Study On The Forming Process And Quality Standard Of Shengmai Dispersible Tablet Based On The Theory Of Component Compatibility Of Chinese Medicine

Objective:1.To study the effect of drug-drug interaction in shengmaiyin prescription,and screen out the most suitable extract method with a fusion theory of herbal components compatibility.To optimize the best extraction processes of Shengmai dispersible tablet.2.Screening the optimum shaping processes in terms of adjuvant category and amount of Shengmai dispersible tablets by studying the properties of adjuvant category.3.To study the qualitative identification of active ingredients and optimize the best Thin-Layer Chromatography(TLC)identification method of Shengmai dispersible tablets.4.To established a content determination method which is high standard,high quality and systematic for the active ingredients in Shengmai dispersible tablets according to the theory of traditional Chinese medicine.5.To study the preliminary stability of Shengmai dispersible tablets.Methods:1.The content of total saponins and lignans determinated by ultraviolet spectrophotometry and extraction rate to scereen the best extraction process by single factor experiment and orthogonal design experiment.2.To optimize accessories by measuring angle of repose compressibility degree of swelling etc.The pelletization disintegration time frangibility and mouthfeel were observed to scereen the filler disintegrants lubricants and sweetener of disperseible tablet by single factor experiment.The disintegration time were observed to scereen the formula and preparation technology of shengmai disperseible tablet by homogeneous design experimental.3.To optimize quality differentiation method of shengmai disperseible tablet by investigating different developer and Test sample preparing method.4.The content of total saponins and lignans of shengmai disperseible tablet determinated by ultraviolet spectrophotometry;and The content of effective components of important monomer determinated by High performance liquid chromatography.5.To investigate the stability of shengmai disperseible tablet,observing the remain specimen was done.Results: 1.The optimum extracting procedure was as following: red ginseng was crashed to coarse powder,and radix ophiopogonis are cut into segments,then refluxing extracted twice with 8 folds of 70% ethanol for 1.5 h each time.2.The results concluded the correlation parameters about the angle of repose,compressibility and swelling degree of excipients of tablets.The optimized prescription of Shengmai dispersible tablets is composed of 58% microcrystalline cellulose,8% cross-linked carboxy methyl cellulose,4% Sodium carboxymethyl starch,2% low-substituted hydroxypropyl cellulose,2% Magnesium stearate,1% stevioside.The preparation process is:the amount of 70% ethanol as a binder,wet granulation method,low-substituted hydroxypropyl cellulose additional,hardness of the tablets was 25 N.3.Established a reliable method for the qualitative identification of the Shengmai dispersible tablets and obtained the content determination method of total saponins,lignans and ginsenoside Rg1,Re and Rb1,ophiopogonin D,schisandrin,Deoxyschizandrin γ-Schizandrin and other important monomer.4.And the preliminary stability test of Shengmai dispersible tablets was also carried out.The results shows that all of the indicators are qualified.Shengmai dispersible tablets has a good stability.5.The detection thresholds of Shengmai dispersible tablets met the needs of general rules on preparations.The disintegration time-limit was less than 3 min and particles were all able to pass through the No.2 sieve.The draft standards of Shengmai dispersible tablets was also established.Conclusion:The established extracting method is high efficiency and less time-consuming,and the preparation process is reasonable for the preparation of Shengmai dispersible tablet under the guidance of the effective component compatibility theory.The method is in good reproducibility,precision and stability and is fit for the quality control of Shengmai dispersible tablet.The developed quality standard has a strict and stability index,which provide a good foundation for industrial production of Shengmai dispersible tablet.The results have reached the anticipated target of the subject.