摘要
旨在探讨中药质量一致性评价问题,试图借鉴化学仿制药与原研药、生物类似物与原创药质量一致性评价发展现状和方法思路,结合中药自身的特殊性,总结目前在中药质量一致性评价领域具有应用潜力的技术手段,包括近红外光谱分析技术、生物活性检测方法、指纹图谱等技术手段,试图寻找合适的中药质量一致性评价方法,为保障中药的安全、有效提供借鉴与思考。
The study on the evaluation of quality consistency of Chinese materia medica（CMM） was presented in this paper. Based on the present and specificity of consistency evaluation for generic drug with its reference listed drug as well as biosimilar with its reference listed drug, combined with the general idea and the particularity of consistency evaluation for TCM, the paper describes the application of near infrared spectroscopy, bioassay and fingerprint in the quality consistency of CMM and investigates its application perspective, and tries to find a suitable evaluation method which can provide reference and thought for security and effectiveness of TCM.
出处
《药物评价研究》
CAS
2016年第1期38-45,共8页
Drug Evaluation Research
