Sustained-release capsule containing tacrolimus solid dispersion and preparation method thereof

[0039]

[0040]

[0041] Dissolve tacrolimus in ethanol, add ethyl cellulose and stir to dissolve it, slowly add povidone K30 to the above solution, and keep stirring until it is fully dissolved. Add the crushed and 200-mesh lactose into the wet granulation pot, pre-mix for 5 minutes, then slowly add the above solution to granulate through the wet granulator equipment. After granulation, put it on a tray, dry it in a common oven at 40°C, and then sieve it through a 70-mesh sieve to obtain SD1. Add lactose, SD1 and magnesium stearate to the mixer in sequence, and mix well to obtain Preparation 1. Formulation 1 was filled in capsules.

[0043]

[0044]

[0045] Formulation 2 was prepared using the same method as described in Example 1. Formulation 2 was filled in capsules.

[0047]

[0048] Formulation 3 was prepared using the same method as described in Example 1. Formulation 3 was filled in capsules.