| 引用本文: | 李煜,杨伟峰,洪利娅.口服固体制剂仿制药物疗效的影响因素[J].中国现代应用药学,2014,31(2):252-256. |
| LI Yu,YANG Weifeng,HONG Liya.Influencing Factors of Me-too Oral Solid drugs on Therapeutic Effects[J].Chin J Mod Appl Pharm(中国现代应用药学),2014,31(2):252-256. |
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| 摘要: |
| 目的 总结近年来影响仿制药物疗效的因素。方法 分析评述近年来的国内外相关文献资料。结果 分析影响仿制药物疗效的3个主要因素，包括原料药的优劣及药物晶型、药物制剂和生物活性评价方法。其中，药物制剂和药物晶型是药物质量标准不可控的2个重要因素。结论 为提高仿制药物的质量及质量标准提供参考。 |
| 关键词: 仿制药物 疗效 影响因素 |
| DOI： |
| 分类号:R284.1；R917.101 |
| 基金项目: |
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| Influencing Factors of Me-too Oral Solid drugs on Therapeutic Effects |
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LI Yu, YANG Weifeng, HONG Liya
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Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
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| Abstract: |
| OBJECTIVE In this paper, we introduced the influencing factors of me-too drugs’ on therapeutic effects. METHODS The related references at home and abroad were summarized in recent years. RESULTS There are three major influencing factors, including quality of active pharmaceutical ingredient and drug polymorphism, drug preparation and the evaluation method of biological activity. Among them, drug preparation and drug polymorphism are two important uncontrolling factors in quality standard. CONCLUSION It provides a reference to improve the quality and quality standard of me-too drugs. |
| Key words: me-too drugs therapeutic effects influencing factors |
