ABSTRACT
The mixing process is one of the key operation units for solid preparation of traditional Chinese medicine. The physical properties such as particle size, density and viscosity of the mixture are key factors that need to be controlled, which will directly affect the performance of the preparation molding process and product quality. Subsequent dripping process performance and appearance qua-lity of dripping pills will be affected by dynamic viscosity of materials in the mixing process. Based on this, with mixing process of compound Danshen dripping pills as the object, a feedforward control method for the dripping pill mixing process was established based on the concept of quality by design(QbD). Firstly, critical quality attribute(CQA)-dynamic viscosity, critical material attributes(CMAs)-the moisture content of compound Danshen extract, average molecular weight of polyethylene glycol 6000 and critical process parameter(CPP)-mixing temperature were identified through the analysis of properties for multiple batches of the raw materials and excipients as well as technological mechanism. Then the Box-Behnken experimental design was used to establish the regression model among CMA, CPP and CMA(R■=0.972 0, RMSE =16.24) to obtain the design space. Finally, through the verification of three batches within the design space, the mixing process temperature was adjusted according to the properties of the raw materials and exci-pients to achieve accurate control of the dynamic viscosity attribute. The relative deviation between the actual dynamic viscosity value and the target value was less than 3.0 %. The feedforward control of the mixing process of compound Danshen dripping pills was rea-lized in this study, which can contribute to improving quality consistency of the mixing process intermediates, simultaneously provide a reference for the research on the process quality control of other Chinese medicine dripping pills.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Research DesignABSTRACT
Objective To prevent the occurrence of academic misconduct in sci-tech periodicals from the source.Methods Based on the control theory in modern management,the method of inductive analysis was adopted.Results To define the feedforward control of academic misconduct in sci-tech periodicals,identify three-level feedforward control that including author,author's institution and the sci-tech periodical editor.Conclusions Three level feedforward control is an effective way to prevent academic misconduct.
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In this work, we obtained the quality information of Panax notoginseng with near infrared spectroscopy in an efficient way. By combining the quality information of raw materials with process parameters in experimental design, quantitative relationship models were established between material quality information, process parameters and product quality of P. notoginseng, thus realizing the feedforward control of the alcohol extraction process. The quantitative models established have high robustness and satisfactory forecasting ability. With new batches of P. notoginseng introduced for the alcohol extraction process, the quality information of raw materials was rapidly obtained. Based on the established models, the process parameters were optimized according to the expected critical quality attributes (CQA), thereby reducing the fluctuation of product quality caused by raw material variation.
ABSTRACT
As a widely applied process control strategy in chemical industry, the feedforward control strategies have been applied in pharmaceutical manufacturing to reduce the quality fluctuation of drugs. The application of feedforward control strategy in the manufacturing of Chinese materia medica (CMM) can help us to understand the relationship between input material attributes, process parameters and critical quality attributes (CQAs), and then to establish an optimal model for the adjustment of process parameters based on input material attributes with the aim of minimizing the variation of CQAs. Before the production of the new batch, the most suitable process parameters for the input materials can be calculated by the optimal model. The motivation of this paper is to provide an overview of recent research on application of feedforward control strategies in pharmaceutical manufacturing and demonstrate perspectives of their application in CMM.
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Objective To investigate the practice and effect of specialist nursing inspection of intravenous infusion in the quality control of specialist nursing. Methods Intravenous infusion treatment nursing group used feed-forward control theory and methods, taking cross-sectional research methods yearly from 2014 to 2016 and referencing intravenous infusion special quality checklist to fully understand the hospital infusion tool selection situation and quality. Intravenous infusion related treatment system operational procedures was established and improved, the monthly quality control plan was made to do quality nursing of intravenous infusion specialist inspections and timely feedback of each month to various sections of the hospital. Results The rational choice of the hospital infusion tool was more reasonable. The proportion of steel needle in 2016 compared with in 2015 and 2014 was decreased by 8.9%(321/920-212/846), 18.8%(321/920-156/968). Intravenous infusion quality was significantly improved in the catheters′normative fix, nursing staffs′mastery of the skills and related expertise control rate, intravenous infusion treatment-related complications e.g. Phlebitis above grade two in 2016 were reduced 22 cases and 30 cases compared with in 2015 and in 2014, meanwhile the number was 18 and 31 in drug extravasation case. Conclusions Special nursing of intravenous infusion has a good effect on the improvement of nursing quality, and feed-forward control is an effective method for quality control of intravenous infusion therapy.
