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眼络通冲剂质量控制标准实验室研究

Research on Standard Lab of Quality Control of Yanluotong Infusion

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【作者】 姜宁华徐宏祥傅应华

【Author】 Jiang Ninghua,Xu Hongxiang,Fu Yinghua TCM Hospital of Jiaxing City(314001)

【机构】 浙江省嘉兴市中医医院浙江省嘉兴市药品检验所嘉兴学院医学院

【摘要】 [目的]研究眼络通冲剂的定性和定量质控指标。[方法]采用硅胶G薄层色谱法对冲剂中两种主要成分川芎和三棱进行定性鉴别;用RP-HPLC法对葛根素进行含量测定,采用Kromasil100-5C18(4.6mm×250mm,5μm)为色谱柱,甲醇-水(30:70)作流动相,检测波长为250nm。[结果]葛根素进样量在0.06~0.65μg的范围内与峰面积呈良好的线性关系,相关系数r=0.9999,日内、日间精密度RSD分别为0.85%和0.48%(n=5)。得高、中、低3个浓度平均加样回收率(n=3)分别为101.2%、101.1%、101.4%,RSD分别为1.1%、0.94%、0.41%。[结论]硅胶G薄层色谱定性法和RP-HPLC定量法结果准确可靠,重现性好,可作为该制剂质控标准。

【Abstract】 [Objective]To observe the indexes of quality control of nature and quantity of Yanluotong Infusion.[Method]Make authentication to the 2 main components of Ligusticum wallichii and rhizoma sparganii on their nature with Silica gel G thin-layer chromatography;make content measurement to puerarin with RP-HPLC,take Kromasil 100-5 C18(4.6mm×250mm,5μm)as chromatogram column,methanol-water(30:70)as flow phase;the measured wavelength is 250nm.[Result]The puerarin sampling in the range 0.06~0.65μg is in good linear relationship with the summit area,the relative coefficient r=0.9999,the intraday and days nicety RSD are respectively 0.85% and 0.48%(n=5);the average sample reclaim rates of high,middle and low concentrations(n=3)are respectively 101.2%,101.1% and 101.4%,RSD is 1.1%,0.94% and 0.41% separately.[Conclusion]Silica gel G thin-layer chromatography and RP-HPLC are correct and reliable for nature and quantity control,with good repeatability,and can be taken as quality control standard of the preparation.

  • 【文献出处】 浙江中医药大学学报 ,Journal of Zhejiang University of Traditional Chinese Medicine , 编辑部邮箱 ,2009年03期
  • 【分类号】R286
  • 【被引频次】1
  • 【下载频次】93
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