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Preparation method of croscarmellose sodium

A technology of sodium carboxymethyl cellulose and carboxymethyl cellulose is applied in the field of preparation of disintegrant croscarmellose sodium, and achieves the effects of short reaction time, reliable performance and easy control of reaction conditions

Inactive Publication Date: 2011-02-09
徐国财
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no relevant patent to apply for protection for the preparation method of chemically cross-linked sodium carboxymethyl cellulose with acid anhydride as cross-linking agent

Method used

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  • Preparation method of croscarmellose sodium
  • Preparation method of croscarmellose sodium
  • Preparation method of croscarmellose sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0036] Dissolve 40 grams of sodium carboxymethylcellulose with 100 grams of organic solvent 1,4-dioxane, stir and dissolve to obtain a homogeneous solution, use sulfuric acid as a catalyst, add a certain amount of sulfuric acid into the sodium carboxymethylcellulose solution, and react The system was acidic, pH = 2.0, reacted at room temperature for 30 minutes to obtain carboxymethyl cellulose; then added 1.5 g of maleic anhydride to the reaction system, reacted at 65°C for 5 hours, the reaction system was weakly acidic, pH = 5, Cool down to room temperature, and process the croscarmellose sodium obtained from the above solution with an alkalized ethanol solvent, which is a homogeneous solution obtained by adding 0.5 g of sodium hydroxide to 100 g of absolute ethanol. Filter, wash with absolute ethanol to pH = 6.5-7.5, and dry at 105°C for 7 hours to obtain croscarmellose sodium powder. The molecular structure of croscarmellose sodium is shown above. Its swelling degree is 15....

Embodiment 2

[0044]Dissolve 30 grams of sodium carboxymethyl cellulose with 100 grams of organic solvent tetrahydrofuran, stir and dissolve to obtain a homogeneous solution, use sulfuric acid as a catalyst, add a certain amount of sulfuric acid to the sodium carboxymethyl cellulose solution to make the reaction system acidic, pH=1.0 , reacted at room temperature for 40 minutes to obtain carboxymethyl cellulose; then added 2.5 grams of succinic anhydride to the reaction system, and reacted for 7 hours at 50° C., the reaction system was acidic, pH=3, and the subsequent processing steps were the same as in Example 1, wherein the alkali The ethanol solvent of dehydration is the homogeneous solution that adds 0.6 gram sodium hydroxide to obtain in 100 gram dehydrated alcohols. Its swelling degree is 13. The degree of substitution of sodium carboxymethylcellulose is 0.85.

[0045] Above-mentioned croscarmellose sodium structural formula is as follows:

[0046]

Embodiment 3

[0048] Dissolve 40 grams of sodium carboxymethylcellulose with 100 grams of organic solvent dimethylformamide, stir and dissolve to obtain a homogeneous solution, use hydrochloric acid as a catalyst, and add a certain amount of hydrochloric acid to the sodium carboxymethylcellulose solution to make the reaction system Acidic, pH = 2.0, react at room temperature for 20 minutes to obtain carboxymethyl cellulose; then add 2 grams of maleic anhydride to the reaction system, react at 60°C for 6 hours, the reaction system is acidic, pH = 2.5, cool down to Room temperature, then use basified ethanol solution (basified ethanol solvent is a homogeneous solution obtained by adding 0.65 gram of sodium hydroxide in 100 gram of absolute ethanol.) Neutralized, filtered and washed with absolute ethanol, and the crude Croscarmellose sodium is dispersed with ethanol solvent and then filtered and washed, and the cross-linked carmellose sodium obtained above is repeatedly dispersed and filtered t...

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Abstract

The invention relates to a preparation method of croscarmellose sodium. In the method, sodium carboxymethylcellulose, organic acid anhydride and an inorganic acid catalyst, with stable performance, are used as raw materials to carry out an esterification synthesis reaction, and croscarmellose sodium is finally prepared. Croscarmellose sodium to be used as a pharmaceutic adjuvant can be synthesized by one-step chemical crosslinking, the invention has the advantages of short reaction time and easily controlled reaction conditions, and the synthesized product has reliable performance and stable quality.

Description

technical field [0001] The invention relates to a pharmaceutical auxiliary material, in particular to a preparation method of a disintegrating agent croscarmellose sodium. Background technique [0002] Pharmaceutical excipients refer to the general term for all pharmaceutical materials except the main drug added to the prescription in order to solve the formability, effectiveness, stability and safety of the preparation during the formulation of the preparation. The essence of the pharmaceutical preparation formulation design process is the process of screening and applying pharmaceutical excipients based on the characteristics of the drug and the requirements of the dosage form. [0003] Pharmaceutical excipients are the basic materials and important components of pharmaceutical preparations, the material basis to ensure the production and development of pharmaceutical preparations, and play a key role in the formulation and production of pharmaceutical preparations. It no...

Claims

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Application Information

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IPC IPC(8): A61K47/38C08K5/092C08L1/26C08J3/24
Inventor 徐国财张晓梅甘颖张宏艳姚宝慧韩笑
Owner 徐国财
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