[关键词]
[摘要]
目的 建立通脑溶栓胶囊的质量控制方法。方法 采用薄层色谱法对制剂中的粉葛、黄芪、鸡血藤和赤芍进行定性鉴别;采用高效液相色谱法对制剂中的粉葛所含成分葛根素进行含量测定。色谱柱:C18色谱柱(4.6 mm×150 mm,5 μm);流动相:甲醇-水(25 ∶ 75);检测波长:250 nm。结果 在薄层色谱中均能检出粉葛、黄芪、鸡血藤和赤芍;葛根素进样量在0.06784~0.40704 μg范围内与峰面积呈良好的线性关系,r=0.9998,平均回收率为98.9 %(n=6),RSD为1.1 %。结论 本研究所建立的方法简便,准确,重复性好,可用于通脑溶栓胶囊的质量控制。
[Key word]
[Abstract]
Objective To establish a quality standard for Tongnao Rongshuan Capsule. Methods Radix Puerariae,Radix Astragali,Caulis Spatholobi and Radix Paeoniae were identified by thin layer chromatography(TLC). Puerarin was determined by high performance liquid chromatography(HPLC). The HPLC system consisted of chromatographic column C18(4.6 mm×150 mm,5 μm) with methanol - water(25 ∶ 75) as the mobile phase,and the detective wave length was set at 250nm. Results Radix Puerariae,Radix Astragali,Caulis Spatholobi and Radix Paeoniae can be detectable by TLC. The linearity range of puerarin was 0.06784~0.40704 μg(r=0.9998),the average recovery was 98.9 %,and RSD was 1.1 %(n=6). Conclusion The established method is simple,accurate and with good reproducibility,and can be used for the quality control of Tongnao Rongshuan Capsule.
[中图分类号]
R284.1
[基金项目]
国家自然科学基金(30300444);科技部中小企业技术创新基金(12C26216106788)。