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Compound enteric-coated preparation and preparation method thereof

An enteric-coated preparation and compound technology, which is applied in the field of aceclofenac acetaminophen enteric-coated compound oral solid preparation and preparation, to achieve the effects of reducing gastric irritation, accurate drug content in the intestine, and the best curative effect

Inactive Publication Date: 2009-09-16
YANGTAI PHARMA SHANDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although the incidence of adverse reactions and the severity of adverse events of aceclofenac are far lower and lighter than those of other NSAIDs, there are also adverse reactions such as indigestion, nausea, diarrhea and abdominal pain.

Method used

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  • Compound enteric-coated preparation and preparation method thereof
  • Compound enteric-coated preparation and preparation method thereof
  • Compound enteric-coated preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] A enteric-coated part:

[0042] Aceclofenac Sodium 100g

[0043] Microcrystalline Cellulose 100g

[0044] Croscarmellose Sodium 8g

[0045] 5% PVP K30 60% ethanol solution 80ml

[0046] Talc powder 5g

[0047] Appropriate amount of enteric coating solution

[0048] Preparation

[0049] 1. Take the prescribed amount of aceclofenac sodium, microcrystalline cellulose, and croscarmellose sodium and mix evenly, 5% PVP K30 60% ethanol solution to make pellets.

[0050] 2. Coating until the weight gain is about 13%.

[0051] B quick release part

[0052] Acetaminophen 500g

[0053] Magnesium Stearate 5g

[0054] Preparation

[0055] The acetaminophen and magnesium stearate are mixed well.

[0056] C Finished product preparation

[0057] Preparation

[0058] Mix the enteric-coated part and the immediate-release part evenly, and pack into capsules.

Embodiment 2

[0060] A enteric-coated part:

[0061] Aceclofenac Sodium 100g

[0062] Microcrystalline Cellulose 100g

[0063] Croscarmellose Sodium 8g

[0064] 5% PVP K3060% ethanol solution 80ml

[0065] Talc powder 5g

[0066] Appropriate amount of enteric coating solution

[0067] Preparation

[0068] 1. Take the prescribed amount of aceclofenac sodium, microcrystalline cellulose, and croscarmellose sodium and mix evenly, 5% PVP K30 60% ethanol solution to make pellets.

[0069] 2. Coating until the weight gain is about 13%.

[0070] B quick release part

[0071] Acetaminophen 500g

[0072] Hydroxypropyl Cellulose 80

[0073] 5% PVP K30 60% ethanol solution 150ml

[0074] Preparation

[0075] Acetaminophen and hydroxypropyl cellulose mixed well, 5% PVP K30 60% ethanol solution to make granules.

[0076] C Finished product preparation

[0077] Preparation

[0078] Mix the enteric-coated part and the immediate-release part evenly, add a small amount of lubricant, and pac...

Embodiment 3

[0080] A enteric-coated part:

[0081] Aceclofenac Sodium 100g

[0082] Microcrystalline Cellulose 100g

[0083] Croscarmellose Sodium 8g

[0084] 5% PVP K30 60% ethanol solution 80ml

[0085] Talc powder 5g

[0086] Appropriate amount of enteric coating solution

[0087] Preparation

[0088] 1. Take the prescribed amount of aceclofenac sodium, microcrystalline cellulose, and croscarmellose sodium, mix them evenly, and make pellets with 5% PVPK30 and 60% ethanol solution.

[0089] 2. Coating until the weight gain is about 13%.

[0090] B quick release part

[0091] Acetaminophen 500g

[0092] Microcrystalline Cellulose 200g

[0093] 5% PVP K30 60% alcohol solution 300ml

[0094] Preparation

[0095] Acetaminophen and microcrystalline cellulose mixed well, 5% PVP K30 60% ethanol solution to make pellets.

[0096] C Finished product preparation

[0097] Preparation

[0098] Mix the enteric-coated part and the immediate-release part evenly, add a small amount of...

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PUM

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Abstract

The invention discloses a compound enteric-coated preparation. The aceclofenac in the compound preparation is dissolved by intestines through a pharmacy means and paracetanol is guaranteed to release in stomach, so that stimulus and untoward effect of the aceclofenac in the compound preparation on the stomach are reduced, and the normal absorption of the paracetanol is guaranteed to improve the compliance of a patient.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to an aceclofenac acetaminophen enteric-coated compound oral solid preparation and a preparation method thereof. Background technique [0002] At present, the prevalence rate of rheumatoid arthritis alone in my country is about 5‰, and the number of patients with rheumatism and rheumatoid diseases exceeds 10 million. The most common class of drugs used to treat arthritis pain and inflammation are the nonsteroidal anti-inflammatory drugs (NSAIDs). Drugs belonging to this category include aspirin, ibuprofen, diclofenac, aceclofenac, and naproxen, etc., which are widely used. [0003] However, NSAIDs often exhibit very serious side effects. There is some evidence that long-term use of NSAIDs may lead to serious gastric adverse reactions such as gastric ulcers, bleeding and perforation. A recent study conducted in the United States showed that in the United States...

Claims

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Application Information

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IPC IPC(8): A61K31/216A61K31/167A61J3/07A61J3/10A61P29/00A61P19/02
Inventor 孟勇涛王海毛德香卢宁
Owner YANGTAI PHARMA SHANDONG
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