Process Optimization Of Fengreganmao BL Granules

BL granule is a traditional Chinese medicine prescription of R Company,which is composed of fritillaria thunbergii and forsythia.It is used to treat the wind-heat type common cold.It failed to put into production in time after our company bought it from R Company.Now,our company plans to resume production of BL granule to meet the increasing demand of the market.This paper mainly studies the material information and production process of the product about the resumption of production.The specific research work will be listed as follows:(1)Information collection and analysis:?the composition of the prescription and the preparation process were analyzed combined with modern technology and production experience;?fritillaria thunbergii and forsythia,the main medicinal materials of the prescription,were analyzed from the aspects of main chemical composition,pharmacological action,common extraction and detection methods and the current situation of the market;?The historical production data are analyzed.The results showed that both the formulation and the technological process could support the resumption of production,but there are still some anomalies to be studied.(2)Trial transfer procedure:Combined with the results of(1)medium analysis,under the guidance of the production process transferred by R Company,the product was successfully prepared by pilot-scale test,but some of the transfer process was not operated according to the legal method,and there are long production cycle,high energy consumption,pelleting difficulties and other defects.(3)Extraction process optimization:Negative control,L9(34)orthogonal test and two-factor anova are used to study the effects of hydrochloric acid on the transfer process,extraction of fritillaria thunbergii and forsythia,alcohol precipitation of forsythia,concentrating B crude drug extract on the basis of(2)pilot production results.Then the extraction and concentration process were optimized according to the research results and the company's production conditions.(4)Optimization of granulation process:The defects of high viscosity,difficult mixing and poor granulation were solved by the granulation process of the original concentrate extraction to extract powder granulation process on the basis of(2)pilot production results.(5)Analysis of abnormal content transfer rate:preparing control samples based on the optimized process to compare test methods,the results showed that the main reason of transfer rate from crude drug to concentrate extraction more than 100 percent was the test methods difference between t crude drugs and finished products,the second main reason is the poor specificity of finished product inspection method.The above research has laid the production technology and technical foundation for the resumption of BL particles production.