乌黄骨外散的质量标准提高研究  

Quality Standard Improvement for Wuhuang Guwai Powder

作　　者：孙毅东[1] 张美容[2] 詹亚坤[1] 张慧[1] 曾祥仲[1] 陈宝婷[1] 张素方 林爱华[1] SUN Yidong;ZHANG Meirong;ZHAN Yakun;ZHANG Hui;ZENG Xiangzhong;CHEN Baoting;ZHANG Sufang;LIN Aihua(Dept.of Pharmacy,Zhuhai Hospital of Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangdong Zhuhai 519015,China;Dept.of Pharmacy,the Fifth Affiliated Hospital of Sun Yat-Sen University,Guangdong Zhuhai 519000,China)

机构地区：[1]广东省中医院珠海医院药剂科,广东珠海519015 [2]中山大学附属第五医院药学部,广东珠海519000

出　　处：《中国医院用药评价与分析》2021年第11期1313-1316,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：广东省中医药局中医药科研项目(No.20202173)。

摘　　要：目的:提高乌黄骨外散的质量标准。方法:在现有质量标准的基础上,建立白芷、大黄的薄层色谱鉴定方法;建立乌头碱、次乌头碱含量测定的高效液相色谱法,色谱柱选用十八烷基硅烷键合硅胶色谱柱(Merck Purospher STAR RP-18 endcapped,250 mm×4.6 mm,5μm),柱温为30℃,流速为0.8 ml/min。结果:大黄、白芷的薄层色谱斑点显色清晰,分离度好,阴性对照无干扰;乌头碱在1.00~6.00μg/ml(r=0.9998)范围内线性良好,次乌头碱在15~90μg/ml(r=0.9999)范围内线性良好,回收率分别为98.83%、99.87%,RSD分别为2.06%、2.63%。结论:该方法操作简便、准确可靠、重复性好,可用于乌黄骨外散的质量控制。OBJECTIVE:To improve the quality standard of Wuhuang Guwai powder.METHODS:Based on the previous quality standard,TLC identification method was established for radix angelicae dahuricae and radix et rhizoma rhei.HPLC method was established for content determination of aconitine and hypaconitine.The column was octadecylsilane chemically bonded silica gel column(Merck Purospher STAR RP-18 endcapped,250 mm×4.6 mm,5μm)at the flow rate of 0.8 ml/min,the column temperature was 30℃.RESULTS:The TLC spots of radix angelicae dahuricae and radix et rhizoma rhei were clear and well separated without negative interference.The linearity was good in the range from 1.00 to 6.00μg/ml(r=0.9998)for aconitine and from 15 to 90μg/ml(r=0.9999)for hypaconitine,with the recovery of 98.83%and 99.87%and the RSD of 2.06%and 2.63%,respectively.CONCLUSIONS:The method is simple,accurate,reliable and repeatable,which can be used for the quality evaluation of the Wuhuang Guwai powder.

关 键 词：乌黄骨外散 乌头碱 次乌头碱 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学] R932