On june27,2014, the pharmasep drug separation and purification technology exchange meeting was held at the Kaiyuan Manju hotel in Shanghai. Nearly 100 technical personnel from pharmaceutical enterprises and scientific research institutes engaged in drug R & D, analysis, production and other aspects attended the exchange meeting.
The technical exchange will focus on the technical means such as conventional liquid chromatograph, preparative liquid chromatograph and related chromatographic filler related to the purification and separation technology of impurities and chiral compounds in the process of drug research and development, as well as the practical application cases of the separation and purification of two categories of drugs: small molecule chemical drugs and traditional Chinese medicine. The atmosphere on the site was warm.
Chengdu biopurify technology Mr. Xie Qilin did“We also had a heated discussion and exchange with guests on the spot.
Reporter: Chengdu biopurify pharmaceuticals Ltd. Xie Qilin
Report title: enlarged production of chemical components of traditional Chinese medicine and related technologies
Meeting site
Xiaobaiming, executive technical director of Xiansheng Pharmaceutical Research Institute, gave his research ideas on the study of generic hetero mass spectrometry. According to the report, the impurity research process includes three parts: impurity research, genotoxic impurity research and methodology research. Among them, the impurity research should go through a series of procedures to determine whether there is a quality standard, whether there is an impurity structure, whether it is necessary to speculate the impurity structure, whether it can be obtained through literature, etc. until the research object is determined, on this basis, whether to continue the research or terminate the research is determined. The study of genotoxic impurities requires highly selective and sensitive analytical methods. After the research object is determined, the drugs need to be located after purchase, synthesis and preparation, and then the impurities are analyzed. This process involves methodological research for optimization.
Reporter: xiaobaiming of Jiangsu Xiansheng Pharmaceutical Co., Ltd
Report title: Thinking on the study of generic drug hetero mass spectrometry
Liuyueqing from Shanghai Medici bio Pharmaceutical Co., Ltd. introduced the establishment of HPLC method in impurity analysis. In the process of drug impurity analysis, HPLC method development process should go through six steps: first, determine the purpose of the analysis method and be familiar with the chemical properties of the compound; Second, determine the initial HPLC analysis conditions, that is, develop an analysis condition reaching the minimum separation limit for the method development experiment; Third, sample preparation, i.e. formulating an appropriate sample preparation process; Fourth, determine the appropriate quantitative methods, and use relative correction factors; Fifthly, the method optimization and durability experiment were carried out; Sixth, complete verification of the method according to the guiding principles.
Reporter: liuyueqing, Shanghai medix biomedical Co., Ltd
Report title: HPLC method establishment in impurity analysis
Dr. zhuwenming from Zhejiang Haizheng Pharmaceutical Co., Ltd. introduced the separation and purification technology and its application in pharmaceutical enterprises. The separation and purification technologies applied by pharmaceutical enterprises include recovery technology, cell crushing technology, preliminary crushing technology, preliminary purification technology, high purification technology and finished product processing, involving instruments and equipment such as preparation chromatography, centrifuge, filter press, supercritical extraction, multistage continuous extraction of beef willow, electrophoresis, simulated moving bed, chromatographic column, extraction tank, etc., of which preparation chromatography is an extremely important equipment in the R & D and production of drugs. The main index for evaluation of preparative chromatography is the amount of pure substances separated per unit time. High pressure preparation has great advantages in saving production time and cost, improving production efficiency, purification efficiency, safety assurance and environmental benefits, making it possible to develop green processes in the process of drug purification.
Reporter: zhuwenming, Zhejiang Haizheng Pharmaceutical Co., Ltd
Report title: separation and purification technology and application in pharmaceutical enterprises
Ma Baiping, a researcher from the Institute of radiation and radiation medicine, Academy of Military Medical Sciences, presided over the technical exchange meeting and made the "composition analysis report of chemical components of traditional Chinese medicine".
Reported by: mabaiping, Academy of Military Medical Sciences
Report title: composition analysis report of chemical components of traditional Chinese Medicine
In addition, Dr. caibin of sagacious chemistry and Dr. xujinyong of Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. were invited to give wonderful presentations.
Reported by: caibin of Ruizhi chemical
Report title: purification and preparation of chiral compounds
Reporter: xujinyong, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd
Report title: Study on the correlation between fermentation and preparation and purification
As the sponsor of this exchange, wanghongyu of bonaijer Technology Co., Ltd. introduced to the participants "the selection of chromatographic packing and process optimization".
Reporter: wanghongyu of bonaijer Technology Co., Ltd
Report title: selection of chromatographic packing and process optimization
Note: the above information is quoted from the instrument information network,
http://www.instrument.com.cn/news/20140701/135343.shtml