Clinical Study On The Treatment Of Chicken Escherichia Coli With Chinese Veterinary Drugs Lianxiang Pulvis

ObjectLianxiang Pulvis is a clinical experience in the treatment of bacterial diarrhea from the First Affiliated Hospital of Guangzhou University of Chinese Medicine.The formula contains Common Andrographis Herb,Rhizoma Atractyloidis,Radix Aucklandiae,Cortex Magnoliae Officinalis,and Rhizoma Zingiberis.Lianxiang Pulvis is able tostrengthen healthy qi to eliminate pathogens,promote qi circulation and relieving pain,dry damp and strengthening spleen,regulate stomach qi actively,stop diarrhea and so on.The small scale veterinary clinical trials on earlier stage,which cooperation with Guangzhou China Agricultural University Experimental Veterinary Drug Company,indicated Lianxiang Pulvis could prevent and control Chicken Colibacillosis effectively.In order to make it play a better role in the poultry industry and to declare the third type of new veterinary drugs,Guangzhou University of Chinese Medicine and Guangzhou China Agricultural University Experimental Veterinary Drug Company were unite to have a detailed study on the effectiveness and safety and quality control.This research would complete part of preclinical study to accumulate data for the clinicaluse and new drug application of Lianxiang Pulvis.MethodsOn the basis of laboratory experiments to expansion of the production process,and obtained different batches of Lianxiang Pulvis samples and verify the feasibility of this process.Then preliminary study on the quality standard of Lianxiang Pulvis,including the prescription,preparation methods,properties,qualitative identification and quantitative detection.After these,study its stability by accelerated test and long-term test method.At last,research of its safety pharmacology,pharmacodynamics,acute toxicity and long-term toxicity.Results1.By finished the 10 batches of pilot production products,showing current process are feasible,the quality of product is met the standard.The production process is feasible,easy to operation,and powder plant of GMP is perfectly able to produce without any special equipment.Existing plant have not to transform,product can meet the quality standard.Tri-waste produced in the production process is easy to handle,which conform to the state relevant policies about requirements of environmental protection.The result of pilot plant test declare that2.Quality specification study of Lianxiang Pul vis indicated that thin layer chromatography(TLC)is easily to operate and has good specificity in identify for Common Andrographis Herb,Rhizoma Atractyloidis,Radix Aucklandiae,Cortex Magnoliae Officinalis,Rhizoma Zingiberis,etc.The accuracy,precision,and specificity of High-performance liquid chromatography are good on content determination for costunolide,dehydrocostus,andrographolide,and Dehydroandro-grapholide.Chromatographic conditions with good separation effect,according with principle of“accuracy,speediness,sensitiveness,and simpleness”.According to pilot test results and the influence of some factors on the content of the actual production process,the provisional gross of Costunolide and Dehydrocostus,Andrographolide and Dehydroandrographolide is no less than 2.5 mg/g and 1.0 mg/g,respectively.3.Accelerate test result manifest that the quality of the sample with good stability,since on the basis of commercially available back,keep condition of(25±2)℃,relative humidity 75%±5%for 6 months,the three batches of pilot samples on the study project had no obvious change contrast with zeroth months.Long-term test show that the sample with good stability,by reason of keeping condition of(25 ± 2)℃,relative humidity 60%±10%for 24 months,the three batches of pilot samples on the study project had no obvious change contrast with zeroth months.It can suggest the expiration period for 24 monthsConclusionsPreclinical study of Lianxiang Pulvis was investigated its preparation technology,quality standard,stability research,safety pharmacology,pharmacodynamics and toxicology.The results shown that,the pilot production process method is feasible and workable,it could be guide the enlarge production,and the cost was equal to the ordinary powder.Polyethylene membrane material for Lianxiang Pulvis inner packing,polyester/aluminum/polyethylene composite film for the outer packing,as the result,its quality is relatively stable.The effective period is tentatively scheduled for 24 month.The qualitative and quantitative methods to study the quality standard were simple,reliable and easy to operate.Lianxiang Pulvis is a preparation for safe,effective,non-toxic side effects of the treatment of diarrhea.