Quality control standard for Qingre Baidu granules
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摘要: 目的 建立清热败毒颗粒剂的质量标准。 方法 采用薄层色谱法（TLC）鉴别处方中的板蓝根、连翘、紫花地丁和甘草，采用高效液相色谱法（HPLC）测定绿原酸的含量，色谱柱为Agilent ZORBAX SB-C18柱（4.6 mm×250 mm，5 μm）；流动相为乙腈（A）与含0.2%甲酸的水溶液（B），梯度洗脱：0~12 min，11%~12%A；流速：1.0 ml/min；柱温：30 ℃；检测波长：327 nm；进样量：20 μl。 结果 薄层鉴别色谱中特征斑点明显，专属性强。绿原酸在6.19~396.00 μg/ml浓度范围内呈良好线性关系，其回归方程为Y=60.239 4X+9.096 3（r>0.999 9），回收率为99.66%（RSD=2.82%）。 结论 该法简便、稳定可靠、重复性好，为控制清热败毒颗粒的质量标准提供了可借鉴的依据。Abstract: Objective To establish a quality control standard for Qingre Baidu granules. Methods Isatidis Radix, Fructus Forsythiae,Herba Violae, and Glycyrrhizae were identified by TLC, and the concentration of chlorogenic acid was determined by HPLC. This method was employed on an Agilent ZORBAX SB-C18 column (4.6 mm×250 mm, 5 μm) at 30℃ with a mobile phase of acetonitrile (A) and 0.2% formic acid (B) using the gradient elution program shown as follows: 0-12 min, 11%-12% A run at the flow rate of 1.0 ml/min. The injection volume was 20 μl and the detection wavelength was 327 nm. Results Characteristic spots could be detected by TLC and the specificity of the method was satisfactory. As for chlorogenic acid, the equation of linear regression of chlorogenic acid was Y=60.239 4X+9.096 3 (r=0.999 9) with the linear range of 6.19-396.00 μg/ml. The average recovery was 99.66% (RSD=2.82%). Conclusion The established method is simple, reliable, reproducible, and can be used for the quantitative determination and quality control of Qingre Baidu granules.
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Key words:
- HPLC /
- TLC /
- chlorogenic acid /
- Qingre Baidu granules
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