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目的:建立六君保玄颗粒质量控制标准.方法:含量测定采用HPLC法测定颗粒剂中马钱苷含量,其色谱柱:Diamonsil C18色谱柱(250 mm×4.6 mm,5μm);柱温:25℃;流动相:乙腈-水(15∶85);流速:1.0 m L/min;检测波长:240 nm;定性鉴别采用TLC法对方中枸杞子、黄连、地龙、丹参4味中药进行鉴别。结果:马钱苷进样量在0.039~0.78μg范围内与峰面积呈良好线性关系,平均回收率为99.78%,RSD为1.11%;枸杞子、黄连、地龙、丹参4味中药TLC鉴别阴性无干扰,专属性强。结论:为中药6类新药六君保玄颗粒质量控制标准的建立提供科学依据。
Objective: To establish the quality control standard of Liujun Bao Xuan granule.METHODS: The content of loganin in granule was determined by HPLC method.The column was Diamonsil C18 column (250 mm × 4.6 mm, 5 μm) ℃; mobile phase: acetonitrile-water (15:85); flow rate: 1.0 m L / min; detection wavelength: 240 nm; qualitative identification by TLC method of the medlar, berberine, earthworm, Results: The logarithm of loganin had a good linear relationship with the peak area in the range of 0.039 ~ 0.78μg with an average recovery of 99.78% and a RSD of 1.11%. The TLC identification results of Chinese wolfberry fruit, berberine, No interference, special and strong. Conclusion: This study provides a scientific basis for the establishment of 6 quality control standards for 6 kinds of new drugs.