Studies On Preparation Process And Quality Standards Of Gusong Jiangu Granule

Object: By consulting literatures of Chinese medicine in Gusong Jiangu prescriptionand researching the preparation process and quality standard, provide foundation fordeveloping a preparation which is safety, effective, stability and reliable.Method:1. Consult literatures about herbs in Gusong Jiangu prescription.2. The research of preparation technology: Extraction technology of Gusong Jiangugranules was optimized by orthogonal test with the amount of water, extraction timeand times as influential factors while the content of icariin and extract rate as indexes.The optimized process was verified. Purify technology was optimized by precipitatingwith ethanol. Dry granulating technology was adopted to make granules and moistureabsorption percentage, dissolve capacity, angle of response and granules yield werechosen as index to investigate suitable supplementary material.3. The study of quality standard: Epimedium, Fructus Corni, Radix Angelicae Sinensis,Atractylodes Macrocephala, Pheretima were identified by thin layer chromatography(TLC) while the content of icariin and loganin were determined by high efficiencyliquid chromatography(HPLC).Result:1. The optimized preparation process was as follows: all the Chinese medicineextracted3times with10times the amount of water,1hour each time; the extractionliquid was merged all together and concentrated to a relative density of1.08~1.10(60℃).After the liquid cooled down to room temperature, adding ethanolslowly and stirring quickly to make sure the concentration was70%.Then the liquidwas filtered and recovered the ethanol until non-ethanol taste by standing24hours.Next, the liquid was concentrated to clear paste which would be dried by vacuumdrying and shattered. The dry powder and the same amount of dextrin mixed togethercompletely which would make granules by drying granulating technology.2. The research of identification: the TLC stain is distinctly and the method was highlyspecific with good reproducibility. HPLC was used to determine the content of icariinand loganin,and the assaying method was researched. As a result, icariin has a good linear relationship in the range of0.434~3.038μg and the related coefficient(r) is0.9998.The linear range of loganin was0.374~2.618μg (r=0.9996).The averagerecovery rate of icariin and loganin were99.76%,99.77%, and RSD were2.11%(n=6),2.00%(n=6) respectively.Conclusion: The preparation process of Gusong Jiangu granules is simple, reasonableand feasible, so it is suitable for industrial production. The quality standard isscientific and reasonable, which can be used to control the quality of Gusong Jiangugranules and ensure they are safety.