Study Of The Production Technology And Quality Standard Of A Chinese Medicine For Treating Influenza

Influenza viruses, which cause an acute respiratory illness, pose a serious threatto human health due to their rapid spread and frequent mutation. Western medicinehaves some intrinsic flaws in treating influenza. In contrast, Traditional ChineseMedicine (TCM) possess a huge advantage of curing influenza. Mabai prescriptiondeveloped in practical application, a Chinese herbal formula, has a good effect againstinfluenza. However, Mabai prescription is not very convenient in use because of theformulation. Therefore, the conversion into granule by Mabai prescription willaccelerate the population in market with the aid of modern technology.In the present study, firstly, we studied the extracting patterns of seven herbs usedin Mabai prescription combining pharmacodynamic evaluation. It was observed thatthe extraction process of all the seven herbs together is efficient with simple operationand high extraction efficiency. Furthermore, the solvent water volume, extractiontime and the concentration of alcohol for precipitation were optimized to acquire aefficient extraction technology with the application of orthogonal test method,resulting in a optimal technology of the first extraction for30minutes with7timesthe amount of water, repeated extraction for20minutes with4times the amount ofwater, concentrated to1:1, and recovered extracts by ethanol precipitation with theethanol concentration up to50%. In the optimization of granule production, spraygranulation method was determined by comparing a variety of formulationtechnologies. In addition, the type of excipients, the proportion of excipients,granulating process (flow temperature, air temperature, feed rate) were investigatedto determine dextrin as the excipient with the ratio of1:1and the optimal granulationprocess: flow temperature of60-80℃, spray rate600-800mL/h, air temperature of30℃. Secondly, in order to construct quality control standards and technicalapproaches for herbs and formulation products, quality standards and testing methodsof seven herbs were established and improved based on Chinese Pharmacopoeia.Moreover, the identification and authentication method for key items of formulationproduct were determined based on efficacy evaluation. Meanwhile, the analysismethodology of key components of ephedrine and puerarin was established. Finally, aserial of pharmacodynamic tests showed that the Mabai granules significantlyinhibited influenza A virus and had certain antipyretic effects on fever in rats and rabbits. These experimental results were consistent with the functions of Mabaigranules, providing a good foundation for its clinical application.This study established a comprehensive production technology and qualitystandards of Mabai granules, which can help the production of clinical samples,contribute to the determining of the parameters of validation process, and providenecessary basis for the registration and declaration of Mabai granules.