院内製剤硫酸アトロピン散の含量均一性

概要

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In the preparation of 0.1% atropine sulfate powder, the effect of the method of preparation on mixing degree, distribution of particle size and component in different particle size was studied by three different methods using tartrazin as a model. Solution mixing method (SMM) as compared with powder dilution method (PDM) and combined method of SMM and PDM, though the component in different particle size was different, gave a good mixing degree which showed small variance at various sampling weight. Distribution of the component in SMM was affected by material or volume of binder. All the particles in granules which passed through 42-mesh sieve and remained on 200-mesh sieve maintained the 90-110% content when 10% water was used as binder in SMM. Furthermore, packaging procedure had little effect on content uniformity of the powder prepared by SMM and PDM. SMM, if the component in the different size fraction was checked, proved to be a very good method in the preparation of the powders with very low content of active ingredient in hospital pharmacy. Thus 0.1% atropine sulfate powder with good content uniformity was obtained by SMM.
日本医療薬学会の論文
1982-12-20