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目的建立金柴抗感胶囊的质量控制标准。方法采用薄层色谱法(TLC)对制剂中连翘和柴胡进行定性鉴别;采用高效液相色谱法(HPLC)对制剂中金银花的有效成分绿原酸进行含量测定。结果连翘和柴胡的供试品在与对照品色谱相应位置均有相同颜色的斑点,阴性样品无干扰;方法学考察表明,绿原酸进样量在0.025~0.750μg范围内峰面积与进样量呈现良好的线性关系(r=0.9999),平均回收率为98.40%(n=6),RSD=1.54%。结论该方法简便、快速、准确,可用于金柴抗感胶囊的质量控制。
Objective To establish the quality control standard of Jinchai Kanggan capsule. Methods Thin layer chromatography (TLC) was used to qualitatively identify forsythia suspensa and Bupleurum chinense L. in the preparation. HPLC was used to determine the content of chlorogenic acid in the preparation. Results Forsythia and Bupleurum tested in the same position with the reference substance chromatography have the same color spots, negative samples without interference; methodological study showed that chlorogenic acid injection volume in the range of 0.025 ~ 0.750μg peak area and The injection volume showed a good linear relationship (r = 0.9999) with an average recovery of 98.40% (n = 6) and RSD = 1.54%. Conclusion The method is simple, rapid and accurate and can be used for the quality control of Jinchai Kanggan capsule.