小儿积散的质量标准研究  

The Quality Specification Research of Xiaoerji Powder

作　　者：王朝山 盛平 陈静梅[2] 张炎才 翁立冬[2] 

机构地区：[1]广州三九脑科医院药剂科,广州510515 [2]广州南方医科大学中医药学院,广州510515

出　　处：《山东化工》2015年第16期103-107,共5页Shandong Chemical Industry

摘　　要：目的：建立小儿积散的质量控制标准方法。方法：采用薄层色谱法对制剂中槟榔、木香、甘草和石榴皮进行定性鉴别;以使君子中胡芦巴碱的含量为指标,采用高效液相色谱法测定方中胡芦巴碱的含量,色谱柱：Agilent zorbax NH2柱,250mm×4.6mm 5μm;流动相：乙腈-水（80：20）,流速1m L/min,柱温30℃,检测波长265nm。结果：定性鉴别中检出石榴皮、槟榔、木香、甘草,薄层斑点清晰,且分离度好、专属性强,阴性对照无干扰;胡芦巴碱含量在0.16～0.80μg范围内与峰面积呈良好的线性关系y=0.0008x＋0.0004（r=1）;测得平均回收率为99.2%,RSD为0.73%（n=6）,每1g样品中含胡芦巴碱0.2308mg。结论：所建立的质量控制方法准确、可靠、专属性强,可以用于小儿积散的质量控制。To establish the quality standards of Xiaoerji Powder. Methods： With each other by thin -layer chromatography of Periearpium Granati, Semen Arecae, Radix Aucklandiae and Radix et Rhizoma Glycyrrhizae for qualitative identification. Take contents of Trigonelline as index, make quantitative analysis and technology investigation with high efficieney liquid chromatography. The HPLC system consisted of Agilent zorbax NH2 （250mm×4.6mm 5μm;）, acetonitrile -water （80：20） as the mobile phase and the flow rate was lmL/min, the column temperature was 30℃, and the detection wavelenth was 265nm. Results： Pericarpium Granati, Semen Arecae, Radix Aucklandiae and Radix et Rhizoma Glycyrrhizae were identified by thin layer chromatography. The characteristic identification was distinct and highly specific. Trigonelline in 0. 16 ～0.80μg scope with the peak area showed a good linear relationship between y =0. 0008x ＋ 0. 0004 （ r = 1 ） ; the average recovery was 99.2%, RSD was 0.73% （ n = 6）, each g sample ambiguous trigonelline 0.2308mg. Conclusion：The quality control method is reliable, accurate and specific. It can be used for quality control of Xiaoerji Powder.

关 键 词：小儿积散 质量标准 薄层色谱法 高效液相色谱法 胡芦巴碱 

分 类 号：R284.1[医药卫生—中药学]