Study On The Prepration Technology And Quality Studard Of Jianpi Anshen Granules

Jianpi Anshen Granules is a traditional Chinese medicine prescription consisting of six Chinese medicines,including Acanthopanax senticosus and Astragalus membranaceus.It is mainly used in the treatment of insomnia.Under the guidance of traditional Chinese medicine theory,the preparation technology and quality standard of Jianpi Anshen granules were systematically studied by using modern preparation techno logy.The preparation technology was reasonable and the quality was controllable.The extraction process research:we used the orthogonal design method to optimize the best water extraction process based on the yield of extraction and total saponins and syringin content.the optimum conditions of water extraction are adding 10 times water and boiling for 2 times,each time 1.5 hours.For decoction liquid contains a large number of inactive ingredients,through the purified experiments,Comparison of three different purified effect,high speed centrifugation,.alcohol sinking and macroporous adsorption resin.The alcohol sinking is determined as the best purification process.By orthogonal test,we determine the optimal alcohol sinking process conditions:merging of decoction liquid,the decoction liquid was concentrated to a relative density of 1.14?1.16(60?),the alcohol concentration of 60%,and placed for 12 hours,filtration.According to three middle-scale production,the extraction process of Jianpi anshen granules was reasonable.The forming process of granules research:through the choice of auxiliary materials and ratio,the optimum auxiliary material was lactose and soluble starch(2:1).Through the orthogonal test,we determine the optimal process conditions:mixed extract powder with 1.5 times auxiliary material(lactose:soluble starch 2:1),using 75%ethanol toprpare soft material.16-mesh sieve granulating,the wet particles was dried in 65? oven,and taked out.With 14-mesh sieve granulating,put the particles into the granules,packing and finishing product.We produce Jianpi anshen granules by the preparation technology determined,we measure critical relative humidity of the granules.Through three batches of samples three middle-scale production,the preparation technology of Jianpi anshen granules is stable,reasonable.Which provides a reliable experimental basis for large-scale production.The quality standard of Jianpi anshen granules:the TLC methods were used to identify the characteristics of Acanthopanax senticosus,Astragali,Ophiopogon japonicus and Lycii Fructus.The results showed that the method was reasonable and feasible,and better separation effect.We inspected the properties,particle size,moisture and melting of Jianpi anshen granules,all results conformed to the pharmacopoeia standard.Applying the high performance liquid chromatography(HPLC)to measure the content of syringoside in the Acanthopanax senticosus.The method is high precision and good repeatability.It can be used for quality control of Jianpi anshen granules.Through the preliminary stability test of the Jianpi anshen granules,the results of three samples showed that inspection,traits,identification,content determination conformed to the pharmacopoeia,the Jianpi anshen granules under sold packaging was stable.