| Alzheimer's disease(AD)is a degenerative disease of the central nervous system,with the aging of human society,the incidence has been increasing.Because of the traditional Chinese medicine contains many kinds of chemical components,according to multiple target diseases,has a unique advantage in the treatment of complex diseases which have multiple factors,the AD pathological target,with a traditional Chinese medicine through a variety of ways or targeting characteristics,is expected to delay the course of AD.Kai Xin San decoction dose prescription is from”Qian-Jin-Fang”,it consists Ginseng,Polygalaceae,Poria cocos,Acorus gramineus,the major function of the drug is to treat amnesia.It's the traditional Chinese prescriptions to treat AD.Based on the classical prescriptions Kai Xin San,selected clinical curative effect as optimal index,and redeveloped into Shenling Puzhi granules.To optimize its preparation technology and establishquality control systemwith effective components in Ginseng,Polygalaceae,Poria cocos,Acorus gramineus.In order to improve the prescription drug also can ensure its safety,this is the key of the traditional compound development for new drugs.Firstly,On the basis of literature research and preliminary animal experiment results,design the extraction route of herbs by orthogonal experiment which the extract rate is evaluation index,and solvent quantity,reflux time,extraction times were optimized.The optimal extraction of Shenling Puzhi granules was as follows: Ginseng,Polygalaceae,Acorus gramineus,Poria cocos were added 8 times the amount of 60% ethanol for 2 times,2 h each time,putting the two extract together,filtering.Secondly,the extracted liquid was concentrated by the decompressed method and the extractum were preparated by the vacuum drying method.The orthogonal experiment was designed with the granules rate as evaluation index.Optimized the type and dosage of the excipients,ethanol concentration.The preparation of molding process was as follows: the test solution was concentrated to cream,vacuum drying to constant weight,crushed into fine powder,added 1.5 times the amount of lactose with 95% ethanol through a 16 mesh sieve.The optimal extraction process and the preparation method is simple,stable and reproducible,and can be used for industrial production of Shenling Puzhi granules.Finally,to establish the preparation and quality standard of Shenling Puzhi granules.TLC was applied for qualitative identification of Ginseng,Polygalaceae,Acorus gramineus,Poria cocos.TLC identification spots were fairly clear.HPLC was used for quantitative determination of ginsenoside Rg1,Re,Rb1 and polygalaxanthone ?.Use the effective components in the index to determine the optimum extraction process of Ginseng and Polygalaceae in Shenling Puzhi granules.Through standard curve,precision,repeatability,stability and recovery rate,to establish the standard of methodology.The optimum extraction process of Ginseng in granules was as follows: ultrasonic extracted 2 times with 100 ml methanol with 30 min each time.The optimum extraction process of Polygalaceae in granules was as follows: reflux extracted 2 h with 70 ml of 50% methanol.A good linearity of Rg1,Re and Rb1 were shown in range of 0.008~6.0 ?g,0.416~23.40 ?g and 0.014~4.40 ?g,the average recovery were 97.89%,100.22% and 102.32%.A good linearity of polygalaxanthone ? was shown in range of 0.069~0.173 ?g,the average recovery was 100.21%.The quality standard can control the quality of Shenling Puzhi granules,ensure the compound preparation is safe and effective,and the method is simple,accurate,stable and repeatable... |
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