| Diabetes mellitus(DM)is a set of clinical syndromes characteristic with disorder of sugar metabolism,which is caused by genetic and environmental factors.Long-term hyperglycemia can induce chronic damage and dysfunction of many tissues and organs including eyes,heart,kidneys,and so on.Based on a clinical experience formula of traditional Chinese medicine(TCM)(pill),which include Puerariae Lobatae Radix,Trichosanthis Radix and other 4 herbs,with the function of nourishing yin,body fluid regenerating for quenching thirst,supplementing qi.The article aims to combine Chinese medicine theory with modern pharmaceutical technology,optimizing the preparation process of the Tiange Diabetes Tablets,establish its quality standards as well as primary pharmacodynamic study.1.Study on preparation processThe extraction process of Puerariae Lobatae Radix with other 5 traditional Chinese medicine:According to Active ingredients in the prescription(perarinum),used HPLC determined the puerarin content of the extract,and the inspection of the methodology shows that the method is reasonably reliable,simple to operate,specific.With content of extract yield and puerarin as the evaluation indexes,through one-factor research and orthogonal test to inspect return method,water decoction method and ultrasonic method.The final best extraction process technology is 30 times of 70% ethanol used to extract 3 times for l.5h with each hour.The molding process of preparations:with appearance hardness,disintegration time,formability as the evaluation indexes,through one-factor research and orthogonal test to select accessories species,dosages,proportion.By screening the results,the optimized process was as follows:Smashed extract add into L-HPC:CMS-Na(4:2)andMCC:dextrin(7:1),10%PVP alcohol as cementing substance,pelletizing by 12-item sieve,drying under 55℃granulated,over 14 meshsieve,added into 0.3% magnesium stearate,stired evenly,pressing tablets,that too.2.Study on quality controlThe quality standards were established based on Chinese Pharmacopeia2015 edition.All iems were tested and up to standard.The Puerariae Lobatae Radix and others were identified by thin-layer chromatogrgraphy(TLC).The content of puerarin in Tiange Diabetes Tablets was determined using high performance liquid chromatography(HPLC).And the sample is chosen in 6months to test each indexes(puerarin content,disintegration time and so on)at room temperature,whose results showed that each indexes were good and keep stable during 6 months.3.Study on Primary PharmacodynamicsDiabetic mice were introduced by intraperitoneal injection of STZ(75mg/kg·d)for two consecutive days.One week after feeding mice adaptability,these mice were randomly divided into 7 groups,namely blank group,model group,Tiange Pill group,(Tiange Pill+metformin hydrochloride)group,Tiange Diabetes Tablets group,(Tiange Diabetes Tablets+metformin hydrochloride)group,metformin hydrochloride group,oral dose 11 weeks.Through physiological index(weight,organ coefficient),biochemical test[FBG,TC,TG,HDL-C,LDL-C],oxidative parameters[SOD,CAT,NO,PCO,MDA]and morphological change of organ to comprehensively evaluate the protective effect of Tiange Jiangtang Tablets on model mice.The results show that Tiange Diabetes Tablets group could cause significant reduction blood glucose levels,increased body weight,decreased in food intake and water intake;the concentration of TC,TG and LDL-C in serum decrease significantly(p<0.05),and the concentration of HDL-C in serum was obviously increased(p<0.05)in the meantime;the content of NO,MDA,PCO was decreased(p<0.05)and the activity of SOD CAT was increased(p<0.05).Above indicated that Tiange Jiangtang Tablets has protective effect on diabetic in mice.The preparation process of Tiange Jiangtang Tablets is scientific and rational,safe and effective pharmaceutical preparations,the quality is stable and controllable. |
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