Studies On Preparation Process And Quality Standard Of Gouqi Fushen Granules

The pathogenesis of IgA nephropathy is not clear now, the duration of the IgAnephropathy is long, and IgA nephropathy is easy to recur, the effect of a longtreatment with Chemical Drugs is not good, the side effects are obvious. GouqiFushen Granules was formulated according to a clinical prescription which had beenused many years and has a good effect. Years of clinical observation shows that it hadthe function of nourishing yin and invigorating kidney, protecting spleen and wasgood for dehumidification, promoting blood circulation to remove blood stasis, it wasused clinically to cure the IgA nephropathy and chronic nephritis. Gouqi FushenGranules had a good start in the treatment of IgA nephropathy, and long-term use of itwith small side effects, can control the clinical symptoms very well, delay the diseasefor patients with renal damage, prolong the survival period, improving the survivalquality of patients.The original prescription in clinical application, the traditional chinese medicinalmaterials were smashed into powder directly to make it big honey bolus, a lot ofeffective chemical composition in Chinese medicinal materials is not well used, andwith a large dose, patient compliance is poor. Also there is no established qualitystandards,the quality is not stable and controllable.This subject used modernextraction and preparation technology, developed the prescription into granules toovercome those disadvantages, and establish a corresponding quality control method,provide the basis for further development of traditional Chinese medicine of six classnew medicine.In this paper, to optimiz the extraction and preparation technology of GouqiFushen Granules, taking the yield of Astragaloside IV and dry extract as index toestablish the optimal extraction process of Gouqi Fushen Granules by using theorthogonal test method, and the enrichment process and dry process were investigatedtoo. In the preparation process, with the moisture absorption rate, formability, fluidityas index to optimize the kinds and dosage of excipient and granulating conditions.andaccording to the optimized preparation technology of the preparation of Gouqi Fushen Granules, in accordance with the provisions of the Chinese pharmacopoeia2010toinvestigate on the performance of the granules.The quality standard of Gouqi FushenGranules were performed,established the method of TLCqualitative identification ofAstragali, Fructus Lycii,Rehmanniae, Gardenia, Angelica sinensis. The maid medicinewas identified by HPLC in accordance with Chinese pharmacopeia(2010editionI),the content ofAstragaloside IV, Buddleoside, Catalpol were measured by using HPLC.Using accelerated test method to investigate the preliminary stability of Gouqi FushenGranules.Eventually the conclusion are:(1)The best extraction technology was as follows:adding water equivalent to8times of volume of material medication, extracting for3times and extracting for2hours each time;(2)The Preparation process:take dextrin asexcipients,1:1proportion mixing with powder,the forming process:Take soluble starchand lactose as excipients,80%ethanol as moistening agent, wet granulation,particleproperties conformed to the requirement of pharmacopoeia;(3)The study of qualitystandard:The relevant spots of Astragali,Fructus Lycii,Rehmanniae,Gardenia,Angelicasinensis on TLC plates were clear without the interference,specific, simple andconvenient operation.Linear relationship of Astragaloside IV in the range of0.8-11.2μg(r=0.9996) was good, average recovery was97.67%(RSD=1.09%,n=6);Linear relationship of Catalpol in the range of0.36-3.6μg(r=0.9998) was good,average recovery was98.68%(RSD=1.05%,n=6);Linear relationship of Buddleosidein the range of0.0875-2.8μg(r=0.9995) was good, average recovery was98.61%(RSD=1.25%,n=6);(4)Accelerated test sample for three months,the results showedthat three batch sample inspection, identification, particles on the properties of(granule size, moisture content, melt), determination of content all conformed to thepharmacopoeia,the Gouqi Fushen Granules was stable.To sum up, Gouqi Fushen Granules produced in the optimization process isfeasible, the quality control method is scientific and reasonable, accurate and feasible,which can effectively control the quality of the Gouqi Fushen Granules.