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作 者:展晓日[1] 史新元[1] 盖伟[1] 乔延江[1]
机构地区:[1]北京中医药大学,北京100102
出 处:《药物分析杂志》2008年第5期689-692,共4页Chinese Journal of Pharmaceutical Analysis
基 金:北京市科技计划课题资助课题(D02050040040111):乳块消片生产过程质量控制体系的研究与建立
摘 要:目的:采用 HPLC 法同时测定乳块消片中丹参素、原儿茶醛、橙皮苷、丹酚酸 B 4种成分的含量。方法:采用 Eclipse XDB-C_(18)色谱柱(4.6 mm×250 mm,5μm);以甲醇-3%醋酸水溶液为流动相梯度洗脱;流速为1 mL·min^(-1);柱温为30℃;检洲波长280 nm。结果:丹参素、原儿茶醛、橙皮苷、卅酚酸 B 进样浓度分别在7.0~223.0μg·mL^(-1)(r=0.9999),0.7~21.5μg·mL^(-1)(r=0.9999),8.5~272.0μg·mL^(-1)(r=0.9999),34.8~1112.0μg·mL^(-1)(r=0.9999)范围内呈良好的线性关系;平均回收率(n=6)分别为101.4%,98.9%,96.2%,99.4%及其 RSD 分别为2.4%,1.8%,1.3%,1.5%。结论:本方法简便,重现性好,结果准确可靠,为乳块消片的质量控制奠定了基础。Objective:To develop a method for the simultaneous determination of 4 components--danshensu, protocatechuic aldehyde, hesperidin and salvianolic acid B, in Rukuaixiao tablets. Method: A gradient HPLC system was used in the quantitative analysis of the above 4 components on the reversed - phase column of Eclipse XDB - C18 ( 4.6 mm × 250 mm, 5 μm) with the mixed solvents of methanol - 3 % acetic acid water solution. The flow rate was 1 mL · min^-1 Column temperature was 30℃. The eluate was monitored with UV absorption at 280 nm. Results : The linear ranges of danshensu, protocatechuic aldehyde, hesperidin and salvianolic acid B were7.0-223.0 μg·mL^-1(r=0.9999),0.7-21.5μg·mL^-1(r=0.9999),8.5-272.0 μg·mL^-1(r =0.9999),34.8 - 1112.0 μg·mL^-1(r =0.9999). The average recoveries(n =6)were 101.4%,98.9%,96.2%,99.4%,with RSD of 2.4%,1.8%,1.3% and 1.5% respectively. Conclusion:The method is simple, accurate and reliable with good reproducibility. It can be used to evaluate and control the quality of Rukuaixiao tablets.
关 键 词:乳块消片 丹参素 原儿茶醛 橙皮苷 丹酚酸B 高效液相色谱法 含量测定
分 类 号:R917[医药卫生—药物分析学]
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