A methodology for producing a pediatric medicinal formulation consisting of granules containing an extract of the milk-white iris (MWIE) was developed. Accessory substances were selected on the basis of the high hygroscopicity and low solubulity of the extract; the optimum conditions for granule production were selected (structural granule formation in a semifluidized bed process). The yield of granules using this methodology was 97.5%. Granules containing MWIE were not toxic (LD 50 = 5.0 -7.7 g/kg) and positive results were obtained on assessment of immunotropic activity. The Manufacturer's Pharmacopeia Article and laboratory guidelines were developed for the pediatric MWIE-containing medicinal granules.

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