麦冬标准汤剂的质量标准研究

Research on Quality Standards of Standard Decoction of Ophiopogon Japonicus Pieces

关键词:  麦冬  标准汤剂  质量评价  特征图谱

Key words:  Ophiopogon japonicus  standard decoction  quality evaluation  characteristic fingerprint

摘要:

目的 建立麦冬标准汤剂的质量标准。方法 从市场上收集15批麦冬饮片并制备成标准汤剂，以甲基麦冬二氢高异黄酮A为指标成分建立含量测定方法，计算出膏率、甲基麦冬二氢高异黄酮A的产量和转移率。建立麦冬饮片标准汤剂的特征图谱分析方法。利用x±3SD法建立标准汤剂的质量标准。结果 麦冬标准汤剂的出膏率标准为29.6%~81.8%；甲基麦冬二氢高异黄酮A转移率的标准为4.86%~28.0%；甲基麦冬二氢高异黄酮A的产量标准为4.75~20.1 μg·g^-1饮片。以4号峰甲基麦冬二氢高异黄酮A为参照峰，计算各特征峰与参照峰的相对保留时间，其相对保留时间应在规定值的±10%之内。结论 建立的2种分析方法分别适用于麦冬标准汤剂的含量测定和特征图谱分析，麦冬饮片标准汤剂的质量标准，可为麦冬配方颗粒的质量评价提供参考。

Abstract:

OBJECTIVE To establish quality standards for the standard decoction of Ophiopogon japonicus pieces. METHODS Fifteen batches of Ophiopogon japonicus pieces were collected. The standard decoctions were prepared by water decoction. Methylophiopogonanone A was considered as the index component and its analysis method was established. The extraction ratio of dry matter, the yield and transfer rate of methylophiopogonanone A were calculated. The characteristic fingerprint method for the analysis of Ophiopogon japonicus standard decoctions was also established. Quality standards for the standard decoctions were developed by the x±3SD method. RESULTS The quality standard of dry matter extraction ratio was 29.6%-81.8%. The quality standard of methylophiopogonanone A transfer ratio was 4.86%-28.0%. The quality standard of methylophiopogonanone A yield was 4.75-20.1 μg·g^-1 pieces. The relative retention time of each characteristic peak and the reference peak was calculated by using the peak No. 4 methylophiopogonanone A as the reference peak. The relative retention time should be within ±10% of the specified value. CONCLUSION The methods are suitable in characteristic fingerprint analysis and content determination for Ophiopogon japonicus standard decoctions. The quality standards for Ophiopogon japonicus standard decoctions can be used for the quality evaluation of Ophiopogon japonicus formula granules.