Comparative Study On Preparation Process And Dissolution Of Jiedu Tongluo Tablets And Dropping Pills

Apoplexy,also named sudden stroke,is a kind of dangerous disease which is serious harm to human body.Stroke has the characteristics of the high incidence,high morbidity and high mortality.China is one of the stroke high-risk areas.Recently,the incidence of stroke is higher and higher,and has a younger trend.So medical workers pay high attention to it and research it thoroughly.JieDuTongLuo Prescription use the "poison damage brain collaterals" pathogenesis,which has the characteristics and advantages of traditional Chinese medicine theory,to understand and treat sudden stroke.it is a new components drug of traditional Chinese medicine.It contains three main elements,total saponins of Panax notoginseng,gardenoside and breviscapine,is a innovative compound effective components of Chinese medicine,which has scientific compatibility.The Indications of the prescription is clear,and it has proved that its clinical curative effect to ischemic stroke is effective.This research studied the extraction,purification process,preparation process,determination method and dissolution of dropping pills and tablet,and then optimize the appropriate dosage forms,so that the good foundation of new drμg research and development,using traditional Chinese medicine to treat ischemic stroke will be laid.Content of the research is as follows.1 The extraction and purification technology research of the active ingredientsBecause that the preparation technology of total saponins of Panax notoginseng and breviscapine has been defined in 10 edition of China pharmacopoeia,so this research just studied the extraction and purification process of gardenoside.on the basis of the early laboratory work,the study used macroporous resin to purify the water extract of gardenia,the contents of gardenoside in the gardenia extract is more than 40%.2 Preparation technology research of dropping pills and tabletsFirst,inspect the admixture method and order of drμg and matrix,the type and dosage of the matrix,type and temperature of condensing agent and the dripping speed by the single factor experiment method.then use orthogonal test design to optimize the proportion of drμg and matrix,solution temperature,dripping distance and temperature of condensing.It can be proved that the optimal matrix is polyethylene glycol 1500 and polyethylene glycol 4000,proportion(drμgs and matrix)of 1:1.8,the medicine storage tank temperature of 80℃,dropping distance is 4.5 cm,condensing agent temperature is 3～6 ℃(bottom of condenser pipe is ice water bathed),dropping speed of 30～60 drops/min.Preparation technology research of tablets:studied the category and amount of the filler and disintegrating agenfor tablets.The dosage of wetting agent and so on,the experimental results confirm that the process preparation is adding 67%dextrin and 3%disintegrating agent(CMS-Na)into the compound powder,after mixing,adding 80%ethanol to make soft material,granulating,drying;and then adding 2%disintegrating agent and 3%magnesium stearate into the Qualified particles,tabletting after mixing.3 The determination research of the prescriptionUsing high performance liquid chromatography method to determin total saponins of Panax notoginseng,gardenoside and breviscapine of the prescription.The experimental results confirmed that the average recovery of gardenoside,breviscapine,notoginsenoside R1,ginsenoside Rg1,Re,Rb1 and Rd were 100.45%(RSD 2.84%),95.0%(RSD 1.71%),101.18%(RSD 2.19%),100.45%(RSD 2.20%),100.13%(RSD 2.91%),99.84%(RSD 2.05%)and 100.31%(RSD 2.03%),all of them meet the requirements,so that the three methods are strong specificity,high precision and good repeatability.4 Dissolution studies of dropping pills and tabletsSmall cup method,rotating speed of 50 r/min,With distilled water as dissolution medium;The dissolution medium volume is 250 mL,temperature is 37 ℃..Weibull distribution prove that significantly higher release rate of effective components from the dropping pills,so that dropping pills have the effect of quick release,which can improve the bioavailability of the preparation.Use the SPSS 17.0 software to analyse the dissolution date,experimental results of two formulations proved that the cumulative dissolution of seven components in the tablets were the same with the pills.Tablets are higher output,lower cost,dose more accurate and more stable than drop pills.Although the dissolution rate of effective components in the tablets are lower than dropp pills,but the cumulative dissolution rate has no obvious difference compared with the tablets and drop pills.So,comprehensively considered,the tablets is the proper dosage forms for the prescription.