抗高原缺氧药雪莲黄酮胶囊的质量控制标准

Quality Control Standard for Xuelianhuangtong Capsules Against High-altitude Hypoxia

目的建立抗高原缺氧药雪莲黄酮胶囊的质量控制标准。方法采用薄层色谱法定性鉴别雪莲的主要有效成分芦丁和绿原酸;采用紫外分光光度法测定制剂中总黄酮的含量,并采用高效液相色谱法测定其中芦丁的含量,色谱柱为Hypersil ODS2 C18柱（150 mm×4.6 mm,5μm）,流动相为甲醇-水（40：60）,流速：1 ml/min;柱温为室温,检测波长为340 nm。结果薄层定性鉴别的斑点清晰,分离效果良好;总黄酮含量在9.84～59.04μg/ml浓度范围内具有良好的线性关系（r=0.999 7）,平均回收率为99.32%,RSD为1.47%（n=6）;芦丁含量在4～120μg/ml浓度范围内具有良好的线性关系（r=0.9999）,平均加样回收率为97.98%,RSD为1.35%（n=6）。结论本实验简便易行,结果准确可靠,重复性好,可作为该制剂的质量控制方法。

Objective To establish the quality control standard for Xuelianhuangtong capsules against high-alti-tude hypoxia. Methods The Rutin and Chlorogenic Acid were identified by thin layer chromatography （ TLC）;total fla-vonoids content were determined by ultraviolet spectrophotometry （ UV） , and Rutin content was determined by high per-formance liquid chromatography （HPLC）. The Hypersil ODS2 C18（150 mm ＆#215; 4. 6 mm, 5 μm） column was used, and the mobile phase consisted of methanol-water（40∶ 60）, and the flow rate was 1 ml/min; the column temperature was room temperature, and the detection wavelength was at 340 nm. Results The spots in the TLC were clear with good dis-association effect;the good linear relationship was achieved within the range of total flavonoids content of 9. 84μg/ml-59. 04μg/ml （r=0. 9997）, and its average recovery ratio was 99. 32% with 1. 47% of RSD （n=6）;the good linear rela-tionship was achieved within the range of Rutin content of 4-120 μg/ml （r=0. 9999）, and its average recovery of appli-cation of sample was 97. 98% with 1. 35% of RSD （n=6）. Conclusion The method is simple, practical and accurate with good repeatability, so it can be used for the quality control of Xuelianhuangtong capsules.