Study On The Preparation Process And Quality Standard Of Jianpi Granules

Piglet diarrhea has always been a troublesome and difficult problem in pig farms.Within 15 days after weaning,piglets have a diarrhea rate of30%-40% and a mortality rate of 15%-20%.Moreover,the sick piglets grow slowly after recovery.The feeding cycle needs to be extended for more than one month,which brings huge economic losses to breeders.Jianpi Granule is a traditional Chinese medicine preparation formula derived from the clinical basic veterinary experience formula.It has been verified in many test sites that it can significantly improve the diarrhea symptoms of piglets and reduce the incidence rate of diarrhea in weaned piglets.Therefore,it has good market application value.In order to obtain Jianpi Granules with stable process and controllable quality,this study conducted research from three aspects: preparation process,quality standard research,and stability test.The specific research contents are as follows:1.Study on the Preparation Technology of Jianpi GranulesJianpi Granules are a combination of four Chinese herbal medicines: Jiaobaizhu,roasted licorice,processed ginger,and plantain.The four medicinal herbs in Fangzhong were extracted by water decoction.Single factor and orthogonal experiments were conducted on the amount of water added,extraction time,and extraction frequency of the decocted herbs.The evaluation indicators were n-butanol extract,extraction rate,and glycyrrhetinic acid content in the extraction solution.To determine the optimal process,while maximizing the assurance of effective ingredients and extraction efficiency,in order to save production energy and reduce production costs,the final extraction process conditions are as follows: boil in water 3times,then in 12 times the amount of water for 2 hours,followed by in 10 times the amount of water for 1 hour,finally in 10 times the amount of water for 1 hour.The extraction rate was 32.72%.The n-butanol extract reached 3.80%,The content of glycyrrhetinic acid was 1.11 mg/g.After verification,the optimized extraction process is stable,reliable,and has good repeatability.Before particle preparation,it is necessary to remove impurities and concentrate the extraction solution to meet the requirements of particle preparation.Based on the investigation of the effects of different filtration methods on the properties and filtration efficiency of the drug solution,a high-speed centrifuge was ultimately used for filtration.By exploring the differences between atmospheric concentration and vacuum concentration under different negative pressure conditions,the final choice was to concentrate between 80℃ and 90℃ under reduced pressure.The study on the preparation process of Jianpi granules involved concentrating the extract into extracts,and then using a fluidized bed for one-step granulation.The selection of excipients for the granules and the parameters of fluidized bed granulation were used as the main evaluation indicators,with the qualification rate,angle of repose,and solubility of the granules as the main evaluation indicators.Finally,glucose: maltodextrin(3:1)was chosen as an adjunct for Jianpi granules;The parameters for fluidized bed granulation were: injection speed of 11-14 r/min,relative density of extract of 1.20-1.22 g/cm3,and air volume of 84-86 m3/h.Finally,the particles were sieved through 10 and 80 mesh sieves to obtain formed particles.2.Study on the Quality Standards of Jianpi GranulesIn order to effectively control the quality of Jianpi Granules,this experiment conducted a systematic and scientific quality study on the product.Using thin-layer chromatography to identify the effective components in Jiaobaizhu,Plantago,Processed Ginger,and Roasted Glycyrrhiza,and the specificity and durability of the four established methods were studied.The experimental results showed that the thin layer identification spots were clear,the negative samples had no interference from the same spots,and the chromatogram had good reproducibility and durability.The samples exhibited spots or fluorescent spots of the same color at the corresponding positions as the reference medicinal material or reference substance,which could effectively identify the effective ingredients of each medicinal material in the formula.Product quantification is based on quality control glycyrrhetinic acid.The high-performance liquid chromatography was used to determine the content of glycyrrhetinic acid.By establishing HPLC,the specificity,linear relationship,precision,daytime stability,repeatability,accuracy,and durability of the prepared samples were investigated.The final determination method is stable and reliable,with good specificity,sensitivity,and durability,and is suitable for the determination of glycyrrhetinic acid content in Jianpi granules.3.Study on the Stability of Jianpi GranulesAccording to the relevant technical guidelines for stability testing issued by the Ministry of Agriculture,three batches of pilot products were subjected to factor testing,accelerated 6-month testing,and long-term sample retention for 12 months.The research results showed that under the influence factor test,there is no significant change in the various detection indicators of Jianpi Granules in the high humidity and strong light tests.Only under the high temperature test,the glycyrrhetinic acid content slightly decreased,but still complied with relevant regulations.Within the specified range of quality standards,the prescription of Jianpi Granules was relatively reasonable,and the production process and packaging conditions were suitable.After long-term testing,the accelerated test showed that the glycyrrhetinic acid content slightly decreased.The average content of glycyrrhetinic acid in the sample decreased from 1.02 mg/g to 0.96 mg/g.Based on the experimental results of its influencing factors,it is suggested that temperature has a slight impact on the content of Jianpi granules and should be stored in a cool place.However,the properties,identification items,and inspection items of other granules have not changed significantly,indicating that Jianpi granules are stable under commercial packaging.