Paracetamol,loratadine and pseudoephedrine sulfate sustained release tablet and preparation method thereof

A technology of sustained-release tablets and sustained-release tablet cores, applied in pharmaceutical formulations, medical preparations containing active ingredients, pill delivery, etc., to achieve stable blood drug concentration, relieve allergic symptoms, and relieve human body fever

Active Publication Date: 2010-11-24
JIANGSU YABANG AIPUSEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Generally, the dose is less and causes adverse reactions, has little stimulation to the gastrointestinal tract, does not cause gastrointestinal bleeding, has no effect on the coagulation mechanism, and has no damage to the liver under normal doses, but it can also cause nausea, vomiting, sweating, diarrhea and Adverse reactions such as paleness

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] prescription:

[0015] Acetaminophen 500g

[0016] Pseudoephedrine sulfate 60g

[0017] Hydroxypropyl methylcellulose K4M 90g

[0018] Calcium hydrogen phosphate dihydrate 85g

[0019] Stearic acid 15g

[0020] Silica 35g

[0021] 70% ethanol appropriate amount

[0022] Magnesium stearate 8g

[0023]

[0024] 1000 pieces

[0025] Coating liquid prescription:

[0026] Opadry white coating powder 30g

[0027] Loratadine 2.5g

[0028] 70% ethanol 500g

[0029]

[0030] 1000 tablets

[0031] Preparation:

[0032] Dissolve loratadine with an appropriate amount of 95% ethanol to make solution A; put 70% ethanol in a triangular flask, place it on a magnetic stirrer, and slowly add Opadry under stirring to make solution B; Add solution A to solution B, stir for 1 hour, make it completely uniform, and set aside.

[0033] Pass the acetaminophen and pseudoephedrine sulfate through an 80-mesh sieve, and the remaining au...

Embodiment 2

[0036] prescription:

[0037] Acetaminophen 500g

[0038] Pseudoephedrine sulfate 60g

[0039] Hydroxypropyl methylcellulose K4M 90g

[0040] Hydroxypropyl methylcellulose K15M 20g

[0041] Calcium hydrogen phosphate dihydrate 65g

[0042] Silica 35g

[0043] 70% ethanol appropriate amount

[0044] Magnesium stearate 8g

[0045]

[0046] 1000 pieces

[0047] Coating liquid prescription:

[0048] Opadry white coating powder 30g

[0049] Loratadine 2.5g

[0050] 70% ethanol 500g

[0051]

[0052] 1000 tablets

[0053] Preparation:

[0054] Dissolve loratadine with an appropriate amount of 95% ethanol to make solution A; put 70% ethanol in a triangular flask, place it on a magnetic stirrer, and slowly add Opadry under stirring to make solution B; Add solution A to solution B, stir for 1 hour, make it completely uniform, and set aside.

[0055] Pass the acetaminophen and pseudoephedrine sulfate through an 8...

Embodiment 3

[0058] prescription:

[0059] Acetaminophen 500g

[0060] Pseudoephedrine sulfate 60g

[0061] Poloxamer 188 130g

[0062] Microcrystalline cellulose 36g

[0063] Lactose 60g

[0064] Sodium Carboxymethyl Starch 15g

[0065] 70% ethanol appropriate amount

[0066] Magnesium stearate 8g

[0067]

[0068] 1000 pieces

[0069] Coating liquid prescription:

[0070] Polyvinylpyrrolidone 30g

[0071] Titanium dioxide 3g

[0072] Dimethyl phthalate 1g

[0073] Loratadine 2.5g

[0074] 70% ethanol 500g

[0075]

[0076] 1000 tablets

[0077] Preparation:

[0078] Dissolve loratadine with an appropriate amount of 95% ethanol to make solution A; put 70% ethanol in a triangular flask, set it on a magnetic stirrer, and slowly add polyvinylpyrrolidone, titanium dioxide and phthalic acid under stirring. Methyl ester, dissolve to make B solution; add A solution to B solution, stir for 1 hour, make it completely uniform, and set aside.

[007...

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PUM

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Abstract

The invention relates to a paracetamol,loratadine and pseudoephedrine sulfate sustained release tablet and a preparation method thereof. The active component of the drug comprises paracetamol, loratadine and pseudoephedrine sulfate, wherein the paracetamol and the pseudoephedrine sulfate exist in a sustained release tablet, and the loratadine exists in a coating; the dissolution limit of loratadine within 45 minutes is 75 percent of the labelled amount thereof; the release amounts of the paracetamol within 2 hours, 4 hours and 8 hours respectively are 20-40 percent, 30-55 percent and above 70 percent of the labelled amount thereof; and the release amounts of the pseudoephedrine sulfate within 2 hours, 4 hours and 8 hours respectively are 40-60 percent, 60-90 percent and above 80 percent of the labelled amount thereof. After the paracetamol,loratadine and pseudoephedrine sulfate sustained release tablet provided by the invention enters a human body, loratadine can quickly release to lighten blockage caused by nasal mucosa congestion; the paracetamol and the pseudoephedrine sulfate slow release, the blood concentration thereof is stable, and the sustained release tablet can continuously release human body fever, sore muscle, headache and the like.

Description

Technical field [0001] The invention relates to a paracetamol and pseudoephedrine sustained-release tablet preparation and a preparation method thereof, and belongs to the field of pharmaceutical preparations. Background technique [0002] A cold is a common respiratory disease caused by a variety of viruses. The early symptoms include dry itchy or burning sensation in the throat, sneezing, nasal congestion, and runny nose. It starts as a clear watery nose, which thickens after 2 to 3 days; it may be accompanied by sore throat. ; Generally there is no fever and systemic symptoms, or only low-grade fever and headache. Healed in 5-7 days. [0003] Cold is one of the most common respiratory diseases, and there are many kinds of medicines used to treat colds. Acetaminophen is an acetanilide antipyretic and analgesic. It acts on the body temperature regulation center of the thalamus to produce an antipyretic effect. Its antipyretic effect is similar to that of aspirin, but its analges...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545A61K31/167A61K31/137A61K9/22A61K9/28A61K9/30A61P11/02A61P29/00A61P37/08
Inventor 赵晓红毛白杨陈再新杨旭跃尹雪琴葛育红谢瑞丽孙海棠
Owner JIANGSU YABANG AIPUSEN PHARMA
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