Preparation method for pharmaceutic adjuvant--magnesium stearate

A technology of magnesium stearate and pharmaceutical excipients, applied in carboxylate preparation, organic chemistry, etc., can solve problems such as complex process, use, and difficult control of preparation conditions, and achieve good product color, stable quality indicators, and production process The effect of easily controlled conditions

Inactive Publication Date: 2013-07-10
郑桂富
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Products beyond this range cannot be used as pharmaceutical excipients
[0004] There are multiple methods for the existing production of pharmaceutical excipient magnesium stearate, most of which have the disadvantages that the process is more complicated and the preparation conditions are not easy to control, and the product quality index of the pharmaceutical excipient magnesium stearate produced is not very stable

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation method of pharmaceutical excipient magnesium stearate comprises the following steps:

[0032] Step 1: Dissolve 0.14kg of sodium hydroxide into 3L of ion-free water under stirring, heat up to 60°C and continue stirring for 15 minutes to obtain a sodium hydroxide solution, keep it warm at 70°C for use;

[0033] The second step: the MgSO of 0. 4kg is mixed under stirring state 4 ·7H 2 O was dissolved in 14L deionized water, heated to 75°C and then stirred for 30 minutes to obtain a magnesium sulfate solution, which was kept at 70°C for later use;

[0034] Step 3: Add 1kg of stearic acid into 15L of ion-free water, heat to 85°C, make the stearic acid completely dissolve into oil and float on the liquid surface; Slowly add sodium oxide solution into the mixture of stearic acid and water, react for 2 hours to prepare sodium stearate solution, cool down to 70°C for use;

[0035] The fourth step: slowly add the magnesium sulfate solution prepared in the secon...

Embodiment 2

[0038] The preparation method of pharmaceutical excipient magnesium stearate comprises the following steps:

[0039] Step 1: Dissolve 0.15kg of sodium hydroxide into 3.5L of ion-free water under stirring, heat up to 70°C and continue stirring for 20 minutes to obtain a sodium hydroxide solution, keep it warm at 65°C for use;

[0040] The second step: the MgSO of 0.5kg is mixed under stirring state 4 ·7H 2 O was dissolved in 15L of ion-free water, heated to 70°C and then stirred for 20 minutes to obtain a magnesium sulfate solution, which was kept at 65°C for later use;

[0041] Step 3: Add 1kg of stearic acid into 20L of deionized water, heat to 90°C, make the stearic acid completely dissolve into oil and float on the liquid surface; Slowly add sodium oxide solution into the mixture of stearic acid and water, react for 2.5 hours to prepare sodium stearate solution, cool down to 65°C for use;

[0042] The fourth step: slowly add the magnesium sulfate solution prepared in the...

Embodiment 3

[0045] The preparation method of pharmaceutical excipient magnesium stearate comprises the following steps:

[0046] Step 1: Dissolve 0.16kg of sodium hydroxide into 4L of ion-free water under stirring, heat up to 75°C and continue stirring for 25 minutes to obtain a sodium hydroxide solution, keep it warm at 75°C for use;

[0047] The second step: the MgSO of 0.6kg is mixed under stirring state 4 ·7H 2 Dissolve O in 16L of ion-free water, heat up to 65°C and continue stirring for 40 minutes to obtain a magnesium sulfate solution, which is kept at 75°C for use;

[0048] Step 3: Add 1kg of stearic acid into 25L of deionized water, heat to 95°C, make the stearic acid completely dissolve into oil and float on the liquid surface; Slowly add sodium oxide solution into the mixture of stearic acid and water, react for 3 hours to prepare sodium stearate solution, cool down to 75°C for use;

[0049] The fourth step: slowly add the magnesium sulfate solution prepared in the second st...

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PUM

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Abstract

The invention provides a preparation method for a pharmaceutic adjuvant--magnesium stearate. The preparation method comprises the following two steps: step 1, subjecting stearic acid and sodium hydroxide to a saponification reaction; and step 2, reacting sodium stearate produced by stearic acid and sodium hydroxide with magnesium sulfate so as to produce the magnesium stearate. The pharmaceutic adjuvant magnesium stearate produced by using the method provided by the invention has stable quality indexes, and in particular, the content of MgO accords with requirements prescribed in Chinese Pharmacopoeia (2010 edition); production process conditions are easily controllable, and the produced magnesium stearate has a good color.

Description

technical field [0001] The invention relates to a preparation method of magnesium stearate as a medical auxiliary material. Background technique [0002] Magnesium stearate is a lubricant with excellent properties. Its main features are good lubricity, light weight and strong adhesion. It can be widely used in industries such as medicine, food and cosmetics. In the pharmaceutical industry, magnesium stearate is mainly used as a lubricant in the process of compressing pharmaceutical tablets. [0003] Magnesium stearate, a pharmaceutical excipient used in the pharmaceutical industry, has high quality requirements, and the key indicator is that the content of MgO is 6.5%-7.5% (Chinese Pharmacopoeia 2010 edition). Products beyond this range cannot be used as pharmaceutical excipients. [0004] Existing methods of producing pharmaceutical adjuvant magnesium stearate have multiple methods, most of which have the disadvantages that the process is more complicated and the preparat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C53/126C07C51/41
Inventor 郑桂富
Owner 郑桂富
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