经典名方麻黄汤物质基准质量评价方法研究

Study on quality evaluation method of classical prescription Mahuang Decoction primary standard substances

分别建立经典名方麻黄汤物质基准的HPLC特征图谱及指标成分含量测定2套方法,为其质量标准的建立及复方制剂的开发利用提供数据基础。首先通过HPLC建立麻黄汤物质基准特征图谱,并测定15批麻黄汤物质基准样品,采用中位数法计算相似度;其次,研究确定物质基准含量测定成分并通过HPLC建立简便的含量测定方法,进行相关方法学考察,计算15批物质基准样品的出膏率及指标成分转移率、含水率等。结果表明,2套方法各具特色,前者特征图谱标定的10个共有峰中指认的6个色谱峰可涵盖物质基准中所有药味,较好的表明麻黄汤物质基准的质量特性。后者含量测定方法简单,实用性强,适合推广至其复方制剂的质量标准建立。通过2套方法共同评价15批麻黄汤物质基准的质量,结果15批样品相似度均大于0.90,平均出膏率18.1%,平均含水率9.7%,指标成分盐酸麻黄碱与盐酸伪麻黄碱总量的平均质量分数和转移率分别为2.3%和26.7%,苦杏仁苷的平均质量分数和转移率分别为2.2%和48.3%,所有数据均未出现离散(平均值的70%~130%以外),符合古代经典名方中药复方制剂物质基准的申报资料要求(征求意见稿)。基于上述研究建立经典名方麻黄汤物质基准质量标准,以期为经典名方麻黄汤复方制剂的开发研究提供参考。

This study aimed to establish the HPLC characteristic chromatogram and content determination method for index components with the primary standard substances of the classical prescription Mahuang Decoction,and to provide data basis for the establishment of its quality standard and the development and utilization of compound preparations.First,HPLC was used to establish the material reference chromatograms of Mahuang Decoction,and 15 batches of standard samples of Mahuang Decoction were determined.Their similarity was calculated by the median method.Secondly,the content of the standard substances was determined and a simplecontent determination method was established by HPLC.Relevant methodology was investigated,and the extraction ratio,index component transfer rate and moisture content of 15 batches of primary standard samples were calculated.The results showed that the two sets of HPLC methods had their own characteristics.The six chromatographic peaks identified from the 10 common peaks in the former characteristic chromatogram covered all the herbal medicines in the standard substances,which can better indicate the quality characteristics of the standard substances of Mahuang Decoction.The latter method(content determination method)was simple and practical,so it was suitable for establishing the quality standard of its compound preparation.Two sets of methods were jointly used to evaluate the quality of 15 batches of Mahuang Decoction.The results were as follows:the similarity of 15 batches of samples was greater than 0.90;the average extraction ratio was 18.1%;the average moisture content was 9.7%;the average content and transfer rate of the standard ingredients ephedrine hydrochloride and total pseudoephedrine hydrochloride were 2.3% and 26.7% respectively,and the average content and transfer rate of amygdalin were 2.2% and 48.3% respectively.None of the data showed dispersion(beyond 70%-130% of the mean value),which met the application data requirements for the substance standards of ancient classical Chinese herbal compound preparations(draft for comments).Based on the above research,the primary substance quality standard of Mahuang Decoction was established in order to provide reference for the development and research of the compound preparation of Mahuang Decoction.