地龙药材的质量标准提升研究
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篇名: 地龙药材的质量标准提升研究
TITLE:
摘要: 目的:为完善和提高地龙药材的质量标准提供参考。方法:采用高效液相色谱(HPLC)法测定药材样品中次黄嘌呤、肌苷的含量,同时按“中药色谱指纹图谱相似度评价系统”(2012版)软件建立地龙药材的HPLC指纹图谱并进行相似度评价。色谱柱为Purospher STAR RP-18 endcapped;流动相为甲醇-水(梯度洗脱);流速为1 mL/min;检测波长为248 nm;柱温为30 ℃;进样量为20 μL。结果:含量测定方法学考察结果显示,次黄嘌呤、肌苷的检测质量浓度线性范围分别为1.58~31.6 μg/mL(r=0.999 9)、5.52~110.4 μg/mL(r=0.999 8);定量限分别为0.316、0.552 μg/mL;检测限分别为0.158、0.110 μg/mL;精密度、稳定性(24 h)、重复性试验的RSD均小于2.0%(n=6);平均回收率分别为103.0%(RSD=1.7%,n=6)、101.2%(RSD=1.2%,n=6)。成功建立了15批样品的HPLC指纹图谱,共确定了8个共有色谱峰。其中有14批样品的HPLC指纹图谱与对照图谱R的相似度>0.900。结论:建立的次黄嘌呤、肌苷含量测定及地龙药材HPLC指纹图谱方法简便、准确、重复性好,可用于地龙药材的质量控制。
ABSTRACT: OBJECTIVE: To provide reference for improving the quality standard of Pheretima. METHODS: The contents of hypoxanthine and inosine in medicinal material samples were determined by HPLC. HPLC fingerprint of Pheretima was established according to “Similarity evaluation system for TCM chromatogramtic fingerprint” (2012 edition) software, and similarity evaluation was conducted. The determination was performed on Purospher STAR RP-18 endcapped with mobile phase consisted of methanol-water (gradient elution) at the flow rate of 1 mL/min. The detection wavelength was 248 nm, and the column temperature was set at 30 ℃. The sample size was 20 μL. RESULTS: The results of methodological investigation of content determination showed that the linear range of hypoxanthine and inosine were 1.58-31.6 μg/mL (r=0.999 9), 5.52-110.4 μg/mL(r=0.999 8), respectively. limits of quantify were 0.316, 0.552 μg/mL, respectively; limits of detection were 0.158, 0.110 μg/mL, respectively; RSDs of precision, stability (24 h) and repeatability tests were all less than 2.0% (n=6). Average recovery rates were 103.0% (RSD=1.7%, n=6) and 101.2% (RSD=1.2%, n=6), respectively. HPLC fingerprint for 15 batches of samples were established, and 8 common peaks were identified. The similarity of HPLC fingerprint of 14 batches of sample with control fingerprint R was higher than 0.900. CONCLUSIONS: The established method for content determination of hypoxanthine and inosine and HPLC fingerprint of Pheretima are simple, accurate and reproducible, and can be used for quality control of Pheretima.
期刊: 2019年第30卷第17期
作者: 王莎莎,曲悦,薛大权,李兰清,向阳,张宝徽
AUTHORS: WANG Shasha,QU Yue,XUE Daquan,LI Lanqing,XIANG Yang,ZHANG Baohui
关键字: 地龙;次黄嘌呤;肌苷;高效液相色谱法;指纹图谱;质量标准
KEYWORDS: Pheretima; Hypoxanthine; Inosine; HPLC; Fingerprint; Quality standard
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