| Objective:1 To establish a method for content determination of main active components of Shengmai dispersible tablets,providing a scientific basis for the quality standard of Shengmai dispersible tablets.2.Saponins are the main active ingredients of ginseng and ophiopogon japonicus,and occupy important pharmacological activities.The effective extraction and separation of total saponins is the key precondition for further study and utilization of shengmai new dosage form.According to the research idea of component Chinese medicine,conduct basic research,and optimum extraction and purification of active ingredients of saponins.3.To study the physical indexes of Chinese medicine preparation materials(extract powder),and explore the mass properties of the powder,the accumulation,the liquidity,the pressure and the stability,and complete its quality consistency evaluation.Methods:1.Establish a content determination method:Using ultraviolet spectrophotometry and shengmai saponins as the index to explore different color rendering methods,with ginsenoside Rgl,Re,Rb 1 and ophiopogonin D for reference substance.The best control and the color rendering method were determined by comparing the effects on the determination of total saponin content.HPLC-UV and HPLC-ELSD were used to determine the content and establish the quality standard,with ginsenoside Rgl,Re,Rb1 and ophiopogonin D for reference substance.2.Extraction process research:Adopting uniform design test method,factors influencing the extraction rate of saponins were selected:ethanol concentration,extraction time,amount of ethanol and extraction times;ginseng was measured by the extract rate,total saponins and ginsenoside Rg1,Re,Rb1;ophiopogon japonicus was measured by the extract rate,total saponins and ophiopogonin D.To determine the optimal extraction process by examining the influence of ginseng,ophiopogon japonicus single extract or mixing on the main active ingredients.3.Purification process research:Taking total saponins as the index,D101 macroporous adsorption resin was used for comprehensive investigation from both static and dynamic aspects.The effects of resin type and PH on adsorption capacity were investigated by static exchange adsorption.Dynamic exchange adsorption is investigated from two aspects:adsorption and desorption,Including the resin diameter ratio,the concentration of the upper sample liquid,the maximum sample size,the alcohol concentration,the dosage and the flow rate of the eluent,so that the best purified process parameters of the drink can be selected.4.Study on the physical properties of ginseng extract powder:Application of BT-1000 powder synthesis characteristic tester for 3 batches of ginseng samples to determine physical parameters,including bulk density,tap density,the collapse of the Angle of repose,Angle,flat Angle,moisture absorption,water content,dispersion,the parameters were normalized and the quality consistency was evaluated from the visual evaluation(radar map)and similarity evaluation.Results:1.The content of total saponins in the samples was determined by using vanillin-acetic acid-perchloric acid colorimetric method,with ginsenoside Re for reference substance.2.Extraction process research:Extract ginseng and ophiopogon japonicus separately.The extraction conditions of ginseng:12 times amount of 85%ethanol,2 times extraction,each time 2h;the extraction conditions of ophiopogon japonicus:12 times amount of 71%ethanol,2 times extraction,each time 0.5h.3.Purification process research:The optimum purification process of ginsenoside is 0.1g/ml of ginseng extract,5.9BV for the upper sample,6.6BV for distilled water,and 5.9BV for 70%ethanol and 1.5ml/min;ophiopogon japonicus is 0.2g/ml of extract,2.9BV for the upper sample,5.2BV for distilled water,and 5.2BV for 60%ethanol and lml/min.4.Study on the physical properties of ginseng extract powder:Thephysical indexes of the three batches of ginseng extracts purified substance from the same manufacturer were close to each other,and the similarity between batches was greater than 99.5%.Conclusion:This study the compatibility of traditional Chinese medicine composition theory with the Chinese medicine extraction and separation technology,modern preparation technology,the combination of both inherited the compatibility of traditional Chinese medicine theory,and using the modern science and technology,provide effective way for research and development of traditional Chinese medicine compound.To establish a method for the determination of the effective components of pharmacological activities and the simultaneous determination of monomers.Through the comparison of the experiment indexes of single and mixed,the extraction and purification process was optimized,and a set of complete and feasible quality standard parameters were worked out.It provides a reliable basis for the preparation and quality control of new drugs. |
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