A kind of paracetamol pharmaceutical composition preparation and preparation method thereof

A technology of acetaminophen and composition, which is applied in the field of acetaminophen pharmaceutical composition preparation and its preparation, can solve problems such as hairy tablet surface, lower pass rate, gastrointestinal tract damage, etc., and achieve stable physical and chemical properties , avoid irritation and damage, and the effect of uniform texture of the preparation

Active Publication Date: 2020-08-14
重庆国泰康宁制药有限责任公司
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Problems solved by technology

And this product is not suitable for long-term use
[0003] In the prior art, the general preparation method of acetaminophen preparations adopts the method of mixing and granulating the raw materials and auxiliary materials together, and the prepared granules are mixed with the raw materials and the total mixture will be affected by the cross-linked polyvinyl alcohol during the placement or tableting process. Ketone absorbs water and disintegrates, which makes the surface of the tablet hairy, affects the appearance, and also leads to unstable drug efficacy, which reduces the pass rate of production, and unqualified products have to be reworked, resulting in low production efficiency and does not comply with GMP management In addition, the preparation prepared by this method is relatively irritating to the gastrointestinal tract, which is likely to cause damage to the gastrointestinal tract, and is likely to cause other adverse reactions in patients.

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  • A kind of paracetamol pharmaceutical composition preparation and preparation method thereof

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[0029] According to one aspect of the present invention, a kind of preparation method of paracetamol pharmaceutical composition preparation comprises the steps:

[0030] (A) After paracetamol, crospovidone, povidone K30, methylparaben, ethylparaben and propylparaben are mixed uniformly, an aqueous binder solution is added for granulation;

[0031] (B) The stirring speed of granulation is between 200-400rpm, and the granulation time is 90-180s;

[0032] (C) The method of gradient temperature change is used for drying, and the temperature of each gradient is controlled between 20-40°C, and the temperature of the previous gradient and the subsequent gradient tend to alternate back and forth, and the difference between the two adjacent gradients 4-5°C, after drying, add alginic acid, calcium carbonate, and colloidal silicon dioxide to pre-mix for 3-5 minutes, then add magnesium stearate and mix for 3-5 minutes, press into tablets, and coat.

[0033] The invention provides a prepa...

Embodiment 1

[0048] 1) According to production requirements, paracetamol, crospovidone, povidone K30, methylparaben, ethylparaben, propylparaben, alginic acid, calcium carbonate, colloidal silicon dioxide, hard These materials of magnesium fatty acid are weighed, and the order particle size of above-mentioned raw materials is controlled at more than 80 orders;

[0049] 2) Adhesive preparation: Weigh the pregelatinized starch of the adhesive prepared by half of the recipe, add an appropriate amount of boiling water to disperse and dissolve, and cool to room temperature to obtain an aqueous solution of pregelatinized starch;

[0050] 3) Mixed granulation: put acetaminophen, crospovidone, povidone K30, methylparaben, ethylparaben and propylparaben into a wet granulator and mix evenly, then add pre- For the gelatinized starch aqueous solution, start stirring and shearing, the stirring rate is 200rpm, and the granulation time is controlled within 90s;

[0051] 4) Put all the wet granules in th...

Embodiment 2

[0056] 1) According to production requirements, paracetamol, crospovidone, povidone K30, methylparaben, ethylparaben, propylparaben, alginic acid, calcium carbonate, colloidal silicon dioxide, hard These materials of magnesium fatty acid are weighed, and the order particle size of above-mentioned raw materials is controlled at more than 90 orders;

[0057] 2) Adhesive preparation: Weigh the pregelatinized starch of the adhesive prepared by half of the recipe, add an appropriate amount of boiling water to disperse and dissolve, and cool to room temperature to obtain an aqueous solution of pregelatinized starch with a concentration of 15% by mass;

[0058] 3) Mixed granulation: put acetaminophen, crospovidone, povidone K30, methylparaben, ethylparaben and propylparaben into a wet granulator and mix evenly, then add pre- For gelatinized starch aqueous solution, start stirring and shearing, the stirring rate is 400pm, and the granulation time is controlled within 180s;

[0059] 4...

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Abstract

The invention provides a acetaminophen pharmaceutical composition preparation and a preparation method thereof. The preparation method comprises the following steps: uniformly mixing acetaminophen, crospovidone, povidone K30, methylparaben, ethylparaben and propyl hydroxybenzoate, and adding a binding agent aqueous solution to pelletize; drying through a gradient variable-temperature method afterpelletizing, controlling the temperature of each gradient to 20-40 DEG C, adding alginic acid, calcium carbonate and colloidal silicon dioxide to pre-mix for 3-5 minutes after drying, adding magnesiumstearate to mix for 3-5 minutes, and tabletting and covering. The preparation method for the acetaminophen pharmaceutical composition preparation is simple in operation step, and is gentle in operation condition; and the preparation method can realize quick dissolving-out of effective ingredients in the preparation, increases a dissolution rate, and is worthy of being widely popularized and applied.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a paracetamol pharmaceutical composition preparation and a preparation method thereof. Background technique [0002] Acetaminophen is an aniline antipyretic, analgesic, and anti-inflammatory drug with strong and long-lasting antipyretic and analgesic effects. It is indicated for fever caused by the common cold or influenza, and is also used to relieve mild to moderate pain Such as headache, arthralgia, migraine, toothache, muscle pain, neuralgia, dysmenorrhea, the finished product is about 0.3-0.6g orally once, and the child is 10-15mg / kg once per body weight, once every 4-6 hours; 12 Children under the age of 10 should not exceed 5 doses per 24 hours, and the course of treatment should not exceed 5 days. And this product is not suitable for long-term use. [0003] In the prior art, the general preparation method of acetaminophen preparations adopts the method of mixing and granulating ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K31/167A61K47/32A61K47/14A61K47/36A61K47/02A61P29/00
CPCA61K9/2009A61K9/2013A61K9/2027A61K9/205A61K9/2095A61K9/28A61K31/167A61P29/00
Inventor 罗磊梅勇杨莉刘勇龙涛袁开超周年华陈小红陈云陈明
Owner 重庆国泰康宁制药有限责任公司
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