复方桔梗止咳片的质量标准研究
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篇名: 复方桔梗止咳片的质量标准研究
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摘要: 目 的:建立复方桔梗止咳片的质量标准。方法:采用薄层色谱法(TLC)对复方桔梗止咳片中桔梗、远志、甘草进行定性鉴别;采用高效液相色谱法-蒸发光散射检测法测定复方桔梗止咳片中桔梗皂苷D的含量。色谱柱为Agilent C18,流动相为乙腈-水(26 ∶ 74,V/V),流速为1.0 mL/min,检测器为蒸发光散射检测器,漂移管温度为105 ℃,载气流速为3.0 L/min,柱温为35 ℃。结果:桔梗、远志、甘草的TLC图谱中斑点清晰,分离度好,阴性对照未见相同斑点。桔梗皂苷D的进样量线性范围为0.421 9~5.062 8 μg(r=0.999 9);定量限、检测限分别为0.364、0.109 μg;精密度、稳定性、重复性、耐用性试验的RSD均小于3.0%;加样回收率为87.32%~91.96%(RSD=1.73%,n=6)。178批样品中,桔梗皂苷D的含量为0.004~0.73 mg/片,有55批(30.9%)样品中桔梗皂苷D含量低于本研究拟定的含量限度(0.10 mg/片)。结论:所建质量标准方法准确、可靠,可用于复方桔梗止咳片的质量控制。
ABSTRACT: OBJECTIVE: To establish the quality standard of Compound Platycodon grandiflorum antitussive tablets. METHODS: TLC was used to identify the P. grandiflorum, Polygala tenuifolia and Glycyrrhiza uralensis qualitatively in Compound P. grandiflorum antitussive tablets. HPLC-ELSD method was used to measure the content of platycodin D in Compound P. grandiflorum antitussive tablets. The determination was performed on Agilent C18 column with mobile phase consisted of acetonitrile-water (26 ∶ 74, V/V) at the flow rate of 1.0 mL/min. ELSD was used with drift tube temperature of 105 ℃, gas flow rate of 3.0 L/min and column temperature at 35 ℃. RESULTS: TLC chromatograms of P. grandiflorum, P. tenuifolia and G. uralensis had clear spots with good separation and no same spot from negative samples. The linear range of platycodin D was 0.421 9- 5.062 8 μg (r=0.999 9). The quantitative limit and detection limit were 0.364, 0.109 μg, respectively. RSDs of precision, stability, reproducibility and durability tests were all lower than 3.0%. The recovery rates were 87.32%-91.96% (RSD=1.73%,n=6). The platycodin D contents of 178 samples ranged from 0.004 to 0.73 mg/tablet. The content of platycodin D in 55 batches (30.9%) of samples was lower than the content limit (0.10 mg/tablet) proposed in this study. CONCLUSIONS: Established method is accurate and reliable, and can be used for the quality control of Compound P. grandiflorum antitussive tablets.
期刊: 2019年第30卷第22期
作者: 杨超,邓晓鸿,周娟
AUTHORS: YANG Chao,DENG Xiaohong,ZHOU Juan
关键字: 复方桔梗止咳片;桔梗;远志;甘草;质量标准;薄层色谱法;高效液相色谱法-蒸发光散射检测法;桔梗皂苷D;含量测定
KEYWORDS: Compound Platycodon grandiflorum antitussive tablets; Platycodon grandiflorum; Polygala tenuifolia; Glycyrrhiza uralensis; Quality standard; TLC; HPLC-ELSD; Platycodin D; Content determination
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