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Iron protein succinylate solubilizing method and oral solution preparation thereof

A technology of iron protein succinate and oral solution, which is applied in the fields of peptide/protein components, blood diseases, pharmaceutical formulations, etc., can solve the problems of insolubility, unstable solution and high free iron content, and achieve the effect of improving solubility

Active Publication Date: 2012-09-19
NANJING TEFENG PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Technical problem: the purpose of this invention is to develop a process that can improve the solubility of iron protein succinate in water, and use this process to prepare iron protein succinate oral solution preparations , in order to solve the problems of poor solubility of the drug in water, unstable solution, high content of free iron, etc., so as to facilitate the popularization and application of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Weigh 0.8g of ferric protein succinate raw material, put it in a 100ml beaker, add 2ml of 1,2-propylene glycol, 1.4g of sorbitol, mix well, add 0.2g of sodium lauryl sulfate, mix well, add 1mol / L NaOH Dissolve the solution in 15ml, add 3g of citric acid, adjust the pH to 6.5-8.0, add 1g of red fruit essence, 0.03g of sodium saccharin, and make iron protein succinate oral solution. Filter through a 0.45 μm or 0.22 μm microporous membrane, and sterilize at a high temperature of 115°C for 20 minutes.

Embodiment 2

[0040] Weigh 0.8g of ferric protein succinate raw material, put it in a 100ml beaker, add 2ml of 1,2-propanediol, 1.4g of sorbitol, mix well, add 0.2g of poloxamer and mix well, add 1mol / L NaOH solution to dissolve Put 15ml in it, add 3g of citric acid, adjust the pH to 6.5-8.0, add 1g of red fruit essence, 0.03g of sodium saccharin, and make iron protein succinate oral solution. Filter through a 0.22 μm microporous membrane, and sterilize at a high temperature of 115°C for 20 minutes.

Embodiment 3

[0042] Weigh 0.8g of ferric protein succinate raw material, put it in a 100ml beaker, add 2ml of 1,2-propylene glycol, 1.4g of sorbitol, mix well, add 0.2g of PEG-400, mix well, add 1mol / L NaOH solution to dissolve Put 15ml in it, add 3g of citric acid, adjust the pH to 6.5-8.0, add 1g of red fruit essence, 0.03g of sodium saccharin, and make iron protein succinate oral solution. Filter through a 0.22 μm microporous membrane, and sterilize at a high temperature of 115°C for 20 minutes.

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PUM

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Abstract

The invention discloses an iron-protein succinylate solubilizing method and an oral solution preparation thereof, which are used for solving the problems of difficulty in dissolving iron-protein succinylate into water, unstable solution and the like. In the method, lauryl sodium sulfate or poloxamer or PEG-400 or beta-cyclodextrin is taken as a solubilizing solvent, and 1,2-propylene glycol and the like are taken as latent solvents, so that the water solubility of the iron protein succinylate are increased, and the free iron content is less than 0.1 percent. An iron protein succinylate oral solution prepared by using a process disclosed by the invention is accordant with relevant regulations in the Imported Medicine Registration Standard JX20000298 and oral liquid dosage form items in the second version of the Chinese Pharmacopeia, edition 2010.

Description

technical field [0001] The invention relates to a solubilization process of insoluble ferric protein succinate and a preparation method thereof for oral solution preparation, which belongs to the technical field of pharmaceutical preparations, and more specifically relates to a solubilization process of insoluble ferric protein succinate and an oral solution thereof method of preparation. Background technique [0002] In 1988, the Italian Panmark Pharmaceutical Company developed a nano-peptide protein iron supplement drug called iron-protein succinylate (ISP), which was successfully launched in Italy and sold in more than 20 countries around the world, including Spain. , Portugal, Greece, Argentina, South Korea, China, etc. have been launched and sold one after another, and are widely welcomed by doctors from all over the world. [0003] Through the patent searches of the State Intellectual Property Office of China (SIPO), Derwent Patent Database (DII) and the United States...

Claims

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Application Information

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IPC IPC(8): A61K38/40A61K9/08A61P7/06A61P3/12
Inventor 陶亮钱晓敏李华锋温天文孙柏旺刘实李述斌罗俊赵千肖建民云琦徐智勇朱怀柏夏秋月邢华训
Owner NANJING TEFENG PHARMA
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