Pharmaceutical Study Of Tongfu Granules

Adhesive Intestinal Obstruction is mainly caused by adhesion intestine,which was due to the abdominal operation,inflammation and wound.It is a common type in intestinal obstruction.Most of patients had got the abdominal operation,inflamnation,wound and tuberculosis,Eating and drinking to much or crazily sporting are the reasons before it happened.Paroxysmal abdominal cramps and Repeated vomiting are the symptom.The yellow liquid can found at the patients,mouth,the sypptom of intestines can be touched and the bowel sounds can be heared.Tongfu granule is a experient prescription,which used to connect intestines,boost spleen and coordinate stomach.It is benefit for the recover of the function of stomach and cutting down the chance of adhesion intestine and intestinal obstruction.This subject is to study on the preparation,and the quality standards and stability in accordance with the demands of new drug of the SFDA.Preparation:Inclusion rate is used as index to study volatile oil extraction process of Citrus auranrium L,Citrus reticulata Blanco,Citrus reticulata Blanco and Atractylodes lancea by orthogonal optimization within L9(34).soaking 0.5 hour,plusing 8 times the total quantity of water and distilling 6 hours are the best process.Inclusion rate,the rate of inclusion compounds and oil content of inclusion compounds are used as indexes to study inclusion compounds process of volatile oil by orthogonal optimization within L9(34).the best process for the inclusion compounds of volatile oil is 6 times the amount ?-cyclodextrins,10 times the total quantity of water and closure 60 min by ultrasonic method.Vacuum drying was adopted with 40?.The contents of anthraquinones,honokiol and magnolol,the rate of harvesting of the extract are used as indexes to study alcohol extraction process of Rheum palmatum and Magnolia officinalis by orthogonal optimization within L9(34),ading 6 times volume of 70%ethanol,refluxing 3 times and refluxing 1.5 hour each time are the best process for the alcohol extract.The contents of naringin,hesperidin and neohesperidin,the rate of harvesting of the extract are used as indexes to study water extraction process by orthogonal optimization within L9(34),adding 8 times volume of water,refluxing 2 times and refluxing 1.5 hours each time are the best process for the water.To study the alcohol precipitation,Purification process of ethanol concentration for the decoction to the relative density of 1.102?1.122(60?),add ethanol capacity to 40%alcohol content,place a 48-hour.Combine the clear liquor after centrifugation(4800 r/min)and ethanolic coneentrated solution,Recycle ethanol and concentrate into thick grease.Dry with 80 oC and shatter extract powder,Take extract powder and cyclodextrin complex mixture.Preparation process for the granules,Mixed results:powdered sugar:Dextrin=1:0.2:0.6.The method of wet particles is adopted with 90%ethanol.the particles obtained at 50? after pelletized.The study of quality staridard with pilot sample:The characteristic compositions,stamdard crude drug and negative sample are taken as indexes with TLC to identify the quality of Rheum palmatum,Citrus aurantium L,Magnolia officinalis,Citrus reticulata Blanco,Citrus reticulata Blanco and Atractylodes lancea.Examine semi-works production's grade size,moisture,colliquation-character and so on,based on volume ? C of pharmacopoeia of people's republic of china(edition 2010).The HPLC mensuration method for anthraquinones has been established for the quality standard of the Tongfu granule.The study of mensuration method is assessed,which include specificity test,system durability test,the investigation of the linear relationship,accuracy test,the investigation of extracting condition,stability test,crepeatability tests and recovery testMeanwhile,the quality standard draft of Tongfu granule in terms of Pharmacopoeia was drafted out.The result showed:The identified method of TLC of Rheum palmatum,Citrus aurantium spots is clear and well-separated without negative interference.The test of granule accord with the demand of Pharmacopoeia.aloe-emodin,rhein,emodin,chrysophanol and physcion show a good linear relationship during the linear ranges,respectively.The average recovery and RSD are all consistent with regulations.According to the demands of new drug and granule,three test samples need to be investigated under stability of accelerated test and left at room temperature,and the result of the preparation quality is stable and controlled.The study results show that the process of the preparation is reasonable,feasible,quality standards can be controlled,product quality is stability.The experiment concentrate on the pharmaceutical study and make a quality standard of Tongfu granule,which provide a scientific foundation for the clinical.