舒痛安Ⅰ号胶囊的质量标准研究
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篇名: 舒痛安Ⅰ号胶囊的质量标准研究
TITLE:
摘要:

目的:建立舒痛安Ⅰ号胶囊的质量标准。方法:采用薄层色谱(TLC)法对制剂中枳壳、连翘进行定性鉴别。采用高效液

相色谱(HPLC)法测定制剂中柚皮苷的含量:色谱柱为Agilent C18,流动相为乙腈-水(20 ∶80,V/V),流速为1.0 ml/min,检测波长为

283 nm,柱温为30 ℃,进样量为10 μl;采用HPLC法测定制剂中连翘苷的含量:色谱柱为Agilent TC-C18,流动相为乙腈-水(23 ∶77,

V/V),流速为1.0 ml/min,检测波长为277 nm,柱温为30 ℃,进样量为10 μl。结果:枳壳、连翘的TLC图斑点清晰,分离度好。柚皮

苷和连翘苷检测质量浓度线性范围分别为57.843~289.214 μg/ml(r=0.999 9)、37.434~187.169 μg/ml(r=0.999 6);精密度、稳定

性、重复性试验的RSD<2%;加样回收率分别为97.20%~102.04%(RSD=1.7%,n=9)、97.14%~102.27%(RSD=2.0%,n=

9)。结论:所建标准可用于舒痛安Ⅰ号胶囊的质量控制。

ABSTRACT:

OBJECTIVE:To establish the quality standard for ShutonganⅠgranule.METHODS:TLC was conducted for the qualitative

identification of Citrus aurantium and Forsythia suspensa. HPLC was conducted for the content determination of naringin in

the preparation;the column was Agilent C18 with mobile phase of acetonitrile-water(20 ∶80,V/V)at a flow rate of 1.0 ml/min,the

detection wavelength was 283 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. HPLC was also used

for the content determination of phillyrin;the column was Agilent TC-C18 with mobile phase of acetonitrile - water(23 ∶77,V/V)at

a flow rate of 1.0 ml/min,the detection wavelength was 277 nm,the column temperature was 30 ℃,and the injection volume was

10 μ l. RESULTS:The C. aurantium and F. suspensa of TLC showed clear spots and good separation. The linear range was

57.843-289.214 μg/ml for naringin(r=0.999 9)and 37.434-187.169 μg/ml for phillyrin(r=0.999 6);RSDs of precision,stability

and reproducibility tests were less than 2%;recoveries were 97.20%-102.04%(RSD=1.7%,n=9)and 97.14%-102.27%(RSD=

2.0%,n=9),respectively. CONCLUSIONS:The standard can be used for the quality control of ShutonganⅠgranule.

期刊: 2016年第27卷第3期
作者: 李腾霞,黄木土,谢新民,晏明,李冬,邹学军,米海鹏
AUTHORS: LI Tengxia,HUANG Mutu,XIE Xinmin,YAN Ming,LI Dong,ZOU Xuejun,MI Haipeng
关键字: 舒痛安Ⅰ号胶囊;薄层色谱法;柚皮苷;连翘苷;高效液相色谱法
KEYWORDS: ShutonganⅠgranules;TLC;Naringin;Phillyrin;HPLC
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