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目的:制定康视明合剂质量控制方法。方法:采用薄层色谱法(TLC)鉴别处方中的当归、黄柏、黄芪;采用高效液相色谱法(HPLC)对处方中的葛根素及芍药苷含量进行定量测定。结果:TLC法能定性检出当归、黄柏、黄芪,斑点清晰,且阴性对照无干扰。定量分析中葛根素和芍药苷分别在1.64~49.20μg·ml-1(r=0.999 9)和4.22~63.30μg·ml-1(r=0.999 6)范围内与峰面积呈良好线性,葛根素平均回收率为99.63%,RSD=2.14%(n=9);芍药苷平均回收率为99.05%,RSD=2.70%(n=9)。结论:本方法准确、可靠、专属性强,可用于康视明合剂的质量控制。
Objective: To develop a method for quality control of Kangshenming Mixture. Methods: Angelica, Phellodendri and Astragalus were identified by TLC. The content of puerarin and paeoniflorin in the prescription was determined by HPLC. Results: TLC method can detect Angelica, Phellodendron, Astragalus qualitatively, the spots are clear, and the negative control has no interference. Quantitative analysis of puerarin and paeoniflorin in the range of 1.64 ~ 49.20μg · ml-1 (r = 0.999 9) and 4.22 ~ 63.30μg · ml-1 (r = 0.999 6) The average recovery was 99.63% and the RSD was 2.14% (n = 9). The average recovery of paeoniflorin was 99.05% and RSD was 2.70% (n = 9). Conclusion: The method is accurate, reliable and specific. It can be used for quality control of Kangshenming Mixture.