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Paracetamol effervescent granule and identification method thereof

A technology of acetaminophen and effervescent granules, which is applied in the fields of pharmaceutical formulations, drug delivery, organic active ingredients, etc. It can solve the problem that acid and alkali agents cannot be mixed with drugs and other excipients at the same time, and the drugs cannot be well developed. Curative effect, unfavorable large-scale production operation and other problems, to achieve the effect of being suitable for industrial production, improving identification items, and good compliance

Active Publication Date: 2012-10-24
HAINAN HULUWA PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, although the above two effervescent agents have many good aspects, there are also some shortcomings: the acid agent and the alkali agent in the effervescent agent cannot be mixed with medicine and other auxiliary materials simultaneously, and need to be mixed step by step separately, and the preparation method is loaded down with trivial details. It is not conducive to large-scale production operations, and the drug release from the preparation is slow, and the curative effect of the drug cannot be well exerted
[0009] However, when the above identification method is used for improved acetaminophen preparations such as acetaminophen effervescent granules, the detection results are often inaccurate due to various interference factors, so a method suitable for acetaminophen effervescent granules is established. Simple, specific, and reproducible identification methods are very important

Method used

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  • Paracetamol effervescent granule and identification method thereof
  • Paracetamol effervescent granule and identification method thereof
  • Paracetamol effervescent granule and identification method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Pass acetaminophen, citric acid, fumaric acid, and sodium bicarbonate through an 80-mesh sieve respectively, and crush sucrose and pass through an 80-mesh sieve for later use.

[0047] Ethanol solution of polyethylene glycol: Weigh 40ml polyethylene glycol 400, appropriate amount of ethanol, dissolve polyethylene glycol in ethanol, stir evenly to obtain polyethylene glycol ethanol solution.

[0048] Weigh the raw materials of the following prescription quantities:

[0049]

[0050] 1) Mix 100g of paracetamol, 16g of citric acid, 24g of fumaric acid, 68g of sodium bicarbonate, 1785g of sucrose, and 15g of stevioside, add 80g of polyethylene glycol ethanol solution to make a soft material, and sieve For wet granules, put the wet granules evenly into an oven at 55°C, dry for 1 hour, and granulate to obtain dry granules for later use.

[0051] 2) Put the dry granules of step 1) in a mixer, mix for ten minutes, detect the intermediate, and pack it separately.

Embodiment 2

[0053] Pass acetaminophen, citric acid, fumaric acid, and sodium bicarbonate through an 80-mesh sieve respectively, and crush sucrose and pass through an 80-mesh sieve for later use.

[0054] The preparation of polyethylene glycol solution in ethanol is the same as in Example 1.

[0055] Weigh the raw materials of the following prescription quantities:

[0056]

[0057]

[0058] 1) Mix 500g of paracetamol, 80g of citric acid, 120g of fumaric acid, 340g of sodium bicarbonate, 8925g of sucrose, and 75g of stevioside, add 395g of polyethylene glycol ethanol solution to make a soft material, and sieve For wet granules, put the wet granules evenly into an oven at 55°C, dry for 1 hour, and granulate to obtain dry granules for later use.

[0059] 2) Put the dry granules of step 1) in a mixer, mix for ten minutes, detect the intermediate, and pack it separately.

Embodiment 3

[0061] Pass acetaminophen, citric acid, tartaric acid, and sodium bicarbonate through an 80-mesh sieve respectively, and crush sucrose and pass through an 80-mesh sieve for later use.

[0062] The preparation of polyethylene glycol solution in ethanol is the same as in Example 1.

[0063] Weigh the raw materials of the following prescription quantities:

[0064]

[0065] 1) Mix 100g of paracetamol, 20g of citric acid, 30g of tartaric acid, 85g of sodium bicarbonate, 1785g of sucrose, and 15g of stevioside, add 80g of polyethylene glycol ethanol solution to make soft material, and sieve to make wet granules , Put the wet granules evenly into an oven at 55°C, dry for 1 hour, and granulate to obtain dry granules for later use.

[0066] 2) Put the dry granules of step 1) in a mixer, mix for ten minutes, detect the intermediate, and pack it separately.

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Abstract

The invention discloses a paracetamol effervescent granule. The paracetamol effervescent granule comprises, by weight, 2%-7% paracetamol, 5%-30% of effervescing agents, 65%-86% of filler, 0.6%-0.8% of flavoring agents and the balance bonding agents, the effervescing agents are composed of acid agents and alkaline agents, the mass ratio of the acid agents to the alkaline agents is 1:1.7, the acid agents are optionally two or three of citric acid, fumaric acid and tartaric acid, and the alkaline agents are sodium bicarbonate. The paracetamol effervescent granule is dissolved in water quickly to form clear and transparent solution great in taste, and is convenient to take, high in bioavailability, qualified in identification items and good in effervescence. The invention further discloses an identification method of the paracetamol effervescent granule, and the identification method is simple in operation and good in anti-interference effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a paracetamol effervescent granule and an identification method thereof. Background technique [0002] A cold is an infection of the upper respiratory tract mucosa caused by many different types of viruses. Its main symptoms are nasal congestion, sneezing, dry cough, mild sore throat, and fever. Systemic symptoms include general discomfort, headache, and myalgia. The use of symptomatic treatment promotes the relief of many symptoms of the common cold. Since there is no drug that can relieve many coexisting symptoms at the same time, various compound preparations have been listed one after another. These compound preparations are composed of drugs with different curative effects to relieve different symptoms that exist at the same time. If the patient has multiple symptoms, especially in the early stage of a cold, it is more appropriate and sometimes more economical to...

Claims

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Application Information

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IPC IPC(8): A61K31/167A61K9/46A61P29/00
Inventor 刘全国陈克领
Owner HAINAN HULUWA PHARMA GRP CO LTD
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