Fharmaceutical Research Of Fibrauretinum Dropping Pills

Fibrauretinum also known as palmatine,Bamatin,palma,Columbamine,etc.,is a kind of alkaloid that extracted and purified from the dry stem of the Fibraurea recisa of menispermaceous plants.It has the efficacy of heat-clearing and detoxifying.It has multiple pharmacological functions such as broad-spectrum antibacterial,anti-virus and strengthening the body’s defense function.The market preparation is currently mostly Tab.ts,capsules and other oral preparations.The dropping pill is a kind of solid dispersions,in which drug highly fragmented and that larger specific surface area and dissolution rate making its high bioavailability.Therefore,the dropping pill belongs to the quick-acting efficient dosage form,that can meet the needs of the treatment of clinical emergency conditions better.1.Study on preparation process of Fibrauretinum dropping pillsStudied the preparation molding process of palmatine dropping pill and set up the preparation process line with dropping forming rate as judgement index to investigate the effect of different factors,such as different matrix type,ratio of substrate,its proportion of substrate to drug,the types of coolant,dropping speed and the dropping distance.Chose three factors(drugs and ratio of matrix,oil bath temperature,condensation temperature)that had a greater influence on dropping pill moulding with orthogonal experiment method to investigate the moulding technique of palmatine dropping pills.And with taking appearance quality,time-limit of dissolution and pellet quality variation coefficient as index,it had determined the optimum process of the preparation of palmatine dropping pill that the the ratio of substrate and drug for PEG4000:PEG6000:palmatine 2:2:1,and the coolant for dimethyl silicone oil,the dropping distance 6.5 cm,dropping speed(20±3)drops/min,oil bath temperature 75～80 ℃,Cooling temperature 14～17℃.The drop pills made from the best process are in accordance with the requirements of the Chinese Pharmacopoeia(2015 edition).2.Analysis and study on the scanning calorimetry analysis of fibrauretinum dropping pillsUsing differential scanning calorimetry analysis,palmatine,polyethylene glycol,the physical mixture of palmatine and polyethylene glycol,palmatine dropping pill and blank dropping pill had been scanned.With analysis of map and data processing,the DSC atlas of palmatine,polyethylene glycol,the physical mixture of palmatine and polyethylene glycol,palmatine dropping pill and blank dropping pill had been compared.The formation of solid dispersions between palmatine dropping pill and the carrier had been known through the change of the endothermic peak.It confirmed that palmatine powder and the carrier PEG4000/6000 interacted with each other in the process of dropping pill by melting method,and formed a eutectic solid dispersions.3.Study on the quality evaluation of fibrauretinum dropping pillsComprehensive evaluation of quality of palmatine dropping pill has been carried out.On the basis of literature,The quality evaluation research of palmatine dropping pill,including character,identification,melting time and weight variation,content and methodology validation,had been conducted by referencing palmatine Tab.t quality standard(Chinese pharmacopoeia 2015 edition)and the requirements of the general rules of Chinese pharmacopoeia 2015 edition to ensure product quality stability and controllable.With thin layer chromatography analysis and the establishment of a finished product palmatine hydrochloride by HPLC in content detection method and methodology,three batch samples were tested,and the results meeting the requirement of pharmacopoeia,so the quality of the research method is sTab.and feasible.The results of the 6-month accelerated test and long-term test stability show that the quality of the flavonoid dropping pills in the storage period is sTab.,and all the indexes are consistent with the standard requirements and the quality is sTab.