objective: To observe aldose reductase AGEs inhibition is a new target fortreatment of chronic complications of diabetes type2, Xie Xin Tangprescription drugs have reported complications of treatment for type2diabetes,it is proposed that Salviae Puerariamade and pueraria were made into ShenHuang capsule on the basis of Xie Xin Tang, through the study process tocomplete and preparation specifications of Shen huang capsule was completedby process research; Completion of the toxicology studies of this product wasfinished by the acute and long-term toxicity.Methods: Selection of native drug Affiliated Hospital of Luzhou Medical,through the process to complete preparations, the choice of Luzhou MedicalCollege animal room medical rats and mice, male and female and female, toaccept the maximum volume administered tolerated dose acute toxicity in mice,using irrigationstomach. Long-term toxicological randomly divided into fourgroups, namely, model group, Capsule parameters yellow, in the low-dosegroup, gavage method to detect the weight of the rats in each group, and theirfur secretions view the blood12weeks after half, blood biochemical andpathological withdrawal two weeks after the other half.Methods: The native drug from Affiliated Hospital of Luzhou Medical were chosen, and completed primary preparations by alcohol extraction. The ratsand mice were chosen from Luzhou Medical College laboratory animal centre,half males and half females. Acute toxicity was measured by gavaging in ratsthrough the maximum tolerance method, observed and recorded about animals’coatsã€ingestionsã€excrementsã€limbs activity and deaths for14days. Long-termtoxicity was measured through mice which randomly divided into modelgroup〠low concentration〠middle concentration and high concentrationShenHuang capsules groups, and gavaged for12weeks, rats’ weight weremeasured every two weeks, and observed the secretions on coats, half of ratswere sacrificed to detected the hemogram〠blood biochemisty andhistopathology, and the same index were detected after stopping drugs for twoweeks in other rats.Results:1ã€Preparation technology: crushed DanShenã€DaHuangã€GeGenand extracted by ethanol, reclaimed and the drugs concentrated. After extracting by ethanol, the DanShen was decocted by water again, and Water-Soluble constituents were extracted, concentrated and vacuum dried. Cr ushedthe dry paste and mixed the baicalin and berberine hydrochloride, and thenjoined accessory, encapsulated.2ã€Acute toxicity: The mice divided into twogroups, ten males and ten females, gavaged182.5g/kg three times a day, thedose was400times equivalent to clinical adult every day. And observed14days, the animals’ coatsã€ingestionsã€excrementsã€limbs activity were normal andno death.3ã€Long-term toxicity: During12weeks gavaging, the rats’ coatsã€ingestionsã€excrem entsã€limbs activity were normal, and weigh changed from 164.38±9.030gã€156.88±15.10gã€157.50±9.636g to198.13±14.37gã€180.00±19.08gã€188.75±24.31g in lowã€middle and high concentrations groups,compared with control group which changed from155.56±7.265g to190.00±16.45g, there were no significant differences(P>0.05); at the end of12weeks, the values of WBCã€RBCã€Hbã€PLTã€BTã€CT in rats’ blood were12.26±2.50ã€7.98±0.98ã€139.56±11.18ã€288.45±47.15ã€19.56±1.25ã€49.75±2.59respective, and after stopping drugs for two weeks the values of WBCã€RBCã€Hbã€PLTã€BTã€CT were12.11±2.62ã€7.26±1.25ã€142.44±8.64ã€220.89±45.54ã€19.78±1.67ã€45.75±2.52respective, compared with control group which valueswere12.39±2.75ã€7.89±1.07ã€144.55±14.05ã€292.11±38.21ã€20.19±1.72ã€47.47±2.72, there were no significant differences (P>0.05); at the end of12weeks, the values of TPã€ALBã€GPTã€GOTã€AKPã€BUNã€CRã€Gluã€CHolin rats’ blood were79.19±3.29ã€30.12±2.11ã€59.24±11.16ã€209.95±32.25ã€327.61±34.24ã€10.91±1.79ã€92.66±5.86ã€5.97±1.22ã€1.78±0.26, and afterstopping drugs for two weeks the values of TPã€ALBã€GPTã€GOTã€AKPã€BUNã€CRã€Gluã€CHol were80.14±5.16ã€31.17±3.01ã€61.56±10.45ã€211.20±26.69ã€319.15±33.44ã€9.78±1.85ã€95.80±5.77ã€5.11±1.29ã€1.22±0.29,compared with control group which values were81.65±4.55ã€29.79±2.56ã€63.09±11.26ã€215.19±31.75ã€341.13±42.06ã€9.67±1.51ã€92.52±6.24ã€6.83±1.33ã€1.50±0.32, there were no significant differences(P>0.05); at theend of12weeks, the index about heartã€liverã€spleenã€lungsã€kidneyã€adrenalglandã€thymusã€uterusã€testicles were1.06±0.05ã€10.20±0.48ã€1.19±0.20〠2.87±0.20ã€1.42±0.17ã€0.31±0.02ã€2.76±0.15ã€0.61±0.08ã€1.05±0.10,andafter stopping drugs for two weeks the values of heartã€liverã€spleenã€lungsã€kidneyã€adrenal glandã€thymusã€uterusã€testicles were1.08±0.08ã€10.60±0.90ã€1.17±0.17ã€2.78±0.26ã€1.41±0.16ã€0.30±0.03ã€2.65±0.18ã€0.62±0.07ã€1.07±0.11,compared with control group which values were0.97±0.08ã€9.77±0.66ã€1.25±0.18ã€2.60±0.28ã€1.49±0.170.31±0.02ã€2.70±0.20ã€0.62±0.07ã€0.56±0.05, there were no significant differences(P>0.05).Histopathology showed there were obvious pathological change in those viscera,compare d with control group, there were no significant differences.Results:1.Basic processing route: salvia miltiorrhizaã€rhubarb and puerariawere concentrated into thick paste by adopting Alcohol extraction anddecoction, Baicalin and Berberine hydrochloride were added intocomminuted dry paste after vacuum drying, Which became Capsule powderand divided into capsules after adding supplementary materialgranulation.2.Acute toxicology: Drugs were chronically administered to micethree times a day, It found that fur, feeding, feces, limbs activity had nochanges and no death cases according to its acute toxicity in in two weeks.3.Long-term toxicology: Shen Huang capsule:50g/kg group,25g/kg group,10g/kg group, Drugs were chronically administered to mice for12weeks and2weeks after the drug was stopped, There was no abnormal in the rat bodyweight, blood picture, blood biochemistry, heart, liver, spleen, lung, kidney,adrenal gland, brain, thymus gland, testicle, uterus histologic examination, there was no significant difference compared with the control and the long-termtoxicity was not displayed. |