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Compound paracetamol tablet and preparation method thereof

A technology of acetaminophen tablets and compound recipes, which is applied in the direction of medical formulas, medical preparations containing active ingredients, and medical preparations containing active ingredients. Reduce, poor dissolution rate and other problems, to achieve the effect of accelerating disintegration and dissolution time limit, improving drug stability, and accelerating dissolution effect

Inactive Publication Date: 2018-07-13
重庆希尔安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the compound paracetamol tablet in the prior art has poor stability, and after long-term storage, its related properties will decrease, such as its disintegration effect decreases, related substances increase, the content decreases more, and the dissolution rate is poor
For example, the patent application number CN201210385530.3 uses dry granulation to coat the aspirin group and acetaminophen components to prevent the interaction between aspirin and acetaminophen, accelerate drug degradation, and then improve the drug composition. stability, but the selected coating material (HPMC) has poor barrier resistance, and it is difficult to coat the granules industrially. The active substances in compound acetaminophen tablets react with each other, and the related substances, disintegration and dissolution effects cannot be guaranteed

Method used

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  • Compound paracetamol tablet and preparation method thereof
  • Compound paracetamol tablet and preparation method thereof
  • Compound paracetamol tablet and preparation method thereof

Examples

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preparation example Construction

[0025] The present invention also provides a preparation method of compound paracetamol tablet, comprising the following steps:

[0026] S1, pretreatment;

[0027] Acetylsalicylic acid, caffeine, acetaminophen, stabilizers, glidants, fillers, and cellulose disintegrating agents are respectively passed through 80-100 mesh sieves, and the binder is respectively passed through 60-80 mesh sieves.

[0028] Prepare the first mixture binder: 3-5% filler (the filler used this time accounts for 3-5% of the mass ratio of all fillers) mixed with water to prepare starch with a mass fraction of 15-20% pulp.

[0029] Preparation of the second mixture binder: the inclusion binder is mixed with a wetting agent to obtain an inclusion binder solution with a concentration of 5-7%, that is, the second mixture binder.

[0030] S2, granulation;

[0031] S2.1, preparing the first mixture;

[0032] Put the weighed acetaminophen, caffeine, and cellulose disintegrating agent into the GHL-250 high-e...

Embodiment 1

[0046] This embodiment provides a kind of compound paracetamol sheet (300,000 tablets), and it is made of various raw materials, and multiple raw materials are 65Kg paracetamol, 35Kg acetylsalicylic acid, 8Kg caffeine, 2Kg compound Disintegrant, 0.5Kg ethyl cellulose and 30.5Kg auxiliary materials. Among them, 2Kg of compound disintegrating agent is 1Kg of hydroxypropyl cellulose and 1Kg of polacrilin potassium; 30.5Kg of auxiliary materials are 0.5Kg of citric acid, 15Kg of starch, 5Kg of talcum powder, 5Kg of pregelatinized starch and 10Kg of ethanol.

[0047] The present embodiment provides a kind of preparation method of compound paracetamol tablet, comprises the following steps:

[0048] S1, pretreatment;

[0049] Acetylsalicylic acid, caffeine, acetaminophen, citric acid, talcum powder, starch, and hydroxypropyl cellulose were respectively passed through a 80-mesh sieve, and the pregelatinized starch was respectively passed through a 60-mesh sieve.

[0050] Preparation...

Embodiment 2

[0067] The composition of the compound paracetamol tablet provided in this example is basically the same as that of the compound paracetamol tablet provided in Example 1, the difference is that the usage amount of each component changes, specifically, various raw and auxiliary materials are 70Kg paracetamol Phenol, 40Kg acetylsalicylic acid, 12Kg caffeine, 4Kg compound disintegrant, 1Kg ethyl cellulose and 54Kg auxiliary materials. Among them, the 4Kg composite disintegrant is 2Kg hydroxypropyl cellulose and 2Kg polacrilin potassium; the 54Kg auxiliary materials are 1Kg citric acid, 25Kg starch, 7Kg talcum powder, 6Kg pregelatinized starch and 15Kg ethanol.

[0068] The preparation method of the compound acetaminophen tablet provided in this example is basically the same as the preparation method of the compound acetaminophen tablet provided in Example 1, except that the operating conditions are changed. Pretreatment and sieving, respectively passing through 100 mesh sieve and...

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Abstract

The invention relates to the field of pharmacy, in particular to a compound paracetamol tablet and a preparation method thereof. The compound paracetamol tablet is prepared from various raw and auxiliary materials including 60-70 parts of paracetamol, 35-40 parts of acetylsalicylic acid, 8-12 parts of caffeine, 2-4 parts of compound disintegrant, 0.5-1 part of inclusion adhesive and 35.5-54 partsof auxiliary material, wherein 2-4 parts of compound disintegrant and 0.5-1 part of inclusion adhesive are 1-2 parts of cellulose type disintegrant and 1-2 parts of polacrilin potassium. The compoundparacetamol tablet also has a good dissolution and disintegration effect after being stored for a long time and is stable in relative substances and contents.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a compound paracetamol tablet and a preparation method thereof. Background technique [0002] Compound paracetamol tablet is a compound preparation, and its indication is antipyretic and analgesic. For fever, headache, neuralgia, toothache, etc. However, compound acetaminophen tablets in the prior art have poor stability, and after long-term storage, their related properties will decrease, such as their disintegration effect will decrease, related substances will increase, their content will decrease more, and their dissolution rate will be poor. For example, the patent application number CN201210385530.3 uses dry granulation to coat the aspirin group and acetaminophen components to prevent the interaction between aspirin and acetaminophen, accelerate drug degradation, and then improve the drug composition. stability, but the selected coating material (HPMC) has poor barrier resistance,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/32A61K31/167A61K31/616A61K31/522A61P29/00
CPCA61K9/2054A61K9/2027A61K31/167A61K31/522A61K31/616
Inventor 陈波唐攀王凤左娟罗磊杨莉梅勇朱锋龙涛陈小雪
Owner 重庆希尔安药业有限公司
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