Study On Preparation Technology And Pharmacodynamics Of Bunao Soft Capsule

As a persistent mental illness,the dementia is quite complicated in etiology which relating to more than 100 causes.Alzheimer's disease and vascular dementia are two main types accounting for over 80% of senile dementia.Along with aging population increase in China,it is great task for medical researchers to find effective treatment.Bunao Extract,a hospital made preparation developed by Gansu Provincial Hospital of TCM,has clinically showed obvious therapeutic efficacy and no significant side effects in treating patients with vascular dementia.As a traditional form of medication,there are some shortcomings existed in Bunao Extract such as inaccurate dosage,inconvenience of storage and carry and not suitable for mass production.At present,soft capsule,a newly developed preparation form,possessed some advantages concerning from high bioavailability and accurate dosage to good control on quality and convenient taking and carry.Given all this,in this research program the preparation form was changed from traditional one to soft capsule based on fixed formula and following are three main aspects:The research on preparation technology of Bunao soft capsulesWe have done some experiments to optimize preparation process: firstly the best purifying method was chosen as water extraction and ethanol precipitation based on orthogonal test,secondly the optimal drying method was confirmed through testing different drying ways,thirdly the optimized forming techniques was selected by taking orthogonal test with single factor.Finally the best extracting process was determined as follows: adding 12 times amount of water and decocting three times for 1.5h at each time,mixing all water solution together and concentrating to the relative density of 1.15 g·mL-1(20 ?),then adding alcohol with concentration of 55%(v/v),allowed to stand 12 h.Recycling alcohol and concentrating to thick liquid,drying it for 1h with microwave method at 55? and 9kw,grinding the dried material and sieving at mesh number of 110,the extract powder was obtained.Blending the powder with 2%aerosol,melting soybean oil at same ratio of powder,2% beeswax and 1.0% span-80 together as matrix,grinding powder and matrix to uniform,final product was gained.2.The research on quality standardsIn the research,root of Angelica sinensis,Rhizoma Chuanxiong and Psoralea Fruit in recipe were qualitatively identified by TLC.The content of paeoniflorin ? ferulic acid and Calycosin-7-glucoside were quantitatively determined by HPLC.The characters,identification,disintegration time limited,microbial limits,content determination and other indicators of preparation were investigated as well as accelerated stability test.In ways that draft quality standards for Bunao soft capsules were established.3.Pharmacodynamic Study of soft capsulesWe established the experimental mice model of vascular dementia through the operation of repeated occlusion of bilateral common carotid arteries of mice and conducted step-down test and Morris water maze test to measure the ability of learning and memory.By HE staining the hippocampus of mice and hippocampal tissue,to determine the content ChAT and AchE.Experimental results showed that the soft capsule could improve learning and memory in vascular dementia and protect hippocampal tissue cells in some extent.Also soft capsule could increase Ch AT activity and inhibit AchE activity.Acute toxicity test showed that no toxicity for mice and high security for oral administration.