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Preparation method of common auxiliary material

A technology of octadecyl alcohol ester and maleic acid mono, which is applied in the field of preparation of sodium stearyl fumarate as an auxiliary material for pharmaceutical preparations, and can solve the problems of increasing unsafe factors, high cost, and high reaction temperature

Active Publication Date: 2014-12-03
SUNSHINE LAKE PHARM CO LTD
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  • Claims
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Problems solved by technology

This method reaction temperature is high, has increased unsafe factor, and cost is high, is unfavorable for suitability for industrialization; And, stearyl alcohol and maleic anhydride reaction are difficult to react completely or easily generate dioctadecyl maleate

Method used

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  • Preparation method of common auxiliary material
  • Preparation method of common auxiliary material
  • Preparation method of common auxiliary material

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Embodiment Construction

[0010] In a first aspect, the present invention provides a method for preparing the intermediate monostearyl maleate for the preparation of sodium stearyl fumarate.

[0011] A preparation method of monostearyl maleate, comprising: reacting stearyl alcohol and maleic anhydride in the presence of an organic basic catalyst to prepare monostearyl maleate.

[0012] By adding an organic basic catalyst, the reaction temperature can be lowered, and problems such as insecurity and high impurities caused by high-temperature reactions can be avoided. The organic basic catalyst is selected from one or more of triethylamine, diethylamine, diisopropylethylamine, pyridine, and ethylenediamine. In some embodiments, the organic basic catalyst is selected from triethylamine.

[0013] The amount of the organic basic catalyst is calculated according to the mass of stearyl alcohol, and the amount is 1%-10%; in some embodiments, the amount of the organic basic catalyst is 2%-4%; in some embodiment...

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Abstract

The invention relates to a preparation method of a common pharmaceutical preparation auxiliary material sodium stearyl fumarate. An organic alkaline catalyst is utilized to lower the reaction temperature, thereby obtaining the high-quality product at high yield. By selecting the reaction conditions, the product satisfying the quality requirements can be prepared, and satisfies the requirements for pharmaceutical preparations. The method is simple to operate, has the advantages of high safety and low cost, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a preparation method of sodium stearyl fumarate, a commonly used pharmaceutical preparation auxiliary material, and belongs to the field of pharmacy. Background technique [0002] Sodium stearyl fumarate, the structural formula is shown in the following formula (1): [0003] [0004] Sodium stearyl fumarate is a hydrophilic lubricant that can improve disintegration and promote dissolution. It is often used in pharmaceutical preparations; it is also used in the field of food industry; it is an important pharmaceutical and food excipient widely used. In the existing production method, commonly used octadecyl alcohol (stearyl alcohol) and maleic anhydride (maleic anhydride) react in toluene at high temperature while removing water, and then obtain sodium stearyl fumarate through steps such as configuration conversion. This method has high reaction temperature, increased unsafe factors, high cost, and is not conducive to indust...

Claims

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Application Information

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IPC IPC(8): C07C69/60C07C67/08C07C67/00
CPCC07B2200/09C07C67/00C07C67/08C07C67/333C07C69/60
Inventor 王振国周辉辉陈勇
Owner SUNSHINE LAKE PHARM CO LTD
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