健脾益肾颗粒的质量标准改进研究  

Improvement in quality standard for Jianpi Yishen granules

作　　者：贾林 曾宏亮 贾昀涛 杨汉初 邓相稳 刘建存 JIA Lin;ZENG Hong-liang;JIA Yun-tao;YANG Han-chu;DENG Xiang-wen;LIU Jian-cun(Hunan New Leading Testing Detection Technology Corporation,Changsha 410000;Institute of Chinese Materia Medica,Hunan Academy of Traditional Chinese Medicine,Changsha 410013;Hunan Dekang Pharmaceutical Co.,Ltd.,Changsha 410205)

机构地区：[1]湖南新领航检测技术有限公司,长沙410000 [2]湖南省中医药研究院中药研究所,长沙410013 [3]湖南德康制药股份有限公司,长沙410205

出　　处：《中南药学》2020年第9期1562-1568,共7页Central South Pharmacy

基　　金：湖南省科药联合基金项目(No.2020JJ9048);湖南省中医药科研计划项目(No.202023)。

摘　　要：目的提高健脾益肾颗粒的质量标准,为健脾益肾颗粒质量评价提供参考。方法选取薄层色谱法对健脾益肾颗粒中党参、枸杞子、女贞子、白术、菟丝子及补骨脂进行定性鉴别;采用高效液相色谱法同时测定处方中特女贞苷、补骨脂素、异补骨脂素与白术内酯Ⅲ的含量。结果党参、枸杞子、菟丝子、女贞子、补骨脂、白术的薄层色谱图与对照药材或相应对照品在相同位置显相同颜色的荧光斑点且分离度好,阴性样品无干扰;特女贞苷、补骨脂素、异补骨脂素与白术内酯Ⅲ分别在0.0656~1.6391μg(r=0.9998)、0.0080~0.1988μg(r=1.000)、0.0050~0.1255μg(r=1.000)和0.0029~0.0713μg(r=0.9998)与峰面积呈良好的线性关系;精密度、稳定性和重复性试验的RSD值均<5%;检测限为0.01~0.03 ng·mL-1,特女贞苷、补骨脂素、异补骨脂素、白术内酯Ⅲ的低、中、高浓度的平均回收率分别在103.8%~104.7%、96.4%~100.2%、99.2%~101.3%、105.6%~107.4%,RSD分别在0.20%~1.2%、1.1%~2.6%、0.60%~1.4%、1.9%~2.8%(n=3)。结论该方法准确可靠,简单易行,专属性和重复性良好,可用于健脾益肾颗粒的定性鉴别和定量测定,可有效评价与控制健脾益肾颗粒的质量。Objective To improve the quality standard of Jianpi Yishen granules,and provide scientific reference for the quality control.Methods Codonopsis Radix,Lycii Fructus,Ligustri Lucidi Fructus,Atractylodis Macrocephalae Rhizoma,Cuscutae Semen and Psoraleae Fructus,which consisted of the prescription,were qualitatively identified by the thin layer chromatography(TLC).While specnuezhenide,psoralen,isopsoralen and atractylenolideⅢ,the effective ingredients in the granules were quantitatively analysed by high performance liquid chromatography(HPLC)simultaneously.Results Based on the TLC analysis,Codonopsis Radix,Lycii Fructus,Ligustri Lucidi Fructus,Atractylodis Macrocephalae Rhizoma,Cuscutae Semen and Psoraleae Fructus in the granules were identified,which all presented the same color of spots at the same position as the reference herbals or substance,with good resolution of sample and without interference of the negative control.At the same time,HPLC analysis showed that the specnuezhenide,psoralen,isopsoralen and atractylenolideⅢhad good linear relationships with the peak area respectively at 0.0656-1.6391μg(r=0.9998),0.0080-0.1988μg(r=1.000),0.0050-0.1255μg(r=1.000),and 0.0029-0.0713μg(r=0.9998).The RSD of precision,stability and repeatability were all less than 5%,and the corresponding average recoveries were at 103.8%~104.7%,96.4%~100.2%,99.2%~101.3%,and 105.6%~107.4%with the RSD at 0.20%~1.2%,1.1%~2.6%,0.60%~1.4%,and 1.9%~2.8%(n=3),respectively.Conclusion The established method is simple,accurate,with good specificity and repeatability.It is helpful to qualitatively identify the herbals and quantitatively determinate the ingredients in the granules,which will help evaluate and control the quality of Jianpi Yishen granules.

关 键 词：健脾益肾颗粒 党参 枸杞子 女贞子 白术 菟丝子 补骨脂 特女贞苷 补骨脂素 异补骨脂素 白术内酯Ⅲ 

分 类 号：R927[医药卫生—药学]