大接骨丹树皮药材质量标准研究

Quality Standard of the Bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu

目的:参照国家药品标准相关方法,建立大接骨丹树皮[The bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu]的质量标准,为民族药大接骨丹树皮质量控制奠定基础与试验参考。方法:采用薄层色谱法考察大接骨丹树皮药材中紫丁香苷定性鉴别方法,参照现行版《中国药典》(2020年版本第四部)方法,拟定6批次大接骨丹树皮药材中水分含有量、总灰分含有量、浸出物含有量,同时,采用高效液相色谱法测定6批次大接骨丹树皮药材中紫丁香苷含量。结果:建立了大接骨丹树皮药材中紫丁香苷的薄层色谱定性鉴别方法,薄层色谱中紫丁香苷斑点清晰,分离度好,重复性好,可用于大接骨丹树皮药材的定性鉴别与质量控制;大接骨丹树皮药材中紫丁香苷含量测定方法结果显示:紫丁香苷在0.1235~1.2353 mg/mL范围内线性关系良好,相关系数r值为0.9999,紫丁香苷平均加样回收率为102.33%,RSD为2.52%。6批大接骨丹树皮药材水分、总灰分、浸出物含有量分别为8.28%~10.53%,4.84%~7.16%,15.63%~22.45%。结论:建立的大接骨丹树皮药材薄层色谱鉴别、水分含有量、总灰分含有量、浸出物含有量和紫丁香苷含量方法,专属性强,方法稳定可行,可用于大接骨丹树皮的质量控制。

Objective:The quality standard for the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu was established according to the relevant methods of national drug standards,which laid a foundation and experimental reference for the quality control of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu.Methods:The qualitative identification method of syringin in the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu was investigated by thin layer chromatography.According to the current edition of“Chinese Pharmacopoeia”(2020 edition,Part 4),the water content,total ash content and extract content of 6 batches of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu were determined.At the same time,the content of syringin in 6 batches of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu was determined by high performance liquid chromatography.Methods:The thin layer chromatography qualitative identification method of syringin in the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu was established.The spots of syringin in the thin layer chromatography were clear,the separation degree was good,and the repeatability was good,which could be used for the qualitative identification and quality control of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu.The results of the determination method of syringin in the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu showed that the linear relationship of syringin was good in the range of 0.1235~1.2353 mg/mL,and the correlation coefficient R value was 0.9999.The average recovery rate of syringin was 102.33%,and RSD was 2.52%.The contents of moisture,total ash and extract in 6 batches of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu were 8.28%~10.53%,4.84%~7.16% and 15.63%~22.45%,respectively.Conclusion:The established methods for thin layer chromatography identification,water content,total ash content,extract content and syringin content of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu were specific,stable and feasible,and could be used for quality control of the bark of Toricellia Angulata Oliv.var.intermedia(Harms)Hu.