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HPLC指纹图谱法评价知柏地黄丸（浓缩丸）的质量
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| 篇名： | HPLC指纹图谱法评价知柏地黄丸（浓缩丸）的质量 |
| TITLE： | |
| 摘要： | 目的：建立知柏地黄丸（浓缩丸）的高效液相色谱（HPLC）指纹图谱，并评价其质量。方法：色谱柱为Dikma Diamonsil C18，流动相为0.1％醋酸溶液-甲醇（梯度洗脱），流速为1.0 mL/min，检测波长为260 nm，柱温为30 ℃，进样量为10 μL。以丹皮酚为参照，分别绘制A、B、C厂有效期内样品和A厂有效期内与有效期外样品的HPLC图谱。采用《中药色谱指纹图谱相似度评价系统》（2004 A）对A、B、C厂有效期内样品及A厂有效期内与有效期外样品进行相似度评价，分别确定共有峰。结果：A、B、C厂各10批有效期内样品的HPLC图谱分别有24、29、32个共有峰，A、B、C厂样品HPLC图谱与对照指纹图谱的相似度均大于0.94，具有较好的一致性。A厂有效期内样品的HPLC图谱与有效期外样品的HPLC图谱具有较好的一致性。结论：本研究建立的HPLC指纹图谱可为评价知柏地黄丸（浓缩丸）的质量提供参考，但其并不能有效鉴别有效期外的样品。 |
| ABSTRACT： | OBJECTIVE： To establish the HPLC fingerprint of Zhibai dihuang pills （concentrated pills）， and to evaluate its quality. METHODS： The determination was performed on Dikma Diamonsil C18 column with mobile phase consisted of 0.1％ acetic acid solution-methanol （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm， and column temperature was 30 ℃. The sample size was 10 μL. Using paeonol as reference，HPLC chromatograms of samples from A，B， C manufacturers within validity period and samples from manufacturer A within validity period and out of validity period were drawn. The similarity of HPLC chromatogram for samples from A， B and C manufacturers and samples from A manufacturer within validity period and out of validity period was evaluated by TCM Chromatogram Fingerprint Similarity Evaluation System （2004 A）. Common peaks of HPLC chromatogram for 3 manufacturers sample within validity period were confirmed. RESULTS： There were 24， 29 and 32 common peaks in HPLC chromatograms for each 10 batches of samples from manufacturer A， B and C within validity period， respectively. The similarity of corresponding HPLC chromatograms of samples from manufacturer A， B and C compared with control HPLC chromatography were all higher than 0.94 with good agreement. HPLC chromatograms of sample from A manufacturer within validity period had good agreement with that from A manufacturer out of validity period. CONCLUSIONS： Established HPLC fingerprint analysis method can represent the quality of Zhibai dihuang pills （concentrated pills）， but cannot effectively identify the expired samples. |
| 期刊： | 2018年第29卷第20期 |
| 作者： | 李雅静，王丰青，谢彩侠，谢惠英，张苗，雷敬卫 |
| AUTHORS： | LI Yajing，WANG Fengqing，XIE Caixia，XIE Huiying，ZHANG Miao，LEI Jingwei |
| 关键字： | 高效液相色谱法；指纹图谱；知柏地黄丸（浓缩丸）；有效期 |
| KEYWORDS： | HPLC； Fingerprint； Zhibai dihuang pills （concentrated pills）； Validity period |
| 阅读数： | 405 次 |
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