Ubenimex capsule medicament composition and preparation method thereof

A technology of Ubenimex and its composition, which is applied in the field of Ubenimex capsule pharmaceutical composition and its preparation, can solve the problems of high production cost, unfavorable large-scale production, complicated preparation process, etc., and achieve production cost reduction and safety Improvement, good dissolution effect

Active Publication Date: 2015-05-06
CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because there are many types of excipients, the preparation process is complicated, and the production cost is high, which is not conducive to industrialized large-scale production

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Prescription of Ubenimex Capsules: (Based on 1000 capsules, unit: g)

[0040] Ubenimex

10.0g

Sucrose Fatty Acid Ester

0.8g

lactose

35.0g

microcrystalline cellulose

125.0g

Magnesium stearate

0.3g

[0041] Preparation Process:

[0042] (1) Mixing: First add the prescribed amount of microcrystalline cellulose, sucrose fatty acid ester and prescribed amount of Ubenimex into the hopper of the mixer in sequence, and perform the mixing operation on the mixer for 10 minutes; then add lactose into the hopper of the above mixer In the process, perform the mixing operation on the mixer for 30 minutes; finally, magnesium stearate is added in the hopper, and mixed for 15 minutes to obtain the total blend powder;

[0043] (2) Capsule filling: Add Ubenimex capsule blend powder into the lower hopper of the capsule filling machine to fill the capsules.

Embodiment 2

[0044] Example 2 Prescription of Ubenimex Capsules: (Based on 1000 capsules, unit: g)

[0045] Ubenimex

10.0g

Sucrose Fatty Acid Ester

1.7g

lactose

52.5g

microcrystalline cellulose

105.0g

Magnesium stearate

0.8g

[0046] Preparation Process:

[0047] (1) Mixing: first add the prescribed amount of microcrystalline cellulose, sucrose fatty acid ester and prescribed amount of Ubenimex into the hopper of the mixer in sequence, and perform the mixing operation on the mixer for 5 minutes; then add lactose into the hopper of the above mixer In the process, carry out the mixing operation on the mixer for 20 minutes; finally, magnesium stearate is added in the hopper, and mixed for 5 minutes to obtain the total blend powder;

[0048] (2) Capsule filling: Add Ubenimex capsule blend powder into the lower hopper of the capsule filling machine to fill the capsules.

Embodiment 3

[0049] Example 3 Prescription of Ubenimex Capsules: (Based on 1000 capsules, unit: g)

[0050] Ubenimex

10.0g

Sucrose Fatty Acid Ester

1.2g

lactose

47.5g

microcrystalline cellulose

100.0g

Magnesium stearate

0.5g

[0051] Preparation Process:

[0052] (1) Mixing: first add the prescribed amount of microcrystalline cellulose, sucrose fatty acid ester and prescribed amount of Ubenimex into the hopper of the mixer in sequence, and perform the mixing operation on the mixer for 25 minutes; then add lactose into the hopper of the above mixer In the process, perform the mixing operation on the mixer for 10 minutes; finally, magnesium stearate is added in the hopper, and mixed for 8 minutes to obtain the total blended powder;

[0053] (2) Capsule filling: Add Ubenimex capsule blend powder into the lower hopper of the capsule filling machine to fill the capsules.

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Abstract

The invention provides an ubenimex capsule medicament composition and a preparation method thereof. Compared with the prior art, the prescription and process for preparing the ubenimex capsule, which are disclosed by the invention has the advantages that auxiliary materials, such as a binder and a disintegrating agent in the prescription are not used, the prescription is simple, and the safety is greatly improved. The preparation technology is easy to operate, and very suitable for large-scale industrial production. The prepared product can be completely dissolved out within a short period of time, and good in dissolving effect, relatively low in content of related substances, and stable in quality, and has a remarkable progress in comparison with the prior art.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition of Ubenimex capsules and a preparation method thereof. Background technique [0002] Ubenimex can effectively interfere with tumor cell metabolism, inhibit tumor cell proliferation, induce tumor cell apoptosis, activate human cellular immune function, stimulate the production and secretion of cytokines, and promote the production and proliferation of anti-tumor effector cells. It is clinically used as an adjuvant therapy for anti-cancer chemotherapy and radiotherapy, and has obvious curative effects on acute and chronic myelogenous leukemia, lung squamous cell carcinoma, and nasopharyngeal carcinoma. Domestically listed dosage forms include tablets and capsules. [0003] Through the clinical follow-up of Ubenimex capsules on the market, it was found that the capsules had problems such as disintegration and slow dissolution of th...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/198A61K47/38A61P35/00
Inventor 王颖刘秀芝邓凤英罗青
Owner CHENGDU EASTON BIOPHARMACEUTICALS CO LTD
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