蒙药材扁蕾质量标准研究  

Quality Standard of Mongolian Medicina Herb of Gentianopsis Barbata

作　　者：朝鲁门 娜仁图雅 李妍 白妍 韩塔娜 CHAO Lumen;NAREN Tuya;LI Yan;BAI Yan;HAN Tana(Inner Mongolian Institute for Drug Control,Hohhot,Inner Mongolia,China 010010)

机构地区：[1]内蒙古自治区药品检验研究院,内蒙古呼和浩特010010

出　　处：《中国药业》2025年第9期66-70,共5页China Pharmaceuticals

基　　金：国家药品标准提高研究课题[446]。

摘　　要：目的提升扁蕾药材的质量标准。方法从扁蕾的产地及使用地区收集6批药材样品,采用性状鉴别法、显微鉴别法、薄层色谱法进行定性鉴别;根据2020年版《中国药典(四部)》对水分、总灰分、酸不溶性灰分、重金属及有害元素、浸出物含量进行检查;采用高效液相色谱法测定药材样品中齐墩果酸的含量,色谱柱为Agilent Eclipse C_(18)柱(250 mm×4.6 mm,5μm),流动相为甲醇-水-冰乙酸-三乙胺(87∶13∶0.04∶0.02,V/V/V/V),流速为1.0 mL/min,检测波长为210 nm,柱温为30℃,进样量为10μL。结果扁蕾药材的根呈圆柱形,茎呈四棱形,叶对生,花萼呈管状钟形,花冠呈管状皱缩形,蒴果呈狭矩圆形。显微特征明显,含叶表皮细胞、木纤维、花粉粒、纤维管胞。薄层色谱图中斑点显色清晰,分离度好。6批药材样品的水分均不超过5.60%;总灰分均不超过5.59%,酸不溶性灰分均不超过2.72%;铅、镉、砷、汞、铜含量均分别不超过0.70×10^(-6),0.20×10^(-6),0.20×10^(-6),0.05×10^(-6),8×10^(-6);乙醇热浸出物含量均不低于21.45%。齐墩果酸的进样量在0.9790~5.8740μg范围内与峰面积线性关系良好(r=0.9999,n=6);精密度、稳定性、重复性试验结果的RSD均小于2.0%;平均回收率为100.44%,RSD为1.45%(n=6)。6批样品中齐墩果酸的含量分别为16.29,16.82,16.52,12.44,12.06,13.27 mg/g。结论该方法操作简便、专属性强、重复性好、结果准确,可用于扁蕾药材的质量控制。暂订扁蕾药材中水分、总灰分、酸不溶性灰分分别不得过7.0%,6.5%,3.0%,乙醇热浸出物、按干燥品计齐墩果酸含量分别不得少于17.0%,1.1%。Objective To provide a reference for improving the quality standard of Gentianopsis barbata.Methods Six batches of Gentianopsis barbata samples were collected from the origin and usage areas,and qualitative identification was performed by morphological identification,microscopic identification,and thin-layer chromatography(TLC)methods.According to the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the moisture content,total ash content,acid insoluble ash content,heavy metals and harmful elements,and extract content of Gentianopsis barbata were checked.The content of oleanolic acid in samples was determined by the high-performance liquid chromatography(HPLC)method,the chromatographic column was Agilent Eclipse C_(18) column(250 mm×4.6 mm,5µm),the mobile phase was methanol-water-glacial acetic acid-triethylamine(87∶13∶0.04∶0.02,V/V/V/V),the flow rate was 1.0 mL/min,the detection wavelength was 210 nm,the column temperature was 30℃,and the injection volume was 10µL.Results The roots of Gentianopsis barbata were cylindrical,the stems were quadrilateral,the leaves were opposite,the sepals were tubular and bell-shaped,the corollas were tubular and wrinkled,and the capsules were narrow and rectangular in shape.Microscopic features were obvious,including leaf epidermal cells,wood fibers,pollen grains,and fibrous lumens.The TLC spots showed clear color and good separation.In the six batches of samples,the moisture content did not exceed 5.60%,the total ash content did not exceed 5.59%,and the acid insoluble ash content did not exceed 2.72%;the contents of lead,cadmium,arsenic,mercury,and copper were lower than or equal to 0.70×10^(-6),0.20×10^(-6),0.20×10^(-6),0.05×10^(-6),and 8×10^(-6),respectively;the content of ethanol thermal extract did not exceed 21.45%.The linear range of oleanolic acid was 0.9790-5.8740µg(r=0.9999,n=6).The RSDs of precision,stability,and repeatability test results were all lower than 2.0%.The average recovery of oleanolic acid was 100.44%with an RSD of 1.45%(n=6).The content of ole

关 键 词：扁蕾 性状鉴别法 显微鉴别法 薄层色谱法 高效液相色谱法 质量控制 

分 类 号：R932[医药卫生—生药学] R284.1[医药卫生—药学] R286.0