RP-HPLC法测定自乳化释药系统中金雀异黄素的含量
RP-HPLC determination of genistein in self-emulsifying drug delivery system
单位(英文)：1. Department of Pharmacy, the Second Affiliated Hospital of Harbin Medical University, Key Laboratory of College in Heilongjiang Province, Harbin 150086, China;
2. Department of Pharmacy, the First Affiliated Hospital of Harbin Medical University, Harbin 150001, China;
3. College of Pharmacy, Harbin Medical University, Harbin 150081, China
分类号：
出版年·卷·期（页码）：2012,32 (5):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
目的: 建立自乳化释药系统中金雀异黄素含量测定的RP-HPLC法。 方法: 采用Diamonsil C18(4.6 mm×200 mm,5 μm)色谱柱,流动相为甲醇-水(65: 35),流速1.0 mL·min-1,检测波长261 nm,柱温25 ℃,进样量20 μL。 结果: 在本色谱条件下金雀异黄素与辅料及溶剂峰分离良好,金雀异黄素质量浓度在1.0~100.0 μg·mL-1范围内与峰面积呈良好的线性关系(r=0.9999),精密度试验的RSD(n=5)为0.4%~4.1%,重复性试验的RSD(n=5)为3.1%,平均回收率(n=5)为101.3%。 结论: 该方法简便、易行,可用于自乳化释药系统中金雀异黄素的含量测定。
-----英文摘要：---------------------------------------------------------------------------------------
Objective: To establish an RP-HPLC method for determining the content of genistein in self-emulsifying drug delivery system. Methods: HPLC analysis was performed on a Diamonsil C18(4.6 mm×200 mm, 5 μm) column with mobile phase of methanol-water(65: 35) at the flow rate of 1.0 mL·min-1; The UV detector wavelength was set at 261 nm, the column compartment temperature was set at 25 ℃, and the injection volume was 20 μL. Results: Genistein had a good linear relation in the range of 1.0-100.0 μg·mL-1(r=0.9999); RSD(n=5) of the precision test was 0.4%-4.1%, RSD(n=5) of the reproducibility test was 3.1%, and the average recovery(n=5) was 101.3%. Conclusion: The developed method is simple, accurate and reliable for determination of the content of genistein in self-emulsifying drug delivery system.
-----参考文献：---------------------------------------------------------------------------------------
1 CHENG Yu-chuan(程玉钏),ZHOU Jian-ping(周建平),LV Hui-xia(吕慧侠),et al.An overview of solid self-emulsifying drug delivery system(固体自乳化药物传递系统的研究概况).Prog Pharm Sci(药学进展),2008,32(2):68
2 Warri A,Saarinen NM,Makela S, et al.The role of early life genistein exposures in modifying breast cancer risk.Br J Cancer,2008,98:1485
3 WANG Jian-bo(王剑波),GU Yi(顾宜),GUO Ping(郭萍),et al.Determination of content and dissolution of genistein capsules by UV spectrophotometry( 紫外分光光度法测定染料木素胶囊含量及溶出度).Chin J Pharm Anal(药物分析杂志),2004,24(5):473
4 TANG Bo(唐波),FENG Yi(冯怡),ZENG Xing(曾星),et al.HPLC/MS/MS determination of genistein in human plasma(HPLC/MS/MS测定人血浆中的染料木素).Tradit Chin Drug Res Clin Pharmacol(中国新药与临床药理),2006,17(5):348
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