Study On Preparation Process And Quality Standard Of Shengjiang Aiye Lotion

Objective:To establish the preparation process of Shengjiang Aiye Lotion,and study the quality standard of Shengjiang Aiye Lotion,so as to lay a foundation for the industrial production and quality control of Shengjiang Aiye Lotion.Methods:According to the provisions on pieces of Ginger and Folium Artemisiae Argyi in Chinese Pharmacopoeia 2015,the quality of Ginger and Folium Artemisiae Argyi was checked.The extraction process of volatile oil from Ginger and Folium Artemisiae Argyi was optimized by Latin hypercube design.The extraction rate of volatile oil was used as the evaluation index to evaluate the selected factors and determine the extraction method of the chinese herbal.Through the comprehensive consideration of reference literature and experimental results,two methods of impurity removal from extract that are ethanol precipitation and heat treatment and cold storage,three solubilizers of volatile oil that are tween 80,HP-β-cyclodextrin and talcum powder,three sterilization methods that are 116℃for 40 min,121℃for 30 min and 126℃for 15 min,which were evaluated synthetically to determine the molding parameters.In the study of quality standard of Shengjiang Aiye Lotion,the ginger and folium artemisiae argyi in the prescription were qualitatively identified by thin layer chromatography(TLC).The content of total flavonoids that are active ingredient in the Shengjiang Aiye Lotion was determined by ultraviolet and visible spectrophotometry.The content of 6-gingerol that are active ingredient in the Shengjiang Aiye Lotion was determined by high performance liquid chromatography(HPLC).The6-month accelerated and long-term stability studies were conducted in accordance with the guidelines for stability tests of raw materials and preparations in the Chinese Pharmacopoeia2015.In the study of initial pharmacodynamics of Shengjiang Aiye Lotion,the frostbite model of rats was established by attaching coins cooled in liquid nitrogen to the exposed skin on the back of rats.The therapeutic effect was evaluated by skin lesions,hemorheology and pathological morphology.Results:The preparation process of Shengjiang Aiye Lotion was as follows:adding 4 times of water to the medicinal materials,and extracting twice by steam distillation with 3.5 hours each time;then collecting volatile oil and extract.The extract was heated and boiled for 10minutes,and then refrigerated at 4℃for 24 hours;then adjusted p H to 5 with citric acid,refrigerated for 24 hours,centrifugated,filtrated.The volatile oil was added in the talcum powder,ground and solubilized,and then added refrigerated filtrate;then added 0.2%sodium benzoate as preservative,sterilized at 121℃for 30 minutes.The three batches of Shengjiang Aiye Lotion were dark brown liquid with special fragrance.In TLC identification,the test sample and control sample shows same spots at corresponding position in the chromatogram.The linear regression equation of the total flavonoids is:A=0.0088c-0.0376,R~2=0.9993,and the linear range is 42.5-93.5μg/m L.It is stipulated that the content of the total flavonoids in the lotion calculated by rutin should not be less than3.0mg/m L.The linear regression equation of the 6-gingerol is:A=14.7169c-6.5459,R~2=0.9994,and the linear range is 10.04-100.40μg/m L.It is stipulated that the content of6-gingerol in the lotion should not be less than 20.0μg/m L.In the 6-month accelerated and long-term stability test,all the indexes are in line with the requirements.The stability of the lotion is good.The initial pharmacodynamics study showed that Shengjiang Aiye Lotion can effectively promote the healing of frostbite surface.Conclusion:In this experiment,the preparation process and quality standard of Shengjiang Aiye Lotion were studied systematically,and the quality standard draft of Shengjiang Aiye Lotion was established preliminarily.The preparation process was stable and simple,and the quality control method established was accurate and reproducible,which laid a foundation for the production and quality control of Shengjiang Aiye Lotion.