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目的:建立调经助孕颗粒的质量控制方法。方法:采用TLC法对调经助孕颗粒中山茱萸、当归进行定性鉴别;采用HPLC法测定调经助孕颗粒中马钱苷的含量,使用Sino Chrom ODS-BP(250 mm×4.6 mm,5μm)色谱柱;乙腈-0.1%磷酸水溶液(14∶86)为流动相;流速:1.0 ml·min-1;柱温:30℃,检测波长:240 nm。结果:TLC色谱中供试品与对照药材相应位置上斑点清晰,阴性无干扰。马钱苷在50.40~1008.00 ng,有良好线性关系(r=0.999 9),马钱苷的平均回收率为98.02%(n=6),RSD值为2.51%。结论:本研究可用于调经助孕颗粒的质量控制,方法简便、可靠、能较好地控制该制剂的质量。
Objective: To establish a method for quality control of menstruation and pregnant women. METHODS: TLC and HPLC method were used to identify the content of loganin in the tablets of Tiaojing Zhuyun Granule. The chromatographic column was SinoChrom ODS-BP (250 mm × 4.6 mm, 5μm) ; Acetonitrile-0.1% phosphoric acid solution (14:86) as mobile phase; flow rate: 1.0 ml · min-1; column temperature: 30 ℃, detection wavelength: 240 nm. Results: TLC chromatogram for the test sample and control medicine corresponding spots on the clear, negative non-interference. Loganin had a good linearity (r = 0.999 9) between 50.40 and 1008.00 ng. The average recovery of loganin was 98.02% (n = 6) with a RSD value of 2.51%. Conclusion: This study can be used for the quality control of the menstruation-assisted pregnancy granule. The method is simple, reliable and can control the quality of the preparation.