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A kind of acetaminophen tablet and preparation method thereof for preventing sticking and splitting

A paracetamol tablet and the technology of paracetamol are applied in the field of paracetamol tablet and preparation thereof, and can solve the problems of little effect of sticking and splintering, difficulty in swallowing by patients, high cost of taking medicine for patients, and the like. Improve dissolution and release, smooth and beautiful one-sided, and solve the effect of missing edges of drugs

Active Publication Date: 2018-01-19
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Acetaminophen in granule form needs to be taken after dissolving, and because acetaminophen itself has a strong bitter taste, it needs to be flavored with sweeteners and fragrances, which increases the manufacturing cost, so the product price is high, and the cost of taking medicine for patients is relatively high. Big
Large-scale (large-dose) acetaminophen is designed into tablets. If the tablet is designed too large, it may cause difficulty in swallowing the patient and reduce medication compliance. If the tablet is designed to be small, it is difficult to solve problems such as sticking and splitting.
The large-scale acetaminophen tablets of many domestic enterprises cannot be industrialized and supplied to the market in large quantities due to the common problems of tablet sticking, slitting, and high friability.
Many manufacturers try to solve the problem of sticking and splitting by controlling the moisture and particle size of the granules. However, it is difficult to control the moisture of the granules in large-scale batch industrial production, and the particle size and moisture of the granules are not uniform. Splinters have negligible effect

Method used

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  • A kind of acetaminophen tablet and preparation method thereof for preventing sticking and splitting
  • A kind of acetaminophen tablet and preparation method thereof for preventing sticking and splitting
  • A kind of acetaminophen tablet and preparation method thereof for preventing sticking and splitting

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1. Raw material and formula

[0023] Acetaminophen 0.5g;

[0024] Pregelatinized starch 0.05g;

[0025] Sodium carboxymethyl starch 0.01g;

[0026] Polyvinylpyrrolidone 0.0028g;

[0027] Starch 0.028g;

[0028] Stearic acid 0.004g.

[0029] 2. Preparation method

[0030] Consists of the following steps:

[0031] (1) each raw and auxiliary material is weighed for subsequent use;

[0032] (2) Paracetamol, pregelatinized starch, sodium carboxymethyl starch are mixed evenly;

[0033] (3) Make a soft material with a binder mixed with 10% starch slurry and 10% polyvinylpyrrolidone, granulate, and dry at 50°C;

[0034] The adhesive is prepared as follows: polyvinylpyrrolidone is dissolved in purified water to prepare a 10% solution, starch is prepared by a pulping method to prepare a 10% starch slurry, and the liquids prepared above are mixed.

[0035] (4) Add stearic acid, mix and compress into tablets.

Embodiment 2

[0037] 1. Raw material and formula

[0038] Acetaminophen 0.5g;

[0039] Pregelatinized starch 0.06g;

[0040] Sodium carboxymethyl starch 0.02g;

[0041] Polyvinylpyrrolidone 0.0028g;

[0042] Starch 0.028g;

[0043] Stearic acid 0.0012g.

[0044] 2. Preparation method

[0045] Consists of the following steps:

[0046] (1) each raw and auxiliary material is weighed for subsequent use;

[0047] (2) Paracetamol, pregelatinized starch, sodium carboxymethyl starch are mixed evenly;

[0048] (3) Make a soft material with a binder mixed with 10% starch slurry and 10% polyvinylpyrrolidone, granulate, and dry at 50°C;

[0049] The binder is prepared as follows: polyvinylpyrrolidone is dissolved in purified water to prepare a 10% solution, starch is prepared by a pulping method to prepare a 10% starch slurry, and the liquids prepared above are mixed.

[0050] (4) Add stearic acid, mix and compress into tablets.

Embodiment 3

[0052] 1. Raw material and formula

[0053] Acetaminophen 0.5g;

[0054] Pregelatinized starch 0.02g;

[0055] Sodium carboxymethyl starch 0.02g;

[0056] Polyvinylpyrrolidone 0.0028g;

[0057] Starch 0.028g;

[0058] Stearic acid 0.0012g.

[0059] 2. Preparation method

[0060] Consists of the following steps:

[0061] (1) each raw and auxiliary material is weighed for subsequent use;

[0062] (2) Paracetamol, pregelatinized starch, sodium carboxymethyl starch are mixed evenly;

[0063] (3) Make a soft material with a binder mixed with 10% starch slurry and 10% polyvinylpyrrolidone, granulate, and dry at 50°C;

[0064] The binder is prepared as follows: polyvinylpyrrolidone is dissolved in purified water to prepare a 10% solution, starch is prepared by a pulping method to prepare a 10% starch slurry, and the liquids prepared above are mixed.

[0065] (4) Add stearic acid, mix and compress into tablets.

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Abstract

The invention provides an acetaminophen tablet preventing sticking and splitting, comprising acetaminophen, pregelatinized starch, sodium carboxymethyl starch, a binder and a glidant; the binder is composed of starch , polyvinylpyrrolidone and water are prepared by mixing the mass ratio of 1‑2:0.1‑0.2:17.8. The tablet prepared by using the above formula has the advantages of smooth and beautiful one-sided surface, high hardness, impact resistance and fast disintegration, and solves the problems of tablet sticking, splintering, edge knocking, etc. affecting the integrity of the tablet, and the tablet can quickly disintegrate Explanation and release, the dissolution rate and release rate are greatly improved, the stability of the product is significantly improved, and the problem of missing edges of the drug caused by the multi-dose packaging of the product and the impact of the drug during transportation is effectively solved.

Description

technical field [0001] The invention relates to the field of medicinal chemistry, in particular to a paracetamol tablet for preventing sticking and splitting and a preparation method thereof. Background technique [0002] Acetaminophen is an aniline antipyretic and analgesic drug, and the clinically applied dose of antipyretic and analgesic effects is relatively large, generally up to 500 mg. The clinical application of acetaminophen is mainly based on tablets and granules. Acetaminophen in granule form needs to be taken after dissolving, and because acetaminophen itself has a strong bitter taste, it needs to be flavored with sweeteners and fragrances, which increases the manufacturing cost, so the product price is high, and the cost of taking medicine for patients is relatively high. Big. Large-scale (high-dose) acetaminophen is designed into tablets. If the tablet is designed too large, it may cause difficulty in swallowing and decrease the compliance of taking the medic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/167A61K47/36A61P29/00
Inventor 李保琴
Owner 蚌埠丰原涂山制药有限公司
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