Research On Puerarin Orally Disintegrating Tablets

Puerarin is an active constituent extracted from the traditional Chinese herb Radix Pueraria lobata Ohwi and P.thomaonii Benth, which has been widely used to treat cardiovascular and cerebrovascular diseases. Puerarin Orally disintegrating tablets (P-ODT) fit to emergency,low side effect and so on.With the guidance of the theories of pharmaceutics,on the basis of abundant literature materies,in combination with the property of Puerarin, we systematically studied Preparation process, Quality standard and Preliminary Stability by adopting the modern pharmacy research technology and according as the national drugs registration policing method.Taking the disintegration time, water-absorbing and hardness as the evaluation indexes, to explore the filling material, dissolution material, effervescence material, lubricatal material, sweet material and dissolving-helper material, the single factor test and orthogonal test was adopted. In the preparation process, P-ODTs were prepared by Wet- pelleting compression. In Quality standard research, HPLC mothed adopted to measure the content of Puerarin in the finished products. In Stability research, tested Appearance, Disintegration time, Hardness, Weight- difference, Brokenness and Dissolution, all the three samples of enlarge test met the request of Quality standard and were proved to be steady during the observation time of three months.The study shows that the preparation process is scientific, reasonabal and practical. Moreover, the quality standard is controllable and the quality of the sample is steady as well.