To Research The Preparation Process And Quality Standards Of Liang Ge Capsule

Objective:Liang Ge Capsule is a compound preparation which consists of Fructus Forsythiae,Scutcllaria Baicalensisi,Fructus Gardeniae,Rheum Officinale,Glycyrrhiza, Mint, Mirabilite seven traditional Chinese medicine. The prescription is derived from the traditional classic square Liang-Ge-San.This topic using modern science and technology, under the guidance of theory of traditional Chinese medicine,to study the Liang Ge capsule preparation process and quality standard, ensure the preparation technology scientific and reasonable, and drew up Liang Ge capsule quality standard, this paper laid a foundation for further research.Methods: In order to keep consistent with the clinical efficacy of traditional decoctions, water was selected as extraction solvent; initially, single factor experiment was conducted to investigate the extraction of mint volatile oil and preparation technology of ?-cyclodextrin inclusion compound for mint volatile oil.The content of geniposide, baicalin, forsythia glycosides, glycyrrhizic acid and the yield of extract, 80% alcohol extract yield were used for the indicators,and the single factor experiment, the orthogonal experiment were adopted to optimize the extracting technique conditions.To identify the fructus forsythiae, gardenia, rhubarb, radix scutellariae, radix glycyrrhizae by the TLC method and to develop an HPLC method for the simultaneous determination of gardenoside?baicalin?forsythin and Glycyrrhizic acid in Liang Ge Capsule.Results:The best extraction technology of peppermint essential oil was as follows : Add 10 times the amount of water,soaking 1h,distilling 3h; The result of the inclusion process is the proportion of 1:7(volatile oil to ?-CD),inclusion under 40 ? for 1.5h.Rhubarb was crushed into fine powder.The extraction results:Herbs were crashed to coarse powder, soaked 30 minutes,and then extracted twice in 10 times water, 0.5 hours every time.4000 r/min, the centrifugal processing 20 min,Filtration, centrifugation, merge the filtrate,Filtrate vacuum concentrated into a relative density of 1.30-1.33(60?),Vacuum drying,crushing.Blending the fine powder,adding 15% aerosil,fill in the capsule.TLC spots were clear, negative control without interference.The results of quantitative analysis:The content of forsythin, baicalin,gardenoside,Glycyrrhizic acid in Liang Ge Capsule shall not be less than 3.6?5.2?0.56?1.72 mg/particle.Conclusion:This experiment studied the Liang Ge capsule preparation technology,The technology is rational and feasible;To establish the qualitative and quantitative detection method which is simple, accurate, reproducible,and can be used to control the quality of Liang Ge capsule.