| Yinhuang particle was manufactured by granules derived technology based on its original liquidpreparation formula liquid formulations according to the new quality control method of twotraditional herbs extract (Lonicera japonica and Scutellaria baicalensis). The extraction of FlosLonicerae chlorogenic acid composition, organic alcohols, esters, has antibacterial, antiviral,antipyretic, excited central nervous system, improving the body immunity; Scutellaria baicalensisextract containing flavonoids baicalin and other components, it also contains beta sitosterol, withXiehuo, anti-inflammatory, sedative, liver, etc. effect.This study changed the original formulationto ensure the original effects in accordance with the preparations extracted into the formulationand stability indicators based on the pharmacopoeia prescription for veterinary clinical application.In order to ensure that all the indexes of the formulations to meet the requirements, the preparationand the index related quality of Yinhuang particle were studied, and the optimum preparationprocess and quality standard were also established. Subsequently, the toxicological studies andPreliminary Application for the Treatment of Mycoplasma gallisepticum Disease.Objective: According to the existing formulas, to establish the preparation process andquality standard, to inspect the stability and the toxicity; to investigate the immune-enhancingeffects in mice and the vaccine enhancement in chickens.Methods: The optimum extraction conditions of raw materials, that is Lonicera japonicaand Scutella baicalensis, were investigated. Extraction of Lonicera japonica adopted ethanolrecirculate extract, extract times, concentration of ethanol, extract time and volume of ethanolwere used as factors, and caffeotannic acid extract rate as index, while Scutellaria baicalensisadopt water extract directely, water amount, extract times, extract time as factors, and baicalinyield as index. The forming process was preferably determined through the selection of materialsand the wetting agent. The quality was inspected by thin layer chromatography for the ultimatequalitative identification of honeysuckle and baicalin to monitor the main ingredients. The stability tests were investigated according to the related testing regulations, that is1,2,3,6months room temperature stability test and1,2,3,6months accelerated stability test. The acutetoxicity on mice and sub-chronic toxicity test on rat were proceeded to evaluate the toxicity offinal products; curation rate on chickens that artificial infected Mycoplasma gallisepticum wereused to value the therapeutic efficacyResults: The preparation process of Yinhuang particle: Lonicera japonica was extractedthrough ethanol reflux at6times,8times and10times ethanol respectively, each times for0.5h,the extracted liquid was combined, filter, adding appropriate amount of water, and adding sulfuricacid to regulate pH value to6-7, stirring, filtration, the filtrate was concentrated to thick paste.Scutellaria also needs to decoction three times using8times water for1h,1h and1h, respectively,then combined the fluid, filtered and condensed. Hydrochloric acid solution of2mol/L was usedto adjust pH to1.0-2.0at80℃, kept the temperature for1h, and standing for12h. Thesedimentation was added with6-8times water, and40%NaOH was used to adjust the pH to7.0,the partes aequales ethanol was added, agitated to haemolyze, and filtered again, hydrochloric acidsolution of2mol/L was used to adjust pH to2.0at60℃, kept the temperature for30min, andstanding for12h. The sedimentation was washed with alcohol until pH was7.0, the sedimentationcan be used once alcohol was exhausted. Collect all the thick paste and root powder followed withappropriate amount of auxiliary material to be particle, then moderate amount of glucose wasadded and95%ethanol was selected as wetting agent.Quality standard: The quality was inspected by thin layer chromatography for the ultimatequalitative identification of honeysuckle and baicalin to monitor the main ingredients. The resultsshowed that the preparation process and quality standard of Yinhuang particle were reasonable andfeasible, which could be used as perfect product quality evaluation.Formulation stability: The stability tests were investigated according to the related testingregulations for6months including the stability at room and accelerated stability test. The trialbatches of samples showed the favorable stability in polyester/aluminum compositepharmaceutical packaging bags under the conditions of stability.Toxicology tests: The acute toxicity and sub-chronic toxicity tests were evaluated the toxicityof final products to ensure the safety in clinical application. The growth and development of rats were not influenced through sub-chronic toxicity test,42days of repeated administration with notoxic reaction.Chicken chronic respiratory disease, a highly contagious infectious disease, In clinical on cancause depression, decreased chicken feed, slow growth, reduce the ratio of feed and meat, chickenwith disease death caused the loss. By means of Yinhuang granules with different doses onchicken disease treatment, protective effect of high, medium dose of artificial infection ofMycoplasma gallisepticum air sac lesions were the best, can reduce the lesion inflammation,promote tissue recovery, improve disease chicken survival state, promote the body to restorehealth.In summary, the optimized preparation process and the quality control of Yinhuang particlewere investigated in this study. This particle has good stability, high safety, and with effect ofstrong antipyretic, analgesic, anti-inflammatory and relieving cough action, which could establisha strong foundation in the clinical application. |
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