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Objective To explore the preventive effect of feedforward control on unexpected extubation in patients with cerebral apoplexy.Methods The clinical data of 42 cerebral apoplexy patients during May 2010 and May 2011 were retrospectively reviewed to find out the risk factors of unexpected extubation.The feedforward control was used to manage 49 cerebral apoplexy patients during June 2011 to June 2012 to control the risk factors.The incidence of unexpected extubation was compared between pre-and post-use of feedforward control. Results After application of feedforward control,the incidences of unexpected extubation of gastric tube,deep vein tubes and urinary tubes reduce were significantly decreased compared to pre-use of feedforward control(all P<0.01).Conclusion The feedforward control on patients with cerebral apoplexy is effective in reducing the incidence of unexpected extubation and ensuring the intubation safety.
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Gaseous ethanol may be recovered from the effluent gas mixture of the sugar cane fermentation process using a staged absorption column. In the present work, the development of a nonlinear controller, based on a neural network inverse model (ANN controller), was proposed and tested to manipulate the absorbent flow rate in order to control the residual ethanol concentration in the effluent gas phase. Simulation studies were carried out, in which a noise was applied to the ethanol concentration signals from the rigorous model. The ANN controller outperformed the dynamic matrix control (DMC) when step disturbances were imposed to the gas mixture composition. A security device, based on a conventional feedback algorithm, and a digital filter were added to the proposed strategy to improve the system robustness when unforeseen operating and environmental conditions occured. The results demonstrated that ANN controller was a robust and reliable tool to control the absorption column.
Deseja-se recuperar o etanol perdido por evaporação durante o processo de fermentação da cana-de-açúcar. Para tanto, faz-se uso de uma coluna de absorção. O controle da concentração de etanol no efluente gasoso da coluna é realizado pela manipulação da vazão de solvente, sendo esta determinada pelo controlador não linear proposto, baseado em um modelo inverso de redes neurais (controlador ANN). Foram feitas simulações adicionando-se um sinal de ruído a medida de concentração de etanol na fase gasosa. Quando perturbações degrau foram inseridas na mistura gasosa afluente, o controlador ANN demonstrou desempenho superior ao controle por matriz dinâmica (DMC). Um dispositivo de segurança, baseado em um controlador feedback convencional, e um filtro digital foram implementados à estratégia de controle proposta para agregar robustez no tratamento de distúrbios ocorridos no ambiente operacional. Os resultados demonstraram que o controlador ANN é uma ferramenta robusta e confiável no controle de uma coluna de absorção.
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Objectives Using the theory and method of feedforward control management to control the blind spot of nursing safety of preoperative fasting time for children,so that the actual preoperative fasting time for children is close to the standard preoperative fasting time.Methods We established preoperative fasting nursing procedure according to feedforward control based on reasons for common long preoperative fasting time of infants facing expected operation from September 2005 to September 2006.Children facing expected operation were divided into the experimental group(66 cases)and the control group(58 cases).They adopted preoperative fasting nursing procedure after feedforward control and the traditional nursing procedure respectively.Preoperative fasting time between the two groups was compared and analyzed.Results There was significant difference about the preoperative fasting time between the two groups,P＜0.01.The actual preoperative fasting time for infants in the experimental group was close to the standard fasting time.Conclusions Using preoperative fasting nursing procedure with feedforward control,the blind spot of nursing can be partially emilinated,and the actual preoperative fasting time for infants is close to the standard.