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Orally taken tamibarotene solid preparation, preparation method and application thereof

A technology of tamibarotene and solid preparation, applied in the field of medicine, can solve the problems of poor fluidity, unqualified content uniformity of tablets or capsules, low dissolution rate, etc., achieves good dissolution rate, improves bioavailability, facilitates absorption effect

Active Publication Date: 2017-09-29
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Because the raw material powder of tamibarotene is light, easy to float and has poor fluidity, the prepared tablets or capsules are prone to unqualified content uniformity and low dissolution rate

Method used

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  • Orally taken tamibarotene solid preparation, preparation method and application thereof
  • Orally taken tamibarotene solid preparation, preparation method and application thereof
  • Orally taken tamibarotene solid preparation, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] This example is used to illustrate the tamibarotene solid preparation of the present invention and its preparation method.

[0046] Tamibarotene solid preparations were prepared according to the following recipe.

[0047]

[0048]

[0049] Preparation:

[0050] (1) pulverize Tamibarotene raw material, sieve to obtain described Tamibarotene;

[0051] (2) the filler, disintegrant and lubricant are sieved;

[0052] (3) after the filler and the disintegrating agent in the step (2) are mixed uniformly, and the tamibarotene in the step (1) is uniformly mixed by an equal amount incremental method;

[0053] (4) add water to the mixture of described tamibarotene, filler and disintegrating agent in step (3) to make soft material, sieve and granulate;

[0054] (5) drying, whole granulation is made into tamibarotene granules;

[0055] (6) adding the lubricant to the tamibarotene granules in step (5) and mixing evenly to prepare the solid preparation.

Embodiment 2

[0057] This example is used to illustrate the tamibarotene solid preparation of the present invention and its preparation method.

[0058] Tamibarotene solid preparations were prepared according to the following recipe.

[0059]

[0060]

[0061] Preparation method: prepared according to the method of Example 1.

Embodiment 3

[0063] This example is used to illustrate the tamibarotene solid preparation of the present invention and its preparation method.

[0064] Tamibarotene solid preparations were prepared according to the following recipe.

[0065]

[0066] Preparation method: prepared according to the method of Example 1.

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Abstract

The invention provides an orally taken tamibarotene solid preparation. The solid preparation comprises tamibarotene, disintegrating agent, filling agent and lubricating agent, wherein the weight of the tamibarotene is 1%-2% of the weight of the solid preparation, the weight of the filling agent is 70%-90% of the weight of the solid preparation, the weight of the disintegrating agent is 8%-25% of the weight of the solid preparation and the weight of the lubricating agent is 0.5%-0.6% of the weight of the solid preparation. The orally taken tamibarotene solid preparation prepared according to the invention has high dissolution rate, content uniformity and stability, is beneficial to the promotion of the bioavailability of human body and is more suitable for clinical application. The invention also provides a preparation method and an application of the solid preparation.

Description

technical field [0001] The invention relates to the field of medicine, in particular to an oral solid preparation of tamibarotene and a preparation method thereof. Background technique [0002] Acute promyelocytic leukemia (APL) is a special subtype of acute myeloid leukemia (AML, or acute nonlymphocytic leukemia), which is classified as type M3 by FAB. More than 90% of APL patients have characteristic chromosomal translocation t(15,17)(q22~23; q12~21), which produces a fusion gene encoding PML-RARα (promyelocytic leukemia-retinoic acid receptor α) protein , Inhibit the function of PML or RARα to prevent cell apoptosis and myeloid cell differentiation, leading to the onset of APL patients. APL is mainly characterized by promyelocytic hyperplasia, with sudden onset, rapid deterioration, obvious bleeding tendency, and prone to disseminated intravascular coagulation. The number of peripheral blood leukocytes is often not increased, and promyelocytes in the bone marrow are >...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/20A61K47/38A61K47/36A61K47/26A61K31/192A61P35/02
CPCA61K9/1623A61K9/1652A61K9/2018A61K9/2054A61K9/2059A61K31/192
Inventor 张志兰曾祎华潘丽
Owner HAIKOU PHARMA FACTORY
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