Preparation Of Compound Sparganii Rhizoma Granules And Its Treatment On The Chronic Renal Failure

OBJECTIVE To "compound Sparganii Rhizoma granules" and optimize of the extraction and preparation technology;To establish the quality standard for "compound Sparganii Rhizoma granules";To study the pharmacodynamics of adenine on chronic renal failure.METHODS Essential oils of Sparganii Rhizoma and Chuanxiong Rhizoma extracted by supercritical CO2 extraction process,and the technological conditions of extraction was optimized by orthogonal test design;herb residue of essential oils extraction and the rest six crude drugs(Rhei Radix et Rhizoma,Radix Astragali,Eucommiae Cortex,Rosae Laevigatae Fructus,Forsythiae Fructus,Taraxaci Herba)were simultaneous extracted by condensed reflux extraction,and the technological conditions of extraction was optimized by orthogonal test design;the extract was further concentrated and prepared into granules.According to the general rules of preparation of the 2015 edition of "Chinese Pharmacopoeia",the content of total flavonoids was choosen as indicator,quality evaluation of "compound Sparganii Rhizoma granules" was investigated,and the initial stability was studied.The chronic renal failure model was induced by adenine,and the model was constructed q.d.for the first 2 weeks,qd alt for the next 2 weeks.SD rats were divided into 7 groups:blank control group(NS),model group(NS),niaoduqing granules group(2.25 g·kg-1),compound Sparganii Rhizoma decoction group(1mL/100g,p=1.1),high,middle,low dosage(12、8、4 g·kg-1)of compound Sparganii Rhizoma granules.Rats were intragastric administered every day for 4 weeks,the renal function of each group was measured,the general condition and the change of renal tissue were observed,and the therapeutic effect of compound Sparganii Rhizoma granules on chronic renal failure was evaluated.RESULTS The optimized technology of essential oils by supercritical fluid extraction:the extraction pressure was 25 Mpa,extraction temperature was 50℃,extraction time was 2 h;The optimized technology of reflux extraction:ethanol concentration was 50%(v/v),material-liquid ratio was 1:12,extraction time was 1 h,extracted three times;extract powder:dextrin was 1:1,0.5%stevioside as sweetener,adding 1%povidone K30 of 75%ethanol solution(v/v),successfully prepared compound Sparganii Rhizoma granules,yield of granules was 98.71%.Established the standard curve of total flavonoids:A=0.01208C-0.01941(r2=0.99907),it had good linear relationship within the scope of 18.86～66.02 μ·mL-1,it had good precision,stability,the recovery met the requirements,the methods were feasible.The appearance met the requirements,thin-layer chromatography of crude drugs had specificity,the percentage of granules that cannot pass through No.1 sieve and particles that pass through sieve No.5 were less than 15%,moisture was less than 8%,content uniformity was less than±5%,which met the requirements of Pharmacopoeia,dissolubility met the requirements.The content of total flavonoids(7.88±0.54)%.The model of CRF was successfully replicated,after treated by compound Sparganii Rhizoma granules,the kidney index reduced,the levels of Scr,BUN reduced,and the level of UP increased in CRF rats.CONCLUSION The extraction technology used was simple,reasonable,and high extraction efficiency,also the granules preparation technology was feasible,under quality control,and effective for treatment.It provided a scientific experimental basis for determinating preparation technology and controlling production conditions of compound Sparganii Rhizoma granules.