康复灵颗粒质量标准研究  

Study on quality standard for Kangfuling granules

作　　者：丁妍[1] 丁敏[2] 贾晓斌[3] 张勇妹[1] 郭贵宾[1] 孙锐[1] 林梅[4] 

机构地区：[1]解放军第三五九医院药械科,镇江212001 [2]解放军第三五九医院医务处,镇江212001 [3]江苏省中医药研究院国家中医药管理局中药释药系统重点研究室,南京210028 [4]南京军区南京总医院门诊部,南京210002

出　　处：《医学研究生学报》2015年第10期1075-1078,共4页Journal of Medical Postgraduates

基　　金：南京军区医学科技创新课题(12MA042)

摘　　要：目的康复灵颗粒可用于治疗辐射损伤,但其质量标准并未建立,文中旨在建立康复灵颗粒的质量标准,以控制其质量。方法采用薄层色谱法,对方中黄芪、当归进行定性鉴别;采用高效液相色谱法测定方中黄芪甲苷的含量：色谱柱为Agilent Zorbax Extend-C18（4.6 mm×250 mm,5μm）,以乙腈-水（32∶68）为流动相,流速为1.0 m L/min,蒸发光散射检测器检测;采用高效液相色谱法测定方中阿魏酸的含量：色谱柱为Agilent Zorbax SB-C18柱（250 mm×4.6 mm,5μm）;流动相：乙腈-0.085%磷酸水（17∶83）,检测波长：320 nm;流速：1.0 m L/min;柱温：35℃。结果采用薄层色谱法鉴别黄芪、当归时,供试品的色谱图中,与对照品色谱对应的位置上,显相同颜色的斑点,阴性对照无干扰。黄芪甲苷的线性范围为0.030 6～0.612 0 mg/m L,R2=0.999;稳定性试验RSD为2.17%;精密度试验RSD为1.89%;重复性试验RSD为1.58%;平均加样回收率为101.26%。阿魏酸的线性范围为0.24～4.80μg/m L,R2=0.999;稳定性试验RSD为1.37%;精密度试验RSD为0.83%;重复性试验RSD为1.14%;平均加样回收率为98.39%。暂定本品按干燥品计算,每克含黄芪甲苷（C41H68O14）不得少于0.19mg,阿魏酸（C10H10O4）不得少于0.08 mg。结论文中建立的方法操作简便、灵敏度高、准确可靠、重现性好,可作为康复灵颗粒的质量控制方法。Objective Kangfuling granules can be used for the treatment of radiation damage,but its quality criteria has not been established. This paper aimed to establish the quality criteria of Kangfuling granules to control its quality. Methods Radix astragali and Radix angelicae sinensis in the formula both were identified qualitatively by TLC. The content of astragaloside IV was examined by HPLC： Agilent Zorbax Extend-C18（ 4. 6 mm × 250 mm,5 μm） was used as the chromatographic column. The mobile phase was consisted of acetonitrile-water（ 32∶ 68） with a flow rate at 1. 0 m L / min. The evaporative light scattering detector was used to detect the compound. The content of astragaloside IV and ferulaic acid was examined by HPLC： Agilent Zorbax SB-C18（ 4. 6 mm × 250 mm,5 μm） was used as the chromatographic column. The mobile phase was consisted of acetonitrile-0. 085% phosphoric acid water（ 17： 83） with a flow rate at 1. 0 m L/min. The wave length was 320 nm and column temperature was set at 35 ℃. Results The same color spot was shown in the chromatogram of the test sample and the control sample in the corresponding position with no interference of negative control. The linear range for Astragaloside IV 0. 030 6mg / m L ～ 0. 612 0 mg / m L with R2= 0. 999. The RSD of stability test was 2. 17%. The RSD of precision test was 1. 89%. The RSD of repeatability test was 1. 58%. The average recovery was 101. 26%.The linear range for ferulaic acid 0. 24-4. 80 μg / m L with R2= 0. 999. The RSD of stability test was 1. 37%. The RSD of precision test was 0. 83%. The RSD of repeatability test was 1. 14%. The average recovery was 98. 39%. This product was tentatively calculated according to the dry matter,the amount of Astragaloside IV and ferulaic acid should not be less than 0. 19 mg / g and 0. 08 mg / g,respectively. Conclusion In this study,the established TLC was used for the qualitative identification of Kangfuling granules,and the content of Astragaloside IV and ferulaic acid was not less than 0.

关 键 词：康复灵颗粒 薄层色谱法 高效液相色谱法 质量标准 

分 类 号：R286[医药卫生—中药学]