| This article is the use of modern extraction and purification technology to extract the active ingredients in the dried tangerine peel out,made oral solution,and a systematic and clinical pharmacology and toxicology studies to prove its high safety,efficacy and quality control.This article from the Citrus Research oral pharmaceutical,pharmacology and toxicology data research,clinical studies three aspects of research,demonstrated the feasibility of new drugs as oral Citrus.1.Pharmaceutical research it's set into technology research,quality standard research,stability studies three parts.The final production process for:take dried tangerine thick powder,add 10 times the amount 70%ethanol reflux extraction three times,each time 1.5 hours,filtration,with the filtrate reduced pressure recovery ethanol,concentrate quiet place for the night,filtration,the precipitation with 50%ethanol(containing 2%of potassium hydroxide)an alkaline solution of dissolved,filtration,filtrate and rare hydrochloric acid neutralization,adjust pH value to 4,exhalation precipitation,collect precipitation to use ethanol heavy crystallization,take crystalline material,adding appropriate an alkaline solution of dissolved completely,add purification water to 1000 ml,adjust pH value to 12,stir well,for a quick.This process condition is stable and reliable,and get the orange peel glucoside high purity,and convenient operation safety,suitable for large-scale production.The final quality standard of the product qualitative identification method for:thin layer chromatography(TLC),this method repeatability,spotted clear.Quantitative identification method for:high performance liquid chromatographic method,this method is simple,rapid,accurate,and can be used to control the quality of the product.This product stability study methods:the character of dried tangerine oral liquid,pH value,content changes as the index,the acceleration test and close to test and storage conditions retention samples under observation for the stability of the dried tangerine oral liquid was investigated.Three batch sample in 40±2?,relative humidity75±5%under the conditions of the place six months and open light intensity of illumination placed 4500±500Lx conditions deal with 10 days,or the character of dried tangerine oral liquid,pH value content is very stable.Through the long-term experiment in 24 months of the same traits of oral dried tangerine,pH value and content to remain in control of the range,can determine the validity of the preliminary dried tangerine oral liquid for two years.2.Pharmacology toxicology research it's set into acute toxicity tests,long-term toxicity tests and drug safety test three parts.Acute toxicity tests:is determined primarily by the dried tangerine or orange peel the absolute fatal dose oral liquid;Formal test take clean level 60 KM mice only,weight of 20 g ± 2 g,random into six groups,and only 10,male and female half.Group 6 for blank control group,through the mouth,irrigation under distilled water,1?5 groups of decline one by one set up different to drug concentration,drug continuous observation after 7 days,and record the mice body weight,mental state,water to feed themselves,activities and clinical manifestation.After testing,dislocated mice put to death,macroscopic observation mice viscera change,with the improvement KouShi method for calculating the LDs0.According to the general new veterinary drug toxicity test technology requirements",provisions LD50>5000 mg/kg for the actual non-toxic,and dried tangerine oral liquid LD50 = 11970 mg/kg,far bigger than the provisions of the 5000 mg/kg,the mice that oral irrigation is safe to serve as a kind of safe and reliable drug use.Long-term toxicity tests:experiment chooses the weight of close SD rats 80 only,male and female half,randomly divided into four groups,set up three drug gradient group and a blank control group,rat stomach to fill medicine,continuous to medicine 30 days.The rat free drink,medicine to observe the appearance of the animals during group,behavior,appetite,feces,weight,death and so on,after withdrawal continue to watch 15 days.Weigh once a week.In the 30 days and a 45 day said every groups were executed 10 rats,hematology,blood biochemical,viscera index and pathological examination.Results the clinical trial animals appear normal,viscera index,hematology index and blood biochemical indicators and blank compared no significant differences;In,high dose group weight compared with blank significantly increased;Dissection main viscera has not seen the obvious visible to the pathological change,histological examination also found no pathological changes.The drug has no obvious long-term aspirin toxicity,after withdrawal has not seen the drug delayed toxicity reaction.Safety test:choose 1 day age BaiYu AA flesh chickens 120 only randomly divided into four groups.Set three drug gradient combination a blank control group,said for seven weeks.Observe the test every day the mental state of chicken feed themselves,and water quantity,the daily gain weight,materials,excrement of shape,than with the situation of death,such as the death of a chicken,the calculation of morbidity,mortality,to the disease chicken for pathological cutting check and histopathological examination.The results in drinking water to add the dried tangerine oral liquid of different doses flesh chickens state of mind,drinking water to feed themselves and feces traits without adverse effects,and add in drinking water were 0.9%,0.3%,the dried tangerine oral liquid to flesh chickens growth of stimulative effect.3.Clinical research it's set into laboratory clinical research and expand clinical research.Clinical research laboratory by establishing chicken growth inhibition models to assess efficacy,expand clinical research through a collection of nature of the cases,drug use to evaluate drug effect.The results using dried tangerine oral liquid,can enhance the poultry appetite,increase intake,reduce feed than meat,improve digestion function,can promote growth poultry role. |
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