A kind of sodium carbosulfonate semi-solid preparation and preparation method thereof

A sodium carboxysulfonate and semi-solid technology, which is applied in the field of medicine, can solve the problems of redness and pain at the injection site of patients, and destroy the use effect of sodium carboxylate tablets, so as to reduce the incidence of adverse reactions, ensure bioavailability, The effect of improving drug safety

Active Publication Date: 2017-02-22
贵州健瑞安药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some by-products produced during the synthesis of carbosulfonate injection can cause adverse reactions such as nausea, dizziness, and redness and pain at the injection site.
[0006] At the same time, there are some oral tablets. After entering the stomach, the gastric acid in the gastric juice will react with it, destroying the effect of sodium carbosulfonate tablets.

Method used

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  • A kind of sodium carbosulfonate semi-solid preparation and preparation method thereof
  • A kind of sodium carbosulfonate semi-solid preparation and preparation method thereof

Examples

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preparation example Construction

[0048] Further, the preparation method of high-purity sodium carboxysulfonate with a purity of more than 99.80% comprises the following steps:

[0049] Step 1. Add 20.8 parts of sodium bisulfite and 100 ml of deionized water to the reaction vessel equipped with a mechanical stirrer, stir and dissolve at a speed of 70.0 to 80.0 r / min, and then add 23.6 parts of adrenal chromozone to control the reaction solution at The reaction is stirred at a speed of 50.0 to 60.0 r / min at a temperature of 15.0 to 25.0 °C, and after an orange-yellow solid is precipitated, continue to stir for 3 to 5 hours, filter, and precipitate to obtain a crude product of sodium carboxysulfonate;

[0050] Step 2. Add the obtained crude sodium carboxylate sulfonate and deionized water of 10.0 to 15.0 times the mass into the reaction flask equipped with mechanical stirring, stir at a speed of 50.0 to 60.0 r / min and heat until the solvent is refluxed, and after the solid is dissolved , add 1.0 part of activate...

Embodiment 1

[0051] Example 1: Preparation of sodium carboxysulfonate suppository 1

[0052] Add 20.8 g of sodium bisulfite and 100 mL of purified water to a 250 mL reaction flask equipped with mechanical stirring, stir (75 r / min) to dissolve, and reduce the stirring speed to 55.0 r / min. Add a cold water bath to control the temperature so that the temperature of the reaction solution is at 18.0℃~19.0℃, add 23.6g of adrenal color hydrazone, an orange-yellow solid is precipitated, continue stirring for 3 hours, and filter to obtain 41.6g of orange-yellow sodium carboxysulfonate crude product.

[0053] 41.6g of crude product and 416g of purified water were added to the reactor in a 500mL reaction flask equipped with mechanical stirring, stirred (53.r / min) and heated to solvent reflux. After the solid was dissolved, 1.0g of activated carbon was added, and continued stirring and refluxing for 30 minutes, filtered while hot, the filtrate was slowly lowered to 14°C, crystallized for 30 minutes, f...

Embodiment 2

[0056] Example 2 Preparation of sodium carboxysulfonate suppository 2

[0057] Add 20.8 g of sodium bisulfite and 100 mL of purified water to a 250 mL reaction flask equipped with mechanical stirring, stir (70 r / min) until dissolved, and reduce the stirring speed to 55.6 r / min. Add a cold water bath to control the temperature so that the temperature of the reaction solution is at 18.5 ℃~19.5 ℃, add adrenal chromozone 23.6g, an orange-yellow solid is precipitated, continue stirring for 3.5 hours, filter, and obtain 41.8g of orange-yellow sodium carboxylate crude product.

[0058] Add 41.8g crude product and 418g purified water to the 500mL reaction flask equipped with mechanical stirring, stir (55.5r / min) and heat to solvent reflux, after the solid is dissolved, add 1.0g activated carbon, continue stirring and refluxing for 30 minutes , filtered while hot, the filtrate was slowly lowered to 14.5°C, crystallized for 30 minutes, filtered, and the precipitate was dried by blasting...

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Abstract

The invention relates to the technical field of medicines and in particular relates to a carbazochrome sodium sulfonate semisolid preparation and a preparation method thereof. The preparation method comprises the following steps: with high-purity carbazochrome sodium sulfonate with the purity above 99.80 percent as an active ingredient, adding a medical matrix to prepare one of suppository, ointment and gel; wherein every10g of the suppository contains 20-80mg of carbazochrome sodium sulfonate; the ointment per 10g contains 40-80mg of the carbazochrome sodium sulfonate; every 5g of the gel contains 40-80mg of the carbazochrome sodium sulfonate. According to the carbazochrome sodium sulfonate semisolid preparation and the preparation method disclosed by the invention, the purity of the carbazochrome sodium sulfonate serving as the active ingredient is above 99.80 percent and by-products are controlled to be below 0.2 percent; when the carbazochrome sodium sulfonate semisolid preparation is used, the adverse reaction incidence in the medication process can be lowered and the medication safety can be improved; meanwhile, the prepared carbazochrome sodium sulfonate semisolid preparation can be delivered by virtue of body cavities so that the high-purity carbazochrome sodium sulfonate is capable of improving the medication safety while high bioavailability of a product is ensured.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a semi-solid preparation of sodium carbosulfonate and a preparation method thereof. Background technique [0002] Sodium carbosulfonate was originally researched by Mitsubishi Tanabe Pharmaceutical Co., Ltd. (MITSUBISHI TANABE company), and it has been included in the twelfth edition of the Japanese Pharmacopoeia by the Ministry of Health and Welfare of Japan. The chemical name is: 1-methyl-6-oxo-2, Sodium 3,5,6-tetrahydroindole-5-semicarbazone-2-sulfonate. [0003] Sodium carbosulfonate is a new generation of hemostatic drug, which is a derivative of sodium carbosalate (Anluoxue). It introduces a sodium sulfonate group into the molecular structure, which overcomes the small solubility of sodium carbosalate and must be prepared by salicylate. The disadvantage of acid-assisted dissolution makes this compound produce a significant hemostatic effect. [0004] Sodium carbosulfonat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/02A61K9/06A61K31/404A61K47/32A61K47/42A61P7/04
Inventor 孙立新李仁祥黄阿三陈玉叶
Owner 贵州健瑞安药业有限公司
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