Study On The Sustained-release Pellets Of Rutin

Hypertension,which is a common chronic disease and a serious threat to human health,often can cause a series of complications of the heart, brain, kidney and other organ,such as cerebral hemorrhage,chronic renal failure. A condition of hypertension,which could be lead to glomerulosclerosis and renal function decreased,and the low status of urine concentrating,azotemia and uremia.Rutin is a monomer that extracted from traditional Chinese medicine with the name of Flos Sophorae.It’s also the main active components of Sophora japonica.At the same time,it has a wide range of pharmacological effects,and a obvious therapeutic effect on cardiovascular disease,could also be used to relieve the symptoms of hypertension,especially. In this pape,to focus on the characteristics that the hypertension is a kind of chronic diseases.the author took the sustained-release principle and the technology that fluidized bed coating with bottom spray to prepare sustained-release pellets of Rutin.First of all,according to the nature of the drug,the author investigated a series of items of Rutin in Sophora japonica extract,such as the character identification, identification of thin Layer Chromatography,determination of content,and so on.A quality control standard for determinating content of Rutin in bulk drugs was created,and the experimental method was also verified.Then,according to the properties of the drug and excipients,based on a large number of preexperiments,we determined the process parameters of the technology that fluidized bed coating with bottom spray.Under the premise of fixed pellets and Rutin content, through the single factor experiment,the effect of the dosage and the final amount of hydroxypropyl methyl cellulose (HPMC), polysorbate-80,opadry-Ⅱ on in vitro release in the spacer layer,the controlled release layer and the isolation layer were investigated and determined. At the same time,it found that lactose dosage,ethylcellulose aqueous dispersion(Surelease) and the content of controlled release coating had a significant effect on the release in vitro of sustained-release pellets of Rutin.Next, we adopted a data software of Design-expert for the Optimization Design with Box-Behnken response surface optimization of the prescription of sustained-release pellets of Rutin.By a large number of experiments,the author obtained a series of test data,used the multivariate quadratic regression equation to fit the data.obtained as a function Between the variables and the response values,maked a detailed analysis,and got the best factor level.Simultaneously.the best prescription of prescription should be verified.Finally,the detection method of the release in vitro of sustained-release pellets of Rutin was established by UV method.In the meantime,the author conducted the qualitative identification of agents by TLC identification.used HPLC method to determine the content and preliminary stability of the preparation,etc.,and establish the quality standard for it.The preliminary stability tests found that the formulation are very stable in the light or at high temperatures.but it had some moisture absorption in high humidity environments.Therefore.sustained release formulations need to be saved in a dry environment.