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Ketamine-containing pharmaceutical composition as well as preparation method and application thereof

A composition and technology of ketamine, applied in the field of medicine, can solve problems such as inconvenient injection and restrictions on outpatients, and achieve the effect of promoting absorption and good curative effect

Active Publication Date: 2021-12-21
GUANGZHOU NEWORLD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, most of the current reports on the antidepressant effect of ketamine are based on intravenous injection, and its application to outpatients is limited due to the inconvenience of injection.

Method used

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  • Ketamine-containing pharmaceutical composition as well as preparation method and application thereof
  • Ketamine-containing pharmaceutical composition as well as preparation method and application thereof
  • Ketamine-containing pharmaceutical composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] This embodiment provides a pharmaceutical composition containing ketamine, the preparation method of which comprises the following steps:

[0044] formula:

[0045] Ketamine 16000mg Citric Acid Monohydrate 120mg Sodium edetate 5mg Cellulose 50mg Tween 80 2mg preservative 0.1mg

[0046] Wherein the cellulose is microcrystalline cellulose, and the preservative is potassium 2,4-hexadienoate.

[0047] Mix the above-mentioned ketamine, citric acid monohydrate, sodium edetate, cellulose, Tween 80, and preservatives, adjust the pH from 4.2 to 4.8 with 1N sodium hydroxide, and then add the injection Dilute to 100mL with water, and mix well to obtain the pharmaceutical composition. The pharmaceutical composition can be loaded into a spray device, and then the pharmaceutical composition is atomized and sprayed out by means of a manual pump or the like.

Embodiment 2

[0049] This embodiment provides a pharmaceutical composition containing ketamine, the preparation method of which comprises the following steps:

[0050] formula:

[0051] Ketamine 16500mg Citric Acid Monohydrate 180mg Sodium edetate 15mg Cellulose 100mg Tween 80 8mg preservative 4mg

[0052] Wherein, the cellulose is hypromellose, and the preservative is sodium benzoate.

[0053] Mix the above-mentioned ketamine, citric acid monohydrate, sodium edetate, cellulose, Tween 80, and preservatives, adjust the pH from 4.2 to 4.8 with 1N sodium hydroxide, and then add the injection Dilute to 100mL with water, and mix well to obtain the pharmaceutical composition. The pharmaceutical composition can be loaded into a spray device, and then the pharmaceutical composition is atomized and sprayed out by means of a manual pump or the like.

Embodiment 3

[0055] This embodiment provides a pharmaceutical composition containing ketamine, the preparation method of which comprises the following steps:

[0056] formula:

[0057] Ketamine 16100mg Citric Acid Monohydrate 130mg Sodium edetate 6mg Cellulose 50mg Tween 80 3mg preservative 0.5mg

[0058] Wherein, the cellulose is microcrystalline cellulose; the preservative is a mixture of 0.25 mg of sodium benzoate and 0.25 mg of potassium 2,4-hexadienoate.

[0059] Mix the above-mentioned ketamine, citric acid monohydrate, sodium edetate, cellulose, Tween 80, and preservatives, adjust the pH from 4.2 to 4.8 with 1N sodium hydroxide, and then add the injection Dilute to 100mL with water, and mix well to obtain the pharmaceutical composition. The pharmaceutical composition can be loaded into a spray device, and then the pharmaceutical composition is atomized and sprayed out by means of a manual pump or the like.

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Abstract

The invention relates to a ketamine-containing pharmaceutical composition as well as a preparation method and application thereof. The ketamine-containing pharmaceutical composition comprises the following components in parts by weight of 16000 to 16500 parts of ketamine; 120 to 180 parts of citric acid; 5 to 15 parts of ethylene diamine tetraacetic acid salt; 40 to 100 parts of an adsorbent; 2 to 8 parts of Tween 80; 0.1-4 parts of a preservative; and the absorbent is a cellulose adsorbent. The ketamine-containing pharmaceutical composition disclosed by the invention can realize a very good drug effect through nasal administration.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a pharmaceutical composition containing ketamine and its preparation method and application. Background technique [0002] Depression is already an extremely common severe mental disorder. The main clinical manifestations are depressed mood, low self-esteem, pessimistic world-weariness, cognitive dysfunction and weakened willpower. Some patients are accompanied by self-injury, suicide and other behaviors. The incidence rate, recurrence rate, and suicide rate of the disease are all very high, which seriously affects the social function of the individual. Among patients with severe depressive disorder, 70% of them will experience fluctuating conditions, recurrent attacks, and persistent symptoms for a long time, and about 1 / 5 of patients with severe depressive disorder will develop into treatment-resistant depression. Currently, more than one-third of the patients do not respond to the tra...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/12A61K9/00A61K47/12A61K47/18A61K47/38A61K47/26A61P25/24
CPCA61K31/137A61K9/12A61K9/0043A61K47/12A61K47/183A61K47/38A61K47/26A61P25/24Y02A50/30
Inventor 吴传斌罗家全陈航平高越曹超
Owner GUANGZHOU NEWORLD PHARMA CO LTD
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