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

[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。

[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.