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Sertraline oral aqueous solution and preparation method

The technology of an aqueous solution and sertraline is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. It can solve the problems of poor medication compliance and bad taste of patients, and achieve accurate dosage, Easy-to-take, easy-to-prepare effect

Inactive Publication Date: 2010-01-27
北京迈劲医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention overcomes the defects of bad mouthfeel of non-aqueous solution and poor drug compliance of patients

Method used

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  • Sertraline oral aqueous solution and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032]Oral solution containing 5 mg / ml sertraline, surfactant, preservative and flavoring agent and its preparation.

[0033] prescription:

[0034] Sertraline Hydrochloride 0.28g (equivalent to Sertraline 0.25g)

[0035] Tween-80 0.25g

[0036] Hydroxypropyl beta-cyclodextrin 0.8g

[0037] Ethanol 2.5ml

[0038] Benzoic acid 0.05g

[0039] Aspartame 0.25g

[0040] water to 50ml

[0041] Preparation method: Take Tween-80, add a small amount of water to make a concentrated solution, and set aside. Take hydroxypropyl β-cyclodextrin, add a small amount of water to dissolve, add sertraline hydrochloride and stir to disperse evenly, add benzoic acid, aspartame, add ethanol and the above-mentioned concentrated solution of Tween-80, set at 50 ℃ water bath, heated to dissolve, add water to the full amount. The resulting mixture can be filtered if desired.

Embodiment 2

[0043] Oral solutions containing 1 to about 20 mg / ml sertraline and preparation thereof.

[0044] prescription:

[0045] Sertraline Hydrochloride 0.056g~1.12g (equivalent to Sertraline 0.25g)

[0046] Tween-80 0.05g~5.0g

[0047] Ethanol 3.5ml

[0048] water to 50ml

[0049] Preparation method: Take Tween-80, add a small amount of water to make a concentrated solution, and set aside. Take a small amount of water, add sertraline hydrochloride and stir to disperse evenly, add ethanol and the concentrated solution of Tween-80 prepared above, place in a water bath at 50°C, heat until dissolved, and add water to make up the full amount. The resulting mixture can be filtered if desired.

Embodiment 3

[0051] Oral solution containing 5 mg / ml sertraline and only one surfactant and its preparation.

[0052] prescription:

[0053] Sertraline Hydrochloride 0.28g (equivalent to Sertraline 0.25g)

[0054] Tween-80 0.5g

[0055] water to 50ml

[0056] Preparation method: Take Tween-80, add a small amount of water to make a concentrated solution, and set aside. Take a small amount of water, add sertraline hydrochloride and stir to disperse evenly, add the concentrated solution of Tween-80 prepared above, place in a 50°C water bath, heat until dissolved, and add water to the full amount. The resulting mixture can be filtered if desired.

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Abstract

The invention relates to sertraline oral solution for treating depression. The invention provides the sertraline aqueous solution for oral administration and a preparation method thereof. The sertraline oral aqueous solution comprises sertraline, pharmacologically acceptable salt thereof, and a or more pharmacologically acceptable excipients. The invention adopts a method of adding the surfactant to prepare the sertraline oral aqueous solution, and overcomes the defects that the nonaqueous solution has no good taste and the patient compliance is not good. Moreover, the invention adopts unit dose package so as to have accurate dosage and convenient administration.

Description

technical field [0001] The invention relates to a sertraline oral aqueous solution for treating depression and a preparation method thereof. It contains sertraline and pharmaceutically acceptable salts thereof and one or more pharmaceutically acceptable excipients. The invention adopts the method of adding surfactant to prepare sertraline oral solution. The invention overcomes the defects of bad taste of the non-aqueous solution and poor compliance of patients taking medicine. In addition, the present invention is packaged in divided doses, so the dosage is accurate and convenient to take. Background technique [0002] Sertraline is a new type of antidepressant that belongs to the class of SSRIs. Experiments have shown that sertraline can selectively resist the depletion of 5-HT in the rat brain induced by chloramphetamine, and inhibit the reuptake of 5-HT. Thereby increasing the content of 5-HT in the synaptic cleft and exerting an antidepressant effect. However, this ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/135A61K47/30A61P25/24
Inventor 马超钟加胜
Owner 北京迈劲医药科技有限公司
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