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A kind of mercaptopurine four-part chewable tablet and preparation method thereof

A technology for mercaptopurine and chewable tablets, which is applied in the field of mercaptopurine quadruple chewable tablets and its preparation, can solve the problems of large dosage, sticky punch, many side effects and the like

Active Publication Date: 2021-10-01
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, mercaptopurine is easy to absorb moisture, and it is easy to produce sticky phenomenon in the industrial production process, and the dose is large and the side effects are many

Method used

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  • A kind of mercaptopurine four-part chewable tablet and preparation method thereof
  • A kind of mercaptopurine four-part chewable tablet and preparation method thereof
  • A kind of mercaptopurine four-part chewable tablet and preparation method thereof

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preparation example Construction

[0023] Specifically, the present invention is realized through the following technical means: a preparation method of mercaptopurine four-part chewable tablet, the preparation method comprising the following steps: the preparation method comprises: heating mercaptopurine, polyethylene glycol 6000 and sorbitol to melting, Rapid cooling and solidification under vigorous stirring; crushing through a 30-mesh sieve; drying; adding the prescribed amount of microcrystalline cellulose, aspartame, disintegrating agent, lubricant and mixing, and pressing with a quarter-point punch to obtain the product. Tablet weight is controlled at 0.60g-0.65g.

[0024] The disintegrant is one of sodium carboxymethyl starch, crospovidone, and low-substituted hydroxypropyl cellulose, and the lubricant is one of magnesium stearate, silicon dioxide, and talcum powder. Wherein the ratio of polyethylene glycol 6000 to sorbitol is 1:1-1:2, and the weight ratio of mercaptopurine to polyethylene glycol 6000 a...

Embodiment 1

[0027] name Single dose dosage (mg / tablet) Proportion(%) Mercaptopurine 50 7.7 polyethylene glycol 6000 97.5 15 Sorbitol 195 30 microcrystalline cellulose 252.2 38.8 aspartame 9.75 1.5 Sodium carboxymethyl starch 3.25 5 Magnesium stearate 0.65 1 total 650 100

[0028] The preparation steps are as follows:

[0029] (a) Pass polyethylene glycol 6000 and sorbitol through a 60-mesh sieve respectively, and heat until melted;

[0030] (b) Add mercaptopurine, rapidly cool and solidify under vigorous stirring;

[0031] (c) Pass through a 30-mesh sieve and pulverize; dry until the water content is lower than 2%;

[0032] (d) Add the prescribed amount of microcrystalline cellulose, aspartame, disintegrant sodium carboxymethyl starch, and lubricant magnesium stearate, mix well, and press into tablets with a quarter-point punch.

Embodiment 2

[0034] name Single dose dosage (mg / tablet) Proportion(%) Mercaptopurine 78 12 polyethylene glycol 6000 97.5 15 Sorbitol 195 30 microcrystalline cellulose 230.7 35.5 aspartame 9.75 1.5 Sodium carboxymethyl starch 3.25 5 Magnesium stearate 0.65 1 total 650 100

[0035] The preparation steps are as follows:

[0036] (a) Pass polyethylene glycol 6000 and sorbitol through a 60-mesh sieve respectively, and heat until melted;

[0037] (b) Add mercaptopurine, rapidly cool and solidify under vigorous stirring;

[0038] (c) Pass through a 30-mesh sieve and pulverize; dry until the water content is lower than 2%;

[0039] (d) Add the prescribed amount of microcrystalline cellulose, aspartame, disintegrant sodium carboxymethyl starch, and lubricant magnesium stearate, mix well, and press into tablets with a quarter-point punch.

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Abstract

The invention relates to a mercaptopurine tablet, which is composed of mercaptopurine, polyethylene glycol 6000, binder, disintegrant, filler and lubricant. In the present invention, polyethylene glycol 6000 and sorbitol are mixed and then mixed with mercaptopurine, heated to melt and then rapidly condensed to form a solid dispersion, sieved and pulverized, and then the pulverized particles are evenly mixed with a disintegrating agent and a lubricant Direct compression. Prepare mercaptopurine into solid dispersion and then perform direct compression, which reduces the risk of mercaptopurine sticking during the production process compared with the commonly used wet granulation tableting process. At the same time, the patient does not need to take it with water, and can chew it directly, which greatly improves the convenience and compliance of the patient's medication. In addition, the four-point chewable tablet is conducive to the realization of precise drug administration and improves the compliance of children.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a mercaptopurine quartered chewable tablet and a preparation method thereof. Background technique [0002] Mercaptopurine is a cell cycle-specific drug that inhibits the purine synthesis pathway. It has a chemical structure similar to purine and is one of the basic chemical substances that make up DNA. In the body, mercaptopurines are converted within cells into substances that interfere with the production of new DNA, which prevents cell division and thus slows the progression of acute lymphoblastic leukemia. Oral absorption of mercaptopurine is incomplete and there are inter-individual differences. The average absorption in vivo is about 50% of the administered dose, and the factors affecting absorption are not yet clear. Mercaptopurine is slightly soluble in water and ethanol, and almost insoluble in ether. Mercaptopurine is easily soluble in alkaline aqu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/52A61K47/10A61K47/26A61P35/02
CPCA61K9/0056A61K9/2018A61K9/2031A61K31/52A61P35/02
Inventor 徐从轩朱亚芳徐成
Owner 南京泽恒医药技术开发有限公司