Pharmaceutical Studies On Danhong Orally Disintegrating Tablets

Orally disintegrating tablets are the new drug preparations ,which are rapidly developed in the medicine field .from the current situations and concrete practice of our country's traditional Chinese medicine , Orally disintegrating tablets are able to be used in the traditional Chinese medicine's industry .Traditional Chinese Medicine (TCM) Injection as the important choice for the acute, serious and emergent diseases' treatment, many problems often occur. The Danhong injection, which has the function of promoting blood circulation and removing blood stasis, is the complex prescription made up of 2 medicinal herbs, including radix salviae miltiorrhizae and flos Carthamus tincuorius L. Using the prescription as model, the project seeks the way and methods of improving the quality of TCM injection theoretically and practically and promotes the development of TCM injection.In this project, aim at the problems proved in the clinic use, Orally disintegrating tablets were chosen to promote its efficacy, safety and stability.In the study of Danhong for injection, based on the characters of active substance, new extracting and separating techniques was applicated.In optimum condition of extraction and separation with macroporous resin, two semi-products, named Danshensu and total safflor yellow, which are active principles, were obtained from separated herbs.Comparing with different removing impurity methods, macroporous resin absorbing method was chose to remove the impurity. By reviewing the resin type, concentration, velocity, PH value , the concentration the alcohol and the volume. Determining the best technics conditions, the method can succeed to make the safflor yellow extraction substance.The decision of Danhong Orally disintegrating tablets prescription was adopted the single factor choice method to choose the high efficient disintegrating agent and fillcrs, lubricants ,optimizing the volume of disintegrating agents and fillcrs ,the main medicine dosage and lubricants .using the out-body disintegrating time and orally disintegrating time as the estimating index. The fluidity of power and appearance of tablet as criteria in the test .At last the amount of glidants and spicery and hardness are get by single factor experiment . the appearance of Danhong orally disintegrating is grey uniform and lubricant .It can disintegrate in mouth only in one minute and taste good .The technology of direct compression is simple and feasible in factories.The quality standards of raw material is established from the general inspection and content .The quality standards are establish according to the 2000 edition of Chinese Pharmacopoeia and the speciality of orally disintegrating tablets. several sample batches experiment show the established method is efficient ,stable and easy.This method can well control the quality of Danhong orally disintegrating tablets .