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益肾降糖胶囊质量控制方法的研究
Study on the quality control method of Yishen Jiangtang capsules
【摘要】 目的建立益肾降糖胶囊的质量控制方法。方法 2018年9月至2019年3月,运用薄层色谱法(TLC)对益肾降糖胶囊中的制何首乌、赤芍、玄参、黄芪、山药、黄芩进行定性鉴别;采用高效液相色谱法测定芍药苷、二苯乙烯苷和黄芩苷的含量。采用Ultimate? XB-C18(4.6×250 mm,5μm)色谱柱;以甲醇-0.2%磷酸溶液为流动相,梯度洗脱;流速为1.0 mL/min;检测波长为230 nm(芍药苷)和320 nm(二苯乙烯苷、黄芩苷),柱温为40℃。结果制何首乌、赤芍、玄参等TLC图斑点清晰,分离度好,阴性对照无干扰。芍药苷、二苯乙烯苷、黄芩苷质量浓度分别在31.320~234.900μg/mL(r=0.999 1),3.939~14.772μg/mL(r=0.999 5)、36.080~270.600μg/mL(r=0.999 5),范围线性关系良好;平均加样回收率分别为98.96%,99.91%,99.89%,(RSD分别为0.76%,1.16%,1.41%,n=6)。结论该方法准确简便,重现性好,可用于益肾降糖胶囊的质量控制。
【Abstract】 Objective To establish the quality control method of Yishen Jiangtang capsules.Methods From September 2018 to March 2019,thin layer chromatography(TLC) was used for the qualitative identification of Polygoni multiflori radix praeparata,Paeoniae radix rubra,Scrophulariae radix,Astragali radix,Dioscoreae rhizoma and Scutellariae radix in Yishen Jiangtang capsules.HPLC method was adopted for the contents determination of paeoniflorin,Stilbene glucoside and Baicalin.The analysis was carried out on an Ultimate? XB-C18 column(4.6×250 mm,5 μm).The mobile phase was composed of methanol-0.2%phosphoric acid aqueous with gradient elution at the flow rate of 1.0 mL/min.The detection wavelength was set at 230 nm(paeoniflorin) and 320 nm(stilbene glucoside,baicalin),the column temperature was 40 ℃.Results The TLC sports of Polygoni multiflori radix praeparata,Paeoniae radix rubra,Scrophulariae radix and Astragali radix were clear and well separated without the interference of negative samples.Paeoniflorin,Stilbene glucoside and Baicalin had good linear relationships within the ranges of 31.320-234.900 μg/mL(r=0.999 1),3.939-14.772μg/mL(r=0.999 5),36.080-270.600 μg/mL(r=0.999 5),whose average recoveries were 98.96%,99.91%,99.89% with the RSDs of 0.76%,1.16% and 1.41%(n=6),respectively.Conclusion The method is simple and accurate with good repeatability,it can be used to control the quality of Yishen Jiangtang capsules.
【Key words】 Drugs,Chinese Herbal; Principal component analysis; Chromatography,thin layer; Chromatography,high pressure liquid; Yishen Jiangtang capsule; Quality control; Paeoniflorin; Stilbene glucoside; Baicalin;
- 【文献出处】 安徽医药 ,Anhui Medical and Pharmaceutical Journal , 编辑部邮箱 ,2021年04期
- 【分类号】R286.0
- 【网络出版时间】2021-03-31 16:35
- 【下载频次】172