| Kang Mi'an tablet is a new compound preparation of Traditional Chinese Medicine, which consists of lalang grass rhizome,berberidis,forsythia suspense and four other herbs.It has the function of clearing away Heat-toxin,promoting urination and treating stranguria.It can be used to cure stranguria syndrome which is caused by Dampness and Heat invading downward,which display as difficulty in micturition,drip constantly,lower urinary tract infection and Chronic prostatitis.With the guidance of the theories of Traditional Chinese Medicine,Kang Mian tablets was studied with modem pharmaceutical technology.For the demand of clinic, the form of drug was chosen as tablet.On the basis of the function and treatment as well as the characters of the component of the herbs,the optimum extract conditions were selected by using orthogonal design.Forsythia suspense,using 8 times water to soak for 2 hours,then dest 6 hours to extract essential oil and usingβ-CD to clathrate it,collect the water-solution after extraction;agrimoniae,lalang grass rhizome, forsythia suspensa's gruffs after extracting and other four herbs,using water to decoct for 3 times,8 times water and 2 hours for one,collect the water-solution,flit and concentrate to extractum whose relative density is 1.15~1.21(60~70℃);the rest agrimoniae and lalang grass rhizome was crashed to fine powder;granulating according to marumerization with those fine powder as carrying agent and extractum as adhesive material,the condition as below:rate of gaining:50~60ml/min;pressure of atomization:0.12Mpa;frequency of atomization:4.0Hz;material temperature:60~80℃;warming temperature:105℃;out temperature:80℃,then rimming the granula,addingβ-cyclodextrin inclusion compound and amidon 10g,tabletting to 1000, then coating with Opadry.After that the quality standard of the Kang Mian tablets was finished.Determine the content of gallic acid in Kang Mian tablets by RP-HPLC.Use TLC to identify SiJihong,forsythia suspensa,berberidis.Then the preliminary stability was fulfilled.That research indicates that the technique of preparation was reasonable and practical,the standard was controllable and the sample' quality were steady as well. |