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目的列举分析常见的化药制剂处方研究存在的问题。方法结合化药制剂处方研究重点,详解了现场核查中发现原料药和辅料考察、处方设计、筛选和优化方面各自存在的问题。结果和结论制剂处方研究作为药学研究的重要部分,是药品审评的重点内容,全面、合理、规范的处方研究是保证药品质量的重要基础。
Objective To analyze the problems existing in the study of prescriptions of common chemical preparations. Methods Combined with the key points of prescription preparation of chemical preparations, the problems existing in the inspection, prescription design, screening and optimization of APIs and excipients found in the on-site inspection were explained in detail. RESULTS AND CONCLUSIONS As a key part of pharmacy research, formulation research of prescriptions is the key content of drug evaluation. Comprehensive, reasonable and standardized prescription research is an important basis for ensuring the quality of medicines.