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Solid preparation for treating pediatric epilepsy and preparation method thereof

A technology for solid preparations and epilepsy, applied in the field of medicine, can solve problems such as poor disintegration and dissolution effects, inaccurate dosage, and difficulty in using it on time, so as to enhance the stability of drugs and solve the effects of swallowing difficulties

Inactive Publication Date: 2015-09-23
黑龙江童医生儿童生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the oral preparations of magnesium valproate, topiramate, and lamotrigine on the market have poor disintegration and dissolution effects and low bioavailability. At the same time, due to the side effects of antiepileptic drugs, antiepileptic drugs for children are still blank. For injections , children have a sense of fear, and it is difficult to consciously cooperate with doctors and parents to use it on time; for bottled oral liquid or syrup, there are disadvantages of secondary or repeated pollution; for tablets, when the dosage for children is less than one tablet, Artificial division is required, resulting in inaccurate dosage. Some coated tablets, sustained-release tablets, and dispersible tablets lose their specific functions such as protection, taste masking, controlled release, and isolation after artificial division.

Method used

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  • Solid preparation for treating pediatric epilepsy and preparation method thereof
  • Solid preparation for treating pediatric epilepsy and preparation method thereof
  • Solid preparation for treating pediatric epilepsy and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0024] The method for preparing a spray-type preparation includes the following steps: coating the core particles containing only epilepsy drug particles or crystals or one or more excipients with a taste-masking mixture, and then drying. The preparation method of core particle comprises:

[0025] The first method, the epilepsy drug raw material powder is placed in the fluidized bed equipment earlier, and then excipients known to those skilled in the art such as PVP, starch, sucrose, syrup, HPMC in a pharmaceutically acceptable solvent (such as water , ethanol, acetone, etc.) is sprayed onto the powder to form granules, and then dried until the solvent evaporates to obtain core particles.

[0026] In the second method, powdered or granular epilepsy drugs and diluents or fillers are mixed with water or pharmaceutically acceptable solvents (such as water, ethanol) to form a wet material. Mix the mixture until it forms a wet mass, ie a kneaded mass. The wet material is then ext...

Embodiment 1

[0029] The influence of embodiment 1 taste-masking coating content on pharmaceutical preparation

[0030] The magnesium valproate dispensing preparation is prepared by the method of the present invention, wherein the medicine contains 7-15% by weight of a taste-masking coating, and the results of the dissolution test in water of the bioavailability of the pharmaceutical composition are shown in Table 1.

[0031] Table 1 Dissolution test results in water

[0032]

[0033]

[0034] The following are specific examples of the present invention, but the scope of the present invention is not limited to the following examples.

Embodiment 2

[0035] The preparation of embodiment 2 core particles

[0036]

[0037] Accurately weigh batches of each core bead ingredient. Place an appropriate batch of pure water in a jacketed pot equipped with a purger, homogenizer, and mixer. Bulk PVP was added and the resulting mixture was allowed to disperse in the water for at least 15 minutes. Sodium valproate (75 kg) was added and the mixture was mixed for at least 15 minutes to disperse. Water is passed through the interlayer. The sodium valproate suspension was homogenized with a mixer and homogenizer for about 90 minutes (range: 80-100 minutes). Agitation is continued in the subsequent steps of preparing the core beads.

[0038] Prepare a pump with three spray pump heads. Load the batch of sugar spheres, NF into the fluidized bed. The sugar balls are fluidized, and the sodium valproate suspension is sprayed through the nozzle according to certain parameters. The core particles were dried at 60°C for at least 15 minute...

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Abstract

The invention discloses a solid preparation for treating pediatric epilepsy and a preparation method thereof. The solid preparation is a dispersed preparation and comprises active agent core particles, wherein the core particles just comprise medicines for treating epilepsy or comprise the medicines for treating epilepsy and one or several excipients. Through the adoption of a taste masking mixture coating comprises the core particles of anti-epileptic medicines, coating particles are formed. The solid preparation is capable of masking the uncomfortable taste, has the function of improving the stability of the medicines, and can be used for solving the problem that children have difficulty in swallowing the bitter medicines.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a solid preparation for treating epilepsy in children and a preparation method thereof. Background technique [0002] At present, typical oral solid dosage forms include tablets, capsules, etc., and these conventional solid dosage forms are mainly suitable for adults. However, children, the elderly, and some special patients have difficulties in swallowing tablets and capsules, so it is often desired to provide a liquid form or a chewable solid dosage form. When the physical and chemical properties of the drug are not suitable for making a liquid preparation, a better choice is to provide A chewable solid dosage form, such as microparticles, that can be sprinkled on soft foods (such as children's food) because it is usually more convenient and simple to administer. [0003] At present, the oral preparations of magnesium valproate, topiramate, and lamotrigine on the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K35/32A61K31/19A61P25/08
Inventor 彭项雨王娜姜波刘晓磊
Owner 黑龙江童医生儿童生物制药有限公司
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