The Pharmaceutical Research Of The Danshan Xiaozhi Granules And The Preliminary Analysis Of Its Protecting Liver Effects Composition

Non-alcoholic fatty liver disease is one of the common clinical diseases in the digestive system.with the change of people's life style and the improvement of people's living standards,the incidence of the disease presents a rising trend year by year and the onset age has a tendency to be more and more smaller.Non-alcoholic fatty liver disease has increasingly become a common threat to humans health.For a long time,People have spend a lot of money and effort to find out the medicine to prevent and treat the disease.And practice has proved that Chinese medicine and its compound preparations has their unique advantages in the treatment of non-alcoholic fatty liver disease.From the national center for liver disease treatment in Hubei Hospital of Traditional Chinese Medicine,Danshan Xiaozhi granules is proved to be effective by the clinical treatment experience in liver disease.It is consists of Satvia miltiorrhiza Bge,Semen cassiae,Crataegus pinn-atifida Bge and so on.In the clinical,it is mainly used in the treatment of non-alcoholic fatty liver disease caused by liver stagnation,blood stasis and retention of dampness.Danshan Xiaozhi granules is mainly taked as tea.To promote its using in the treatment of nonalcoholic fatty liver disease,at the same time,to overcome the too many times drinking of tea and the disadvantages of traditional decoction including inconvenience decoction,excessive doses,tasting bitter and inconvenience carrying,we develop it into granules in this thesis topic.To promote its clinical application,we make the quality standards for Danshan Xiaozhi granules and observe the stability of it.At the same time we also has carried on the preliminary analysis of the Protecting Liver effects composition.All of these are Laying a solid foundation for developing it into hospital preparations.Considering Danshan Xiaozhi granules as a whole,the preparation process was investigated.By the method of orthogonal experiment,the extraction process was studied,and the reliable technical parameters were obtained;types and dosage of Supplementary material and the critical relative humidity were studied systematicly by using Modern preparation technology.then the reasonable preparation process was established;Pilot verification was carried on and it can be stepped into industrialization.By using Analysis methods,Danshan Xiaozhi granules's characteristics,TLC,Content determination of a variety of effective composition,the size of the granules,melting of granules,heavy metals,arsenic salt,and water examination have been studied systematiciy.Perfect quality standards was made for it.And these can effectively control the immanent quality of Danshan Xiaozhi granules.According to the stability of natural medicine research in the TCM guiding principles,based on the quality standards of Danshan Xiaozhi granules,accelerated tests and room temperature observing tests were used to study the stability of Danshan Xiaozhi granules.The indicators have no obvious changes,which indicates that Danshan Xiaozhi granules have stable quality in the warranty period.thus it provide the basis for its clinical application.The analysis of liver cell extraction-HPLC was established,and we applied it to analyze the Protecting Liver effects composition of the Danshan Xiaozhi granules.As a result,the Protecting Liver effects composition can be detected partially from water extraction of Danshan Xiaozhi granules.It can prove the hepatoprotective effect of the Danshan Xiaozhi granules from the cellular level.