Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting

A technology of direct compression of dry powder and paracetamol, which is applied in the directions of medical preparations containing active ingredients, pill delivery, organic active ingredients, etc., can solve the problems of poor fluidity and compressibility, etc., and achieve the effect of stable storage process.

Inactive Publication Date: 2010-06-16
上海裕信生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the fluidity and compressibility of acetaminophen and pseudoephedrine hydrochloride fine powder are worse than those of granules, the formula of paracetamol and pseudoephedrine tablets described above is difficult to be directly used for direct powder compression

Method used

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  • Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting
  • Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting
  • Paracetamol and pseudoephedrine hydrochloride tablets made by dry powder direct tabletting

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Weigh 500g of paracetamol, 30g of pseudoephedrine hydrochloride, 48g of microcrystalline cellulose, 5.3g of fumed silicon dioxide, and 48g of pregelatinized starch, and add the above-mentioned components in stages according to the principle of equal mixing, and stir until Mix evenly, and then directly compress into tablets, making a total of 1000 tablets.

Embodiment 2

[0014] Weigh 5000g of acetaminophen, 300g of pseudoephedrine hydrochloride, 480g of microcrystalline cellulose, 53g of fumed silica, and 480g of pregelatinized starch, and add the above-mentioned components in small to many portions according to the principle of equal mixing, and stir until mixed Evenly, and then directly compressed into tablets, a total of 10,000 tablets were made.

Embodiment 3

[0016] Weigh 1000g of paracetamol, 60g of pseudoephedrine hydrochloride, 96g of microcrystalline cellulose, 10.6g of fumed silicon dioxide, and 96g of pregelatinized starch, and add the above-mentioned components in stages from less to more according to the principle of equal mixing, and stir until Mix evenly, and then directly compress into tablets, making a total of 2000 tablets.

[0017] Two, effect embodiment.

[0018] 1. Dissolution rate comparison.

[0019] Determination method: use RCZ-6C type drug dissolution apparatus, according to the dissolution determination method (Chinese Pharmacopoeia 2005 edition two appendix XC first method), with 1000ml water as solvent, 37 ℃, rotating speed is 100r.min -1 , sampling time is 45min, get solution and filter in right amount, get continued filtrate 20 μ l, measure according to the method under assay item, calculate the stripping amount of acetaminophen and pseudoephedrine hydrochloride in every tablet.

[0020] Sampling and ana...

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PUM

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Abstract

The invention relates to an antipyretic and analgesic and a nonsteroid anti-inflammation analgesic drug and concretely relates to a paracetamol and pseudoephedrine hydrochloride tablet, which is obtained by directly tablet forming dry powder, which is used for remedying the cold. The paracetamol and pseudoephedrine hydrochloride tablet consists of the components of the following weight portions of500 portions of paracetamol, 30 portions of pseudoephedrine, 48 portions of microcrystalline cellulose, 5.3 portions of vapor phase silicon dioxide and 48 portions of pre-gelatinized starch. The invention is fit for remedying the symptoms caused by the cold of fever, headache, the ache of the whole body and limbs, nasal obstruction, rhinorrhea, sneezes etc.

Description

technical field [0001] The invention relates to an antipyretic, analgesic and non-steroidal anti-inflammatory analgesic, in particular to an acetaminophen pseudoephedrine tablet which is dry powder and directly compressed into tablets for treating colds. Background technique [0002] PARACETAMOL AND PSEUDOEPHEDRINE HYDROCHLORIDE COMPOUNDTABLES is an over-the-counter drug for the treatment of colds recorded in the second part of the Chinese Pharmacopoeia. It has good curative effect, large clinical dosage and few side effects, and is very popular among patients. At present, there are more than ten pharmaceutical factories in my country producing paracetamol and pseudoephedrine tablets, but most of them are produced by wet granulation and tableting formula and technology. The formula is: 500g of paracetamol (4-ACETAMIDOPHENOL), 30g of pseudoephedrine hydrochloride , microcrystalline cellulose 90g, sodium starch glycolate 25g, 4% hypromellose solution 120g-160g, magnesium steara...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/167A61K31/137A61K9/20A61P29/00
Inventor 吴增宝汪峰张尧升张前珍金星
Owner 上海裕信生物制药有限公司
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