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机构地区:[1]广东药科大学中药学院,广州510006 [2]广东药科大学国家中医药管理局中药数字化质量评价技术重点研究室,广州510006 [3]广东药科大学广东高校中药质量工程技术研究中心,广州510006
出 处:《中国药房》2017年第27期3828-3831,共4页China Pharmacy
基 金:国家自然科学基金资助项目(No.81274059)
摘 要:目的:建立脑得生固体分散体胶囊的高效液相色谱(HPLC)指纹图谱。方法:采用HPLC法。色谱柱为Hyspersil ODS2,流动相为乙腈-0.05%磷酸溶液(梯度洗脱),流速为1.0 m L/min,检测波长为210 nm(葛根素)、345 nm(羟基红花黄色素A),柱温为30℃,进样量为10μL。以葛根素、羟基红花黄色素A为参照,测定10批样品的HPLC图谱,采用《中药色谱指纹图谱相似度评价系统》(2012版)进行相似度评价,共有峰指认及其化学成分确认。结果:在210、345 nm波长处,10批样品的HPLC图谱分别有29、23个共有峰;相似度均>0.90;各共有峰药材归属分别为三七、川芎、红花、葛根、山楂;在210、345 nm波长处各确认了7种化学成分。结论:该研究所建HPLC指纹图谱可为脑得生固体分散体胶囊的鉴别和质量评价提供参考。OBJECTIVE: To establish HPLC fingerprints of Naodesheng solid dispersion capsules. METHODS: HPLC method was adopted. The determination was performed on Hyspersil ODS2 column with mobile phase consisted of acetonitrile -0.05% phos- phoric acid (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelengths were 210 nm (puerarin), 345 nm (hy- droxfsafflor yellow A). The column temperature was 30℃, and sample size was 10 μL. Using puerarin and hydroxysafflor yellow A as reference, HPLC fingerprints of 10 batches of sample were determined. Similarity evaluation, common peak identification and chemical components confirmation were performed by using Similarity Evaluation System of TCM Chromatographic Fingerprints (2012 edition). RESULTS: There were 29 and 23 common peaks in HPLC fingerprints of 10 batches of samples at 210 nm and 345 nm, respectively. The similarity was higher than 0.90. The medicinal material attribute of common peaks were Panax notogin- seng, Ligusticum chuartxiong, Carthamus tinctorius, Pueraia lobata and Crataegus pirmatifida. Moreover, 7 chemical components were identified at 210, 345nm, respectively. CONCLUSIONS: Established HPLC fmgerprints can provide reference for identifica- tion and quality evaluation of Naodesheng solid dispersion capsules.
关 键 词:脑得生固体分散体胶囊 高效液相色谱法 指纹图谱
分 类 号:R917[医药卫生—药物分析学]
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