光谱学与光谱分析
光譜學與光譜分析
광보학여광보분석
SPECTROSCOPY AND SPECTRAL ANALYSIS
2014年
10期
2632-2638
,共7页
李洋%吴志生%潘晓宁%史新元%郭明晔%徐冰%乔延江
李洋%吳誌生%潘曉寧%史新元%郭明曄%徐冰%喬延江
리양%오지생%반효저%사신원%곽명엽%서빙%교연강
在线近红外光谱%关键质量属性%质量控制%中药%生产过程
在線近紅外光譜%關鍵質量屬性%質量控製%中藥%生產過程
재선근홍외광보%관건질량속성%질량공제%중약%생산과정
On-line NIR%Critical quality attributes%Quality control%Chinese materia medica%Production process
中药生产过程具有多单元复杂性特点,制剂生产的各个环节均会影响中药产品的最终质量,在线近红外光谱技术具有快速、无损和不污染环境等优势,能够作为一种快速评价中药生产过程中关键质量属性的分析技术。以院校相关研究为切入点,系统阐述了在线近红外光谱技术在中药生产过程分析与控制方面的应用,并结合院校中药生产在线近红外光谱分析平台搭建为例,以此为依据阐明中药在线近红外光谱分析技术应用的可行性。进而,从企业应用角度出发,较为全面的综述了目前国内大多数应用在线近红外光谱技术的中药生产企业的研究成果及其中药产品。按照中药产品的两大剂型(液体制剂与固体制剂)进行分类,以液体制剂不同生产环节(提取、浓缩及醇沉等)为区分点,以固体制剂不同成品剂型(片剂、胶囊剂及膏剂等)为区分点,分别对近10年来中药生产过程中在线近红外应用进行系统综述,阐明中药生产全过程在线近红外技术应用的可靠性,为中药生产现代化提供有效的技术支撑。
中藥生產過程具有多單元複雜性特點,製劑生產的各箇環節均會影響中藥產品的最終質量,在線近紅外光譜技術具有快速、無損和不汙染環境等優勢,能夠作為一種快速評價中藥生產過程中關鍵質量屬性的分析技術。以院校相關研究為切入點,繫統闡述瞭在線近紅外光譜技術在中藥生產過程分析與控製方麵的應用,併結閤院校中藥生產在線近紅外光譜分析平檯搭建為例,以此為依據闡明中藥在線近紅外光譜分析技術應用的可行性。進而,從企業應用角度齣髮,較為全麵的綜述瞭目前國內大多數應用在線近紅外光譜技術的中藥生產企業的研究成果及其中藥產品。按照中藥產品的兩大劑型(液體製劑與固體製劑)進行分類,以液體製劑不同生產環節(提取、濃縮及醇沉等)為區分點,以固體製劑不同成品劑型(片劑、膠囊劑及膏劑等)為區分點,分彆對近10年來中藥生產過程中在線近紅外應用進行繫統綜述,闡明中藥生產全過程在線近紅外技術應用的可靠性,為中藥生產現代化提供有效的技術支撐。
중약생산과정구유다단원복잡성특점,제제생산적각개배절균회영향중약산품적최종질량,재선근홍외광보기술구유쾌속、무손화불오염배경등우세,능구작위일충쾌속평개중약생산과정중관건질량속성적분석기술。이원교상관연구위절입점,계통천술료재선근홍외광보기술재중약생산과정분석여공제방면적응용,병결합원교중약생산재선근홍외광보분석평태탑건위례,이차위의거천명중약재선근홍외광보분석기술응용적가행성。진이,종기업응용각도출발,교위전면적종술료목전국내대다수응용재선근홍외광보기술적중약생산기업적연구성과급기중약산품。안조중약산품적량대제형(액체제제여고체제제)진행분류,이액체제제불동생산배절(제취、농축급순침등)위구분점,이고체제제불동성품제형(편제、효낭제급고제등)위구분점,분별대근10년래중약생산과정중재선근홍외응용진행계통종술,천명중약생산전과정재선근홍외기술응용적가고성,위중약생산현대화제공유효적기술지탱。
The quality of Chinese materia medica (CMM ) is affected by every process in CMM manufacturing .According to multi-unit complex features in the production of CMM ,on-line near infrared spectroscopy (NIR) is used as an evaluating tech-nology with its rapid ,non-destructive and non-pollution etc .advantages .With the research in institutions ,the on-line NIR ap-plied in process analysis and control of CMM was described systematically ,and the on-line NIR platform building was used as an example to clarify the feasibility of on-line NIR technology in CMM manufacturing process .Then ,from the point of application by pharmaceutical companies ,the current on-line NIR research on CMM and its production in pharmaceutical companies was rel-atively comprehensively summarized .Meanwhile ,the types of CMM productions were classified in accordance with two formula-tions (liquid and solid dosage formulations) .The different production processes (extraction ,concentration and alcohol precipita-tion ,etc .) were used as liquid formulation diacritical points ;the different types (tablets ,capsules and plasters ,etc .) were used as solid dosage formulation diacritical points ,and the reliability of on-line NIR used in the whole process in CMM production was proved in according to the summary of literatures in recent 10 years ,which could support the modernization of CMM production .