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Medicinal-grade magnesium stearate and refining process thereof

A magnesium stearate, pharmaceutical grade technology, applied in the field of pharmaceutical grade magnesium stearate and its refining, can solve the problems of large container equipment, low production efficiency, high heavy metal content and sulfate content, and meet the requirements of low heavy metal The effect of content requirements, high product quality level, and simple preparation process

Active Publication Date: 2010-06-23
HUNAN ER KANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Traditional magnesium stearate is mainly synthesized by double decomposition method. The magnesium stearate synthesized by this method has the disadvantages of low purity, large container equipment, low production efficiency, high energy and water consumption, and high heavy metal content and sulfate content. for medicinal purposes

Method used

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  • Medicinal-grade magnesium stearate and refining process thereof
  • Medicinal-grade magnesium stearate and refining process thereof
  • Medicinal-grade magnesium stearate and refining process thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0033] (2) Preparation of iron-modified sepiolite adsorbent

[0034] Take 3 parts of sepiolite fine powder 10g and place them in 100mL beakers respectively, add FeCl with mass fractions of 2.5%, 5.0%, and 10% in sequence 3 The solution was 50mL, the solid-liquid ratio was 1:5, the reaction was stirred for 30min, and the precipitation was allowed to stand for 24h, during which time it was stirred 7-8 times. Discard the supernatant, transfer the lower precipitate to a funnel, filter, and wash with water until the effluent does not contain Fe 3+ , Mg 2+ until. Take it out, put it in an oven at 150°C and bake it for more than 8 hours, smash it with a ceramic bowl, dry it, and crush it through a 100-mesh sieve to prepare 2.5%, 5.0% and 10% iron-modified sepiolite adsorbents. The iron-modified sepiolite adsorbent is placed in a sealed bag in a desiccator for standby.

[0035] Preparation of pharmaceutical grade high-purity magnesium stearate with low heavy metal content

[00...

Embodiment 1

[0049] The preparation method of embodiment 1 magnesium stearate

[0050] Add 100g of food-grade magnesium stearate into the dissolving tank, then add 1000ml of absolute ethanol into the dissolving tank, stir at a stirring speed of 120rpm for 20 minutes, and heat to 50°C to fully dissolve; add the obtained solution to 10g / L of iron-modified sepiolite adsorbent, oscillating for 2 hours, filtered; the filtrate was distilled under reduced pressure at 60°C to recover ethanol, and the product was collected; Stir at a stirring speed of 120rpm for 20 minutes to fully wash with water at a certain temperature, wherein the mixing ratio of magnesium stearate and purified water is 1:8 (g / ml); filter, separate the solids, and discard the filtrate; The raw materials were dried in an oven at 80° C. for 4 hours; the dried raw materials were crushed and sieved, inspected and packaged to obtain products. The magnesium stearate content of the pharmaceutical grade magnesium stearate prepared by...

Embodiment 2

[0054] Add 200g of food-grade magnesium stearate into the dissolving tank, then add 2000ml of absolute ethanol into the dissolving tank, stir at a stirring speed of 130rpm for 30 minutes, and heat to 60°C to fully dissolve; add the obtained solution to 20g / L of iron-modified sepiolite adsorbent, oscillating for 3 hours, filtered; the filtrate was distilled under reduced pressure at 70°C to recover ethanol, and the product was collected; Stir at a stirring speed of 150rpm for 30 minutes to fully wash with water at a certain temperature, wherein the mixing ratio of magnesium stearate and purified water is 1:8 (g / ml); filter, separate the solids, and discard the filtrate; The raw materials were dried in an oven at 85° C. for 5 hours; the dried raw materials were crushed and sieved, inspected and packaged to obtain products. The magnesium stearate content of the pharmaceutical grade magnesium stearate prepared by the method is 99.87%, and the heavy metal content is 5.1ppm, which ...

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Abstract

The invention provides a medicinal-grade magnesium stearate and a refining process thereof. The process comprises the following steps: (a) adding a food-grade magnesium stearate in a dissolving tank and then adding absolute ethyl alcohol, stirring for 15 to 30 minutes at the speed of 100 to 150 rpm under the temperature of 50 to 70 DEG C, wherein the mixing proportion of the magnesium stearates and the absolute ethyl alcohol is 1 to 10 (g / ml); (b) adding 10 to 20 g / ml sepiolite absorbents modified by iron to the obtained solution for oscillation and absorption for 2 to 3 h and then filtering;(c) distilling the filtrate at reduced pressure under the temperature of 60 to 70 DEG C to recover ethyl alcohol, thereby collecting a product; (d) adding the product in the dissolving tank and adding purified water, stirring for 15 to 30 minutes at the speed of 100 to 150 rpm under the temperature of 70 to 90 DEG C, wherein the mixing proportion of the magnesium stearates and the purified water is 1 to 8 (g / ml); (e) filtering, drying, sieving, testing and split charging to obtain the product.

Description

technical field [0001] The invention relates to the field of pharmaceutical excipients, in particular to a pharmaceutical grade magnesium stearate and a refining method thereof. Background technique [0002] Magnesium stearate, the molecular formula is Mg(C 17 h 35 COO) 2 , is widely used in cosmetics, food and pharmaceutical preparation industries, mainly used as a lubricating release agent for tablets, and can also be used as an ingredient in cosmetics and as a stabilizer for polyvinyl chloride and paint in combination with calcium soap and zinc soap The drier has produced better social and economic benefits. Magnesium stearate, as a widely used pharmaceutical excipient, is generally considered non-toxic when taken orally. In the production of pharmaceutical capsules and tablets, it is mainly used as a lubricant and excipient, and its concentration is generally 0.25%-5.0% (w / w). However, oral administration of large amounts can cause diarrhea or mucosal irritation. A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C53/126C07C51/42
Inventor 帅放文王向峰章家伟
Owner HUNAN ER KANG PHARMA
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