The present invention relates to a quality-stable
clotrimazole cream (3%) and a preparation method thereof. The
clotrimazole cream is prepared from the following components:
clotrimazole,
isopropyl myristate, cetanol, octadecanol, Tween 60, Span 60,
benzyl alcohol and
purified water; and the clotrimazole cream is prepared by heating and melting an
oil phase (including the cetanol, octadecanol,
isopropyl myristate, partial Tween 60, and Span 60), homogenizing and mixing with an aqueous phase (including the
purified water and
benzyl alcohol) and a
drug phase (including the
purified water, Tween 60 and clotrimazole) at a certain temperature, and then conducting rapid cooling. The clotrimazole cream can be slowly and smoothly released in a medium of pH 4.5 (in simulated vaginal conditions) to reduce
dose risks, besides, physicochemical stability of the clotrimazole cream is superior to that of other clotrimazole cream products, and the preparation process is simple, short in time consumption, low in
energy consumption, and suitable for industrial production.