枳壳精准煮散饮片质量的均一性

枳壳精准煮散饮片质量的均一性

作者：黄娟 张靖 宫璐 李西文 张鹏 徐文 丘小惠 黄志海 来源：《世界中医药》2017年第11期

摘要 目的：探讨精准煮散饮片与市售原饮片成分溶出及质量均一性差异。方法：应用ITS2序列作为DNA条形码对枳壳饮片进行鉴定;比较枳壳市售原饮片及精准煮散饮片的干膏收率;采用HPLC-DAD法进行3批次饮片混合粉碎前后质量均一性、指纹图谱及相似度评价。结果：枳壳煮散饮片出膏率略高于市售饮片出膏率;精准煮散饮片提取液中柚皮苷溶出较市售饮片高，市售饮片柚皮苷、新橙皮苷批间溶出量有明显的差异性RSD分别为9.71%及24.71%，混合制成煮散饮片后差异缩小RSD分别为4.73%、4.94%。指纹图谱相似度评价结果显示，制成煮散饮片后相似度提高，且共有峰峰面积均有提高。结论：枳壳市售饮片制成精准煮散饮片基本属性没有变化，但精准煮散饮片能提饮片的煎煮效率及均一性，发展精准煮散饮片具有良好的应用前景。

关键词 枳壳;精准煮散饮片;DNA条形码;指纹图谱

Abstract Objective：This study aimed to evaluate the composition dissolution and quality uniformity of precise powder decoction pieces （PPDP） of Aurantii Fructus （AF），compared with the traditional commercial slices.Chemical fingerprint methods and DNA molecular

identification technology based on internal transcribed spacer 2 （ITS2） were applied.Methods：Different specifications of PPDP were prepared，their dry extract contents were compared with those of commercial slices.Three batches of commercial slices were collected，and the content

uniformity，fingerprint and similarity evaluation before and after the mixing and pulverization were analyzed by HPLC-DAD and DNA sequence alignment.Results：Paste rate of PPDP were slightly higher than that of the traditional commercial slices.The dissolution of naringin of PPDP was higher than that of traditional commercial slices.RSD of inter-assay dissolutions of naringin and

neohesperidin of commercial slices were 9.71% and 24.71% respectively，which could be reduced to 4.73% and 4.94% after mixing and preparing into PPDP.Finger print image shows there were high similarity between decoction and slices.Conclusion：PPDP and traditional commercial slices of AF shared consistent properties.PPDP apparently improved the extraction rate，the dissolution rate and quality uniformity，and it is recommended to be used in clinical practice.

Key Words Aurantii Fructus; Precise powder decoction pieces; DNA; Fingerprint 中图分类号：R91;R289.5文献标识码：Adoi：10.3969/j.issn.1673-7202.2017.11.057 枳壳为芸香科植物酸橙Citrus aurantium L.及其栽培变种的干燥未成熟果实，具有理气宽中，行滞消胀等功效，可用于胸胁气滞，胀满疼痛，食积不化，痰饮内停，脏器下垂[1]。既往医学研究表明，枳壳有促胃肠动力、抗消化不良、抗氧化、抗菌、消炎、抗抑郁和抗肿瘤作

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用[2-5]。黄酮、生物碱、挥发油是其主要药理活性成分，目前研究普遍以柚皮苷、新橙皮苷的含量来评价枳壳的质量[6-7]。

宋代以前所用枳壳的原植物为芸香科枸橘Poncirus trifoliata Raf.，直至明代原植物主要来源衍变为酸橙及其变种，目前尚有福建、广东等地区至今仍以柑橘属Citrus L.多种植物作为枳壳药用来源。我国各地区的枳壳类药材的基原、分布各不相同，江西清江产的“江枳壳”为枳壳的道地药材，其原植物为酸橙的变种臭橙C.aurantium ‘Xiucheng’，少部分为香橙C.aurantium ‘Xiangcheng’。主流品种“川枳壳”其原植物为酸橙，产量较大的“湘枳壳”原植物是以枸橘为砧木，酸橙为接穗的嫁接品种，称为枳橙C.aurantium×P.trifoliata[8]。

由于酸橙的栽培变种品种繁多，且有枸橘属来源的品种，造成枳壳商品来源复杂混乱，特别是切制成薄片片后大多有混杂。产地与生长的差异化、货源的不稳定性、中药饮片的形态差异等因素，导致枳壳饮片批间、批内质量不均一，直接影响临床用药疗效的稳定。因此需要一种易于鉴定和检测，可经标准化工艺制备、规模化生产、质量均一，以提高临床用药精准性的新型饮片。因此，根据我们前期提出的“精准煮散饮片”的概念与思路方法，将对枳壳煮散饮片进行研究。鉴于中药材化学成分体系的复杂性，我们采用化学指纹图谱表征药材化学组成结合DNA分子鉴定技术，以饮片规格、含量均匀度、指纹图谱与相似度评价、DNA序列比对为考查重点，对煮散体系的合理性及优越性进行综合评价研究。