Vigabatrin oral liquid preparation for children and preparation method thereof

An oral liquid of vigabatrin and the technology of vigabatrin acid, applied in the field of medicine, can solve the problems of poor taste, slow onset of action, difficult for children to accept, etc., and achieve the effects of easy and flexible dosage adjustment, suitable concentration and convenient taking.

Inactive Publication Date: 2018-11-23
江苏福锌雨医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] For epilepsy patients, especially children, ordinary tablets have poor oral compliance, are difficult to adjust the dose, and have a slow onset of action; granules need to be prepared into solutions with warm water before use, and omissions in the preparation process will lead to The dosage is not easy to control, and the taste is not good without flavoring agents, which is not easy to be accepted by children

Method used

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  • Vigabatrin oral liquid preparation for children and preparation method thereof
  • Vigabatrin oral liquid preparation for children and preparation method thereof
  • Vigabatrin oral liquid preparation for children and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Table 1 The prescription of vigabatrin (5g / 100ml) oral liquid

[0020] ingredient

Dosage

effect

Vigabatrin

5g

Anti-epileptic drugs

sucrose

30g

Sweetener

Hypromellose

2g

Glue

Strawberry flavor

0.01

Fragrance

Menthol

0.05

Fragrance

Methyl paraben

0.1g

preservative

Propylparaben

0.02g

preservative

Propylene Glycol

20ml

Solvent

water

To 100ml

Solvent

[0021] Preparation Process:

[0022] (1) Take the prescription amount of methyl paraben and propyl paraben, add an appropriate amount of purified water at 70-90°C and stir for 20 minutes until dissolved.

[0023] (2) Add the prescribed amount of hydroxypropyl methyl cellulose to the above solution and mechanically stir for 30 minutes to dissolve.

[0024] (3) Add the prescribed amount of sucrose to the above solution and mechanically stir for 30 minutes to dissolve.

[0025] (4) Allow the above solution to cool to room temperature, add the prescribed amount of flavor and menthol, and mechanically stir for 10 m...

Embodiment 2

[0028] Table 2 Prescription of vigabatrin (5g / 100ml) oral liquid

[0029] ingredient

Dosage

effect

Vigabatrin

5g

Anti-epileptic drugs

Mannitol

25g

Sweetener

Sodium carboxymethyl cellulose

2g

Glue

Orange flavor

0.01

Fragrance

Menthol

0.05

Fragrance

Methyl paraben

0.1g

preservative

Propylparaben

0.02g

preservative

Propylene Glycol

20ml

Solvent

water

To 100ml

Solvent

[0030] Preparation Process

[0031] (1) Take the prescription amount of methyl paraben and propyl paraben, add an appropriate amount of purified water at 70-90°C and stir for 20 minutes until dissolved.

[0032] (2) Add the prescribed amount of sodium carboxymethyl cellulose to the above solution and mechanically stir for 30 minutes to dissolve.

[0033] (3) Add the prescribed amount of mannitol to the above solution and stir mechanically for 20 minutes to dissolve.

[0034] (3) Allow the above solution to cool to room temperature, add the prescribed amount of flavor and menthol, and mechanically st...

Embodiment 3

[0037] Table 3 Prescription of vigabatrin (5g / 100ml) oral liquid

[0038]

[0039]

[0040] Preparation Process:

[0041] (1) Take the prescription amount of methyl paraben and propyl paraben, add an appropriate amount of purified water at 70-90°C and stir for 20 minutes until dissolved.

[0042] (2) Add the prescribed amount of methyl cellulose to the above solution and mechanically stir for 30 minutes to dissolve.

[0043] (3) Add the prescribed amount of maltitol to the above solution and mechanically stir for 30 minutes to dissolve.

[0044] (3) Allow the above solution to cool to room temperature, add the prescribed amount of flavor and menthol, and mechanically stir for 10 minutes to dissolve.

[0045] (4) Add propylene glycol to the above solution, stir for 10 minutes, dilute the purified water to the prescribed amount, filter with a 0.45 micron filter membrane, quality inspection, and package in glass bottles.

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PUM

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Abstract

The invention belongs to the technical field of medicine, and discloses a vigabatrin oral liquid preparation for children and a preparation method thereof. Antiepileptic medicine of vigabatrin is usedas an active ingredient; proper auxiliary materials, such as sweetening agents, mucilage, aromatics and preservatives are added; liquid with clear and transparent appearance, good mouthfeel and highstability is prepared. The vigabatrin preparation is a solution type; the concentration is proper; the medication dosage can be precisely regulated; the taking is convenient; the absorption is fast; the effect taking speed is high; the clinic medication and family medication requirements can be met; the medicine can be easily accepted by children patients. The vigabatrin oral liquid preparation provided by the invention can sufficiently overcome the defects that the dosage of tablets and granules cannot be precisely regulated, and the medicine taking by children is difficult.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a vigabatrin oral liquid preparation for children and a preparation method thereof. Background technique [0002] Epilepsy is a common childhood disease that is prone to multiple occurrences, and it is a paroxysmal dysfunction of the central nervous system. The main pathological changes of epilepsy are sudden, repeated and short-term central nervous system dysfunction caused by excessive discharge of brain neurons, which has the characteristics of sudden, temporary, and repetitive. The clinical manifestations of the patient are sudden loss of consciousness, limb twitching, and mental And behavioral disorders. According to relevant domestic data survey statistics, epilepsy accounts for 0.8 to 1.5% of the population. The incidence of children is particularly high, and may affect the mental and development of children. The occurrence of epilepsy seriously endangers family ha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/197A61K47/38A61P25/08
CPCA61K9/0095A61K31/197A61K47/38
Inventor 陈鹏李健华张彦卓
Owner 江苏福锌雨医药科技有限公司
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