The Study On Processing Technology And Quality Standards Of Huangshi Powder

This topic is the drug of folk prescription on pharmaceutical research, which can clear heat and detoxicate, hemostatic converges, the effect of the boils, for various causes of burn and illustrates the ulcer, fistula, bedsore etc. However,the original forms is suspension type spray, when the drug for spray injured trauma surface has certain stimulation, this topic to follow the powder's advantage, combining with the production practice, optimization of process, cost savings. Introducing superfine comminution to increase the drugs of dispersion, coating, adhesion, transdermal absorption of skin and reduce the stimulus. In use process can protect victim, absorb wound secretion and promote clotting and healing, and can reduce the stimulation of wounds, namely, to alleviate the pain patients for enterprise to bring economic benefits.This basic pharmaceutical researches was carried out in this dissertation; the selection of manufacturing techniques, the establishing of quality standards and the evaluation of preliminary stability were achieved, establishing the foundation for the preparation marketing. According to the functions and indications of the prescription, together with the physico-chemical properties of the ingredients, through comparative researches and orthogonal experiments, the optimum extraction process was determined as follows: rhubarb, rhizoma coptidis, cortex phellodendri three kinds of herbal medicine with 8 times volume ethanol refluxing extraction,80%,twice 2 hours, then combine two extract and filtrate. The filtrate to use reduced pressure concentration(-0.08MPa～-0.1 MPa, temperature for 50℃～60℃, degrees≤0.2MPa),concentrate the relative density for 1.10～1.12 (50℃). Pulvis fellis suis hot dissolving and boil. Mixed liquid, while stirring join mineral, vacuum drying (temperature for 55℃～65℃,-0.08 MPa). Join with sanguis draconis and superfine pulverizing, accordingly.The quality standard of huangshi powder was established. TLC was used to identify the ingredients in prescription respectively, among which rhubarb, sanguis draconis, pulvis fellis suis, coptis chinensis and cortex phellodendri had comparatively better results, thus the methods were included into the normal text of quality standard. The moisture content, difference of filling weight, arsenic salt, heavy metals, microbial limits were controlled; the total count of dracorhodin should not be lower than 0.56mg/g; the total count of total anthraquinone should not be lower than 14.5mg/g. And the corresponding research methodology.The stability of samples was investigated by accelerate and normal temperature observations. The results of the preliminary stability research indicated that lots sample properties, identification, inspection, content determination are in conformity with the provisions. (long-term stability testing continues).Research shows that preparation technology is reasonable and practical, the standard is controllable, and the quality of the sample is stable on the whole as well.