摘要
目的:建立千喜片的定性定量方法,对制剂质量进行有效控制。方法:采用TLC方法,对方中主药穿心莲和千里光分别进行鉴别。采用HPLC法测定穿心莲中穿心莲内酯和脱水穿心莲内酯的含量,色谱柱为Agela C18(5μm,250 mm×4.6 mm)柱,以甲醇(A)-水(B)为流动相,进行梯度洗脱(0～15 min,45%A;15～35 min,45%A→60%A),流速1.0 mL.min-1,检测波长为225 nm(穿心莲内酯)和254 nm(脱水穿心莲内酯)。结果:穿心莲和千里光的TLC鉴别专属性强;穿心莲内酯和脱水穿心莲内酯的线性范围分别为0.0646～0.968μg(r=0.9998)和0.196～2.94μg(r=0.9999),平均回收率(n=6)分别为99.5%(RSD=1.1%)和103.4%(RSD=1.1%)。结论:本方法简便、可靠、准确,可用于千喜片的质量控制。
Objective ： To establish the qualitative and quantitative methods for Qianxi tablets. Methods： The Andrographis Herba and Senecionis Scandentis Hebra in Qianxi tablets were identified by TLC. The contents of andrographolide and dehydroandrographolide were determined simultaneously by HPLC. An Agela C lS column （5 p,m,250 mm × 4. 6 mm） was adopted, and the mobile phase was methanol （A） -water（ B ）with gradient elution （0- 15min ,45% A;15 - 35 min,45% A→60A）at the flow rate of 1.0 mL · min^-1. Results：The methods of identifying Andrographis Herba and Senecionis Scaudentis Hebra by TLC had strong specificity. The calibration curves were linear in the rangs of 0. 0646 - 0. 968 μg （ r = 0. 9998 ） for andrographolide and 0. 196 - 2. 94 μg （ r = 0. 9999 ） for dehydroandrographolide ; The mean recoveries （ n = 6） were 99. 5 % （ RSD = 1.1% ） and 103.4% （ RSD = 1.1% ）, respectively. Conclusion： This method is simple, reliable accurate,and can be used to the control the quality of Qianxi tablets.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第11期2154-2157,共4页
Chinese Journal of Pharmaceutical Analysis
