| 基于国家药品评价抽检探讨雷公藤多苷片的质量现状 |
| 投稿时间：2020-11-23 点此下载全文
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| 引用本文：王亚丹,汪祺,何风艳,吴先富,戴忠,马双成.基于国家药品评价抽检探讨雷公藤多苷片的质量现状[J].中国现代中药,2021,23(8):1326-1330 |
| DOI：10.13313/j.issn.1673-4890.20201123001 |
| 摘要点击次数: 401 |
| 全文下载次数: 141 |
| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 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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| 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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| 何风艳 |
HE Feng-yan |
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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| 吴先富 |
WU Xian-fu |
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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| 戴忠 |
DAI Zhong |
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:2019年国家药品评价性抽检项目 |
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| 中文摘要:雷公藤多苷片在临床上广泛用于治疗类风湿性关节炎、红斑狼疮、肾病综合征等自身免疫性疾病，疗效确切。2019年，国家药品抽验项目对市场上流通的172批雷公藤多苷片进行了质量评价，发现该品种质量状况较差，存在不同企业制剂化学成分、疗效和毒性差异大，同企业制剂批次间质量不稳定以及残留溶剂超过《中华人民共和国药典》2015年版限度等问题，产生原因主要与药材质量参差不齐、生产工艺差异大及质量标准不完善等有关。为提高雷公藤多苷片质量，建议统一生产工艺、完善药材和制剂质量标准，同时开展一致性评价研究。 |
| 中文关键词:雷公藤多苷片 质量现状 化学成分 疗效 毒性 质量标准 |
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| Discussion on Quality Status of Tripterygium Glycosides Tablets Based on the National Drug Sampling and Inspection Project in 2019 |
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| Abstract:Tripterygium Glycosides Tablets (TGT) is widely used for the treatment of rheumatoid arthritis, lupus erythematosus, nephrotic syndrome, and other autoimmune diseases, with definite therapeutic effect. The quality of 172 batches of TGT on the market was evaluated in the national drug sampling and inspection project in 2019. During the inspection, we found the poor quality of samples, great difference in chemical constituents, efficacy, and toxicity among samples from different manufactures, unstable quality of samples among batches from the same manufacture, and the residual solvent content higher than the limit specified in Chinese Pharmacopoeia (2015 edition). The causes are the uneven quality of medicinal materials, huge difference in production process among manufactures, and imperfect quality standards. In a bid to improve the quality of TGT, efforts should be made to unify the production process, improve the quality standards of medicinal materials and preparations, and carry out corresponding consistency evaluation. |
| keywords:Tripterygium Glycosides Tablets quality status chemical constituents efficacy toxicity quality standards |
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