Research And Development Of Zhizhu Orally Disintegrating Tablet

Functional dyspepsia is defined as persistent or recurrent upper abdominal pain or discomfort not explained by structural or biochemical abnormalities, including early satiety, epigastric fullness, belching, acid regurgitation, heartburn, nausea, vomiting and so on, it is one of the main clinical digestive system disease currently. In common use and digestive classic prescription, there is good curative effect to the function indigestion. The traditional Chinese herbal medicine pill takes inconvenient, collapse in stomach the speed is slow. The efficacy of medicine is hard to release. It can't attain to expect the curative effect. Orally disintegrating tablet as a new dosage form appears abroad medicine market in recent years. It can dissolve in a minute without water, so it has the characteristics of facility, fast and high bioavailability. We will traditional pill an absorption for making into mouth cavity collapse slice, making its in mouth cavity starting collapse, quickly medicine, from but attain soon the purpose that effect is efficiently. In this paper, orthogonal method was used for selecting the best extracting technology and the ingredient of prescription. The best extracted conditions by water were as follows: extracted with 10 times the amount of herbs by water for 3 times and each time 1.0 hour. We pass the collapse slice assist to anticipate, a product for feeling with collapse time ect. Making sure mouth cavity soon collapsing slice prescription has with system the method.To control the quality of zhizhu orally disintegrating tablet ,we established the qualitative and quantitative methods for the extracts and medicine. The identification of Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus in the extract and zhizhu orally disintegrating tablet by TLC. The content of youpi in the extract and zhizhu orally disintegrating tablet were determined by HPLC.Finally,the scale-up experiment for industrial production was carried out. The experimental results showed that the zhizhu orally disintegrating tablets produced after scale-up experiment were in accordance with Chinese pharmacopoeia in appearance,weight difference and ingredient. It indicated that production technology in this study had a high recurrence and production quality was easily controlled, so it could be industrially produced.The subject carried out a systematical study of the zhizhu orally disintegrating tablets on the preparation technology and quality control method. It also established the foundation for suiting to industrial production.