| 从雷公藤多苷片看中药制剂临床相关质量标准的建立思路 |
| 投稿时间：2020-09-03 点此下载全文
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| 引用本文：孙昱,王亚丹,文海若,汪祺,马双成.从雷公藤多苷片看中药制剂临床相关质量标准的建立思路[J].中国现代中药,2021,23(8):1331-1334 |
| DOI：10.13313/j.issn.1673-4890.20200903002 |
| 摘要点击次数: 437 |
| 全文下载次数: 125 |
| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 孙昱 |
SUN Yu |
国家药品监督管理局 药品审评中心，北京 100022 |
Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China |
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| 王亚丹 |
WANG Ya-dan |
中国食品药品检定研究院，北京 100050 |
National Institutes for Food and Drug Control, Beijing 100050, China |
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| 文海若 |
WEN Hai-ruo |
中国食品药品检定研究院，北京 100050 |
National Institutes for Food and Drug Control, Beijing 100050, China |
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| 汪祺 |
WANG Qi |
中国食品药品检定研究院，北京 100050 |
National Institutes for Food and Drug Control, Beijing 100050, China |
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| 马双成 |
MA Shuang-cheng |
中国食品药品检定研究院，北京 100050 |
National Institutes for Food and Drug Control, Beijing 100050, China |
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| 基金项目:国家自然科学基金项目（81503347，81503068） |
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| 中文摘要:对活性较强、安全性风险较高的雷公藤多苷片的质量控制情况进行研究。探讨进一步加强中药制剂质量控制的关键问题：1）如何提高中药制剂的批间质量一致性；2）如何建立中药制剂临床相关的质量标准（如功效成分、毒性成分的研究和控制）。建议重点关注活性较强、安全性风险较高的中药制剂品种，旨在为建立中药制剂临床相关的质量标准提供参考。 |
| 中文关键词:质量标准 批间一致性 均一化处理 生物活性 |
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| Considerations on Establishing Clinically Relevant Specifications of Traditional Chinese Medicine Preparations with Tripterygium Glycoside Tablets as An Example |
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| Abstract:This article studies the quality control of Tripterygium Glycoside Tablets with high activity and high safety risk. The key issues on further strengthening the quality control of traditional Chinese medicine (TCM) preparations are discussed: 1) how to improve the quality consistency of TCM preparations between batches; 2) how to establish clinically relevant specifications for TCM preparations (such as research and control of active ingredients and toxic ingredients). It is recommended to focus on the TCM preparations with strong activity and high safety risks. This article aims to provide a reference for establishing clinically relevant specifications of TCM preparations. |
| keywords:specification batch-to-batch consistency homogenization biological activity |
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