PURPOSE: To obtain the subject pharmaceutical, excellent in thermal stability, having tolerance even to mechanical pressure and high specific activity without causing inactivation even in carrying out heat treatment for a long period by spray-drying an enzymic aqueous solution containing disaccharides and solidifying the solution.
CONSTITUTION: Bacillus sp. KSM-K16 which is an alkalophilic bacterium is inoculated into a liquid culture medium and aerobically cultured at 3O°C for 48hr by shaking culture to produce an enzyme (e.g. alkaline protease K-16). After completing culture, the culture solution is centrifuged to remove the microorganism. The supernatant is lyophilized to afford powder, which is subsequently dissolved in ion exchange water and dialyzed against a 10mM tris(hydroxymethyl)aminomethane (tris)-hydrochloric acid buffer solution (pH 7.5). An aqueous solution containing disaccharides such as maltose type disaccharides (e.g. lactose) in an amount of 1-100 wt.% based on the enzyme is then added and the resultant mixture is spray-dried by using hot air at 150°C and 60°C discharge gas temperature with an atomizer type spray dryer, etc., and solidified to afford the objective enzymic solid pharmaceutical.
IKUGA YUTAKA
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