The Study On New Technology And Quality Standard Of Liver-Protecting Tablet

Liver-protecting Tablet comprises Bupleurum,Capillaris,Indigowoad root,Shizandra, Pulvis fellis suis and Mung bean.It is a national essential drug,with significant clinical effects.It is used for chronic hepatitis and early cirrhosis.Liver-protecting Tablet's traditional production technology is relatively backward.The quality standards are at low level.It is the secondary development based on the original process.We conducted a systematic research on the preparation technology,quality standard and stability.It provides a scientific basis for the secondary development of Liver-protecting Tablet.1.Extraction process:Supercritical carbon dioxide was used to extract the active principle from Shizandra.In addition,the extracts were included byβ-cyclodextrin. Bupleurum was extracted by ethanol.We used L₉(3⁴)orthogonal test to optimize the best extraction process.The results shows that the extraction process is effective,reliable and practical.2.Optimum process:We used the single-factor study process to determine the best technics for adhesives,disintegrants and lubricants.With"Opadry"for thin-film coating, replacing the original sugarcoated.The results shows that the optimum process is effective, reliable and practical.3.Quality standard:In this study,TLC method was used on the qualitative identification of Schisandra,Bupleurum and Pulvis fellis suis.The results show that the establishment of TLC analysis of the method is simple,clear spots and good reproducibility. HPLC method was used to investigate the contents of Schisandra for Liver-protecting Tablet.The study is provide a scientific basis for the test of the main components of Liver-protecting Tablet,which greatly raised the level of product quality control.4.Inspection of Stability:By accelerate stability and long-period stability of the goods for inspection,its character,identification,disintegration time and determination were in line with Pharmacopeial standards.The present study provided a scientific basis for the industrialization of new technology Liver-protecting Tablet's large-scale production.It has laid a good foundation for the research and development of new drug.Meanwhile,it can offer references for the modernization of traditional Chinese medicine.