈一水溶液,梯度洗脱,检测波长254mm,柱温25℃,体积流量1ml/min,测定黄芪注射液制备过程中成分的变化。结果精确测定了黄芪注射液的不同操作后固体量,第3次水提液含量仅为6.1%;HPLC图谱显示12号峰在醇沉第2次后含量明显减少。结论黄芪注射液的工艺合理性有待验证和优化,高效液相的动态分析定性描述了黄芪注射液的化学成分变化,为建立其指纹图谱提供参考。Objective To dynamically the preparation process of Huangqi injection and to verify the rationality and existing problems of the process. Methods The preparation was made by the current standard (WS3-B-3335-98) issued by Ministry of Health, and the solid amount of the key processes were measured. The HPLC separation was performed on a Agilent Zorbax Bio-C18 reversed-phase column (250 mm× 4.6 mm, 5 μm) in gradient mode of acetonitrile-water with UV detection at 254 nm. The column temperature was kept at 25 ℃, and the flow rate of mobile phase was 1.0 ml/min. Results Solid amounts of different operations of Huangqi injection were measured accurately. The content of the third water extracts was only 6.1%, and the changes of HPLC pointed the content of the 12 peaks of the second peaks decreased obviously. Conclusion The technological rationality of Huangqi injection need to be verified and optimized, the dynamic analysis of HPLC describes the changes of chemical constituents of Huangqi injection qualitatively, which also provides a reference value for establishing its fingerprint.
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