胆木叶药材的质量标准研究  

Study on Quality Standard for the Leaves of Nauclea officinalis

作　　者：张小强[1,2] 吴云[1,2] 杨一帆[1,2] 王振中[1,2] 丁岗[1,2] 

机构地区：[1]江苏康缘药业股份有限公司,江苏连云港222001 [2]中药制药过程新技术国家重点实验室,江苏连云港222001

出　　处：《中国药房》2017年第15期2097-2100,共4页China Pharmacy

基　　金："重大新药创制"科技重大专项(No.2013ZX09402203)

摘　　要：目的:建立胆木叶药材的质量标准。方法:采用显微鉴别法和薄层色谱法(TLC)对药材进行定性鉴别;测定药材水分、灰分;采用高效液相色谱法测定药材中异长春花苷内酰胺含量:色谱柱为Lichrospher C18,流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1 mL/min,检测波长为226 nm,柱温为30℃,进样量为10μL。结果:胆木叶的显微鉴别特征性强,TLC图斑点清晰,分离度好,阴性对照无干扰。异长春花苷内酰胺检测质量浓度线性范围为0.010 5~0.21 mg/mL(r=0.999 5);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率为96.25%~101.82%(RSD=1.86%,n=9)。测得药材样品总灰分为5.27%~6.44%,酸不溶性灰分为0.23%~0.36%,水分为9.48%~11.46%,异长春花苷内酰胺含量为0.124%~1.003%。结论:该研究所建标准可用于胆木叶药材的质量控制。OBJECTIVE： To establish the quality standard for the leaves of Nauclea officinalis. METHODS： Microscopic identi- fication and TLC methods were used for qualitative identification of N. officinalis. The moisture and ash of medicinal materials were determined. HPLC method was adopted to determine the content of strictosamide in medicinal materials. The determination was per- formed on Lichrospher C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution （gradient elution） at the flow rate of 1 mL/min, injection volume was 10 ~tL. The detection wavelength was set at 226 nm, and the column temperature was 30 ~C. RESULTS： Microscopic identification of the leaves of N. officinalis had strong characteristics, and TLC sports were clear and well-separated without interference from negative control. The linear range of strictosamide were 0.010 5-0.22 mg/mL（r=- 0.999 5）; RSDs of precision, stability and reproducibility tests were all lower than 2.0%. Average recoveries were 96.25-101.82% （RSD=1.86%, n=9）. Total ash of medicinal materials was 5.27%-6.44%, acid insoluble ash was 0.23%-0.36% ,water content was 9.48%-11.46%, strictosamide was 0.124%-1.003%. CONCLUSIONS： Established standard can be used for quality evaluation ofN. officinalis.

关 键 词：胆木叶 质量标准 显微鉴别法 薄层色谱法 含量测定 高效液相色谱法 

分 类 号：R927[医药卫生—药学]