薬理と治療

Abstract

[We investigated the safety of long−term intake or excess intake of a drink containing glucosylceramide derived from Amorphophallus Konjac in a double−blind, placebo−controlled, parallel group study. The subjects for the safety evaluation of long−term intake were 43 healthy volunteers（test drink group：22 adults, placebo drink group：21 adults）. The subjects in the test drink group（glucosylceramide：1.8 mg）or placebo drink group were given 1 bottle per day for 12 weeks. The subjects for the safety evaluation of excess intake were 44 healthy volunteers（excessive test drink group：22 adults, placebo drink group：22 adults）. The subjects in the excessive test drink group（glucosylceramide：5.4 mg）or placebo drink group were given 1 bottle per day for 4 weeks. Any abnormal changes in clinical findings such as laboratory blood test, urinalysis and physical examination were not observed. These results confirmed that the drink containing glucosylceramide was safe, even when it was taken for long−term（12 weeks）or excess amount（a dosage three times the standard amount）.（Jpn Pharmacol Ther 2008；36：303−14）KEY WORDS Glucosylceramide, Long−term intake, Excess intake, Safety evaluation, We investigated the safety of long−term intake or excess intake of a drink containing glucosylceramide derived from Amorphophallus Konjac in a double−blind, placebo−controlled, parallel group study. The subjects for the safety evaluation of long−term intake were 43 healthy volunteers（test drink group：22 adults, placebo drink group：21 adults）. The subjects in the test drink group（glucosylceramide：1.8 mg）or placebo drink group were given 1 bottle per day for 12 weeks. The subjects for the safety evaluation of excess intake were 44 healthy volunteers（excessive test drink group：22 adults, placebo drink group：22 adults）. The subjects in the excessive test drink group（glucosylceramide：5.4 mg）or placebo drink group were given 1 bottle per day for 4 weeks. Any abnormal changes in clinical findings such as laboratory blood test, urinalysis and physical examination were not observed. These results confirmed that the drink containing glucosylceramide was safe, even when it was taken for long−term（12 weeks）or excess amount（a dosage three times the standard amount）.（Jpn Pharmacol Ther 2008；36：303−14）KEY WORDS Glucosylceramide, Long−term intake, Excess intake, Safety evaluation]