Study On Preparation And Quality Standard Of A Kind Of Uterine Perfusate

Objective: This preparation is a kind of uterine perfusion agent used in the prevention and treatment of sow endetritis,and has a good curative effect.In this study,the preparation process and quality standard were studied in order to determine the best preparation process and establish its qualitative and quantitative quality control standards,so as to provide the basic methodological research theory and test data for the declaration of new veterinary drugs.Methods: In this study,orthogonal test was used to optimize the factors affecting the extraction effect of the preparation,and the concentration method,clarification process and molding process were studied in order to select the optimum preparation process parameters.The prescription medicinal materials of Herba epimedii,Sop Horae Flavescentis Radix,Leonurus japonicus Houtt,Sanguisorbae Radix and Sarcandrae Herba were studied by thin layer chromatography,and the best thin layer qualitative identification method was obtained.The content of icariin in the preparation was determined by high performance liquid chromatography(HPLC),and the stability of the preparation was investigated by long-term test and accelerated test.Results:(1)The optimum preparation process of the preparation was selected as follows: taking the prescription quantity of medicinal materials,adding 12 times the amount of water to soak for 1.5 hours,decoction and extraction for 3 times,each decoction for 1.5 hours,the first decoction needs to add water absorption,the extract is combined and filtered,the filtrate was concentrated to the ratio of 1 to 1,and the gelatin content is 0.08% by adding 1% gelatin solution.After mixing evenly,after staying overnight,the mixture was centrifuged with 4500r/min for 30 min,the centrifugate was added to 1000 m L,after adding 1g potassium sorbate and adjusting its p H to 4.5~6.0,it was sterilized by high pressure steam after filling.(2)A thin layer identification method of Herba epimedii,Sop Horae Flavescentis Radix,Leonurus japonicus Houtt,Sanguisorbae Radix and Sarcandrae Herba was established.The results showed that the chromatogram of each medicinal material was clear,the spots were round,the development distance was moderate,the separation degree was good,and there was no interference from each negative control.(3)A method for the determination of icariin was established and the content of icariin in three batches of pilot-scale samples was determined,the limit of icariin content in the preparation was0.40 mg/ml.(4)The long-term test and accelerated test were only carried out for 3months,and the indexes of the preparation changed little,and the preparation was stable within three months.Conclusion: The optimized preparation process is stable and reproducible,and can be used in industrial production.The established quality control standard is simple and accurate,and the quality of the sample remains stable within 3 months.