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

A technology of solid dispersion and tacrolimus, which is applied to medical preparations containing active ingredients, medical preparations with non-active ingredients, capsule delivery, etc., can solve problems that are not conducive to industrialization and increase production costs, and achieve The effect of reducing the number of doses, easy to reproduce, and simple preparation process

Inactive Publication Date: 2016-06-15
华益泰康药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This not only greatly increases the production cost, but also is not conducive to the promotion of industrialization

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[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.

Embodiment 2

[0043]

[0044]

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

Embodiment 3

[0047]

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

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Abstract

The invention belongs to the field of pharmaceutical preparations and particularly discloses a sustained-release capsule containing tacrolimus solid dispersion and a preparation method thereof. The sustained-release capsule contains 1 part by weight of tacrolimus, 0.6-6.0 parts by weight of polyvidone K30 and ethyl cellulose, lactose, excipient and lubricating agent. The sustained-release capsule containing tacrolimus solid dispersion is simple in preparation process, easy to reproduce and suitable for industrial popularization.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a slow-release capsule containing tacrolimus solid dispersion and a preparation method thereof. Background technique [0002] Tacrolimus is a neutral macrolide antibiotic isolated from a main fermentation product of Streptomyces in the soil of Tsukuba, Japan in 1979. It is a new type of potent immunosuppressant. Its main pharmacological effect is that it can effectively inhibit the activation of T lymphocytes, and combine with endogenous cell receptors to form an immunophilin complex, thereby exerting pharmacological effects. A large number of animal experiments and clinical application studies have found that the immunosuppressive effect of tacrolimus is 10 to 100 times higher than that of cyclosporin A, and the incidence of side effects is lower than that of cyclosporin A, and the degree is also mild. Clinically, it has been widely used in the treatment of organ tran...

Claims

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Application Information

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IPC IPC(8): A61K9/52A61K31/436A61K47/32A61P37/06
CPCA61K9/4866A61K9/1623A61K31/436A61K47/32
Inventor 徐国杰邹小超李惠惠谭海松诸弘刚
Owner 华益泰康药业股份有限公司
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