文章摘要
王楠,任洁,林春燕,付兴情,董媛,张雯洁.彝药云南红药胶囊中毒性药味制黄草乌的质量控制研究[J].中国药事,2024,38(8):927-933
彝药云南红药胶囊中毒性药味制黄草乌的质量控制研究
Quality Control of Aconiti Vilmoriniani Radix with Toxic Herbs of Ethnic Yi Herbal Medicine Yunnan Hongyao Capsules
投稿时间：2023-10-19  
DOI：10.16153/j.1002-7777.20230882
中文关键词: 云南红药胶囊  黄草乌  显微鉴别法  高效液相色谱法  滇乌碱
英文关键词: Yunnan Hongyao capsules  Aconiti Vilmoriniani Radix  microscopic identification method  HPLC  yunaconitine
基金项目:
作者单位
王楠 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
任洁 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
林春燕 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
付兴情 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
董媛 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
张雯洁 云南省食品药品监督检验研究院，工业和信息化部产业技术基础公共服务平台，昆明 650106 
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中文摘要:
      目的：探索云南红药胶囊中毒性药味制黄草乌的质量控制方法，为制定质量标准提供依据。方法：采用显微鉴别方法筛选制剂中具专属性的显微特征，采用HPLC法对制黄草乌中滇乌碱进行限量检查。使用Eclipse Plus C18 （4.6 mm×250 mm，5 μm）色谱柱，以甲醇-缓冲盐溶液（水-三乙胺-磷酸比例为600∶2∶1）（40∶60）为流动相，流速1.0 mL·min-1，检测波长260 nm，柱温30 ℃。结果：制黄草乌的石细胞特征具较强专属性。HPLC法测定时，滇乌碱进样量在12.24~367.18 ng范围内呈良好线性关系（r＞0.9998），平均回收率为93.2%，RSD=1.96%（n=6）。15批次样品中滇乌碱的量均小于拟定限度。结论：石细胞特征可用于鉴别制黄草乌，滇乌碱限量检查方法分离效果好，可为复方制剂云南红药胶囊中制黄草乌的控制提供依据。
英文摘要:
      Objective: To explore the quality control method of Aconiti Vilmoriniani Radix with toxic herbs of Yunnan Hongyao Capsules, and to provide a basis for the formulation of quality standards. Methods: Microscopicidentification method was used to screen the specific microscopic features of the preparation. The limit test ofyunaconitine in Aconiti Vilmoriniani Radix was determined by HPLC. The column was Eclipse Plus C18 (4.6mm×250 mm, 5 μm), and the mobile phase was methanol-buffered salt solution (water-triethylamine-phosphoricacid was 600∶2∶1) (40∶60) at the flow rate of 1.0 mLmin-1. The detection wavelength was 260 nm andthe column temperature was 30 ℃. Results: The stone cell characteristics of Aconiti Vilmoriniani Radix had astrong specificity. Determined by HPLC, the injection volume of Yunaconitine showed a good linear relationshipin the range of 12.24-367.18 ng (r＞0.9998); the average recovery was 93.2% with RSD of 1.96% (n=6).Theamount of yunaconitine in 15 batches of samples was lower than the proposed limit. Conclusion: The stone cell characteristics can be used to identify Aconiti Vilmoriniani Radix, and the separation effect of the limit testmethod of yunaconitine is good, which can provide a basis for the control of Aconiti Vilmoriniani Radix in thecompound preparation of Yunnan Hongyao capsules.
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