基于UPLC含量测定的不同厂家穿心莲胶囊质量评价  

Evaluation on Quality of Chuanxinlian Capsule from Various Manufacturers Based on Content Determination of UPLC

作　　者：赵振霞 苏建 孔亚萍 刘永利 ZHAO Zhen-xia;SU Jian;KONG Ya-ping;LIU Yong-li(Hebei Institute for Drug Control,Shijiazhuang 050011,China)

机构地区：[1]河北省药品检验研究院,石家庄050011

出　　处：《中国现代中药》2020年第9期1545-1548,1575,共5页Modern Chinese Medicine

摘　　要：目的:建立同时测定穿心莲胶囊中穿心莲内酯与脱水穿心莲内酯含量的方法,并对不同厂家产品的质量进行评价。方法:采用双波长超高效液相色谱法测定穿心莲胶囊中穿心莲内酯与脱水穿心莲内酯的含量。色谱条件为ACQUITY UPLC BEH C18(100 mm×2.1 mm,1.7μm)色谱柱,以乙腈-水为流动相梯度洗脱,流速为0.3 mL·min-1,柱温为30℃,检测波长为225 nm(穿心莲内酯)、254 nm(脱水穿心莲内酯)。结果:在建立的检测条件下,穿心莲内酯和脱水穿心莲内酯均能达到基线分离,两者的进样量线性范围分别为0.0826~2.0648(r=0.9999)、0.0408~1.0197μg(r=0.9999);平均加样回收率分别为98.7%、100.7%(RSD分别为1.0%、1.8%,n=9)。27批穿心莲胶囊样品中,穿心莲内酯与脱水穿心莲内酯的含量分别为0.94~7.50、5.62~10.12 mg/粒。结论:建立的方法操作简便、快速,可用于穿心莲胶囊的质量控制及评价。Objective:To establish a method for simultaneously determining the contents of andrographolide and dehyandrographolide in chuanxinlian capsule,and evaluate the quality of chuanxinlian capsule from various manufacturers.Methods:UPLC method was adopted.The samples were conducted by ACQUITY UPLC BEH C18(100 mm×2.1 mm,1.7μm)and eluted with acetonitrile-water as the mobile phase with gradient elution and the flow rate was 0.3 ml·min-1.The column temperature was 30℃and the detection wavelength was set at 225 nm(andrographolide),254 nm(dehyandrographolide).Results:Under this condition,andrographolide and dehyandrographolide could be separated in baseline.The linear range of them were 0.0826-2.0648(r=0.9999)and 0.0408-1.0197μg(r=0.9999).The average recovery rates were 98.7%and 100.7%(RSD=1.0%and 1.8%,n=9).The content of andrographolide and dehyandrographolide in sample of 27 batches were 0.94-7.50 and 5.62-10.12 mg/capsule.Conclusion:The established method is simple and rapid,and can be used for the quality control and evaluation of chuanxinlian capsule.

关 键 词：穿心莲胶囊 超高效液相色谱法 含量测定 穿心莲内酯 脱水穿心莲内酯 

分 类 号：R289[医药卫生—方剂学]