Pediatric Asthma Granules Pharmacy Part Of The Study

Calming pedo-asthma granule is an empirical formula for curing asthmatic attack in children, which can relive the exterior syndrome and dissolve the retention of fluid, eliminate phlegm and calm the asthma, and have indications of bronchial asthma, bronchiolitis and asthmatic bronchitis in children et al.The preparation conditions, quality standard, and stability have been studied.一,Preparation processIn extraction study, we combined the function of formula with the physico-chemical property of each drug, to optimize the extraction way of principal drug Ma huang; the extraction process of essential oil and other active component. In the study of extraction way of Ma huang, we made content of total alkaloids as index to optimize steam distillation; decoction alone; and decoction with other drugs. In extraction of essential oil in Xixin, we made content of oil as index to optimize four factors: particle size; soak time; extraction time and water volum. The optimized process are using cut crude drug; distill with 10 times water for 4 hours. In extraction of Ziwan, we made shionone as index and used single factor model to optimize extract dissolvent. We chose 90% ethanol. And then we used three factors and three levels orthogonal test to optimize the volume of dissolvent; extraction time; frequency of extraction. The determination is to add 12 times 90% ethanol, extract 1. 5 hours. In decoction study of other drugs, we made the content of total alkaloids; baicalin and yield rate of dry extract as indexes. The optimized process is to add 10 times water, extract 3 times and 1. 5 hours each time.In concentration and drying process, we investigated variation of total alkaloids; baicalin; and shionone after oncentration and drying. Result: little change has happen. The methods are feasibility.In shaping process study, we made hydroscopicity; dissolubility and taste as indexes to optimize the dosage of corrigent; proportion of dextrin and sugar powder. And we made the degree of granulating difficulty and the granule yield as indexes to optimize density of ethanol to granulate. The shaping process is: to mix powder extract;β-CD inclusion compound; the mixture of dextrin and sugar powder at 1:0.7 and 1. 5% aspartame, then to granulate by extruding with 90% ethanol, and to dry under 60℃, to size the granulation at last.The experimental result of semi-works production indicated that the preparation process is maneuverability stabile.二,Quality standard studyIn order to set up quality standards of the preparation, we used TLC to distinguish Ma huang; Ziwan; Xixin; Chuanshegan; Huangqin, and HPLC to determine Ephedrine in the preparation. Result: The spots in TLC are clear, and have high specificity. The assay method is precise; reliable and can be used to control quality of the preparation.三,Preliminary study of stabilityWe preliminary researched the stability of the semi-works preparation for three months stored at room temperature. We inspect the sample at 0; first; second and third month using established quality standards. All the inspect results meet the requirement. This studyindicate that the preparation have good stability.