Study On Production And Quality Of Protect Liver Chewable Tablets

Chronic hepatitis serious influence of the human health,great harm to life safety,the search for chronic hepatitis,become the enormity of the task of scientific research and clinical,also in the world today is an urgent need to solve one of the major public health problem.Protect liver chewable tablet use of national essential drugs protect liver piece of legal prescription,mainly composed of radix bupleuri,herba artemisiae,radix isatidis,fructus schisandrae,pig bile powder,mung bean,early used in the treatment of chronic hepatitis and liver cirrhosis.It is novel and convenient to take and is more suitable for patients with difficulty in swallowing.Compared with the previous dosage forms,it has the advantages of fast drug dissolution,good absorption and high bioavailability.Purpose:According to the national legal prescription,optimization of the extraction and preparation technology parameters to determine the best process conditions after pilot production,through the study of hepatinica chewable tablet quality standard inspection product stability,safety and efficacy,which explicitly protect liver chewable tablet preparation technology feasibility,stability and security.Methods:The feasibility,stability and safety of the preparation process of liver chewing tablet were investigated by examining the stability,safety and effectiveness of the product,Results:Using the optimal design of single factor test and orthogonal test,determine the optimal production technology of fructus schisandrae ethanol extraction process?This is 8 times the amount of 95%ethanol extract 2 times,each time 2 hours,with the highest content of fructus schisandrae alcohol armour for the iconic composition.In molding process study,examines the taste masking agent,filling agent,wetting agent,lubricant,the best choice and dosage,aims to produce uniform particles,tabletting ideal,stable quality,protect liver chewing tablets,and compared with the current pharmacopoeia process,has been clear about the key process parameters,the actual production efficiency have improved.In this paper,the quality standard of the chewable chewable tablets was established through the quality research test,and the quality assurance of the test,the pilot and the process of production was established.According to the method of quality evaluation in accordance with the national regulations,this paper studies the characters,identification,inspection,content determination and so on,and obtains the accurate,stable and feasible test method.Conclusion:The stability test of the chewing-protected chewers was carried out,including accelerated stability test and long-term stability test,through three consecutive batches of pilot production.And through the stability study,the shelf life of the chewable tablets was tentatively determined to be two years.The results of stability study indicate that the quality of the product has not changed,which indicates that the preparation technology of protecting liver chewing tablet is reasonable,the test method is accurate,the quality standard is reasonable,and it can be better applied to the actual production.This paper provides a scientific basis for the commercial production of the chewable chewing tablet,which lays a good foundation for the development of new drugs,and provides a feasible reference for the modernization of Chinese medicine.