摘要
目的：在临床前研究中，建立蒜氨酸原料药的质量控制方法。方法：采用薄层色谱法对原料药中的蒜氨酸进行定性鉴别；采用高效液相色谱法，Agilent ZORBAX SB-C18色谱柱（4．6mm×250mm，5μm），检测波长220nm，柱温25℃，以100％水为流动相，流速0．8mL·min^-1，进样量20μL，以利巴韦林为内标对原料药中的蒜氨酸进行了含量测定。结果：蒜氨酸的薄层色谱鉴别专属性强；蒜氨酸在8-160μg·mL^-1范围内线性关系良好。蒜氨酸的平均回收率为99．86％，RSD为1．3％。结论：本方法定性、定量准确，可用于控制蒜氨酸原料药的质量。
OBJECTIVE To establish the quality control standard of alliin. 1VIETItODS Alliin were identified by TLC;The content of Alliin was determined by HPLC with internal standard substance. Agilent ZORBAX SB-C18 column（4. 6 mm × 250 mm, 5 μm） was used, the detection wavelength was at 220 nm, the column temperature was at 25 ℃ ,The mobile phase was water,the flow rate was 0. 8 mL·min^-1 ,and the injection volume was 20μL. RESULTS Identification of TLC had good specificity;The calibration curve was linear in the range of 8- 160μg·mL^-1 for Alliin. The mean recovery of alliin was 99. 86% with RSD of 1.3%. CONCLUSION This method is simple, reliable, accurate,and can be used to control the quality of alliin.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2008年第5期363-366,共4页
Chinese Journal of Hospital Pharmacy
基金
新疆维吾尔自治区高技术研究与发展计划项目(编号:200511112)
