Lamotrigine oral liquid preparation and preparation method thereof

A lamotrigine oral liquid, lamotrigine technology, which is applied in the directions of pharmaceutical formulations, drug delivery, nervous system diseases, etc. Facilitates absorption and improves bioavailability

Inactive Publication Date: 2015-09-30
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] The purpose of the present invention is to provide a kind of oral liquid preparation of lamotrigine, which solves the problems of complex dose adjustment and dosage division of the preparation in the medication process existing in the prior art

Method used

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  • Lamotrigine oral liquid preparation and preparation method thereof
  • Lamotrigine oral liquid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1 (oral liquid)

[0033]

[0034] The preparation method of the oral liquid preparation of lamotrigine in the present embodiment 1 is specifically implemented according to the following steps: Weigh the following components: lamotrigine 2g, sodium benzoate 1g, sorbitol 50g, sucrose 100g, aspartame 0.5 g, 1ml of strawberry essence, 0.5g of sodium lactate, 0.01g of amaranth, appropriate amount of hydrochloric acid, and the balance is purified water. Add sorbitol and lamotrigine, disperse evenly with a small amount of hot water, add to the liquid preparation tank, heat and boil for a period of time, cool, and stir for 10 minutes; mix the weighed sodium lactate, water-soluble sucrose and Spartan and amaranth are respectively dissolved in a small amount of warm water at 50°C and added to the liquid mixing tank, add fragrance, add purified water and stir; adjust the pH value to 2.5-4.0 with pH regulator hydrochloric acid, and then add purified water Dilute to f...

Embodiment 2

[0035] Embodiment 2 (syrup)

[0036]

[0037]The preparation method of the oral liquid preparation of lamotrigine in the present embodiment 2 is specifically implemented according to the following steps: Weigh the following components: 2 g of lamotrigine, 1 g of sodium benzoate, 50 g of sorbitol, 450 g of sucrose, 1 ml of strawberry essence, and amaranth Red 0.0025g, appropriate amount of hydrochloric acid, the balance is purified water, the total amount of the above is 1000ml; take an appropriate amount of purified water and put it in a liquid mixing tank, heat to 40°C, add sucrose and sorbitol under stirring conditions, heat and boil until completely dissolved, Standby; put the weighed lamotrigine in a small beaker, dissolve it completely with hot water, and add it to the liquid preparation tank; add the weighed sodium benzoate, strawberry essence, and amaranth into the liquid preparation tank respectively , add purified water, and stir for 3 minutes; add the weighed pH r...

example

[0039] 1. Li, 8 years old, was clinically diagnosed with epilepsy with a medical history of 5 years. He had taken various anti-epileptic drugs and could not effectively control the seizures. While taking sodium valproate, add the composition of Example 1 of the present invention, the initial dose is 25 mg, take it every other day, and take it for two consecutive weeks; then once a day for two weeks, 25 mg each time. Thereafter, the dose is increased every 1-2 weeks, with a maximum increase of 25-50 mg. After 3 months, the drowsiness, headache and dizziness of the patient were basically eliminated, the taste was good, the swallowing property was good, and the medication compliance was good.

[0040] 2. Yan, 12 years old, was clinically diagnosed with epilepsy, with a medical history of 5 years and about 11 seizures per month. Taking the composition of Example 2 of the present invention, using this product as monotherapy, the initial dose is 25 mg, once a day, for two weeks; th...

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PUM

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Abstract

The invention discloses a lamotrigine oral liquid preparation. Each 1000ml of the lamotrigine oral liquid preparation contains 0.4-2g of lamotrigine, 10-500g of a sweetener, 0.5-1.5ml of a perfume, 0.5-1.5g of an antiseptic, 0.001-0.1g of a coloring agent, a proper amount of a pH adjusting agent, and the balance of purified water, and the pH value of the lamotrigine oral liquid preparation is 2.5-4.0. The invention also discloses a preparation method of the lamotrigine oral liquid preparation. The lamotrigine oral liquid preparation can effectively cover the bad taste of medicines, can be conveniently swallowed, can be accepted by patients (especially children), and has good administration compliance.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a lamotrigine oral liquid preparation, and also relates to a preparation method of the lamotrigine oral liquid preparation. Background technique [0002] Lamotrigine is a new broad-spectrum antiepileptic drug. For the treatment of partial seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Monotherapy or add-on therapy for various types of epilepsy in adults and children has good curative effect and safety, especially for intractable epilepsy. The existing lamotrigine dosage form has defects such as dysphagia, inaccurate dose division, and poor medication compliance. At present, there is no dosage form of lamotrigine suitable for special populations (especially children) on the market, and there are no related reports. Contents of the invention [0003] The object of the present invention is to provide an ora...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K31/53A61P25/08
Inventor 彭项雨刘晓磊姜波王娜
Owner 黑龙江童医生儿童生物制药有限公司
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