Method for preparing magnesium stearate

A technology of magnesium stearate and tablet hardness, applied in the field of preparation of magnesium stearate, can solve problems such as reducing tablet hardness, retarding drug dissolution, etc., and achieves improved tablet hardness, excellent fluidity, and improved drug dissolution. Effect

Active Publication Date: 2015-04-29
ANHUI SUNHERE PHARMA EXCIPIENTS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, magnesium stearate is hydrophobic, and there are usually adverse phenomena of retarding drug dissolution and reducing tablet hardness due to overlubricating effect.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] 1. Saponification reaction: Put in 800kg of drinking water and start heating. When the temperature rises steadily to 50°C, add 13kg of caustic soda according to the dosage ratio, stir and heat to 85°C, add 90kg of 1865 stearic acid, stir while adding, saponification reaction time 30min;

[0015] 2. Metathesis reaction: Slowly add 50kg of magnesium sulfate after the saponification reaction, and then cool down to 80°C for 40 minutes for the metathesis reaction;

[0016] 3. Washing and drying: wash the material with purified water to neutrality, and use flash evaporation to dry the material until the moisture content of the material is 15%;

[0017] 4. Hot-melt extrusion: use a twin-screw extruder to perform hot-melt extrusion on the material. When the material reaches 118°C, the crystal form changes to form white transparent granular crystals;

[0018] 5. After the crystals were pulverized and sieved, 85 kg of improved magnesium stearate with a specific volume value ...

Embodiment 2

[0020] 1. Saponification reaction: Put in 900kg of drinking water and start heating. When the temperature rises steadily to 50°C, add 14kg of caustic soda according to the dosage ratio, stir and heat to 89°C, add 85kg of 1865 stearic acid, stir while adding, saponification reaction time 35min;

[0021] 2. Metathesis reaction: Slowly add 45 kg of magnesium sulfate after the saponification reaction, and then cool down to 75°C for 42 minutes for the metathesis reaction;

[0022] 3. Washing and drying: wash the material with purified water to neutrality, and then dry it by flash evaporation until the moisture content of the material is 14%;

[0023] 4. Hot-melt extrusion: use a twin-screw extruder to perform hot-melt extrusion on the material. When the material reaches 116°C, the crystal form changes to form white transparent granular crystals;

[0024] 5. After the crystals were pulverized and sieved, 80.1 kg of improved magnesium stearate with a specific volume value of 1.4...

Embodiment 3

[0026] 1. Saponification reaction: Put in 900kg of drinking water and start heating. When the temperature rises steadily to 50°C, add 15kg of caustic soda according to the dosage ratio, stir and heat to 92°C, add 95kg of 1865 stearic acid, stir while adding, saponification reaction time 40min;

[0027] 2. Metathesis reaction: Slowly add 48kg of magnesium sulfate after the saponification reaction, and then cool down to 80°C for a metathesis reaction time of 46 minutes;

[0028] 3. Washing and drying: wash the material with purified water to neutrality, and then dry it by flash evaporation until the moisture content of the material is 13%;

[0029] 4. Hot-melt extrusion: The twin-screw extruder is used to perform hot-melt extrusion on the material. When the material reaches 120°C, the crystal form changes to form white transparent granular crystals;

[0030] 5. After the crystals were pulverized and sieved, 87kg of improved magnesium stearate with a specific volume value of...

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PUM

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Abstract

The invention discloses a method for preparing magnesium stearate which neither holds up drug dissolution nor reduces tablet hardness. The method comprises the processes of saponification, replacement reaction, washing and drying, hot-melt extrusion, grinding and sieving and the like. 1865 stearic acid, caustic soda flacks and magnesium sulphate are used as main raw materials, and the obtained magnesium stearate can be used for remarkably avoiding adverse phenomena of holding up drug dissolution and reducing tablet hardness due to the over-lubrication effect, has the specific volume lower than 1.5g/ml and the angle of repose of 30 degrees, and is capable of effectively improving the tablet hardness by about 30% and fully improving drug dissolution when used in a tablet at the same proportion as ordinary magnesium stearate.

Description

technical field [0001] The invention relates to a preparation method of magnesium stearate, in particular to a preparation method of magnesium stearate which does not retard drug dissolution and does not reduce tablet hardness, and belongs to the field of organic chemical industry. Background technique [0002] Magnesium stearate is a white, light and non-sandy fine powder; it has a slight peculiar smell; it has a slippery feeling in contact with the skin, and is mainly used as a lubricant, anti-adhesive agent, and glidant. It is especially suitable for the granulation of oils and extracts, and the granules produced have good fluidity and compressibility. Used as a glidant in direct compression, etc. It is widely used in cosmetic, food and pharmaceutical preparations. [0003] When magnesium stearate is in the preparation of solid preparations, especially for bulk drugs with high viscosity and poor material fluidity, the excellent lubricity and anti-sticking properties of ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C53/126C07C51/41
CPCC07C51/412C07C53/126
Inventor 武蛟毕勇刘传祥李杰余伟夏叶青叶永超徐玉勋朱岩陈晓雪
Owner ANHUI SUNHERE PHARMA EXCIPIENTS
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