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A kind of oral solid preparation of Tamibarotene, its preparation method and application

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

Active Publication Date: 2020-09-01
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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  • A kind of oral solid preparation of Tamibarotene, its preparation method and application
  • A kind of oral solid preparation of Tamibarotene, its preparation method and application
  • A kind of oral solid preparation of Tamibarotene, its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

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

[0047]

[0048]

[0049] Preparation:

[0050] (1) pulverizing the tamibarotene raw material, and sieving to obtain the tamibarotene;

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

[0052] (3) After the filler and the disintegrant in the step (2) are mixed uniformly, they are uniformly mixed with the tamibarotene in the step (1) in equal increments;

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

[0054] (5) dry, whole grain is made into Tamibarotene granule;

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

Embodiment 2

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

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

[0059]

[0060]

[0061] Preparation method: prepare with reference to the method of Example 1.

Embodiment 3

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

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

[0065]

[0066] Preparation method: prepare with reference 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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Patent Type & Authority Patents(China)
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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