| 丹参多酚酸口腔崩解片的质量标准研究 |
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| 引用本文： | 周毅生,孟江,咸银库,廖华卫,刘林,段芳. 丹参多酚酸口腔崩解片的质量标准研究[J]. 广东药学院学报, 2009, 25(2): 150-153 |
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| 作者姓名： | 周毅生 孟江 咸银库 廖华卫 刘林 段芳 |
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| 作者单位： | 广东药学院,中药学院,广东,广州,510006;广东药学院,中药学院,广东,广州,510006;广东药学院,中药学院,广东,广州,510006;广东药学院,中药学院,广东,广州,510006;广东药学院,中药学院,广东,广州,510006;广东药学院,中药学院,广东,广州,510006 |
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| 摘 要： | 目的建立丹参多酚酸口腔崩解片的质量标准。方法采用薄层色谱法鉴别丹参多酚酸口腔崩解片中主要成分丹酚酸B,采用高效液相色谱法及紫外可见分光光度法分别测定丹参多酚酸口腔崩解片中的丹酚酸B及丹参总酚酸的含量,并测定其崩解时限和片重差异。结果丹参多酚酸口腔崩解片平均崩解时限为23．5s,且片重差异符合规定;丹酚酸B在41．04—205．2μg·mL^-1范围内色谱峰面积与进样量间线性关系良好,r=0．9996,平均回收率为99．96％,RSD为0．55％;原儿茶醛在41．36～248．16μg·mL^-1范围内色谱峰面积与进样量间线性关系良好,r=0．9996,平均回收率为96．67％,RSD为1．54％。结论建立了该制剂的质量标准,其鉴别与含量测定方法简便、可靠,可作为该制剂的质量控制指标。
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| 关 键 词： | 丹参多酚酸 丹参酚酸B 口腔崩解片 质量标准 |
Quality standard of orally disintegrating tablets of salvianolic acids |
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| ZHOU Yi-Sheng,MENG Jiang,XIAN Yin-Ku,LIU Lin,DUAN Fang. Quality standard of orally disintegrating tablets of salvianolic acids[J]. Academic Journal of Guangdong College of Pharmacy, 2009, 25(2): 150-153 |
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| Authors: | ZHOU Yi-Sheng MENG Jiang XIAN Yin-Ku LIU Lin DUAN Fang |
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| Affiliation: | ZHOU Yi-Sheng,MENG Jiang,XIAN Yin-Ku,LIU Lin,DUAN Fang(School of Traditional Chinese Medicine,Guangdong Pharmaceutical College,Guangzhou,Guangdong 510006,China) |
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| Abstract: | Objective To establish the quality standard of orally disintegrating tablets of salvianolic acids.Methods The main ingredient of the tablets,salvianolic acid B,was identified by TLC.The contents of salvianolic acid B and total salvianolic acids in the orally disintegrating tablets of salvianolic acid were measured by HPLC and UV.The disintegration time and tablet weight were determined.Results The tablets of salvianolic acids disintegrated in 26.5 seconds,and the tablet weight was fit for the criterion.A go... |
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| Keywords: | salvianolic acids B salvianolic acid orally disintegrating tablets quality standard |
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