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Meclofenoxate hydrochloride microcapsule and method for preparing injection thereof

A technology of meclofenxate hydrochloride and microcapsules, which are applied in the field of meclofenxate hydrochloride freeze-dried preparations and their preparation, can solve the problems of unsatisfactory effect, high cost, limited wide application and the like, and improve bioavailability. , slow release, reduce the effect of hydrolysis reaction

Inactive Publication Date: 2008-10-08
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the production cycle of sterile packaging preparations is long, the cost is high, and the output of a single batch is small, thereby limiting the wide application of this product in clinical practice; the freeze-dried preparation is a freeze-dried powder prepared after freeze-drying an aqueous solution, and the stability of the product is low. Not good, although many manufacturers add a lot of additives in the production process to stabilize the changes of raw materials and improve the quality of medicines, but the effect is not satisfactory

Method used

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  • Meclofenoxate hydrochloride microcapsule and method for preparing injection thereof
  • Meclofenoxate hydrochloride microcapsule and method for preparing injection thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Meclofenoxate Hydrochloride 60g

[0061] Gelatin 180g

[0062] Dextran 150g

[0063] Span 20g

[0064] Poloxamer 20g

[0065] Preparation Process

[0066] (1) 60g meclofenoxate hydrochloride is added in the water for injection, dissolves completely;

[0067] (2) add 180g gelatin and 20g span to step (1) gained solution, prepare water-in-oil emulsion with mechanical stirring method;

[0068] (3) Add 500ml of 30% dextran solution and 20g poloxamer to the solution obtained in step (2), and prepare water-in-oil-in-water multiple emulsion by mechanical stirring;

[0069] (4) the potassium hydroxide solidified liquid that is 3mol / L is dripped by the solubility of step (3) gained multiple emulsion in the high-voltage electrostatic field by the orifice injection, and the electric field voltage is 2.2kv, and the injection speed is 5ml / min After solidification for 10 minutes, the microcapsules were filtered out, and the microcapsules were washed with water until the pH was ...

Embodiment 2

[0071] Meclofenoxate Hydrochloride 250g

[0072] Gelatin 800g

[0073] Dextran 300g

[0074] Egg Yolk Lecithin 100g

[0075] Polyoxyethylene Hydrogenated Castor Oil 100g

[0076] Preparation Process

[0077] (1) 250g meclofenoxate hydrochloride is added in the water for injection, dissolves completely;

[0078] (2) Add 800g gelatin and 100g egg yolk lecithin to the solution obtained in step (1), prepare water-in-oil emulsion with high-pressure homogenization;

[0079] (3) Add 600ml of 50% dextran solution and 100g polyoxyethylene hydrogenated castor oil to the solution obtained in step (2), prepare water-in-oil-in-water multiple emulsion with high-pressure homogenization;

[0080] (4) the sodium ethylate solidified liquid that is 6mol / L is dripped by the solubility of step (3) gained multiple emulsion in the high-voltage electrostatic field by the orifice injection, and the electric field voltage is 4.4kv, and the injection speed is 20ml / min, After solidification for 60 ...

Embodiment 3

[0082] Meclofenoxate Hydrochloride 100g

[0083] Gelatin 250g

[0084] Dextran 180g

[0085] Soy Lecithin 50g

[0086] Hydrogenated Soy Lecithin 50g

[0087] Tween 80 50g

[0088] Polyoxyethylene Stearate 50g

[0089] Preparation Process

[0090] (1) 100g meclofenoxate hydrochloride is added in the water for injection, dissolves completely;

[0091] (2) Add 250g gelatin, 50g soybean lecithin and 50g hydrogenated soybean lecithin to the solution obtained in step (1), prepare water-in-oil emulsion with mechanical stirring;

[0092] (3) Add 30% dextran solution 600ml, 50g Tween 80 and 50g polyoxyethylene stearate to step (2) gained solution, prepare water-in-oil-in-water multiple emulsion with mechanical stirring;

[0093] (4) the sodium hydroxide solidified liquid that is 5mol / L is the sodium hydroxide solidified liquid that the solubility of step (3) gained compound emulsion is dripped into the high-voltage electrostatic field by the orifice injection, and the electric f...

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Abstract

The invention provides a meclofenoxate hydrochloride microcapsule for injection and a production method thereof. The meclofenoxate hydrochloride microcapsule for the injection is composed of the meclofenoxate hydrochloride and adjuvant, which is characterized in that the adjuvant contains gelatin, dextran and emulsifier. The invention also provides the production method of a meclofenoxate hydrochloride freeze-dry powder and injection. As the meclofenoxate hydrochloride microcapsule with high stability in water is used, the meclofenoxate hydrochloride is not hydrolyzed when redissolving; the clarity is good after redissolving; thereby a product in the invention has the advantages of good stability and good quality, which is good for storing the product for a long time.

Description

technical field [0001] The invention relates to a meclofenoxate hydrochloride microcapsule for injection and a preparation method thereof, and also relates to a meclofenoxate hydrochloride freeze-dried preparation and a preparation method thereof. It belongs to the field of medicine. Background technique [0002] Meclofenoxate hydrochloride was artificially synthesized by French scientist Professor Thuillier in 1957. Its chemical name is p-chlorophenoxyacetic acid dimethylaminoacetate. It is a central stimulant drug that has been used for many years. Oxygen, nervous disorder, and can control enuresis in children caused by deep sleep and low awakening alert point. In 1996, it was discovered that it can remove lipofuscin and free radicals in nerve cells, promote body metabolism, protect cell membranes, enhance memory and improve intelligence. It is called an activator of brain cell metabolism, which can promote the utilization of carbohydrates by brain cells. Increase the in...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K9/08A61K31/221A61K47/36A61P25/00
Inventor 邱民
Owner HAINAN LINGKANG PHARMA CO LTD
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