CAJ | 학술논문

作者参考相关文献，结合目前中药生产工艺研究状况及中药品种保护审评工作实践，就生产工艺对已上市中药品种安全性影响的有关问题进行了逐项分析。发现生产工艺过程、工艺变更及新技术的应用等因素都会对已上市中药品种的安全性产生一定影响，针对这些问题提出加强中药基础研究、建立高于现行质量标准的内控质量标准、加强工艺验证、利用中药品种保护制度进行品种改进提高等相应的监管建议。
작자삼고상관문헌，결합목전중약생산공예연구상황급중약품충보호심평공작실천，취생산공예대이상시중약품충안전성영향적유관문제진행료축항분석。발현생산공예과정、공예변경급신기술적응용등인소도회대이상시중약품충적안전성산생일정영향，침대저사문제제출가강중약기출연구、건립고우현행질량표준적내공질량표준、가강공예험증、이용중약품충보호제도진행품충개진제고등상응적감관건의。
Analysis has been made on the key factors in production processes that have an impact on the safety of marketed tradi-tional Chinese medicinal products based on literature research, current production situation, and practice of reviewing the protected products.It has been found that production process, technology changes, and novel technology all play certain role in safety of marketed traditional Chinese medicinal products.Therefore, the following recommendations have been made:to strengthen the fun-damental research, establish in-house quality control with higher quality standards than current national quality standards, strengthen validation of production processes, make better use of the protection system to improve quality of traditional Chinese me-dicinal products.