| OBJECTIVE:To establish the extraction process of swertiamarin,and to prepare swerpine bitterin tablets from swertiamarin.Methods:Determine the source of medicinal materials.The method of extracting sulfasoeglucoside from medicinal materials is mainly through ethanol or water as the solvent.After the extraction,the extract is concentrated and the extract is adsorbed by macroporous resin and eluted with ethanol to obtain sphagnum sprouts.The bitter glycoside,the resulting sulfasoeglucoside is a mixture,and the ingredients are slightly different depending on the active ingredients in the medicinal material,and the extract is used to prepare swertiamarin by macroporous resin.After the Spodoptera curcinoid monomer was obtained,the prescription was designed using the concept of quality derived from the design,and the inspection indicators were as follows:basis for specification selection,selection of excipients,selection of raw material particle size,compatibility of raw and auxiliary materials,dissolution examination,and pressure Pieces of parameters to explore,coating parameters explored.This product preparation process includes weighing,screening,mixing,intermediate determination,tableting,coating,and aluminum-plastic packaging.In the process of prescription exploration and process research,relevant parameters are accumulated,key process parameters are established,and key attributes affecting product quality are determined.According to the characteristics of product formulations,the establishment of inspection indicators,the main inspection indicators have traits,dissolution,tablet weight differences,microbial limits and content.With reference to the 2015 edition of the four pharmacopoeias,dissolution testing,microbiological limits,and content were tested for verification.The samples were tested for stability and the stability of the samples was evaluated.Results:The extraction process of medicinal materials was established.The main processes included extraction,concentration,adsorption,separation and purification.The specific parameters were:extraction of water 10 times,extraction time 0.5 hours,extraction times 3 times;extract concentration temperature 45??55?.vacuum degree 0.085mpa?0.095mpa;30%ethanol solution as eluent,elution rate with ethanol 0.8?1.0BV/h,elution volume about 3?4 times BV,elution end point According to the results of swertiamarin,the eluent concentration temperature was 45?55? and the vacuum degree was 0.085?0.095mpa.Concentrate the eluent to 0.20?0.25kg solution/kg herb;Concentrate the sample and refrigerate it at 10? for more than 24 hours to crystallize the sample of swertiamarin.Remove the sample and add 1 to 2 times the crystal sample.Ethanol was repeatedly washed 3 to 5 times,and the solution was filtered to obtain the swertiamarin sample.The preparation process of swertiapicrin tablets is to mix the materials for weighing the prescribed amount in a three-dimensional mixer for 15 minutes.The rotation speed of the three-dimensional mixer is 10r/min.After mixing,the prescription magnesium stearate is added and magnesium stearate is added thereto.After mixing for 5 min,the intermediates were tested(traits,contents).The traits should be white powder,and the content should be 37.0%to 45.0%.After the intermediates pass the inspection,the diameter of the stamp is 8mm,the pressure of the tablet press is 80?100N,the difference between the weight of the plain tablets when pressing is ± 2%,and the coating pan speed is 3?5 r/min,the weight gain of the coating was 3.0%to 4.0%.The establishment of quality institutes is feasible and there are no significant changes in the main indicators of stability studies.Conclusion:The established process parameters can produce qualified samples.The established quality standards can effectively control the product quality.The results of the stability study show that the swertiapicrin tablets are of stable quality. |
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