关于2010年版《中国药典》栀子药材含量测定指标选择的商榷

Discussion on Quality Marker of Gardeniae Fructus in 2010 Edition of “Chinese Pharmacopoeia”

摘要:

目的: 完善栀子药材的HPLC质量控制指标. 方法: 采用Agilent Zorbax SB-C₁₈色谱柱(4.6 mm×250 mm,5 μm),流动相乙腈(A)-0.2%磷酸溶液(B)梯度洗脱(0~15 min,6%~16%A;15~22 min,16%~21%A;22~34 min,21%~24%A;34~50 min,24%~42%A),京尼平苷、西红花苷-1的检测波长分别为238,440 nm. 结果: 不同产地栀子中京尼平苷质量分数23.025~53.693 mg·g^-1,均符合2010年版《中国药典》≥1.8%的规定;其中2批栀子的外观颜色为灰棕色、棕黄色,西红花苷-1的含量极低,分别为1.963,3.434 mg·g^-1,应为不合格药材. 结论: 仅以京尼平苷作为栀子药材的质量控制指标不够合理,建议增加西红花苷-1的含量测定,为新版《中国药典》的修订提供参考.

Abstract:

Objective: To improve HPLC for quality control of Gardeniae Fructus. Method: HPLC system consisted of a Agilent Zorbax SB-C₁₈ column(4.6 mm×250 mm,5 μm) and mobile phase of acetonitrile(A)-0.2% phosphoric acid(B) with gradient elution(0-15 min,6%-16%A;15-22 min,16%-21%A;22-34 min,21%-24%A;34-50 min,24%-42%A),monitoring wavelength was set at 238,440 nm for geniposide and crocin-1,respectively. Result: The content of geniposide in Gardeniae Fructus collected from different areas ranged from 23.025-53.693 mg·g^-1,this result conformed to requirements (no less than 1.8%) in 2010 edition of “Chinese Pharmacopoeia”;but the content of crocin-1 in two samples(1.963,3.434 mg·g^-1) were lower than others,color of these two samples were gray-brown and brown-yellow,them should be substandard medicine. Conclusion: The content of geniposide as only standard for quality control of Gardeniae Fructus is not rational,the content of crocin-1 should be also taken into consideration.This paper may be useful for editing the new edition of ‘Chinese Pharmacopoeia’.