The Study Of The Quality Standard And Material Base Of Zhong-Jie-Feng Injection

Sarcandra glabra is a drug contained by the The Pharmacopoeia of the PRC2010edition, is the plant of Chloranthaceae which is used as medicine by dry herb.Theherb is acrid-bitter flaver,neutral in nature.Its' functions include removing heat tocool blood,promoting blood flow and removing ecchymoses, dispelling wind andremoving obstruction in the meridians and so on. The herb is also used for thesuggillation and purpura which usually caused by the heat in blood, rheumatic painand the injury from fractures.Zhong-Jie-Feng(ZJF) injection is extracted by Sarcandra glabra,using themethod of boiling water and alcohol precipitation, adding excessively egg protein toeliminate tannin and some(6‰mL/mL) Twain80to help dissolve.It has the efficacyof clearing away the heat evil and expelling superficial evils, subsiding swelling andremoving stasis. It could be used to treat pneumonia, appendicitis, cellulitis, bacillarydysentery, abscess caused by heat toxin, and cancer of the digestive tract, pancreaticcancer, liver cancer etc, if we combined it with zhong jie feng stablet.To control the quality in an all-around way so as to ensure the safety andefficacy of injection,the chemical components of ZJF injection have been studiedsystematically. The main research work of this thesis is summarized as follow:1. QAMS is used for multi-index content determination of medicinal materialsof Sarcandra glabra and its' injections. Through the determination of one of thecomponents (isofraxidin), we can establish a relative correction factors (RFC)between the composition and other effective components (Chlorogenic acid,Chlorogenic acid,4-Dicaffeoylquinic acid,Caffeic acid and Rosmarinic acid), andthen calculate the other components of the content, realize the simultaneousdetermination of multi-component.2. It has been established for a TLC identification towards the distinctiveconstituent of ZJF injection.3. According to the relevant regulations(aim at injections) of the the ThePharmacopoeia of the PRC, published in2010, more inspections about ZJF injection should be done, such as related substances, total solid, burning residue. And we alsoestablish an inspection item about abnormal toxicity, anaphylaxis, hemolysis andagglomeration of ZJF injection, on the basis of the guiding principle ofPharmacopoeia Committee about injection security inspection.4. Fingerprint is buiLt to reflect flavone and coumarin chemical componentswith ZJF injection as subject investigated, so that product quality and batchhomogeneity could be controlled. And we also make a relative study between ZJFinjection and its crude drugs.5. Content determination of Isofraxidin and Rosmarinic acid was developedwith HPLC in Sarcandra glabra crude drugs, but in ZJF injection, it is fumaric acid.So medicine quality could not be controlled very well because of the absence ofrelevance. And we build a content determination of Isofraxidin and Rosmarinic acidin ZJF injection with HPLC in order to avoid this situation.6. This theme analyzed the content of total sugar, general flavone, amino acid,twain80and eLement of ZJF injection of20batches from two companies.In conclusion, through the study mentioned above on ZJF injection, fingerprintand the content determination of ZJF injection is established, initially revealed thechemical material base. It is a very important significance to ensure the qualitycontroll ability and safe and effective of the ZJF injection. This method, can bewidely used to study many other traditional Chinese medicine, and providesreferences to completely quality control of it.