Nefopam hydrochloride naproxen sodium compound sustained-release preparation and preparation method thereof

A technology of nefopam hydrochloride and naproxen sodium, applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc. Short time and other problems, to achieve the effect of reducing the number of medication, improving clinical efficacy, and strengthening analgesic effect

Inactive Publication Date: 2010-12-29
HENAN UNIVERSITY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the peak plasma concentration of Nefopam fluctuates greatly after oral administration, which is prone to adverse reactions
However, naproxen has a high solubility and releases rapidly in the stomach after oral administration, resulting in high local concentration in the stomach, causing adverse reactions such as burning, and naproxen is metabolized faster and has a shorter analgesic effect time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] The Nefopam Hydrochloride Naproxen Sodium Compound Sustained-release Preparation of the present invention is prepared by the following formula.

[0049] 1. Nefopam Hydrochloride Sustained Release Pellets

[0050] Formula containing pill core: Nefopam hydrochloride 70g, starch 30g, hypromellose (HPMC E3) 1.8g;

[0051] The formulation of the sustained-release layer: 75 g of ethyl cellulose aqueous dispersion product Surelease (Surelease), 0.7 g of hypromellose (HPMC E3). The above-mentioned raw materials are available on the market, and are easy to buy.

[0052] 2. Naproxen sodium enteric-coated sustained-release pellets.

[0053] The formula containing pill core: Naproxen sodium 50g, microcrystalline cellulose 50g, hypromellose (HPMC E3) 2.7g;

[0054] Sustained-release layer formula: acrylic polymer aqueous dispersion Eudragit RS30D 60g, acrylic polymer Eudragit RL30D 20g, triethyl citrate (TEC) 8ml, talcum powder 10g;

[0055] Enteric layer formula: acrylic polyme...

Embodiment 2

[0070] The Nefopam Hydrochloride Naproxen Sodium Compound Sustained-release Preparation of the present invention is prepared by the following formula.

[0071] 1. Nefopam Hydrochloride Sustained Release Pellets:

[0072] Pill core formula containing medicine: Nefopam hydrochloride 60g, sucrose or lactose 15g, starch 25g, hypromellose (HPMC E3) 1.8g;

[0073] Sustained-release layer formula: Surelease (Surelease) 75g, povidone (PVP-K30) 0.7g;

[0074] 2. Naproxen sodium enteric-coated sustained-release pellets

[0075] Drug-containing pill core formula: Naproxen sodium 50g, sucrose or lactose 20g, starch 30g, hypromellose (HPMC E3) 2.7g;

[0076] Sustained release layer formula: acrylic polymer aqueous dispersion Eudragit RS30D 50g, acrylic polymer aqueous dispersion Eudragit NE30D 25g, triethyl citrate (TEC) 7.5mL, talcum powder 10g;

[0077] Enteric-coated layer formulation: acrylic polymer aqueous dispersion Eudragit L30D-55 70g, triethyl citrate (TEC) 7mL.

[0078] The ...

Embodiment 3

[0089] The Nefopam Hydrochloride Naproxen Sodium Compound Sustained-release Preparation of the present invention is prepared by the following formula.

[0090] 1. Nefopam Hydrochloride Sustained Release Pellets

[0091] The formula containing pill core: Nefopam hydrochloride 70g, microcrystalline cellulose 20g, starch 10g, povidone (PVP-K30) 2g;

[0092] Sustained-release layer formulation: 75 g of ethyl cellulose aqueous dispersion Surelease, 0.7 g of polyethanol (PEG4000).

[0093] 2. Naproxen sodium enteric-coated sustained-release pellets

[0094] Pill core formula containing medicine: Naproxen sodium 50g, microcrystalline cellulose 30g, sucrose or lactose 20g, povidone (PVP-K30) 3.2g;

[0095] Sustained release layer formula: acrylic polymer aqueous dispersion Eudragit NE30D 64g, acrylic polymer aqueous dispersion Eudragit RL30D 16g, triethyl citrate (TEC) 8mL, talc 10g;

[0096] Enteric-coated layer formulation: acrylic polymer aqueous dispersion Eudragit L30D-55 70g,...

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Abstract

The invention provides a nefopam hydrochloride naproxen sodium compound sustained-release preparation and a preparation method thereof. The compound sustained-release preparation is prepared by mixing a nefopam hydrochloride sustained-release micro-pill and a naproxen sodium enteric sustained-release micro-pill according to a specific dosage proportion. The method is to combine the nefopam hydrochloride and the naproxen sodium which are two different medicines used for easing pains in different positions to prepare the compound sustained-release preparation which has synergistic action of thetwo medicines, greatly improved pain easing effect and reduced toxic and side effect. The compound sustained-release preparation can reduce medicine taking times for each day, improve the compliance of a patient, control the blood concentration of the medicine and stabilize the blood concentration, and has higher bioavailability.

Description

technical field [0001] The invention relates to a compound sustained-release pharmaceutical preparation, in particular to a compound sustained-release preparation of nefopam hydrochloride and naproxen sodium and a preparation method thereof. It belongs to a compound analgesic preparation. Background technique [0002] Pain is a complex physiological and psychological activity, and it is one of the most common clinical symptoms. Tens of millions of people in the world suffer from trauma, postoperative pain, cancer and other pains every day. Due to the strict control of the use of opioid analgesics for the treatment of moderate and severe pain, some patients with severe pain are in a situation where there is no effective analgesic treatment, and they are suffering from pain. [0003] Nefopam hydrochloride is a new type of non-narcotic analgesic with mild antipyretic and muscle relaxant effects. The chemical structure belongs to the cyclized o-methyldiphenhydramine class, wh...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/395A61K31/192A61P29/00
Inventor 陈洪轩马莉陈志鹏肖衍宇王忠伟贾和平高瑛罗欣
Owner HENAN UNIVERSITY
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