Study On The Preparation Process And Quality Standard Of A Laxative Granule

Objective: To develop a granule for the treatment of senile constipation(temporarily named as Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule),to optimize the extraction and preparation process of Atractylodes macrocephala,Cistanche,fructus aurantii and to establish its quality standard.Methods: This topic mainly studied the extraction process,the molding process and the quality standard of Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule.1.Extraction process research: In the investigation of water extraction process of Atractylodes macrocephala,Cistanche and fructus aurantii,the single-factor test was used to investigate the particle size,extraction times,extraction time,and the influence of liquid-to-liquid ratio on the extraction process.With polysaccharide content,ointment rate,echinacoside,verbascoside and naringin as indicators,the optimal water extraction process of Atractylodes,Cistanche,and fructus aurantii was optimized by extraction times,extraction time and liquid-to-liquid ratio.2.Research on molding process: In combination with actual conditions,the indicators such as the difficulty of granulation,the rate of pellet formation,the moisture absorption rate of raw material and excipients,material characteristic,etc.And the process parameters such as excipients,wetting agents,drying temperature and drying time are selected.3.Quality standard research: Qualitative identification and determination of active constituents of Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule by thin-layer chromatography,high performance liquid chromatography and ultraviolet-visible spectrophotometry were carried out to establish corresponding quality standards.The draft quality standard of Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule was established.Results:1.Extraction process results: The best water extraction process for Atractylodes,Cistanche,fructus aurantii is: a prescription of Atractylodes,Cistanche,fructus aurantii A,B,C grams,plus D times amount of water soaked E min in the extraction tank,it is heated to boiling for extraction F times,G h each time,the filtrate of each extraction is combined,centrifuged at 3000 rpm for 20 min,the supernatant is concentrated into a thick paste(relative density 1.05-1.10),and dried under reduced pressure(75 ° C,-0.08 Mpa).2.The result of the molding process: mannitol is used as the excipient,and the mixed mogroside and stevioside in H mixed ratio is used as a flavoring agent,An appropriate amount of xylo-oligosaccharide is added.The mixture is fully mixed according to the ratio I.The above mixture is uniformly mixed with the pulverized dry powder according to the ratio J.Adding L-based ethanol to soft material with a specific gravity of K,sieving and granulating.Wet granules are dried in an oven at 60°C for 1 hour,and granulating with No.1 sieve and No.5 sieve.The obtained granules are packaged in a double-layer aluminum-plastic composite film to obtain a finished product.3.Results of research on Quality standard: A thin—layer chromatography(TLC)identification method for Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule was established.A high performance liquid chromatography(HPLC)method was established for the determination of echinacoside,verbascoside and naringin in Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule,through system suitability test,negative interference test,linear relationship test,precision test,repeatability test,solution stability test,sample recovery rate test and durability test.A method for determining the total polysaccharide content in Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule by ultraviolet-visible spectrophotometry(UV-Vis)was established.A unit packaging of Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule is not less than 10.5 mg in terms of echinacoside,not less than 0.75mg in terms of verbascoside,and the total polysaccharide is not less than 45 mg Calculated with glucose.Conclusions: The preparation process and quality standards of Atractylodes macrocephala,Cistanche,fructus aurantii laxative granule were studied.The extraction,molding process and better quality standards of this product were established,which provided basis for product quality assurance.