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Gabapentin and pregabalin compound capsule and preparation method thereof

A technology of pregabalin and gabapentin, which is applied in the field of gabapentin and pregabalin compound capsules and their preparation, can solve problems such as poor particle fluidity, and achieve the effects of stable release, prolonging blood drug concentration and improving compliance.

Active Publication Date: 2022-07-12
HAINAN HEMEI PHARCEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, pregabalin is prone to intramolecular condensation, and the fluidity of the particles is poor. The preparation of sustained-release preparations or gastric retention preparations of gabapentin is not suitable for pregabalin. Therefore, a new technology is needed to meet the needs of sufficient mixing, preparation The compound capsule of gabapentin and pregabalin, at the same time, when reducing the dosage of gabapentin, it can also maintain a certain blood concentration, improve its bioavailability, and greatly reduce the adverse reactions of gabapentin

Method used

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  • Gabapentin and pregabalin compound capsule and preparation method thereof
  • Gabapentin and pregabalin compound capsule and preparation method thereof
  • Gabapentin and pregabalin compound capsule and preparation method thereof

Examples

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Embodiment 1

[0031] A preparation method of gabapentin and pregabalin compound capsules, comprising the following steps:

[0032] Step S1: in parts by weight, mix 20 parts of pregabalin with a particle size of 50 meshes, 7 parts of polyglycerol fatty acid ester, 2 parts of carboxymethyl cellulose and 5 parts of 65% ethanol solution by mass, and stir to obtain a load. drug suspension;

[0033] Step S2: according to the mass ratio of 12:1, take 240 parts of gabapentin with a particle size of 50 meshes, add the drug-loaded suspension, stir and disperse at 300 r / min for 30 minutes, make pellets, dry, and sieve to obtain drug-loaded pellets;

[0034] Step S3: take the drug-loaded pellets and add them to the sericin-containing film solution, sonicate at 10W for 30 minutes, stand for 30 minutes, and filter to obtain the film-loaded drug-loaded pellets;

[0035] The preparation method of the sericin-containing film liquid is as follows: according to the mass-to-volume ratio of the material to liq...

Embodiment 2

[0038] A preparation method of gabapentin and pregabalin compound capsules, comprising the following steps:

[0039]Step S1: by weight, mix 30 parts of pregabalin with a particle size of 150 meshes, 13 parts of polyglycerol fatty acid esters, 9 parts of povidone and 15 parts of 65% ethanol solution by mass, and stir to obtain a drug-loaded mixture. suspension;

[0040] Step S2: according to the mass ratio of 8:1, take 240 parts of gabapentin with a particle size of 70 meshes, add the drug-loaded suspension, stir and disperse at 700 r / min for 50 min, make pellets, dry, and sieve to obtain drug-loaded pellets;

[0041] Step S3: taking the drug-loaded pellets and adding them to the sericin-containing film solution, sonicating at 300W for 5 minutes, standing for 20 minutes, and filtering to obtain film-loaded drug-loaded pellets;

[0042] The preparation method of the sericin-containing film liquid is as follows: according to the mass-to-volume ratio of the material to liquid, 1 ...

Embodiment 3

[0045] A preparation method of gabapentin and pregabalin compound capsules, comprising the following steps:

[0046] Step S1: by weight, mix 25 parts of pregabalin, 9 parts of polyglycerol fatty acid ester, 5 parts of hydroxypropyl methylcellulose and 10 parts of 65% ethanol solution with a particle size of 100 meshes, and stir, A drug-carrying suspension is obtained;

[0047] Step S2: according to the mass ratio of 10:1, take 250 parts of gabapentin with a particle size of 60 meshes, add the drug-loaded suspension, stir and disperse at 500 r / min for 40 minutes, make pellets, dry, and sieve to obtain drug-loaded pellets;

[0048] Step S3: take the drug-loaded pellets and add them to the sericin-containing film solution, ultrasonically treat at 250W for 15 minutes, let stand for 25 minutes, and filter to obtain film-loaded drug-loaded pellets;

[0049] The preparation method of the sericin-containing film liquid is as follows: according to the mass-to-volume ratio of the mater...

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Abstract

The invention provides a gabapentin and pregabalin compound capsule and a preparation method thereof.The preparation method comprises the steps that pregabalin, polyglycerol fatty acid ester, an adhesive and an ethanol solution are stirred and mixed to prepare a drug-loaded suspension, gabapentin is added, stirring and dispersing are conducted, pelleting is conducted, and drug-loaded pellets are obtained; and finally, coating the surfaces of the drug-loaded pellets soaked and dispersed in a film solution by adopting the film solution containing sericin to form an isolation film layer, so as to obtain film drug-loaded pellets, and filling the film drug-loaded pellets into capsules, so as to obtain the gabapentin and pregabalin compound capsules. The gabapentin and pregabalin compound capsule prepared by the invention not only effectively improves the drug loading capacity of the drug-loaded pellet, but also has excellent in-vitro dissolution rate and release rate, and greatly reduces adverse reactions caused by gabapentin, especially headache, insomnia, edema and ataxia; meanwhile, the gabapentin and pregabalin compound capsule is stable in quality, and the combination of gabapentin and pregabalin raw material medicines is effectively realized.

Description

technical field [0001] The invention relates to the technical field of preparation of pharmaceutical capsules, in particular to a compound capsule of gabapentin and pregabalin and a preparation method thereof. Background technique [0002] Gabapentin (Gabapentin), other names as Dieli, Norritin, Nunotine, etc., is a neurological drug or an anti-epileptic drug and an anticonvulsant. Gabapentin is a synthetic amino acid with a similar structure to γ-aminobutyric acid (GABA) and is a derivative of γ-aminobutyric acid (GABA). It binds to the cerebellum, and then affects the amino acid transport of the nerve cell membrane and has an inhibitory effect. Its indications in China have been expanded to the treatment of postherpetic neuralgia. Compared with similar products currently used, gabapentin has the advantages of fast oral absorption, good tolerance, and good therapeutic effect. [0003] But gabapentin adverse reactions show that the most common adverse events are somnolence...

Claims

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Application Information

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IPC IPC(8): A61K9/64A61K31/197A61P25/08A61P25/02A61K31/196
CPCA61K31/196A61K31/197A61K9/5084A61K9/5052A61P25/08A61P25/02A61K2300/00Y02A50/30
Inventor 殷三福王宇丰
Owner HAINAN HEMEI PHARCEUTICAL CO LTD
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