| ObjectivesThe extraction of traditional Chinese medicine is an important step in the production of Chinese medicine products,and the design of extraction workshop is of great importance to the production of the whole traditional Chinese medicine pharmaceutical factory.The workshop design should not only meet the needs of the production of traditional Chinese medicinal preparations,but also consider the particularity of the traditional Chinese medicine.At present,the production of traditional Chinese medicine is still in manual or semi-automated state in our country.In many chief production processes,we still rely on employees’ experience to make judgement.This mode of operation not only causes high labor intensity and low production safety,but also makes the process parameters difficult to be accurately controlled.Therefore,the product quality between batches is of great difference,the production efficieny is low and the cost is high,which results in poor competition ability with other developed countries.The establishment of the automatic control system of traditional Chinese medicine extraction can solve the stability and reliability of the preparing process and composition of Chinese medicine products from the source of the product,and enable the manufacture integrate with the national GMP standard better,which is beneficial to guarantee the quality of products.Automatic control can enhance the production capacity of traditional Chinese medicine extraction and increase the output value,which will make the extraction of traditional Chinese medicine an important part of enterprise profit.At present,many modern Chinese medicine enterprises have made the extraction of raw Chinese medicine materials as a breakthrough to enter the international market.Therefore,the automation design of extraction,concentration and precipitation of traditional Chinese medicine will change the characteristics of traditional Chinese medicine production model.It will help traditional Chinese medicine industry in our country realize pipelining,continuous and automatic extraction in the design of workshop and preparing process,which may improve production efficiency,medicine quality and batch uniformity of traditional Chinse medicine production in new situation,thus to promote the upgrading of extraction technology and realize digital pharmaceutical manufacture gradually.In order to enhance production efficiency and product quality,we designed an automatic extraction workshop of advanced domestic level according to the needs of our pharmaceutical enterprise and the requirements of current national GMP in this work.Methods:1.Firstly,the production capacity was re-planned according to the traditional extraction process of oral solution.Then,the process and layout of traditional Chinese medicine extraction workshop was designed from aspects of capacity design,material balance,equipment selection and design,production process flow design and workshop plane design.2、Base on the process and layout design of workshop,the automatic control design of key process parameters of extraction,concentration,alcohol precipitation,ethanol blending,ethanol recovery and Clean-in-place(CIP)cleaning were performed according to extraction process flow of traditional Chinese medicine.The system was controlled using ECS-100 decentralized control system software.3.Take the production of Antiviral Oral Solution,a major product of our company,as an example,the performance of the automatic extraction workshop after put into production was investigated from output,safety,labor number,product yield,energy consumption,cost and product quality.Results:1.The process and layout design of automatic extraction workshop with an annual 6000-ton throughput of traditional Chinese medichinal materials was completed.It provides basis for the design of automatic control system of workshop in the next step.2.The automatic control system of extraction workshop was completed,and the system was controlled using ECS-100 decentralization control system software.The system can meet the needs of production safety of chemical system.Meanwhile,the system software can be conveniently embedded in the Field Bus equipment and the third party distributed control system,which not only satisfies the requrirements of user operation,but also facilitates maintenance and use.The design of automatic extraction workshop is in line with the requirements of GMP.It is mature,reliable,stable and advanced.The workshop can effectively achieve online automatic control in the production of traditional Chinese medicine extraction,so as to promote the process of digital pharmaceutical manufacture of the enterprise.3.Take the production of Antiviral Oral solution as an example,the output,safety,labor number,yield,energy consumption,cost and product quality were compared before and after the automatic extraction workshop was put into production.After the workshop was put into production,the annual output has increased year by year,the incidence of safety accidents has decreased significantly,the labor number has been reduced to the half of that of traditional extraction workshop,and the annual extraction amount has been risen to more than 1.7 times of that of traditional extraction workshop.In term of production cost,it is 17% lower than that of the traditional extraction workshop.In terms of energy consumption,compared with traditional extraction workshops,about 10 million yuan is saved every year,reduce carbon emissions by 641729 kilograms.In addition,the automatic extraction workshop can achieve the product yield close to the traditional extraction workshop without considering the work experience of workers,and the yield and quality of product is relatively more stable than that of traditional extraction plant.Conclusion:This work introduced online automatic control system and detection system to extraction of traditional Chinese medicine,which enable the chief processes to realize continuous production.In the case of ensuring product quality,the use of automatic extraction workshop overcomes some weakness existing in the production of traditional extraction workshop,and enhances the production efficiency and batch uniformity of medicine qulity of the pharmaceutical enterprise as well.This study provides valuable practical reference for the design,validation and use of the automatic control system in traditional Chinese medicine extraction workshop of pharmaceutical enterprises.It also offers a certain research evidence for gradual realization of digital pharmaceutical manufacture. |
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