目的:建立蒙药复方制剂壮伦-5汤处方中肋柱花药材的定性和定量方法,解决肋柱花材代被替代现象.方法:采用显微鉴别法观察粉末中花粉粒;獐牙菜苦苷对照品和肋柱花药材为对照,以乙酸乙酯-甲醇-水-甲酸(12∶2∶2∶0.5)为展开剂进行薄层鉴别研究;采用Agilent Eclipse Plus C18色谱柱(250 mm × 4.6 mm,5 μm),0.2％磷酸溶液(A)-乙腈(B)为流动相,梯度洗脱,检测波长238 nm,以獐牙菜苦苷为对照品对不同厂家壮伦-5汤,进行含量测定.结果:12批壮伦-汤中8批次为肋柱花,2批次为紫花地丁,2批次为其它药材.8批壮伦-汤中獐牙菜苦苷含量范围较大,在0.2～11.7 mg·g-1之间.结论:建立的鉴别方法简单、有效,含量测定方法稳定、专属性强,可为该制剂的监管提供技术支撑,对传统中蒙药制剂标准的提升具有借鉴作用.
Abstract
Objective:To establish the qualitative and quantitative methods of Lomatogonium carinthiacum(Wulf.)Reichb.in the prescription of Mongolian medicine Polypill Zhuanglun-5 decoction,and solve the phe-nomenon of Lomatogonium carinthiacum(Wulf.)Reichb.being replaced.Methods:Microscopic identification method was used to observe the pollen grains in the powder;The reference substance of swertiamarin and Lomato-gonium carinthiacum(Wulf.)Reichb.were used as the control,and the ethyl acetate methanol water formic acid(12∶2∶2∶0.5)was used as the developing agent for TLC identification;HPLC was used under the condin-tion including Agilent Eclipse Plus C18(250 mm × 4.6 mm,5 μm)as chromatographic column and 0.2％phosphoric acid solution(A)-acetonitrile(B)as mobile phase with gradient elution at 238 nm of detection wavelength were used.Contents of Zhuanglun-5 decoction from different manufacturers were determined with swertiamarin as reference substance.Results:Among the 12 batches of Zhuanglun-5 decoction,8 batches were Lomatogonium carinthiacum(Wulf.)Reichb.,2 batches were Viola yedoensis,and 2 batches were other medicinal materials.The content of swertiamarin in 8 batches of Zhuanglun-5 decoction ranged from 0.2 to 11.7 mg·g-1.Conclusion:The established identification method is simple and effective,and the content determination method is stable and has strong specificity.It can provide technical support for the supervision of the preparation,and has a reference effect for the improvement of traditional Chinese and Mongolian pharmaceuti-cal preparation standards.
维普
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