化橘红药典标准的修改建议及其等级标准的建立

Suggestions for the quality standard in Chinese pharmacopoeia of Citri Grandis Exocarpium and the establishment of its grade standard

针对现行《中国药典》化橘红标准中基原混乱、实际使用的药用部位与规定不符等问题,经过大量的文献考证、市场调研及实验研究,提出了化橘红药典标准合理的修改建议。化橘红最初植物来源为化州柚,柚是化州柚匮乏时期出现的替代品,二者化学成分的种类和含量均有较大差异,有必要加以区分,建议将化州柚作为化橘红的唯一基原。化橘红在实际使用中,药用部位逐渐由外层果皮演变为幼果,二者化学组成相同且幼果有效成分含量更高,因此建议:化橘红应增加幼果这一药用部位。此外,还建立了化橘红等级标准,可以区分药材基原、评价质量优劣。研究为完善化橘红质量标准提供了依据,并将规范化橘红市场流通,促进化橘红资源合理利用,加速化橘红进入国际市场。

This study is aimed to address the main deficiencies in the quality standard of Citri Grandis Exocarpium(CGE)in current Chinese Pharmacopoeia,including the confusion of the plant origins and the inconsistency between the actual and the specified medicinal parts.Based on large amounts of historical evolution studies,market researches and testing results,several suggestions were proposed as follows:Citrus grandis‘Tomentosa’(CGT)was the original plant source of CGE while Citrus grandis(L.)Osbeck(CGO)was used as a substitute when shortage of CGT resources.However,there were great differences between the chemical compositions and contents of CGT and CGO,and thus it is necessary to make them distinguished.We suggested that CGT should be used as the only plant origin of CGE.Meanwhile,the medicinal parts of CGE gradually transformed from the epicarp to immature fruit during the practical process,the immature fruit had the same chemical compositions with epicarp and higher contents of the active components.So we suggested supplementing the medicinal parts of CGE with immature fruit.Furthermore,we established the grade standard of CGE,which could be applied to distinguish the plant origins and evaluate the quality grades.In conclusion,this study provides suggestions for the improvement of the quality standard of CGE,which is of great significance for standardizing its marketing activities,promoting the rational use of plant resources and accelerating CGE into the international market.