Study On Preparation Process And Quality Standards Of Miao Shan Diabetes Rehabilitation Granules

MiaoShan diabetes rehabilitation granules is made by the15Chinese herbal medicine of Roots of kudzu vine, glutinous rehmannia, Medlar, dogwood, Dwarf LiLyturf Tuber, Astragalus, Potentilla discolor, Leeches, balsam pear and other six herbs.It has the function of treatment of common cold, body fluid regenerating for quenching thirst, reinforcing qi strengthening exterior defence, Supplementing qi and nourishing yin. In the clinicaL which is major for the treatment of type II diabetes. This article aims to optimizing the preparation process of the Miao Shan Diabetes rehabilitation granules rehabilitation particles, and to establish its quality standards. This subject is based on Chinese medicine theory as a guide, application of modern pharmaceutical technology and methods,Carried out a systematic experimen-tal study on the preparation process and the quality standards of the Miao Shan Diabetes rehabilitation granuLes, to ensure sure that the preparation process is scientific and rational, safe and effective pharmaceutical preparations, the quaLity is stabLe and controllable.1. Study on preparation processThe extraction process of voLatile oil:with voLatile oil extraction volume as evaluation indexes,inspected the water absorption rate,amount of water, the extraction time on the effect of volatile oil extraction,using single factor test for optimization of optimum extraction conditions. The results of the volatile oil extraction conditions is:complement the herb medicine3times amount of water absorbed, and then with10times amount of water and steam distillation extraction6h. The volatile oil by adding the amount of ethanol dissolved in standby.The water extracting process of plant medicine:Mix the residue after extractionthe volatile oil with other12traditional Chinese medicine,with content of extract yield, puerarin and polysaccharide as the evaluation indexes,inspected the soak time, the amount of add water, extraction time and extraction times on the effect of water extraction,by orthogonal test, to select the best option of water extraction technology. The results of water extraction technology:complement1.2times of the amount of water absorbed, add10times volume water, soak for0.5h, reflux extraction3times, each time1.5h.The purification process of water extraction liquid:with content of extract yield, puerarin and polysaccharide as the evaluation indexes, inspected the proportion of liquid concentrate, the amount of chitosan and flocculation temperature on the effect of purification, Using single-factor test for optimization of purification conditions. The results of chitosan to clarify the conditions as follows:the water extract was concentrated to a crude drug: water=1:8, in the30℃water bath, adding1%chitosan acetic acid solution which volume isl.5%(with chitosan, g/g), stirring, make it dispersed, insulation5-10min, put it aside for24h, and filter the supernatant of it.The processing of the Leech and balsam pear:Leech direct to powder through80mesh screen, reserved. The balsam pear blender, use microwave vacuum drying oven to dry,after a large number of tests to explore, In the end, we identified the balsam pear dry conditions:At35℃-40℃,-85KPa-95KPa, under pulse time3min conditions for dry1h. Taken out, grinding to80mesh,get the balsam pear powder, reserved.The molding process of preparations:By comparing the experimental inspected the amount of adhesives and flavoring agent which investigated the affect granulation. ResuLts:the purified Liquid solution was concentrated to a relative density of1.30-1.35(60℃C heat measurement) thick paste, join the prescribed proportion of Leeches and balsam pear powder, whiLe adding three times as thick paste amount of dextrin and0.5%of acesuLfame, mixed,system for soft material,20mesh granulating,40℃dry8h,60mesh whole grain, and inject into the VolatiLe Oil,sealed12h.2. Study on quality standardStudy on TLC quaLitative:identified MiaoShan diabetes rehabilitation granules contained Roots of kudzu vine, glutinous rehmannia, Medlar, dogwood, Dwarf Lilyturf Tuber, Astragalus, Potentilla discolor, Leeches etc.9traditionaL Chinese medicine. The results showed that the the product in reference substance chromatography corresponding control medicinal materials or position,all show the same color spot,and the negative control in the corresponding position without interference.And after repeated experiments,the reproducibility is good.Study on content of HPLC:Use HPLC method determined the puerarin content of the granuLes,with octadecylsiLane chemically bonded silica as filler; The mobile phase was methanol-1%acetic acid water (21:79); The fLow rate of1ml/min; Column temperature was30℃; Detect waveLength of250nm.And the inspection of the methodology shows that the method is reasonably reLiable, simple to operate, specific, reproducible, accurate and reliable, can be used for the quality of Miao Shan Diabetes rehabilitation granules.The content of puerarin is not less than4.16mg in each bag.