Study On Quality Control Of Platycodon Grandiflorum Granules And Evaluation Standard

Objective: To conduct quality testing research on the course of Platycodon grandiflorum,decoction pieces,Platycodon grandiflorum standard decoction,Platycodon grandiflorum dry extract and Platycodon grandiflorum particles?Methods:1.First collect 15 batches of Platycodon grandiflorum decoction pieces,checking the characters,identification,inspection,extraction,determination of content so as to choose the applicable decoction pieces by Platycodon grandiflorum formula particles?2.Make the standard decoction from qualified decoction pieces,make feature chart to characterize the features of Platycodon grandiflorum decoction by calculating extract rate,active ingredient content and transfer rate.3.Conduct single factor investigation using extraction time,extraction times and water volume.Then design orthogonal test of three factors at three different levels to get optimal extraction technique of Platycodon grandiflorum dry extract?4.Make 15 batches of extracts according to optimal extraction technique,separation method and drying methods of Platycodon grandiflorum.Design production techniques of granule through inspecting kinds of excipients,ratio between excipients and extract,wetting agent,drying methods and so on.Conduct physical and chemical analysis on particles and make the result as the reference frame of establishing quality standard of Platycodon grandiflorum formula particles.Results:1.The water content,ash content,extract,Platycodin D of 15 batches meet the quality standard of the first Platycodon grandiflorum in Chinese pharmacopoeia 2015 edition2.The extract rates of standard decoction in 15 batches are no less than 25%,transfer rates of Platycodin D are no less than 16%,and the content of Platycodin D is no less than 0.02%.Fingerprint similarity in 15 batches are no less than 0.95.3.Optimal extraction technique of Platycodon grandiflorum dry extract is to add 12 times,extract 3 times with 1.5 h each time according to the result of orthogonal test.The content of Platycodin D in 9 batches is between 0.01% and 0.04% with extract rates between 20% and 65%.4.Choose dextrin as granulating excipients when deciding excipients techniques.Make granular soft material from 80% ethanol as wetting agent in extract and dextrin proportion between 0.6:1 to 1:1.Dry in 60? to make granular,then finish granule with griddle 1 and griddle 5.Preliminarily formulate quality standard of Platycodon grandiflorum formula particles.Extract rates of 15 batches of dry extracts are no less than 42.1%.Water content of granular checked is no less than 7.0%.Reject ratio of particle size is not exceeding 11.0%.The content of Platycodin D is no less than 0.03%.Transfer rates of Platycodin D are no less than 24%.Fingerprint similarity of Platycodon grandiflorum particles is no less than 0.95.