Preparation Technology Of Cordyceps Sinensis Mycelium Dropping Pills

Objective Studies have shown that Cordyceps sinensis mycelium have antioxidant,immune and other effects.This study used Cordyceps sinensis mycelium as research subjects,aiming to develop which into dropping pills preparations.This systematic study included pre-formulation study,extraction technology,preparation process,quality standard evaluation and preliminary study of stability;,which has prepared the stable Cordyceps sinensis mycelium dropping pills,meted the needs of enterprises and markets,wishing to improve the quality of life.MethodsPre-formulation study:this section established an analytical method of polysaccharides in the Cordyceps sinensis mycelium by the UV spectrophotometry.After that,regarding the amount of effective ingredient as the index,established Cordyceps sinensis mycelium medicinal material sources,and investigated the physicochemical properties of Cordyceps sinensis mycelium by thin layer chromatography(TLC).Research on extraction technology:regarding the polysaccharides which extracted from Cordyceps sinensis mycelium as the index,the best extraction conditions of the medicinal materials were optimized through orthogonal test and single factor test(including the study of soaking time,solvent amount,decoction time and decoction times).Research on preparation model process:this part inspected the type of the matrix and coolant and some other conditions;screened the best proportion of the matrix and medicine,the temperature of the coolant,dropping distance and melting temperature,adopting the orthogonal experiment in order to optimize the preparation technology.And on the basis of laboratory test data,used dropping pill machine to carry out the preparation technology of dropping pill,ultimately determined the preparation technology of dropping pills.Quality standards evaluation:the research of the quality standards of Cordyceps sinensis mycelium dropping pills included appearance character,TLC identification,weight variation,disintegration time,content determination,and other aspects of the standard researches.Preliminary study of stability:according to the influence factors test and the test of accelerating stability,we can have the basic understanding of the quality characteristics of dropping pills and change rules.ResultsThis result of pre-formulation study demonstrated that the analytical method for polysaccharides by the UV spectrophotometry,obtained good linear relationship,high precision and the recovery rate met the requirements for the determination.In the TLC,the medicine is at the same place of the reference substance,showing the same color of fluorescence spot and the negative control without interference.This study investigated the amount of polysaccharides in various sources of medicinal materials,taking Cordyceps sinensis mycelium as the dropping pills’ research subject.The optimum extraction process of Cordyceps sinensis mycelium:this paper indicated the drugs were added 8 times amount of water,soaked for 45min,and water decocted and extracted for 3 times,60min/time.The optimumed preparation technology:the optimal process of dropping in the lab was drug:matrix=2:3,PEG2000:PEG4000=2:1,the condensate was silicon oil,the melted temperature was 80 ℃,the temperature of nozzle was 30℃,and the dropping distance was 7cm,the lower part of the condensate temperature was 10℃.Based on the laboratory preparation,by dropping mechanism for dropping pill to determine the best process that was drug:matrix(PEG2000)=2:3,the condensate was silicon oil,the oil bath temperature was 120℃,the fluid temperature was 120℃,the temperature of nozzle was 40℃,the condensate temperature was 30 ℃,and the dropping distance was from 6 to 8 cm.Quality evaluation:three successive batch samples of Cordyceps sinensis mycelium dropping pills,the appearance was round,pills weight variation,dissolution time and other indicators comply with the provisions,TLC method was good in specificity.In UV the determination of content of polysaccharides in Cordyceps sinensis mycelium dropping pills,the amount of polysaccharides should not be less than 179mg/g.In HPLC,the determination of content of adenosine should not be less than 0.034%.The methods were simple,precise and reproducible.According to preliminary researches of stability experiments,through the systematic information of dropping pills stability influence factors tests and accelerating tests,we could determine the drug storage information,packaging materials and other relevant conditions,to improve the stability of the effective components of drugs.Conclusions The Cordyceps sinensis mycelium as the research object,this paper finished the entire contents of the Cordyceps sinensis mycelium dropping pills,including pre-formulation study,extraction technology,molded process research,quality evaluation and supplied reliable quality control methods.It also laid a solid foundation for further developments of pharmacokinetic study and industrialization researches.