Preparation And Evaluation Of Yanhoushuning Tablets

In recent years, due to the decline in air quality, the stimulation of spicy food, alcoholand tobacco, the incidence of throat diseases has increased year by year, which has becomea major factor of harm to human health. At present, the main treatment drugs for throatdiseases in the market are western medicines which have many kinds of side effects. Whilefew varieties of traditional Chinese medicines are available in the market. Andrographispaniculate, which is known as the Chinese medicine antibiotics, has good effects of heatclearing, detoxicating, blood cooling, and reduction of swelling. Beside, that no tablets ofwhich raw material is Andrographis paniculate is listed on the market makes it possible toopen up a broad prospect in the treatment of throat diseases. Therefore, Andrographispaniculate used as a raw material in my study, assisted by a herb named Wikstroemia indicawhich aims to develop a new medicine of the treatment for throat diseases. What’s more,buccal tablets which can produce a long efficacy in the local is selected as the dosage form.I have made a preliminary exploration on the preparation process and the efficacy in orderto provide the experimental basis for a new drug.The thesis was consisted of six parts. In the first part, it was the course of theresearch on the extraction process, which was based on our analysis of each individualcomponent contained in each herbal medicine in its pharmacological action,parmadynamics, physical and chemical properties, as well as the main action of the wholerecipe, its extraction process has been classified into two parts. Andrographis paniculatewas extracted by ethanol, Wikstroemia indica by methanol. In the extraction technique ofWikstroemia indica, The orthogonal test design was used to determine the four main factors of extraction process, including amount of methanol, extraction time, extraction operationfrequency and ultrasonic power. The content of daphnoretin was determined by HPLC. Weconducted that the optimum extracting conditions of daphnoretin were: extracted with12times methanol solution twice,2h each time, ultrasonic power was160W.The second part is the purification process. Andrographis paniculate and Wikstroemiaindica extract liquid were concentrated. In order to get high purity andrographolide anddaphnoretin, the Andrographis paniculate and Wikstroemia indica extracts were dividedwith solvent and re-crystallization by two times.The third part is the tablets-forming of Yanhoushuning Tablets. We decided a finalforming process based on different kinds of contents, proportion of forming auxiarymaterials and dosage of Aspartame, and different types of ashesive. We conducted that theoptimum tablets-forming: andrographolide5%, daphnoretin2.5%, a2:1mixture ofmannitol and lactose91%, aspartame1%and amount of binder PVP which can be pressedtablet with good taste and good color.In the fourth part, we studied the acute toxicity and anti-inflammatory effects ofYanhoushuning Tablets. In the oral acute toxicity test, there were no obvious aymptoms andno death, the maximum tolerated dose(MTD) of both sexes were greater than10g·kg-1which is equivalent to approximately1,000times the adult dosage(adult weight:60kg).Through our studies, We conducted that it is non-toxic and safe for human health ofYanhoushuning Tablets.The fifth part was the conclusion which consisted of the extraction process, purificationprocess, the acute toxicity test and the anti-inflammatory test of Yanhoushuning Tablets.The sixth part is an overview about study on the advances in Andrographis paniculate,Wikstroemia indica and buccal tablets in recent years. It will be helpful in the followingstudy of exploiting the preparation process and the efficacy in order to provide theexperimental basis for a new drug.