Metaxalone capsule and preparation method thereof

A technology of metaxalone and capsule, applied in the field of pharmaceutical preparations, can solve problems such as low bioavailability, and achieve the effects of high bioavailability and fast dissolution rate

Active Publication Date: 2014-06-11
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Patent 200580014388.X describes a method for preparing a bioavailable metaxalone solid dosage form, which points out that the bioavailability of commercially available metaxalone tablets is low, and it needs to be taken with food to improve the drug bioavailability of

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1: prescription:

[0030] Metaxalone 40g

[0031] Macrogol 4000 30g

[0032] Tween-80 0.1g

[0033] Butter 10g

[0034] Silica 20g

[0035] Crospovidone 2g

[0036] Appropriate amount of purified water

[0037] Makes 100 capsules

[0038] Process steps:

[0039] (1) First, the raw material metaxalone is pulverized to a particle size of less than 10um with an ultrafine pulverizer;

[0040] (2) Polyethylene glycol 4000 of recipe quantity is dissolved in water under water-bath heating condition, constantly stirs with stirring paddle;

[0041] (3) Slowly add the micronized metaxalone raw material into the polyethylene glycol aqueous solution, and stir at constant temperature for 1 hour;

[0042] (4) Take the prescribed amount of Tuwen-80 and put it into the raw material solution, stir for 2 minutes, then add the prescribed amount of butter, and stir quickly at constant temperature for 30 minutes;

[0043] (5) Fully mix the prescription a...

Embodiment 2

[0046] Embodiment 2: prescription:

[0047] Metaxalone 40g

[0048] Polyvinylpyrrolidone 40g

[0049] Polysorbate 0.1g

[0050] olive oil 8g

[0051] Silica 20g

[0052] Croscarmellose Sodium 2g

[0053] Makes 100 capsules

[0054] Process steps:

[0055] (1) First, the raw material metaxalone is pulverized to a particle size of less than 10um with an ultrafine pulverizer;

[0056] (2) The polyvinylpyrrolidone of recipe quantity is dissolved in water under the water-bath heating condition, constantly stirs with stirring paddle;

[0057] (3) Slowly add the micronized metaxalone raw material into the polyvinylpyrrolidone aqueous solution, and stir at constant temperature for 1 hour;

[0058] (4) Get the prescription amount of polysorbate and put it into the raw material solution, stir for 2 minutes, then add the olive oil of the prescription amount, and stir quickly at constant temperature for 30 minutes;

[0059] (5) Fully mix the prescription amoun...

Embodiment 3

[0062] Metaxalone 40g

[0063] Hypromellose 30g

[0064] Hydrogenated Castor Oil 0.3g

[0065] Vitamin E 12g

[0066] Silica 24g

[0067] Croscarmellose Sodium 1.5g

[0068] Appropriate amount of purified water

[0069] Makes 100 capsules

[0070] Process steps:

[0071] (1) First, the raw material metaxalone is pulverized to a particle size of less than 10um with an ultrafine pulverizer;

[0072] (2) The hypromellose of prescription quantity is dissolved in water under the water-bath heating condition, constantly stirs with stirring paddle;

[0073] (3) Slowly add the micronized metaxalone raw material into the hypromellose aqueous solution, and stir at constant temperature for 1 hour;

[0074] (4) Get the prescription amount of hydrogenated castor oil and put it into the raw material solution, stir for 2 minutes, then add the vitamin E of the prescription amount, and stir quickly at constant temperature for 30 minutes;

[0075] (5) Fully mix the pr...

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Abstract

The invention relates to a metaxalone capsule and a preparation method thereof. The metaxalone capsule content comprises the following components: 20-60% of metaxalone, 20-40% of high molecular material, 5-20% of oil and fat, 10-20% of adsorbent and 0.1-1% of disintegrant. The metaxalone capsule prepared by the invention has the characteristics of high dissolution rate and high bioavailability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to metaxalone capsules and a preparation method thereof. Background technique [0002] Metaxalone is a central muscle relaxant that can block polysynaptic pathways in the spinal cord, has a sedative effect, and also has anticholinergic and antipyretic and analgesic effects. It is a kind of off-white odorless crystalline powder, easily soluble in chloroform, soluble in methanol and 96% ethanol, insoluble in water. After oral administration, the absorption is relatively complete, and it is mainly metabolized into glucuronide in the liver and excreted by the kidneys. The t1 / 2 is about 3.5h. Clinically, it is mainly used as an adjuvant drug for local muscle spasm and severe pain caused by inflammation and trauma. Oral: adult, 0.8g, 3-4 times / day. Common adverse reactions are drowsiness, anorexia, nausea, vomiting, dizziness, dry mouth, urinary retention, anemia and jaundice...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/421A61P21/02A61P29/00
Inventor 范敏华刘华
Owner HAINAN PULIN PHARMA
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