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篇名: | 蒙药益肾散的质量标准研究 |
TITLE: | |
摘要: | 目的:建立蒙药益肾散的质量标准。方法:采用薄层色谱法(TLC)对制剂中大黄、诃子进行定性鉴别;采用高效液相色谱法测定制剂中芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚的含量:色谱柱为 Inertsil C18,流动相为甲醇-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为254 nm,柱温为35 ℃,进样量为10 μL。结果:大黄、诃子的TLC图斑点清晰,分离度好。芦荟大黄素、大黄酸、大黄素、大黄酚、大黄素甲醚检测进样量线性范围分别为23.55~117.75 ng(r=0.999 9)、44.72~223.62 ng(r=0.999 8)、43.18~215.90 ng(r=0.999 7)、77.41~387.12 ng(r=0.999 9)、46.02~230.10 ng(r=0.999 7);精密度、稳定性、重复性试验的RSD<2.0%;加样回收率分别为95.80%~99.66%(RSD=1.21%,n=6)、95.01%~98.07%(RSD=0.92%,n=6)、95.06%~97.84%(RSD=0.50%,n=6)、95.19%~97.66%(RSD=1.07%,n=6)、95.07%~98.20%(RSD=0.95%,n=6)。结论:该研究所建标准可用于蒙药益肾散的质量控制。 |
ABSTRACT: | OBJECTIVE: To establish the quality standard for Mongolian medicine Yishen powder. METHODS: TLC was used for the qualitative identification of Rheum palmatum and Terminalia chebula in the preparation; HPLC was used for the contents determination of aloe emodin, rhein, emodin, chrysophanol and physcion: the column was Inertsil C18 with mobile phase of methanol-0.1% phosphoric acid (gradient elution) at a flow rate of 1.0 mL/min, detection wavelength was 254 nm, column temperature was 35 ℃ and the injection volume was 10 μL. RESULTS: The TLC pots of R. palmatum and T. chebula were clear and well-separated, negative control without interference. The linear range was 23.55-117.75 ng for aloe emodin(r=0.999 9), 44.72-223.62 ng for rhein(r=0.999 8), 43.18-215.90 ng for emodin(r=0.999 7),77.41-387.12 ng for chrysophanol (r=0.999 9) and 46.02-230.10 ng for physcion (r=0.999 7); RSDs of precision, stability and reproducibility tests were lower than 2.0%; recoveries were 95.80%-99.66%(RSD=1.21%,n=6), 95.01%-98.07%(RSD=0.92%,n=6),95.06%-97.84%(RSD=0.5%,n=6),95.19%- 97.66%(RSD=1.07%,n=6) and 95.07%-98.20%(RSD=0.95%,n=6). CONCLUSIONS: The established standard can be used for the quality control of Mongolian medicine Yishen powder. |
期刊: | 2017年第28卷第6期 |
作者: | 王美丽,海祺山,戴丽丽,田香,白玉霞 |
AUTHORS: | WANG Meili,HAI Qishan,DAI Lili,TIAN Xiang,BAI Yuxia |
关键字: | 蒙药益肾散;薄层色谱法;高效液相色谱法;含量测定 |
KEYWORDS: | Mongolian medicine Yishen powder; TLC; HPLC; Content determination |
阅读数: | 350 次 |
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