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Nefopam hydrochloride bilayer slow-release tablet and preparation method thereof

A technology of Nefopam hydrochloride and sustained-release tablets, which is applied in the direction of pharmaceutical formulas, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc. Problems such as large fluctuations in drug concentration peaks

Inactive Publication Date: 2011-06-08
COSCI MED TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] The common dosage form of Nefopam hydrochloride is ordinary tablets. Because it is a constant-release preparation, the effective blood concentration can be reached in about 45 minutes after taking the medicine, and the action time is short. In order to achieve the therapeutic effect, the dosage of the drug can achieve the therapeutic effect. In addition, the peak blood concentration of ordinary tablets fluctuates greatly, which is prone to adverse reactions.

Method used

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  • Nefopam hydrochloride bilayer slow-release tablet and preparation method thereof

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Embodiment 1

[0026] Preparation Process

[0027] (1) Preparation of immediate-release granules

[0028] Pass each component in the prescription through a 100-mesh sieve, and set aside. Fully mix the prescribed amount of pregelatinized starch and 1 / 2 amount of sodium carboxymethyl starch, then mix it with Nefopam hydrochloride in an equal increment method, and add 10% povidone K 30 The aqueous solution is a soft material made of adhesive, 20-mesh sieve is used to make wet granules, air-dried at 50°C, granulated with 20-mesh sieve, 1 / 2 amount of sodium carboxymethyl starch and magnesium stearate are added to mix well, and the content of intermediates is determined , to calculate the tablet weight.

[0029] (2) Preparation of sustained-release granules

[0030] Pass each component in the prescription through a 100-mesh sieve, and set aside. Fully mix the mixture of hydroxypropyl methylcellulose 100LV, pregelatinized starch and microcrystalline cellulose 101 in the prescribed amount, and...

Embodiment 2

[0033] Immediate release layer:

[0034] Preparation process: with embodiment 1

Embodiment 3

[0036] Immediate release layer:

[0037] Hypromellose K100LV

[0038] Preparation process: with embodiment 1

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Abstract

The invention relates to a nefopam hydrochloride bilayer slow-release tablet and a preparation method thereof. The nefopam hydrochloride bilayer sustained-release tablet is characterized by being prepared by the step of jointly tabletting a quick release layer and a slow release layer into a bilayer tablet, wherein the proportion of nefopam hydrochloride as the main drug contained in the quick release layer and the slow release layer is (1:1)-(1:5). The invention belongs to the technical field of medical preparations and aims at providing the nefopam hydrochloride bilayer slow-release tablet capable of relieving pain rapidly and relieving and easing pain uniformly and persistently and a preparation method thereof. The bilayer slow-release tablet has the advantages of not only decreasing side effects of a common nefopam hydrochloride preparation to the gastrointestinal tract, but also lowering the medicine-taking frequency of patients, reducing adverse effects and improving patient compliance.

Description

technical field [0001] The invention relates to a Nefopam hydrochloride double-layer sustained-release tablet and a preparation method thereof, which is characterized in that the double-layer sustained-release tablet is jointly compressed into a double-layer tablet by an immediate-release layer and a sustained-release layer, wherein the immediate-release layer and the sustained-release layer The proportion of the main drug Nefopam hydrochloride contained in the slow-release layer is 1:1-1:5. It belongs to the technical field of pharmaceutical preparations. Background technique [0002] Nefopam hydrochloride is a new type of non-addictive strong analgesic with mild antipyretic and muscle relaxant effects. As an analgesic, it has been widely used clinically as early as the early 1970s. Nefopam hydrochloride is different from opioid analgesics and non-steroidal anti-inflammatory drugs in terms of structure and pharmacology. It has no anesthesia and no tolerance , no dependenc...

Claims

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Application Information

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IPC IPC(8): A61K9/24A61K31/395A61K47/38A61P25/04A61P29/00
Inventor 李育巧
Owner COSCI MED TECH CO LTD
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