| 高妍,康帅,何风艳,宋平顺,邹雪梅,戴忠,马双成.铁丝威灵仙药材、饮片及其制剂心脑静片掺伪威灵仙的检测方法研究[J].中国药事,2023,(1):59-65 |
| 铁丝威灵仙药材、饮片及其制剂心脑静片掺伪威灵仙的检测方法研究 |
| Study on the Detection Method of Adulterant Clematidis Radix et Rhizoma in Smilacis Radix et Rhizoma Crude Drugs, Decoction Pieces and Preparation Xinnaojing Tablets |
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| DOI：10.16153/j.1002-7777.2023.01.007 |
| 中文关键词: 铁丝威灵仙 掺伪鉴别 威灵仙 齐墩果酸 心脑静片 高效液相色谱法 |
| 英文关键词: Smilacis Radix et Rhizoma adulteration detection Clematidis Radix et Rhizoma oleanolic acid Xinnaojing tablets high performance liquid chromatography |
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| 中文摘要: |
| 目的：建立铁丝威灵仙掺伪威灵仙的鉴别分析方法，为铁丝威灵仙药材、饮片及其制剂心脑静片的质量监管提供技术支持。方法：样品前处理方法为水提-酸水解法，以威灵仙的专属性水解成分齐墩果酸作为鉴别指标，采用高效液相色谱法，选择Waters XbridgeTM C18(250 mm×4.6 mm，5 μm)色谱柱，流动相为乙腈(A)-水(B)，梯度洗脱，流速1 mL·min-1，柱温30 ℃，检测波长205 nm，进样量10 μL。结果：本研究建立的铁丝威灵仙药材、饮片及其制剂心脑静片掺伪鉴别方法，经验证，阴性无干扰，齐墩果酸检测限为1.96 μg·mL-1。共测定7批铁丝威灵仙饮片，14批心脑静片制剂，发现1批饮片掺伪，心脑静片样品未发现掺伪现象。结论：所建立的方法准确、快速、通用性强，可有效鉴别铁丝威灵仙药材、饮片及其制剂心脑静片中掺伪威灵仙的问题，并为含铁丝威灵仙的其他相关制剂掺伪鉴别方法的建立提供参考。 |
| 英文摘要: |
| Objective: To establish a method for the identifi cation and analysis of Smilacis Radix et Rhizoma mixed with adulterant Clematidis Radix et Rhizoma, which could provide technical support for the quality control of its crude drugs, decoction pieces and preparation Xinnaojing tablets. Methods: Water extraction combined with acid hydrolysis was used as the sample pretreatment method. Oleanolic acid, which was identified as an exclusive hydrolyzed ingredient of Clematidis Radix et Rhizoma, was used as the identification index. HPLC (high performance liquid chromatography) was used gradiently eluted with acetonitrile(A)-water(B) as the mobile phase at the flow rate of 1 mL·min-1. Waters XbridgeTM C18 (250 mm×4.6 mm, 5 μm) was chosen as column, and the column temperature was 30 ℃. The detection wavelength was 205 nm. The sample size was 10 μL. Results: In this study, the established method for adulteration identifi cation of Smilacis Radix et Rhizoma crude drugs, decoction pieces and preparation Xinnaojing tablets was validated. The negative control sample showed no interference. The detection limit of oleanolic acid was 1.96 μg·mL-1. A total of 7 batches of Smilacis Radix et Rhizoma decoction pieces samples were tested, among which one batch was found mixed with adulterant. By testing 14 batches of Xinnaojing Tablets, no adulteration was found. Conclusion: The established method was accurate, fast and highly applicable on eff ectively identifi cation of Smilacis Radix et Rhizoma mixed with adulterant Clematidis Radix et Rhizoma of its crude drugs, decoction pieces and preparation Xinnaojing tablets, which could also provide a reference for adulteration identification methods for other related preparations containing the Smilacis Radix et Rhizoma. |
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