Investigation And Study On The Production Process Parameters Kang'ai Injection

With major active ingredients of ginseng,astragalus and kuh-seng,Kang'ai injection is a traditional Chinese medicine injection frequently used as a clinical adjuvant therapy for cancer.It can strengthen body resistance,improve taste and enhance the immunity of organism.It is usually used in combination with other drugs for the treatment of non-small cell lung cancer,liver cancer,breast cancer,gastric cancer,intestinal cancer and other cancers,as well as tumors,leucopenia and hepatitis B.Production technologies decide the quality of traditional Chinese medicine injections.In this project,the key steps in the production of Kang'ai injection were investigated,production technologies were improved,contents of active ingredients?ginsenoside Rg1,Re,astragaloside and oxymatrine?were tested,and the safety of the products was evaluated so as to make the injection safe and reliable.In this paper,the production technologies for Kang'ai injection were optimized,And the parameters of the optimized process were reviewed.The extracted solution concentration method in the extraction technology,the time needed for water deposition,status after activated carbon was added and time need for the reaction of activated carbon in the refining technology were studied.In terms of the injection production technology,midbody ultrafiltration?membrane 100KD and 10KD?'s impacts on the contents of ingredients,as well as sterilization's impacts on the contents of ingredients of finished injections were observed.Currently,macromolecular substances in traditional Chinese medicine injections are usually removed through ultrafiltration,so as to reduce allergic reactions caused by injections.In this paper,filtrate's allergic reactions to Rat basophilic leukemia cell line 2H3?RBL-2H3?,before and after ultrafiltration were studied to evaluate ultrafiltration's role in ensuring the safety of Kang'ai injection.In this paper,HPLC-UV methods were adopted to explore ways for measuring the contents of ginsenoside Rg1,Re in Kang'ai injection.Octadecylsilane bonded silica gel was used as filler and Shimadzu VP-ODS C-18?150mm×4.6mm,5?m?was selected as chromatographic column.Moving phase were water?0.05%phosphoric acid?–acetonitrile?80:20?,liquid flow:1.0mL/min.HPLC-UV methods were adopted to explore ways for measuring the contents of astragaloside in Kang'ai injection.Octadecylsilane bonded silica gel was used as filler and Shimadzu VP-ODS C-18?150mm×4.6mm,5?m?was selected as chromatographic column.Moving phase:Water?1%phosphoric acid,with pH value standing at 2.5 after being adjusted by triethylamine?-acetonitrile?93:7?,liquid flow:1.0mL/min,detection wavelength:220nm,column temperature:30?.The methods were simple,convenient,rapid,accurate and stable with strong sensitivity,which can be used as reference for the control of the quality of the injection.In this paper,the safety of the Kang'ai injection was produced with improved technology which was evaluated through the RBL-2H3 degranulation experiment.Firstly,key steps in the RBL-2H3 degranulation experiment were studied.The RBL-2H3 cell?-hexosaminidase release rate detection method was studied via special substrate coloration.The best concentrations of substrate solvent?concentration of sodium citrate buffer?and stop buffer?NaCO₃/NaHCO₃?,concentration of substrate,as well as the amount of added lysate were measured.The experimental wavelength of?-hexosaminidase was measured and concentration of positive drugs was screened.Then,it was confirmed that the experiment model based on RBL-2H3 cells and measurement indexes of?-hexosaminidase release rate,histamine release amount and cell degranulation rate were the best experiment conditions.The quality of the optimized production technologies for Kang'ai injection was controlled by virtue of the HPLC method.After measuring the contents of active ingredients as well as the percentage of active ingredients in total solids?g/g?before and after the optimization of the production technologies,the concentration,activated carbon adsorption,ultrafiltration and sterilization technologies'impacts on decontamination effects and the contents of active ingredients were confirmed.The results of the study showed that extractors can either concentrate while extracting or contracting the extracted liquid at a time.Decoloration and edulcoration by adding activated carbon in purification technologies will not significantly lower the contents of midbodies.The best period for edulcoration by activated carbon is 48h.Ultrafiltration?ultrafiltration membrane 100KD and 10KD?won't significantly lower the contents of major activated ingredients during edulcoration and allergen removal.The ultrafiltrated filtrate's sensitization to RBL-2H3 cells has dropped.Therefore,it can be deduced that allergenic impurities may have been removed.The sterilization of finished products in purification technologies caused little loss of contents.Sterilized finished products had little impacts on sensitization to RBL-2H3 cells,but the sterilization of finished products were a necessary procedure.