| 水飞蓟素原料药及其制剂体外溶出的研究 |
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| 引用本文： | 张自然,陶建生,邹凌燕,奉建芳.水飞蓟素原料药及其制剂体外溶出的研究[J].中南药学,2007,5(6):496-500. |
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| 作者姓名： | 张自然 陶建生 邹凌燕 奉建芳 |
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| 作者单位： | 上海中医药大学中药学院 上海201203(张自然，陶建生)，上海医药工业研究院 上海200437(邹凌燕，奉建芳) |
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| 摘 要： | 目的考察水飞蓟素及其制剂(片剂和胶囊剂)的体外溶出度。方法参照美国药典桨法,以人工胃液(SGF)、模拟空腹状态下的肠流质(FaSSIF)、模拟进食状态下的肠流质(FeSSIF)为试验介质分别进行体外溶出实验,采用LC-ESI-MS技术测定水飞蓟素中3种主要成分(水飞蓟宁、水飞蓟宾A和水飞蓟宾B)的体外溶出度。结果水飞蓟素溶解度低,溶出慢,不同制剂在不同介质中的体外溶出速率存在差异,制剂的体外溶出与原料药物的溶出及溶解度有一定的相似性。结论制剂的溶出可以指导体内试验与临床用药,原料药物的溶出及溶解度测定可以指导制剂的溶出测定。
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| 关 键 词： | 水飞蓟素 溶出度 |
| 文章编号： | 1672-2981(2007)06-0496-05 |
| 修稿时间： | 2007年2月2日 |
Dissolution of silymarin and its products Legalon capsules and Yiganling tablets |
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| ZHANG Zi-ran,TAO Jian-sheng,ZHOU Ling-yan,FENG Jian-fang.Dissolution of silymarin and its products Legalon capsules and Yiganling tablets[J].Central South Pharmacy,2007,5(6):496-500. |
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| Authors: | ZHANG Zi-ran TAO Jian-sheng ZHOU Ling-yan FENG Jian-fang |
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| Abstract: | Objective To determine the dissolution of silymarin and its products Legalon capsules and Yiganling tablets.Methods The USP paddle method was adopted to study the dissolution of silymarin.SGF,FaSSIF,and FeSSIF were used as the test media.The contents of Silydianin,silybin A and silybin B were measured by LC-ESI-MS technique.Results The solubility of silymarin was low and the dissolution was slow.There was quality difference among different products.Conclusion The method is accurate and reliable for silymarin products. |
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| Keywords: | LC-ESI-MS |
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