蒙药材博格日乐吉根的质量标准研究

Study on Quality Standard for Mongolian Medicinal Materials of Ramulus Rubis

关键词:  蒙药材  博格日乐吉根  质量标准  显微鉴别  薄层色谱法  高效液相色谱法

Key words:  Mongolian medicine  Ramulus Rubis  quality standard  microscopic identification  TLC  HPLC

摘要:

目的 建立蒙药材博格日乐吉根的质量标准，提高其质量控制水平。方法 以收集的8批博格日乐吉根药材为研究对象，对其进行外观性状考察；采用显微鉴别和薄层色谱（thin-layer chromatography，TLC）等方法，对显微结构和化学成分进行鉴别；采用HPLC测定药材中指标性成分的含量；根据中国药典2015年版（四部）相关方法对其进行一般检查项研究。结果 对药材外观性状及显微结构特征进行了描述，TLC法鉴别结果显示8批药材与各对照品在相同位置上显相同颜色的斑点。咖啡酸、表儿茶素和鞣花酸分别在0.864~43.20，7.390~369.5，7.800~78.00 μg·mL^-1内线性关系良好。仪器精密度、重复性、稳定性试验的RSD均<3%，平均回收率分别为98.69%，101.2%和103.6%。根据实验结果，暂定药材中咖啡酸不得<0.025 1 mg·g^-1，表儿茶素不得<0.420 6 mg·g^-1，鞣花酸不得<0.368 0 mg·g^-1，水分不得>13.6%，总灰分不得>4.3%，乙醇浸出物不应<2.9%。结论 该研究可为博格日乐吉根药材质量标准的制定提供实验依据。

Abstract:

OBJECTIVE To establish the quality standard for Mongolian medicine of Ramulus Rubis, and improve its quality control level. METHODS Staking the 8 batches of medicinal materials as the research object, the appearance characteristics were investigated; the microstructure and chemical composition were identified by means of micro-identification and thin-layer chromatography(TLC); the indicator components in medicinal components were analyzed by HPLC; and the general examination items was studied with reference to the appendix of the 2015 edition of People's Republic of China Pharmacopoeia (Part 4). RESULTS The character and microstructure of Ramulus Rubis were described. TLC identification results showed that 8 batches of medicinal materials showing the same color spots were in the corresponding position with reference substance. Caffeic acid, epicatechin and ellagic acid exhibited good linear relationships within the ranges of 0.864-43.20, 7.390-369.5, 7.800-78.00 μg·mL^-1, respectively. RSDs of instrument precision, repeatability, and stability tests were <3%, and the average recoveries were 98.69%, 101.2%, and 103.6%, respectively. According to the experiment results, caffeic acid, epicatechin, ellagic acid should not be <0.025 1, 0.420 6, 0.368 0 mg·g^-1, respectively. Moisture and total ash should not >13.6% and 4.25%, and ethanol extracts should not <2.90%. CONCLUSION This study can provide an experimental basis for the establishment of the quality standard of Ramulus Rubis.