杞菊地黄口服液的质量标准提高研究
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篇名: 杞菊地黄口服液的质量标准提高研究
TITLE:
摘要: 目的:为完善和提高杞菊地黄口服液的质量标准提供参考。方法:根据2015年版《中国药典》(四部)0502法对杞菊地黄口服液中枸杞子、菊花、牡丹皮进行薄层色谱(TLC)鉴别,分别以枸杞子、菊花和丹皮酚为对照,展开系统分别为三氯甲烷-乙酸乙酯-甲酸(6 ∶ 1 ∶ 0.5,V/V/V)、三氯甲烷-异丙醇-甲酸(10 ∶ 1 ∶ 0.5,V/V/V)和环己烷-乙酸乙酯(3 ∶ 1,V/V);采用高效液相色谱法(HPLC)同时测定杞菊地黄口服液中莫诺苷、马钱苷及丹皮酚的含量[色谱柱为InertSustain C18,流动相为乙腈-0.03%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长分别为240 nm(莫诺苷和马钱苷)和274 nm(丹皮酚),柱温为40 ℃,进样量为10 μL]。结果:在枸杞子、菊花、牡丹皮TLC供试品图谱中,与对照药材/对照品图谱相应的位置上显相同颜色的斑点,且阴性对照无干扰。莫诺苷、马钱苷及丹皮酚检测质量浓度的线性范围分别为2.12~106.17、1.91~95.63、4.78~239.16 μg/mL(R2=0.999 9、0.999 9、0.999 8);定量限分别为2.12、1.91、2.39 μg/mL;检测限分别为0.53、0.48、0.59 μg/mL;精密度、重复性、稳定性试验的RSD均小于2% (n=6);平均回收率分别为98.27%、97.06%、97.65%,RSD分别为0.80%、1.18%、1.36%(n=6);耐用性试验的RSD均小于2%(n=3)。结论:本研究建立的方法操作简便、专属性强、耐用性好,可为完善杞菊地黄口服液的质量标准提供一定参考。
ABSTRACT: OBJECTIVE: To provide reference for perfecting and improving the quality standard of Qiju dihuang oral liquid. METHODS: According to No. 0502 method stated in 2015 edition of Chinese Pharmacopeia (part Ⅳ), TLC method was used to identify the fruit of Chinese wolfberry, Dendranthema morifolium and Paeonia suffruticosa in Qiju dihuang oral liquid. Using the fruit of C. wolfberry, D. morifolium and paeonol as control, the deployment systems were trichloromethane-ethyl acetate-formic acid (6 ∶ 1 ∶ 0.5, V/V/V), trichloromethane-isopropanol-formic acid (10 ∶ 1 ∶ 0.5, V/V/V) and cyclohexane-ethyl acetate (3 ∶ 1, V/V). The contents of morroniside, loganin and paeonol in Qiju dihuang oral liquid were determined by HPLC. The determination was performed on InertSustain C18 column with mobile phase consisted of acetonitrile-0.03% phosphoric acid solution(gradient elution)at the flow rate of 1.0 mL/min. The detection wavelength was set at 240 nm (morroniside and loganin) and 274 nm (paeonol), and the column temperature was 40 ℃. The sample size was 10 μL. RESULES: In TLC of the fruit of C. wolfberry, D. morifolium and P. suffruticosa, same color spots were shown in the corresponding positions of reference substance/control chromatogram without interference from negative control. The linear ranges of morroniside, loganin and paeonol were 2.12-106.17, 1.91-95.63 and 4.78-239.16 μg/mL (R2=0.999 9, 0.999 9, 0.999 8), respectively. The limits of quantitation were 2.12, 1.91, 2.39 μg/mL; the limits of detection were 0.53, 0.48, 0.59 μg/mL, respectively; RSDs of precision, reproducibility and stability tests were lower than 2% (n=6). The average recoveries were 98.27%, 97.06% and 97.65% RSD were 0.80%, 1.18% and 1.36% (n=6). RSDs of durability tests were all lower than 2% (n=3). CONCLUSIONS: The established method is simple, specific and durable, and can provide reference for improving the quality standard of Qiju dihuang oral liquid.
期刊: 2019年第30卷第13期
作者: 周建华,洪挺,张昆艳,杨毅生
AUTHORS: ZHOU Jianhua,HONG Ting,ZHANG Kunyan,YANG Yisheng
关键字: 杞菊地黄口服液;质量标准;提高;薄层色谱法;高效液相色谱法
KEYWORDS: Qiju dihuang oral liquid; Quality control; Improvement; TLC; HPLC
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