Development Of A Traditional Compound Chinese Medicine Freeze - Dried Powder

The objective was to prepare a compound traditional Chinese medicine lyophilizedpowder, and study the quality and stability of the lyophilized powder.The water alcoholprecipitation was applied to traditional Chinese medicine extract. Orthogonal test method wasused to the removal of tannin by gelatin method, taking transfer rate of the main component(chlorogenic acid, table to spring and matrine) in the liquid and the removal of tannic acid asindex, concentrate proportion of Chinese medicine extract, pH and temperature was explored.Using orthogonal experiment method,freeze-drying process parameters can be calculated byfreeze-dried rate;High performance liquid chromatography (HPLC) was applied to contentanalysis of chlorogenic acid,epigoitrin and sophocarpidine.To evaluate the security by testingthe vessel stimulation, hypersensitivity and hemolytic test in vitro.The stability was evaluatedby classical stress test, accelerated test and and long-term test.Test results: tannide can not be completely removed by water alcohol precipitation.Tannins was removed by gelatin,and the effective compounds in liquid transfer rate wasbiggest,when the solution concentration ratio was1:3, pH was7, temperature was80℃.Freeze-dried formula: the pharmaceuticals concentration was20%, scaffold was10%mannitol,and pH is6-7.The lowest total melting point of the sample was-3--8℃.Freeze-dryingprocess:freezing at-50℃for5h,the primary drying at-20℃for14h,the secondary drying30℃for10h.The producing was well in formability, appearance and Complex dissolution.Thecomponent content was uniform and stable. It did not occur hemolysis, allergy and irritationreaction. The producing was stable of traitsin in the high temperature test, illuminationstability test, accelerated test and long-term test.In conclusion, Prescription is reasonable.Preparation technique of lyophilized powder isfeasible.The quality is control.