Studies On Cabazitaxel Injection

Cabazitaxel is a novel taxane antitumor drug that is a microtubule inhibitor prepared by subtracting from the yew extract of semiotetic synthesis.FDA on June 17,2012 approved the listing,Sanofi Aventis for the original research firm,for the treatment of docetaxel regimens of hormone refractory metastases of prostate cancer.China’s incidence of prostate cancer is lower than Europe and the United States,but also showed an upward trend year by year,the use of carbapamide treatment may become a new treatment options.Cabazitaxel is active against docetaxel-sensitive and insensitive tumors.Studies have shown that the drug has a good killing effect on human cell lines,and the clinical response is small,mainly neutropenia.Because of the efficacy of this product is good,low adverse reactions,so far this product is not listed in the country,in order to facilitate the clinical needs of the majority of patients,to be developed cardibasai injection.According to the physical and chemical properties of the raw materials of carbapasset,the main research items are as follows:solvent selection,stable pH range,selection of packaging materials,solvent removal method selection,selection and optimization of freeze-drying parameters,Solvent elimination temperature selection,the relevant key process parameters to establish the preparation of the main drugs,including liquid,intermediate detection,sterilization filtration,filling,semi-pressure plug,freeze drying,pressure plug,rolling cover and so on.The target of the developed product is not less than the reference preparation,and the impurity spectrum of the prepared preparation should be consistent with the reference preparation.In the quality study,according to the nature of the drug to establish the indicators,the main indicators of the solution with the pH value of the solution,clarity and color of the solution,traits,insoluble particles,related substances,bacterial endotoxin,sterile and content.In accordance with the five pharmacopoeia of 2015 edition,we tested the method of sterilization,bacterial endotoxin and content,and established the relevant substance inspection method in combination with drug impurity,and studied the impurities in excess of the identification limit.The adoption of the draft established drug standards research on the stability of three batch samples,inspection index has clarity and color character,pH value,solution and related substances and content,etc.The results show that the inspection indexes of the test and reference preparations,all the indexes in limit range,drug quality stability.This topic the research results show that the kappa he injection preparation stability,comprehensive quality standard study,good stability results,scientific and feasible,and has the ability to support mass production.