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Enteric-coated sustained-release granules for treatment of epilepsy and preparation method thereof

A slow-release granule and enteric-coated technology, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulations, can solve problems such as increasing side effects and reducing drug efficacy, and achieves a smooth drug release rate. Durability, simple preparation method, and the effect of improving drug efficacy and bioavailability

Inactive Publication Date: 2019-04-30
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Most of these preparations are dissolved in the stomach. With the prolongation of the residence time in the stomach, the damage of dexoxypyramide by gastric acid increases, which not only reduces the efficacy of the drug, but also increases the side effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Prescription: dextromethorphan 55g, hydroxypropyl methylcellulose 12g, methylcellulose 8g, xanthan gum 4g, cellulose acetate phthalate 20g, micronized silica gel 1g.

[0024] Preparation Process:

[0025] Preparation of dry particles: Dissolve hydroxypropyl methyl cellulose with 70% ethanol to prepare a solution of hydroxypropyl methyl cellulose with a mass fraction of 15% in ethanol; Add hydroxypropyl methyl cellulose ethanol solution to the mixture of oxypyramide, methyl cellulose and xanthan gum to make a soft material. The soft material is passed through a sieve to make wet granules and dried. The drying temperature is 50℃ and the drying time is 20min. , Make dry particles;

[0026] Fluidized bed coating: mix cellulose acetate phthalate and micronized silica gel uniformly, dissolve it with a 75% mass fraction of ethanol solution, prepare a coating solution with a mass fraction of 12%, and grind through a colloid mill; The prepared dry granules are put into a fluidized be...

Embodiment 2

[0028] Prescription: 42 g of dextromethorphan, 25 g of hydroxypropyl methyl cellulose, 8 g of methyl cellulose, 3 g of xanthan gum, 20 g of polyvinyl acetate phthalate, and 2 g of magnesium stearate.

[0029] Preparation Process:

[0030] Preparation of dry particles: dissolve hydroxypropyl methylcellulose with 80% ethanol to prepare a 20% hydroxypropyl methylcellulose ethanol solution; Add hydroxypropyl methyl cellulose ethanol solution to the mixture of oxopyram, methyl cellulose and xanthan gum to make a soft material. The soft material is passed through a sieve to make wet granules and dried. The drying temperature is 60℃ and the drying time is 15 minutes. , Make dry particles;

[0031] Fluidized bed coating: mix polyvinyl acetate phthalate and magnesium stearate uniformly, dissolve it with a 70% mass fraction of ethanol solution, prepare a coating solution with a mass fraction of 15%, and pass it through a colloid mill Grind; then put the prepared dry particles into a fluidize...

Embodiment 3

[0033] Prescription: 78 g of dextropyrrolate, 6 g of hydroxypropyl methyl cellulose, 4 g of methyl cellulose, 2 g of xanthan gum, 9 g of ethyl cellulose, 1 g of talc.

[0034] Preparation Process:

[0035] Preparation of dry particles: Dissolve hydroxypropyl methyl cellulose with a proper amount of ethanol with a concentration of 50% to prepare a hydroxypropyl methyl cellulose ethanol solution with a mass fraction of 18%; Add hydroxypropyl methyl cellulose ethanol solution to the mixture of oxypyrrolidone, methyl cellulose and xanthan gum to make a soft material. The soft material is passed through a sieve to make wet granules and dried. The drying temperature is 40℃ and the drying time is 30min. , Make dry particles;

[0036] Fluidized bed coating: mix ethyl cellulose and talc evenly, dissolve it with an ethanol solution with a mass fraction of 85%, prepare a coating solution with a mass fraction of 10%, and grind through a colloid mill; then dry the prepared The granules are put ...

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Abstract

The invention provides enteric-coated sustained-release granules for treatment of epilepsy. With dextrohydroxypyramide as an active ingredient, dextrohydroxypyramide is dispersed in a carrier materialof a mixture of hydroxypropyl methyl cellulose, methyl cellulose and xanthan gum in a specific proportion, and the dextrohydroxypyramide enteric-coated granules prepared by fluidized bed coating granulation are released in an artificial intestinal juice, have gentle and lasting drug release speed, do not generate sudden release phenomenon, achieve the effect of sustained and controlled release, and effectively guarantee the efficacy of drugs and pharmacy safety. The preparation method is simple, does not use materials with large toxicity in the preparation process, is economical and environmentally friendly, and is suitable for large-scale promotion.

Description

Technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an enteric-coated sustained-release granule for treating epilepsy and a preparation method thereof. Background technique [0002] Epilepsy is a common chronic neurological disease with repeated sudden onsets of loss of consciousness and convulsions as the main symptoms. The seizures are usually directly caused by the transient abnormal synchronization activities of neurons in the brain, but its specific pathogenesis It is still unclear. As a common disease, according to the World Health Organization, about 50 million people worldwide suffer from epilepsy. Since epilepsy can occur at any time, and there is generally no warning before the onset, it is very harmful; in addition, patients with epilepsy are often accompanied by complications such as depression, anxiety, migraine, infertility, low libido, and autism. It is very difficult to treat epilepsy. At present, the drugs...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K9/52A61K47/38A61K47/36A61K47/04A61K31/4015A61P25/08
CPCA61K9/501A61K9/5036A61K9/5042A61K9/5047A61K31/4015A61P25/08
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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