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Ubenimex capsule composition and preparation method thereof

A technology of Ubenimex and composition, which is applied in the field of Ubenimex capsule composition and its preparation, can solve the problems of long-term stability investigation of uninjected liquid, influence of Ubenimex stability, complex preparation process, etc. To achieve the effect of improving bioavailability, cheap price of finished medicine, and overcoming dissolution and disintegration hysteresis

Active Publication Date: 2013-06-12
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101601649B discloses a Ubenimex fat emulsion injection and its preparation method. The average particle size of the prepared fat emulsion is about 300nm, which is suitable for patients who cannot swallow, are in a coma or have digestive system disorders, but the preparation process of the preparation Complexity, high production cost, and the long-term stability of the injection is not investigated in the patent
CN101002931B discloses a Ubenimex tablet and its preparation method. The surface of the prepared tablet is smooth and clean, but the preparation process requires the wet granules containing the drug to be baked at 80°C for 4 hours, which easily affects the stability of Ubenimex

Method used

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  • Ubenimex capsule composition and preparation method thereof
  • Ubenimex capsule composition and preparation method thereof
  • Ubenimex capsule composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Preparation Process:

[0041] 1) Prepare the prescribed amount of povidone with 16% ethanol solution to make 12% PVP solution, then dissolve the prescribed amount of sodium lauryl sulfate and sucrose stearate in the solution, and finally add the prescribed amount Ubenimex, so that it can be dispersed evenly, and the drug-containing adhesive can be prepared;

[0042] 2) Pass the prescribed amount of lactose, microcrystalline cellulose, croscarmellose sodium and polacrilin potassium through 80-100 mesh sieves respectively, and mix them uniformly to prepare blank mixed auxiliary materials;

[0043] 3) Mix the drug-containing adhesive obtained in step 1) with the blank mixed auxiliary materials obtained in step 2 through the high-pressure sprayer of the spray dryer, and dry at 25°C for 5 minutes to obtain granules with a moisture content of 1.0%.

[0044] 4) Sizing the granules obtained in step 3) with an 18-mesh sieve;

[0045] 5) Add the granules obtained in step 4) to ...

Embodiment 2

[0047] The preparation process is the same as in Example 1, wherein the drying temperature in step 3 is 24°C, the drying time is 5 minutes, and the moisture content is reduced to 0.5%.

Embodiment 3

[0049] The preparation process is the same as in Example 1, wherein the drying temperature in step 3 is 23°C, the drying time is 4 minutes, and the moisture content is reduced to 1.3%.

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Abstract

The invention discloses an ubenimex capsule composition. Each unit preparation of ubenimex capsule consists of 10-30mg of ubenimex, 85-105mg of lactose, 95-118mg of microcrystalline cellulose, 8-10mg of croscarmellose sodium, 6-7mg of polacrilin potassium, 4.5-5.5mg of povidone, 1-2.5mg of sodium lauryl sulfate, 0.2-0.7mg of sucrose stearate and 3-4mg of magnesium stearate. According to the invention, the prepared ubenimex capsule can be used for effectively promoting the dissolution of ubenimex and improving the bioavailability; spray drying at 20-25 DEG C is adopted for granulation, the granulation efficiency is improved, the damage of ubenimex caused by high temperature is avoided, and the drug stability is improved; by combining an inner disintegrating agent and an outer disintegrating agent, the disintegrating speed of capsule is further increased, and the shortcomings of common capsule dissolution and disintegrating lag are overcome; and compared with prior art, the method is more suitable for industrial mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an ubenimex capsule composition and a preparation method thereof. Background technique [0002] Ubenimex, its chemical name is: N-[(2S,3R)-3-amino-2-hydroxy-4-phenylbutyryl]-L-leucine; molecular formula: C 16 h 24 N 2 o 4 ; Molecular weight: 308.37; Its structural formula is as follows: [0003] [0004] Ubenimex is a dipeptide compound isolated from the culture medium of Streptomyces olivine by Japanese scholar Umezawa Hamao in 1976, which can competitively inhibit aminopeptidase B, leucine peptidase and cysteine Aspartase, etc., induce tumor cell apoptosis and promote host immune function. It can be used in conjunction with chemotherapy, radiotherapy and combined application in patients with leukemia, multiple myeloma, myelodysplastic syndrome and hematopoietic stem cell transplantation, as well as other solid tumors. [0005] Ubenimex is odorless...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/198A61K47/38A61P35/00A61P37/04A61P7/06A61P35/02
Inventor 王颖
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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