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Nifurtimox dry suspension and preparation method thereof

A technology of dry suspension and nifurolimus, which is applied in the direction of pharmaceutical formula, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc.

Active Publication Date: 2015-05-27
柏思德天津医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the problem that nifurolimus tablets cannot or are difficult to administer to patients with neuroblastoma, the present invention provides a new drug that is convenient for transportation and carrying without increasing the hidden danger of stability, and is more suitable for children, infants and young children. Preparation form, dry suspension, the new preparation form of nifurolimus significantly improves its application in patients with neuroblastoma, and fully exerts its drug effect, so that the majority of children with neuroblastoma can choose drugs independently, reaching The purpose of curing and controlling the disease

Method used

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  • Nifurtimox dry suspension and preparation method thereof
  • Nifurtimox dry suspension and preparation method thereof
  • Nifurtimox dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] 1000 bags prescription:

[0064]

[0065] Preparation:

[0066] ① Pass Nifurolimus through a 200-mesh sieve, and each auxiliary material through a 100-mesh sieve;

[0067] ②Mix nifurolimus and all the excipients evenly in the method of equal increment;

[0068] ③ Put the mixed powder obtained in step ② into a one-step granulator, spray water into the granulator, and dry until the water content of the granules is less than 1%.

[0069] ④ Subpackage the granules obtained in step ③ to obtain the dry suspension of the present invention.

Embodiment 2

[0071] 1000 bags prescription:

[0072]

[0073] Preparation method, with embodiment 1.

Embodiment 3

[0075] 1000 bags prescription:

[0076]

[0077] Preparation:

[0078] ① Pass Nifurolimus through a 180-mesh sieve and set aside;

[0079] ② Each auxiliary material is passed through an 80-mesh sieve, and mixed evenly in an equal increment method;

[0080] ③ Mix the powders obtained in steps ① and ② with the method of equal increments, and the obtained mixed powders are directly packed to obtain the nifurolimus dry suspension of the present invention.

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Abstract

The invention provides a dry suspension containing nifurtimox. The dry suspension comprises the following components in parts by weight: 60 parts of nifurtimox, 300-400 parts of a filling agent, 20-50 parts of a suspending aid, 20-40 parts a flocculant and 0.5-1 part of a solubilizer. The dry suspension is relatively applicable to patients suffering from nifurtimox adaptation diseases, and is good in stability.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to a dry suspension containing nifurolimus and a preparation process thereof. Background technique [0002] Nifurtimox, English name Nifurtimox, chemical name 3-methyl-4-(5'-nitrofuryl methylene-amino)tetrahydro-4H-1,4-thiazine-1,1 dioxide. The marketed preparation of nifurolimus is a tablet produced by Bayer Company, which is mainly used to treat early American Chagas disease caused by trypanosomes. At present, there is an invention patent (Patent No. 101500557) for the anti-cancer use of nifurolimus in China, which discloses its therapeutic effect on cancer, especially neuroblastoma. [0003] About 50% of neuroblastoma occurs in children before the age of 2, about 2 / 3 of the children are diagnosed before the age of 5, and occasionally occurs in adults. The tumor is the leading cause of childhood cancer death, it is the most common extracranial solid tumor i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/541A61K47/38A61P35/00
Inventor 吴文涛任弘光
Owner 柏思德天津医药科技有限公司
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