十味板蓝根颗粒质量标准研究探讨  

Research of Study on the Quality Standard of Compound Isatidis Radix Granules

作　　者：鲁毅 刘梅 段靖 贾琳 贾奕扬 李燕思 LU Yi;LIU Mei;DUAN Jing;JIA Lin;JIA Yiyang;LI Yansi(Department of Pharmacy,the air force Hospital from eastern theater of PLA,Nanjing 210002,China)

机构地区：[1]中国人民解放军东部战区空军医院药剂科,南京210002

出　　处：《中国民族民间医药》2023年第21期36-40,共5页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立十味板蓝根颗粒的质量标准。方法:采用TLC法对板蓝根、黄芩、防风等主要成分进行定性鉴别。采用高效液相色谱法测定以(R,S)-告依春作为指标成分进行定量测定。色谱柱为:InertSustain C 18(4.6 mm×250 mm,5μm),流动相为甲醇-0.02%磷酸溶液(5∶95,V/V),流速为1.0 mL·min^(-1)。检测波长为245 nm,柱温为30℃,进样量为10μL。结果:薄层色谱分离度良好,斑点清晰;(R,S)-告依春在进样量0.040~0.400μg范围内与其峰面积线性关系良好(r=0.999,n=5),精密度、稳定性、重复性实验的RSD≤1.20%。平均加样回收率为100.83%,(RSD=1.17%,n=6),并确定每袋15 g颗粒剂中,(R,S)-告依春含量不得少于0.62 mg。结论:建立的质量标准增加了含量测定,操作方便,结果准确,精密度好,专属性强,可用于十味板蓝根颗粒质量控制。Objective To establish standard of Compound Isatidis Radix Granules.Methods Isatidis Radix,Scutellaria baicalensis Georgi,Saposhnikoviae Radix as index components were qualitative identified by TLC.(R,S)-goitrin as index compent was quantitatively analyzed by HPLC.The InertSustain C 18(4.6 mm×250 mm,5μm)column was used with the mobile phase of methanol-0.02% phosphoric acid(5∶95,V/V)at the flow rate of 1.0 mL·min^(-1).The detection wave-length was set at 245 nm,and the column temperature was 30℃.The sample size was 10μL.Results TLC spots were clear,and separated nicely.Particle size,moisture,dissolubility and content uniformity test were conformed to the specification.(R,S)-goitrin showed a good linear relationship within the range of 0.040-0.400μg(r=0.999,n=5).The average recovery was 100.83%(RSD=1.17%,n=6);the RSDs of precision,stability and repeatability tests were no more than 1.20%.The content of(R,S)-goitrin was initially determined no less than 0.62 mg.Conclusion The content determination is a worthy addition to the established quality standard.The method is easy,simple,accurate and stable in results with good specificity,which is applicable to quality control of Compound Isatidis Radix Granules.

关 键 词：十味板蓝根颗粒 (R S)-告依春 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]