摘要
[目的]建立舒血宁注射液中总黄酮醇苷含量测定方法,为其质量控制提供技术手段。[方法]采用ExtendC18柱(4.6 mm×250 mm,5μm),以乙腈-0.1%甲酸水(v/v)为流动相,梯度洗脱,流速为1 mL/min,进样体积为15μL,柱温为35℃,检测波长为360 nm。[结果]槲皮素、山奈酚及异鼠李素3种黄酮的分离及线性关系良好;精密度,重复性和稳定性RSD均都小于5%;平均回收率在99.5%~100%之间且RSD均值小于5%。30批舒血宁注射液中总黄酮醇苷平均含量为1.06 mg/mL且无统计学差异。[结论]本方法简便、准确、可靠,适用于舒血宁注射液中总黄酮醇苷含量的测定,为舒血宁注射液质量控制提供了科学依据。
[Objective] To establish a high performance liquid chromatography（HPLC） method to determine the content of total favonol glycosidesfor quality control of Shuxuening injection. [Methods] The HPLC analysis was performed on an Extend-C18 column（4.6×250mm, 5 μm）. Acetonitrile and water containing 0.1% formic acidwas selected asmobile phrasein a gradient elution at a flow rate of 1 mL/min. The injection volume was 15 μL.The column temperature was set up at 35℃.The detection wavelength was 360 nm. [Results] There were good separation and the linear relationships of quercetin、kaempferol and rhamnetin. The RSD of precision, the repeatability and stability all were less than 5%. The sample recoveriesranged from 99.5% to 100% and their RSD values were less than 5%.The averagecontent of total flavonoid glycosides in 30 batches of Shuxuening injections was 1.06 mg/mL and there was no significantly different from different batches. [Conclusion] The method could be applied to determinethe total content of flavonoid glycosides of Shuxuening injection accurately and reliably, which provide a scientific basis for the quality evaluation of Shuxuening injection.
作者
田吉
李晋
何俊
关秀伟
张纲
李志刚
常艳旭
TIAN Ji LI Jin HE Jun GUAN Xiu-wei ZHANG Gang LI Zhi-gang CHANG Yan-xu(Tianjin State Key Laboratory of Modern Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193 China Hebei Shineway Pharmaceutical Co. Ltd., Landang 065200, China State-Local Joint Engineering Laboratory of New Drugs Department Technology for Traditional Chinese Medicine Injection, Langfang 065200, China Hebei Province Engineering Research Center for Traditional Chinese Medicine Injection, Langfang 065200, China)
出处
《天津中医药》
CAS
2017年第6期415-418,共4页
Tianjin Journal of Traditional Chinese Medicine
基金
国家重大新药创制项目(2014ZX09201022-004)
关键词
舒血宁注射液
槲皮素
山奈酚
异鼠李素
总黄酮醇苷
Shuxuening injection
quercetin
kaempferol
rhamnetin
total flavonoid glycosides
