| 水分活度用于中药临方制剂微生物控制的应用现状及前景 |
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| 引用本文： | 李益萍,王优杰,赵立杰,鲜洁展,林晓,吴飞,洪燕龙.水分活度用于中药临方制剂微生物控制的应用现状及前景[J].上海中医药大学学报,2022,36(1):85-90. |
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| 作者姓名： | 李益萍 王优杰 赵立杰 鲜洁展 林晓 吴飞 洪燕龙 |
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| 作者单位： | 上海中医药大学中药现代制剂技术教育部工程研究中心 上海201203;上海中医药大学中药学院 上海201203;上海中医药大学中药现代制剂技术教育部工程研究中心 上海201203;上海中医药大学中药学院 上海201203;上海中医药大学中医健康服务协同创新中心 上海201203 |
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| 基金项目： | 国家自然科学基金资助项目(81973490);上海市自然科学基金资助项目(20ZR1458400,18ZR1439800,18ZR1436600,19ZR1457700);上海市“科技创新行动计划”技术标准项目(20DZ2200900)。 |
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| 摘 要： | 水分活度(简称a;)是食品和化妆品行业快速评价微生物风险和产品稳定性的重要指标之一。基于a;的原理深入分析a;对微生物生长的作用,综述目前药学研究中a;的应用现状,并借鉴食品、化妆品行业中a;的测量方法及应用方案,探讨a;用于中药临方制剂微生物风险控制的应用前景。此外,由于中药临方制剂对时限性的特殊要求,常规的细菌检测过程耗时过长,不能与其特性相适应,因而a;的引入将大大降低产品微生物检验的时限压力,有助于提高制剂的安全控制能力,为中药临方制剂的开发和应用提供高效可行的质控方案。
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| 关 键 词： | 水分活度 药品生产 中药临方制剂 微生物生长 栅栏因子 |
Application status and prospect of water activity in microbial control of personalized traditional Chinese medicine preparations |
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| LI Yiping,WANG Youjie,ZHAO Lijie,XIAN Jiechen,LIN Xiao,WU Fei,HONG Yanlong.Application status and prospect of water activity in microbial control of personalized traditional Chinese medicine preparations[J].Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai,2022,36(1):85-90. |
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| Authors: | LI Yiping WANG Youjie ZHAO Lijie XIAN Jiechen LIN Xiao WU Fei HONG Yanlong |
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| Institution: | (Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;School of Pharmacy,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Traditional Chinese Medicine Health Service Collaborative Innovation Center,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China) |
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| Abstract: | Water activity(a;)is an important index for rapid evaluation of microbial risk and product stability in food and cosmetics industry. Based on the principle of a;,the effect of a;on microbial growth was deeply analyzed and the application status of a;in pharmaceutical research was reviewed. The application prospect of a;in microbial risk control of personalized traditional Chinese medicine(TCM)preparations was discussed by referring to the measurement methods and application schemes of a;in food and cosmetics industry.In addition,due to the time-limitation requirements of personalized TCM preparations,the conventional bacterial detection process takes too long time to adapt to the characteristics of personalized TCM preparations. Therefore,the introduction of a;will greatly reduce the time-limitation pressure of product microbial testing,help to enhance the safety control ability of preparations,and provide an efficient and feasible quality control scheme for the development and application of personalized TCM preparations. |
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| Keywords: | water activity pharmaceutical production personalized traditional Chinese medicine preparations microbial growth hurdle factor |
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