Mechanical Technology Study On Erlong Zuoci Pills And Production Process Validation

Currently,hand-made method,as one of the main production methods of traditional Chinese medicine pills,still has shortcomings at the same.The operating points mainly depend on the experience,and those great differences make poor stability.With the 2010 version of Good Manufacture Practice of Medical Products being carried out,the standard and normalization of Chinese traditional medicine manufacture is already a trend.Mechanical technology of pills are taken more and more seriously.Erlong Zuoci Pills,also as Tinnitus Pills or Chaici Dihuang Pills,come from Collector of crane Pavilion.It increases two herbs-magnet(calcined)and bamboo leaves bupleurum-on the basis of Liuwei Dihuang Pills.Erlong Zuoci Pills have the effect of nourish the kidneys and calm the livers,and as a classical prescription,it has definite curative effect and wide application on deficiency of liver-yin and kidney-yin,hearing loss,tinnitus,and dizziness.There is no literature reports about the study on mechanical technology of pills in the variety.The research subject of this paper will focus on the preparative technology of Erlong Zuoci Pills.By collating and analyzing the technological process and control parameters of the mechanical technology of pills,we can determine the main process parameters,namely,the raw materials were crushed to fine powder and mixed,the ratio of Powder : Honey is selected as 1:0.4,water addition was 7% and refined medicine 1 time,the transmission frequency at 0.9,the mold tool mouth of 5.0mm and knife size at 5.2mm,the pill weight control in every 10 pills weight 1.00 ~ 1.15 g,drying temperature at 75℃,were selected.At the same time,with the use of quality risk management method,we have already made a process critical evaluation for Erlong Zuoci Pills.It is concluded that the key technical parameters of the corresponding,and based on this,three batch process validation have already done.All above has further confirmed that the process is stable,reliable,and the products meet quality standards.What’s more,through the research of this paper,it summarized the process improvement program of the method about Chinese traditional medicine(water-honey pills),especially from technology and technology assessment based on risk analysis,and verification of the mass production.This paper has finished the optimization of process parameters of mechanical technology of pills and completed the large production process validation of Erlong Zuoci Pills.Other traditional pills for the future of technology improvement,can also provide reference.