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

作　　者：王楠 任洁 林春燕 付兴情 董媛 张雯洁 Wang Nan;Ren Jie;Lin Chunyan;Fu Xingqing;Dong Yuan;Zhang Wenjie(Yunnan Institute for Food and Drug Control,Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform,Kunming 650106,China)

机构地区：[1]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

出　　处：《中国药事》2024年第8期927-933,共7页Chinese Pharmaceutical Affairs

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 C_(18)(4.6 mm×250 mm,5μm)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。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:Microscopic identification method was used to screen the specific microscopic features of the preparation.The limit test of yunaconitine in Aconiti Vilmoriniani Radix was determined by HPLC.The column was Eclipse Plus C_(18)(4.6 mm×250 mm,5μm),and the mobile phase was methanol-buffered salt solution(water-triethylamine-phosphoric acid was 600:2:1)(40:60)at the flow rate of 1.0 mL·min^(-1).The detection wavelength was 260 nm and the column temperature was 30℃.Results:The stone cell characteristics of Aconiti Vilmoriniani Radix had a strong specificity.Determined by HPLC,the injection volume of Yunaconitine showed a good linear relationship in the range of 12.24-367.18 ng(r>0.9998);the average recovery was 93.2%with RSD of 1.96%(n=6).The amount 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 test method of yunaconitine is good,which can provide a basis for the control of Aconiti Vilmoriniani Radix in the compound preparation of Yunnan Hongyao capsules.

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 

分 类 号：R917[医药卫生—药物分析学]