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Memantine Hydrochloride Oral Solution

A technology of memantine hydrochloride and oral solution, applied in the field of medicine, can solve problems such as quality problems of pharmaceutical preparations

Active Publication Date: 2018-01-02
YANTAI RONGCHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] However, due to the presence of water, it is easy to bring problems to the quality of pharmaceutical preparations

Method used

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  • Memantine Hydrochloride Oral Solution

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0172] Preparation of internal standard solution: take naphthalene, add chloroform to make a solution containing about 0.2mg per 1ml, and obtain it;

[0173] Preparation of reference substance solution: Accurately weigh 12.5 mg of memantine hydrochloride reference substance, put it in a 25ml measuring bottle, dissolve it with water and dilute to the mark, shake well, and obtain;

[0174] Determination method: Accurately measure 2ml each of the reference substance solution and memantine hydrochloride oral solution, put them separately in 10ml stoppered test tubes, add 2ml of 5mol / L sodium hydroxide solution respectively, shake well, add 3ml of internal standard solution precisely, and vortex Shake and mix for 5 minutes, let stand for 5 minutes, separate the chloroform layer, accurately measure 1 µl each, inject it into the gas chromatograph, and record the chromatogram; calculate the peak area according to the internal standard method, and obtain that.

[0175] 2. 【Related Su...

Embodiment 1

[0182] Embodiment 1: Preparation of memantine hydrochloride oral solution

[0183] formula:

[0184] Memantine Hydrochloride 50mg,

[0185] Citric acid 200mg (the pH value of final liquid medicine is 4.05),

[0186] Soy Lecithin 25mg,

[0187] Sucralose 20mg,

[0188] Sodium Benzoate 150mg,

[0189] Water, add appropriate amount to 100ml.

[0190] Preparation method:

[0191] (1) Add all materials except the acid-base regulator to 80% purified water, stir to dissolve;

[0192] (2) adding an acid-base regulator and monitoring the pH value of the solution in the resulting solution to make it reach the prescribed pH range;

[0193] (3) Add water to the full amount, compare the pH value of the solution, and add an acid-base regulator if necessary so that the solution reaches the pH value range specified by the prescription (the actual usage of the acid-base regulator is as described in the formula), to obtain final product, The oral solution sample can be labeled as ...

Embodiment 2

[0210] Embodiment 2: Preparation of memantine hydrochloride oral solution

[0211] With reference to the formula and preparation method of Example 1, the only difference is that the phospholipids are changed into an equivalent amount of egg yolk lecithin, the flavoring agent sucralose is changed into 1000 mg of sucrose, and the preservative sodium benzoate is changed into 75 mg of paraben ethyl ester and mud. Propyl parkinate 75 mg was combined to prepare an oral solution sample marked as Ex2.

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Abstract

The present invention relates to memantine hydrochloride oral solution, more particularly relates to a kind of memantine hydrochloride oral solution with excellent pharmaceutical properties. The memantine hydrochloride oral solution of the present invention comprises: memantine hydrochloride, an acid-base regulator, a flavoring agent, a preservative, and water. The memantine hydrochloride oral solution of the present invention not only has excellent chemical stability, but also has excellent biological effects, such as excellent oral absorption effect.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a pharmaceutical composition for treating mental and nervous system diseases, in particular to a pharmaceutical composition of memantine hydrochloride, and more particularly to a memantine hydrochloride oral solution with excellent pharmaceutical properties . The memantine hydrochloride oral solution of the present invention not only has excellent chemical stability, but also has excellent biological effects, such as excellent oral absorption effect. Background technique [0002] Alzheimer's disease (AD) is one of the common diseases of the elderly. It is mainly manifested as memory loss and recognition impairment. It is a progressive neurodegenerative disorder. The fourth killer. At present, the etiology of this disease has not been fully elucidated, and it has always been a thorny problem in treatment. The research and development of anti-dementia drugs has attracted great at...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/13A61K47/24A61P25/28
Inventor 张永光熊晓滨逯忠祥柳莉张丽
Owner YANTAI RONGCHANG PHARMA