Research On Screening And Emission Scenarios Of High-interest APIs In The Pharmaceutical Industry

Chinese pharmaceutical industry has maintained a rapid development posture in the development process of more than 60 years,which has become a recognized major country in the world in the manufacture and use of API.With the gradual emergence of the large-scale pharmaceutical effect,the pollution problem caused by the continuous expansion of the production scale and output of API has also attracted widespread attention.Some Active pharmaceutical ingredients(API)that have not been used effectively in drug production will have a serious impact on the environment due to their strong toxicity,persistence,accumulation and other properties.The drug production process is complex,there are many stains in the production,the related research on the potential emissions of API is vague,and there are no corresponding targeted regulatory policies and regulations at present,which brings great pressure for environmental protection.In response to the above problems,the contents and conclusions of this research are as follows:(1)This study followed the principle of index system construction and constructed a screening index system including 5 first-level indicators and 15 second-level indicators by using Delphi method.Analytic hierarchy model was used to determine the ranking of first-level indexes in the system as follows:special toxicity(0.3865),accumulation(0.2121),persistence(0.2121),general toxicity(0.1198),and exposure attribute(0.0694).The evaluation index system combined with the three-level screening model was used to obtain the list of the first batch of drug substances with top 20 scores,such as ibuprofen,finacetine and metformin.(2)Secondly,through screening and identifying the scene of China’s API production process,the technological process and product nodes of China’s fermentation and chemical synthesis pharmaceutical were obtained.Based on the actual production process,a three-phase estimation model of API potential emissions was obtained by combining the principle of material balance and iterative algorithm.Through questionnaire survey,field investigation and expert demonstration,eight extraction methods of API commonly used in China’s pharmaceutical industry were obtained,which were successively filtration,extraction,membrane separation,crystallization,adsorption,chromatography,centrifugation and distillation.The reference range,emission factor and corresponding model parameters of API extraction rate in the extraction process were determined.A calculation model of API potential emissions based on scientific theory and with certain calculation accuracy has been formed.(3)Finally,some drug firms in shandong API to extract phase blowdown nodes were analyzed,and the selection of caffeine and aminopyrine two typical drugs,for API production,extraction and final destination field sampling,the key link to the use of high performance liquid chromatograph,by external standard method to construct two drugs standard curve,and the actual content of the apis,samples The results showed that the extraction rate of drug active components in the process of caffeine crystallization could meet more than 90%,the three-phase loss rate of drug was less than 10%,and the distribution was basically in line with the design of related parameters of emission factors in the process of crystallization.In the filtration process,the extraction rate of active ingredients could reach about 85%,and the three-phase loss rate was less.The extraction rate of the extraction step can also be maintained at more than 90%and the distribution of water phase and solid waste phase is basically in line with the relevant design.The main extraction steps of aminopyrine drugs,such as filtration,crystallization and centrifugation,can maintain the extraction rate of 84%,92.86%and 88.94%,respectively.In line with the corresponding extraction range designed above,the error between the reference value of the emission factor model and the actual production value can be controlled within 3%,which has a good estimation accuracy.This study established a more scientific and effective bulk API high attention selection index system,build the pharmaceutical industry in our country API emissions scenario potential emissions calculation model and API,but to the pharmaceutical industry in our country provide data support API manufacturing API in quantitative research,to solve the problem of environmental pollution problems of drug active ingredient for reference.