咳清胶囊的质量标准提高研究
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篇名: 咳清胶囊的质量标准提高研究
TITLE: Study on the Improvement of Quality Standard for Keqing Capsules
摘要: 目的:完善和提高咳清胶囊的质量标准。方法:根据2015年版《中国药典》(四部)通则0502法对咳清胶囊中吉祥草、桑白皮进行薄层色谱(TLC)鉴别[展开剂分别为二氯甲烷-乙酸乙酯-甲酸(10∶4∶0.2,V/V/V)、乙酸乙酯-甲醇-浓氨试液(12∶2∶1,V/V/V)];采用高效液相色谱法(HPLC)同时测定咳清胶囊中吗啡、磷酸可待因的含量[色谱柱为XBridgeC18,流动相为乙腈-0.01mol/L磷酸二氢钾水溶液(以5%磷酸溶液调节pH至2.7)(5∶95,V/V),流速为1.0mL/min,检测波长为210nm,柱温为35℃,进样量为10µL]。结果:在吉祥草、桑白皮供试品TLC图谱中,与对照药材图谱相应的位置上显相同颜色的斑点,且阴性对照无干扰。吗啡、磷酸可待因检测进样量的线性范围分别为0.30156~2.11090、0.06493~0.45452µg(r=0.9999、0.9999),检测限分别为0.00010、0.00128µg,定量限分别为0.00034、0.0425µg,精密度、稳定性(12h)、重复性、耐用性试验的RSD均小于3%(n=6),平均加样回收率分别为96.18%、95.95%(RSD=1.78%、2.07%,n=6)。18批咳清胶囊样品中吗啡、磷酸可待因的含量范围分别为0.97~1.37、0.16~0.37mg/g。结论:本研究建立了咳清胶囊吉祥草、桑白皮的TLC鉴别方法以及吗啡、磷酸可待因的HPLC含量测定方法,操作简便、准确可靠、专属性强,提升和完善了该制剂的质量标准。
ABSTRACT: OBJECTIVE:To optimi ze and improve the quality standard for Keqing capsules. METHODS :According to general rule 0502 method stated in 2015 edition of Chinese Pharmacopeia (part Ⅳ),TLC method was used to identify Reineckia carnea and Morus alba in Keqing capsules [the developing solvents were dichloromethane-ethyl acetate-formic acid (10 ∶ 4 ∶ 0.2,V/V/V) and ethyl acetate-carbinol-ammonia (12 ∶ 2 ∶ 1,V/V/V),respectively]. The contents of morphine and codeine phosphate in Keqing capsules were determined by HPLC. The determination was performed on XBridge C 18 column with mobile phase consisted of acetonitrile-0.01 mol/L potassium dihydrogen phosphate aqueous solution (pH value adjusted to 2.7 with 5% phosphoric acid solution)(5 ∶ 95,V/V)at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm,and the column temperature was 35 ℃. The sample size was 10 µL. RESULTS :In TLC of R. carnea and M. alba in samples ,same color spots were shown in the correspon ding positions of reference substance chromatogram without interference from negative control. The linear range of morphine and codeine phosphate were batches of Keqing capsules were 0.97-1.37,0.16-0.37 mg/g,respectively. CONCLUSIONS :TLC identification method for R. carnea and M. alba ,as well as HPLC content determination method for morphine and codeine phosphate in Keqing capsules are established;the method is simple ,accurate and reliable with strong specificity ,which improves the quality standard of Keqing capsules.
期刊: 2020年第31卷第05期
作者: 刘学,邱红燕,彭静,刘春艳,曲书阅,马莹,许乾丽,沈祥春,陶玲,茅向军
AUTHORS: LIU Xue,QIU Hongyan, PENG Jing,LIU Chunyan,QU Shuyue,MA Ying,XU Qianli,SHEN Xiangchun,TAO Ling,MAO Xiangjun
关键字: 咳清胶囊;质量标准;吗啡;磷酸可待因;薄层色谱法;高效液相色谱法
KEYWORDS: Keqing capsules ;Quality standard ;Morphine;Codeine phosphate ;TLC;HPLC
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