Study On Prescription Technology Optimization And Quality Standard Of Ribavirin Injection

Ribavirin Lin also called three ribavirin and Leigh Bhave,be nice,is a veteran of nucleoside antiviral drugs,the clinical wide application in the treatment of respiratory tract infection,virus,influenza virus,oral herpes and many other aspects have made significant effect.The first drug in 1972 by the United States ICN Pharmaceuticals biochemical pharmaceutical company successfully developed and listed.China began to develop in 1973,1981,the raw materials of spray and injection in various forms have been gradually began to enter the market registration approval.Ribavirin injection Topfond Pharmaceutical Co.the company’s current production has reached about 80 million,as one of the pillar product topfond.The sterilization process F0 registered prescription Ribavirin Injection’s current value is less than 8,the product sterility assurance level is low,the higher risk of aseptic quality.And the sterilization process need filling aseptic filtration and sterile by the mode of production,personnel operation and production environment is difficult to control the production process in the preparation of filling,cleaning and sterilization of high frequency,resulting in higher costs.In addition,drug registration formulation with 102% labeled amount of feed,activated carbon ratio is 0.4%larger adsorption on the main raw materials of high cost drugs.In view of the above situation,this topic on Ribavirin Injection’s prescription process was optimized and the optimized products of quality and stability,the main research results obtained as follows:1,Through the study of different pH value of the content of related substances,such as the quality of the samples under the conditions of the situation,determine the best pH value is5.2-5.4;through the study of different sterilization conditions related substances,content of sample quality,determine the sterilization process is 115 c * 30 minutes by adding the amount of wet heat sterilization;the activated carbon.100%,to determine the raw material feeding theory indicate the amount of carbon added,liquor quality and volume ratio of 0.1%.The prescription after the optimization process can improve the aseptic production process to ensure the ability of Ribavirin Injection,and with the transformation of the mode of production by filtration and aseptic filling for sterilization,reduce the difficulty of operation personnel process control and production environment,production process in the preparation of cleaning and sterilization by filling the frequency once a day Reduced to once every 7 days,each batch of raw materials to reduce the amount of 4.8kg,saving the cost of raw materials1700 yuan.2,The formulation and process after optimization of three batches of product quality is evaluated comprehensively,Ribavirin Injection developed a method for determination of related substances.And from the specific sample solution,stability,limit of quantitation and detection limits,linearity and range,accuracy and precision,durability and other aspects of the inspection method was confirmed.Relative to the current Chinese Pharmacopoeia standards,clear the four known impurity limits: Leigh Bhave Lin acid is less than or equal to0.23% and three were less than 0.23%,less than 0.23% amide uracil and uridine is less than or equal to 0.23%.Accurate and controllable methods to establish new standards,reasonable limit.3,According to Ribavirin Injection quality standard of three batches of products were investigated for acceleration and long-term stability,the three batch of products in the accelerated and long-term experiments on its properties,pH value,content,related substances,visible foreign matter,endotoxin and other quality indicators compared with the initial value did not change significantly,further The prescription proved the optimized process is stable and reliable,stable,safe and effective drug quality.Study on the prescription process optimization and quality in March 2017 was issued by CFDA re registration documents,this document number: 2017B00621,at present,has been applied to industrial production of 44 million 550 thousand,the total output value of about 30 million 739 thousand and 500 yuan,26 million 284 thousand and 500 yuan to create profits for the company.