中国中药杂志

2014, v.39(14) 2787-2790

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医疗机构制剂动态化质量控制的研究思路
Study thought of pharmaceutical preparations quality standards by dynamic quality control technology

郁丹红;毛晨梅;吕承哲;金慧臻;姚鑫;贾晓斌;
YU Dan-hong;MAO Chen-mei;LV Cheng-zhe;JIN Hui-zhen;YAO Xin;JIA Xiao-bin;Department of Pharmacy,Affiliated Children's Hospital,Soochow University;Department of Pharmacy,First Affiliated Hospital of Soochow University;Key Laboratory of New Drug Delivery System of Chinese Materia Medica,Jiangsu Provincial Academy of Chinese Medicine;

摘要(Abstract):

医疗机构制剂,特别是作为"独家秘方"的中药复方制剂,是我国医疗卫生行业的特色产物,同时又是医疗机构相互竞争的重要手段。虽然医疗机构制剂所具有的优势和特色,是药物研究所以及制药企业无可比拟的,但是,多年来医疗机构制剂的质量标准一直未达到理想水平。众所周知,药品的质量控制是医疗机构制剂发挥疗效的重要保证,尤其是在人们对药品的安全性、有效性日益重视,国家对医疗机构制剂监管日趋严格的形势下,医疗机构更加应该重视自身产品的质量。该文结合医疗机构制剂质量控制的现状,以"过程动态质量控制技术"为指导,建立符合医疗机构特点的医疗机构制剂,特别是中药制剂质量控制的研究方法,以期提高制剂质量标准,改善制剂质量的稳定性,提高临床疗效,最终为完善、统一和规范医疗机构制剂的质量提供新的思路。
Pharmaceutical preparations,particularly as a "secret recipe" of traditional Chinese medicine in medical institutions,are the product of China's medical and health industry,and they are also an important means of competing of different medical institutions. Although pharmaceutical preparations have advantages and characteristics than institutes for drug and pharmaceutical companies,the quality standards of pharmaceutical preparations in medical institutions has not reached the desired level over the years. As we all know,the quality of pharmaceutical preparations is important to ensure the efficacy,especially under the environment of people pay more sttention on drug safety and effectiveness and contry increase emphasis on the stste of pharmaceutical preparations. In view of this,we will improve the grade,stability,and clinical efficacy of pharmaceutical preparations by the advanced equipment,testing instruments and the process dynamic quality control technology. Finally,we hope we can provide new ideas for the quality control of pharmaceutical preparations.

关键词(KeyWords): 医疗机构制剂;过程动态质量控制技术;质量标准
pharmaceutical preparations;process dynamic quality control;quality standards

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作者(Author): 郁丹红;毛晨梅;吕承哲;金慧臻;姚鑫;贾晓斌;
YU Dan-hong;MAO Chen-mei;LV Cheng-zhe;JIN Hui-zhen;YAO Xin;JIA Xiao-bin;Department of Pharmacy,Affiliated Children's Hospital,Soochow University;Department of Pharmacy,First Affiliated Hospital of Soochow University;Key Laboratory of New Drug Delivery System of Chinese Materia Medica,Jiangsu Provincial Academy of Chinese Medicine;

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