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目的:建立藏药十味诃子丸的质量控制方法。方法:采用显微鉴别和薄层色谱法进行定性鉴别,采用HPLC法测定羟基红花黄色素A和没食子酸的含量。结果:通过显微可鉴别出红花和诃子;TLC法可鉴别出诃子、红花、山矾叶、紫草茸、獐牙菜和藏茜草及其活性成分的特征斑点;羟基红花黄色素A回归方程为Y=2.526 3×106X-1.1957×104(r=0.999 7)线性范围0.013 6~0.271 7μg;没食子酸方程Y=3.052 9×106X-9.392×103(r=0.999 7),线性范围0.157 9~0.947 5μg;平均回收率分别为99.9%,99.1%;RSD分别为2.2%,1.6%(n=6)。结论:建立的方法可全面控制十味诃子丸的质量,鉴别方法专属性强,定量方法准确,可有效控制该制剂的质量。
Objective: To establish a quality control method of Tibetan medicine Shiwei Myrobalan pill. Methods: Qualitative identification was carried out by micro-identification and TLC. The contents of hydroxysafflor yellow A and gallic acid were determined by HPLC. Results: The safflower and myrobalan were identified by microscopy. The TLC spots showed the characteristic spots of Myrobalan, safflower, Syzygium, Persimmon, Swertia and Tibetan madder and their active ingredients; The regression equation of yellow pigment A was Y = 2.526 3 × 106X-1.1957 × 104 (r = 0.999 7) and the linear range was 0.013 6 ~ 0.271 7μg. The equation of gallic acid was 3.052 9 × 106X-9.392 × 103 (r = 0.999 7) The linear range was from 0.157 9 to 0.947 5 μg. The average recoveries were 99.9% and 99.1%, respectively. The RSDs were 2.2% and 1.6%, respectively (n = 6). Conclusion: The established method can fully control the quality of Shiwei Myrobalan Pill. The identification method has strong specificity and accurate quantitative method, which can effectively control the quality of the preparation.