Pharmaceutical Study Of Shaogan Floating Sustained-release Double-layer Tablets

The antidepressant prescription of peony and liquorice is based on Shaoyao Gancao decoction(SGT) which come out of 《Treatise on Exogenous Febrile Disease》. this prescription is composed by total glucosides of paeony and flavononids from glycyrrhiza in a proportion of 5 to 3.SGT has the functions of nourishing yin with its sour-sweet property and relieve pain,it is commonly use in all kinds of painful disease.Recently,Epidemiological studies have shown that pain and inflammation have a close relationship with the occurrence and development of depression.A large number of pharmacological studies confirmed that total glucosides of paeony and flavononids from glycyrrhiza have a definite effect in aspect of anti-inflammation, antidepressant.liver protection and so on.This sduty is aimed to develop a kind of anti-depressant drug. The main research content is as follows:1.Extraction process:With the content of total glucosides of paeony and flavononids from glycyrrhiza as examining index,using single factor experiment and orthogonal experiment to optimize the extraction process,the best extraction process is as follows:20 times volume of 70% ethanol as extraction solvent, paeony herbs is immersed for 15 min,extract 2 times,1 h each time by water bath reflux extraction method;25 times volume of 80% ethanol as extraction solvent,extract 2 times,1 h each time.2.The preparation technology of extract:According to the static adsorption experiment, D101 resin was used to enrich total glycosides of paeony, the adsorption quantity and elution quantity of total glycosides of paeony were taken as the evaluation index, the best enrichment process was optimized by the dynamic adsorption experiment,the results were as follows:the sample liquid concentration was 0.2 g/mL, the largest volume of sample concentration was 3.5 BV, the adsorption velocity was 1 BV/h,70% ethanol as elution solvent,elution velocity was2 BV/h, water elution amount to 4 BV, the eluent dosage was 3BV.3.The quality standard research of extract:The quality of total glucosides of paeony and flavononids from glycyrrhiza were controlled through external property,moisture，qualitative and quantitative analysis. Total glucosides of paeony accounts for 85%, paeoniflorin accounts for 65% of the total glucosides of paeony extractFlavononids from glycyrrhiza accounts for 90%,liquiritin accounts for 74%.4.The forming process research of double -layered tablets:the prescription composition of fast release layer and gastric floating sustained-release layer were optimized,and the optimized ratio of fast release layer and sustained release layer was 3:7.The composition of each layer were as follows:Prescription composition of fast release layer was:total glucosides of paeony and flavononids from glycyrrhiza extract accounted for 47% of the prescriptions,9.17% PVPP and 5.29% CMS-Na as main disintegrating agent,21.74% MCC as the auxiliary disintegrating agent, calcium hydrogen phosphate as the filling agent,accounted for 13.8%,micro-powder silica gel as drug modifying agent and lubricant,accounted for 3%,1.0% SDS as cosolvent.Prescription composition of gastric floating sustained-release layer was:total glucosides of paeony and flavononids from glycyrrhiza extract accounted for 47%, 14.68% HPMC K100M and 12.54% HPMC K4M as slow-release material and lightweight gastric floating materials,4% sodium bicarbonate and 4% citric acid were added to keep the tablets stay afloat,7.89% PEG 6000 and 7.89% lactose were added as the filler,micro powder silica gel as the lubricant account for 2%.Quality standar research of double layered tablets:the qualitative and quantitative analysis of the double layered tablets were taken by the thin-layer chromatography (TLC) and high performance liquid chromatography(HPLC),TLC identification met the requirements,paeonifl-orin was taken as the index ingredient to control the quality of double-layer tablets,the paeoniflorin content should be not less than 75 mg each piece of double-layer tablets.Moreover,weight difference between each piece of tablet,external property and dissolution met the requirements.