Injection Danhong (powder For Injection), Pharmaceutical Research

Traditional Chinese Medicine (TCM) Injection as the important choice for the acute, serious and emergent diseases' teatment, 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 carthami. 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, the freeze-dry form was 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 polyphenolic acids and total flavonids which are active principles, were obtained from separated herbs.The freeze-dry method is defined with the preparation confecting liquid, the excipient and the freeze-dry conditions.Exploring and establishing methods of quality control of semi-products and final products is very important means to ensure quality of final products. Characters, analyses of active components, safety have been studied for quality evaluation of semi-products and final products.The chromatographic fingerprint was established for botanical drugs, their semi-products and final products. High performance liquidchromatography was carried out under optimized experimental condition by means of gradient elution and UV detection. The method is specificity, reproducibility and applicability.The analysis of the components, stimulation and hemolysis for the powder for injection indicates that the new process can promote the content of effective components, reduce the similation and increase the stability.