Study On Preparation Technology And Quality Standard Of Ginsenoside Rd Enteric-coated Dropping Pill

Objective:Ginsenoside Rd?GRd?is one of the main active ingredients in ginseng and has a lot of biological activities.However,it has poor water solubility,easily degraded under acidic conditions and easily oxidized by oxides,and has low bioavailability.In order to improve the bioavailability of GRd,and expand the scope of application,the preparation technology and quality standard were studied.Methods:Thermal stability and dissolution test of GRd.The solid dispersion method was used to prepare GRd enteric-coated dropping pill core,and the single-factor and orthogonal factor experiments were conducted to study the forming process of the dropping pill,and then the process of coating GRd enteric-coated dripping pills was optimized.Finished product were detected by Fourier Transform Infrared spectrometer?FTIR?and Differential Scanning Calorimetry?DSC?analysis.Measured the cumulative release of GRd enteric-coated drip pills,draw a curve,and perform a linear or non-linear fit on the release mode.Establish the quality standard of GRd enteric-coated drip pills.Results:The thermal stability of GRd was determined by High Performance Liquid Chromatography?HPLC?,FTIR,and DSC analysis.Results the content of sample treated at70?changed little compared with that at room temperature,the content of samples treated at75?and 80?degraded little compared with that at room temperature,and the material structure did not change.Experiments can be performed in this temperature range.The optimal preparation process of pellet core was determined as follows:The temperature was 70?,dimethyl silicone oil was used as the condensing agent,the matrix ratio was PEG4000:PEG6000=4:1,the dropping distance is 6cm,and the ratio of the drug to the matrix was 1:8.The optimal process parameters for drip pills coating were determined as follows:The material temperature was 40⁴3?,the inlet air temperature was 65?,the outlet air temperature was maintained at 41?above,the main engine speed was 9 r·min^-1,the inlet air rotation was 1300 r?min^-1,the exhaust air rotation was 1000 r?min^-1,and the atomization The pressure was 0.25MPa,Hydroxypropyl Methyl Cellulose Phtalate?HPMCP?was selected as the coating material,the concentration of the coating solution was 15%,and the coating time was 45min.FTIR and DSC analysis showed that a solid dispersion was formed;the release fitting results showed that the dropping pills conformed to the first-order release equation with a fitting constant of 0.9861,The release amount of GRd in 0.1mol?L^-1hydrochloric acid within 2h was lower than the detection line;melting time of GRd enteric-coated dripping pills was 23.11min,the weight difference was 7.83%,which meet the requirements of the Chinese Pharmacopoeia,the content was 1.3mg/granule,the quality standard was established.Conclusion:The preparation process of GRd enteric-coated dripping pills is reasonable,stable and feasible,which will protect GRd from acid damage,and the quality evaluation method can effectively control its quality.It can effectively improve the bioavailability of GRd and provide an experimental basis for its clinical application.