川木香有效部位质量标准研究

Study on quality standard of the effective part of Chuanmuxiang

目的:分析市售川木香提取物质量评价情况,建立川木香总内酯有效部位的质量标准。方法:通过调查市售川木香提取物,分析总结质量标准现状。实验采用薄层色谱鉴别法(TLC)对川木香总内酯有效部位进行定性鉴别,采用2020年版《中国药典》(四部)的方法检查其干燥失重和总灰分,并利用高效液相色谱法(HPLC)对其有效成分(木香烃内酯、去氢木香内酯)进行含量测定。结果:市售川木香提取物存在含量标准不明确、质控项目较少的问题,亟待进一步完善质量标准。本实验所建立的川木香总内酯有效部位的薄层色谱专属性强、斑点清晰、分离度好;理化性质检查中干燥失重不超过0.50%,总灰分不超过0.20%;含量测定中,木香烃内酯(COS)和去氢木香内酯(DEH)的总量均值为72.01%,大于50%。结论:所建立的质量研究方法简便易行、结果可靠,重现性好,可用于川木香总内酯有效部位的质量控制与评价。

Objective:To analyze the quality evaluation of the extracts of Chuanmuxiang on the market and establish the quality standard for the effective part of total lactones in Chuanmuxiang.Method:By the investigation of the extracts of Chuanmuxiang on the market,the current situation of the quality standard was analyzed and summarized.Thin-layer chromatography(TLC)was used to qualitatively identify the effective part of total lactones in Chuanmuxiang,and its loss on drying and total ash content were checked by the methods recorded in 2020 edition of Chinese Pharmacopoeia(Part IV).The contents of its effective components(Costunolide(COS)and Dehydrocostuslactone(DEH))were detected by high performance liquid chromatography(HPLC).Result:There were some problems such as unclear content standard and few quality control items of the extracts of Chuanmuxiang on the market,so it was urgent to further improve the quality standard.The TLC of the effective part of total lactones in Chuanmuxiang established in this experiment had strong specificity,clear spots and good separation.In the physical and chemical property inspection,the loss on drying was not more than 0.50%,and the total ash content was not more than 0.20%.In the content determination,the average of COS and DEH contents was 72.02%,more than 50%.Conclusion:The established quality research method is simple,reliable and reproducible,and can be used for the quality control and evaluation of the effective part of total lactones in Chuanmuxiang.