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Risperidone oral solution and preparation method thereof

A technology for oral solution and risperidone, which is applied in the field of risperidone oral solution and its preparation, can solve problems such as slow clearance speed, and achieve the effects of rapid absorption, easy taking, and increased medication compliance

Inactive Publication Date: 2019-04-09
AVENTIS PHARMA HAINAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Slower clearance in elderly patients and patients with renal insufficiency

Method used

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  • Risperidone oral solution and preparation method thereof
  • Risperidone oral solution and preparation method thereof
  • Risperidone oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Prescription composition:

[0029] Preparation Process:

[0030] 1. Heat a certain amount of purified water to 75°C.

[0031] 2. Preparation of 1 mol / l sodium hydroxide solution: add the weighed sodium hydroxide to the quantitative purified water, stir and dissolve to make a 1 mol / l sodium hydroxide solution.

[0032] 3. Part of the purified water is transferred from step 1, a part of which is used to clean the container; the remaining part of the purified water is used to dissolve the material and make up the volume.

[0033] 4. Weigh quantitative purified water to fully dissolve the prescribed amount of benzoic acid, and record the experimental phenomenon.

[0034] 5. Weigh the recipe amounts of benzoic acid, tartaric acid and sucralose and add them to a beaker containing hot water in turn, keep heating at 70-80°C, and stir to completely dissolve the above materials, and judge the dissolution status by visual inspection. .

[0035] 6. After completely dissolving...

Embodiment 2

[0040] Prescription composition:

[0041] Preparation Process:

[0042] 1. Heat a certain amount of purified water to 75°C.

[0043] 2. Preparation of 1 mol / l sodium hydroxide solution: add the weighed sodium hydroxide to the quantitative purified water, stir and dissolve to make a 1 mol / l sodium hydroxide solution.

[0044] 3. Transfer part of purified water from step 1, part of which is used for cleaning the container and the remaining part of purified water is used for dissolving materials and making constant volume.

[0045] 4. Weigh the quantitative purified water to fully wet the prescription methylparaben and propylparaben, and record the experimental phenomenon.

[0046] 5. Take by weighing the recipe quantities of methylparaben, propylparaben, DL-tartaric acid, and sucralose and join them successively in the beaker containing hot water, keep heating at 70-80 °C simultaneously, and stir to make the above The material was completely dissolved, and the dissolution w...

Embodiment 3

[0052] Prescription composition:

[0053] Preparation Process:

[0054] 1. Heat a certain amount of purified water to 75°C.

[0055] 2. Preparation of 1 mol / l sodium hydroxide solution: add the weighed sodium hydroxide to the quantitative purified water, stir and dissolve to make a 1 mol / l sodium hydroxide solution.

[0056] 3. Transfer part of purified water from step 1, part of which is used for cleaning the container and the remaining part of purified water is used for dissolving materials and making constant volume.

[0057] 4. Weigh the quantitative purified water to fully wet the prescription amount of ethyl paraben, and record the experimental phenomenon.

[0058] 5. Weigh the recipe quantities of ethyl paraben, DL-tartaric acid, and sucralose and add them to a beaker containing hot water in turn, keep heating at 70-80°C, and stir to dissolve the above-mentioned materials completely. Dissolution was judged visually.

[0059] 6. After completely dissolving, the abo...

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Abstract

The invention belongs to the field of pharmaceutic preparations and relates to a risperidone oral liquid preparation. The risperidone oral liquid preparation takes risperidone as the effective ingredient, proper ingredients like a pH buffer, a corrigent, a sweetening agent and a preservative are added, and a solution preparation process is used to prepare the colourless clear liquid preparation. According to the risperidone oral liquid preparation, a drug is dispersed in a medium at a molecular state, the absorption speed is high, the drug effect is taken quickly, the risperidone oral liquid preparation is convenient to take, the dose is easy to divide, and the various requirements on clinical medication, patient compliance and industrial scale production are met at the same time.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a risperidone oral liquid and a preparation method thereof. Background technique [0002] This product is a phenylpropisoxazole derivative, which is a new generation of antipsychotics. with 5-HT 2 The receptor has a high affinity for the dopamine D2 receptor. This product can also bind to α1 receptors, has low affinity with H1 receptors and α2 receptors, and does not bind to cholinergic receptors. This product is a powerful D2 receptor antagonist that can improve the positive symptoms of schizophrenia; however, it causes less motor function depression and catalepsy than classic antipsychotics. A balance of 5-HT and dopamine antagonism in the central system can reduce the likelihood of extrapyramidal side effects and extend its therapeutic effect to negative and affective symptoms of schizophrenia. This product is rapidly and completely absorbed by oral administration, and its absorpti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/519A61K47/26A61P25/18
CPCA61K9/0095A61K31/519A61K47/26
Inventor 司俊仁马莉
Owner AVENTIS PHARMA HAINAN
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