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A kind of carboxymaltose iron pharmaceutical composition and preparation method thereof

A technology of carboxymaltose iron and its composition, which is applied in the field of carboxymaltose iron pharmaceutical composition and its preparation, and can solve problems such as the hydrolysis of nicotinamide carboxymaltose iron that has not been seen yet

Active Publication Date: 2019-02-26
南京恒生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Nicotinamide is a component of coenzyme Ⅰ and coenzyme Ⅱ, and participates in various metabolic processes in the body. It is mainly used as a cosolvent in pharmaceutical preparations for the prevention and treatment of pellagra to improve the water solubility of insoluble drugs. It has not been seen that nicotinamide can inhibit Related reports on iron hydrolysis of carboxymaltose

Method used

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  • A kind of carboxymaltose iron pharmaceutical composition and preparation method thereof
  • A kind of carboxymaltose iron pharmaceutical composition and preparation method thereof
  • A kind of carboxymaltose iron pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Prepare the injection according to the proportioning in Table 1 and the following process, measure the reducing sugar content, and the data are listed in the table below: Weigh the carboxymaltose iron and auxiliary materials of the prescribed amount, add them to the water for injection, stir to dissolve, and adjust the pH value of the injection 5.0 to 7.0, and then filtered with a 0.22 micron membrane filter, the filtrate was filled in ampoules and sterilized. The sterilized injection was taken to determine the content of reducing sugar in the injection.

[0025] Table 1

[0026]

[0027] Studies have found that adding different excipients to the carboxymaltose iron solution, only when nicotinamide is added, the reducing sugar content in the injection is less than 0.19%, which is better than the carboxymaltose iron injection produced by the Swiss company Vifor.

[0028] Determination method of reducing sugar content:

[0029] Blank test: Take 1.0ml of water, put it...

Embodiment 2

[0036] According to the proportioning in Table 2 and the following process to prepare the injection, measure the reducing sugar content, the data are listed in the table below: take the carboxymaltose iron and auxiliary materials of the prescription amount, add in the water for injection, stir to dissolve, and then use 0.22 micron Membrane filtration, the filtrate is filled in ampoules and sterilized. The sterilized injection was taken to determine the content of reducing sugar.

[0037] Table 2

[0038]

[0039]

[0040]Studies have found that adding different concentrations of nicotinamide in different concentrations of carboxymaltose iron injection can reduce the reducing sugar content.

Embodiment 3

[0042] Prepare injection according to prescription in table 3 and following process, and injection measures reducing sugar content, is listed in the following table:

[0043] Weigh the carboxymaltose iron and auxiliary materials of the prescribed amount, add them to the water for injection, stir to dissolve, then filter with a 0.22 micron filter membrane, fill the filtrate in ampoules, and sterilize. The sterilized injection was taken to determine the content of reducing sugar.

[0044] table 3

[0045]

[0046] Studies have found that when nicotinamide is used and the pH value is adjusted within the range of 4.0-8.0, the content of reducing sugar is within 0.15%, which is significantly better than the 0.19% of carboxymaltose iron injection produced by Swiss Vifor company. Preferably, the pH range is 5.0-7.0, and the reducing sugar content of the carboxymaltose iron injection is within 0.1%.

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Abstract

The invention discloses a ferric-carboxymaltose pharmaceutical composition and a preparation method thereof. The ferric-carboxymaltose pharmaceutical composition comprises 10-30 parts by weight of ferric carboxymaltose, 1-15 parts by weight of nicotinamide, one or more kinds of pH regulators which are pharmaceutically acceptable, and water for injection. The preparation method includes the following steps that 1, the ferric carboxymaltose and the nicotinamide are added into the water for the injection to be dissolved; 2, the pH value of a solution obtained in the step 1 is adjusted through the pH regulators; 3, filtration, filling and sterilization are conducted on a solution obtained in the step 2. The pharmaceutical composition is characterized in that the stability is good, the ferric carboxymaltose is uneasy to degrade in a long-term storage process, and the generation of reducing saccharide is restrained.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition of iron carboxymaltose and a preparation method thereof. Background technique [0002] Iron deficiency anemia is one of the four most serious nutritional diseases in the world today, and it is also the most common type of anemia in all parts of the world, including my country. Its incidence rate is very high, especially in developing countries. Research on methods of preventing and treating iron deficiency anemia has always been a focus of attention of medical workers. [0003] Oral or injectable iron is the most commonly used and most effective treatment for iron deficiency anemia. Oral iron supplementation is often used as the drug of choice for iron deficiency anemia because it is effective, cheap and safe. Oral iron supplementation is still the mainstay in China. However, oral iron often has obvious symptoms of gastrointestinal discomfor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/716A61K31/455A61K33/26A61P3/02A61P7/06
CPCA61K31/455A61K31/716A61K33/26A61K2300/00
Inventor 王芳韦超杨炫王宁
Owner 南京恒生制药有限公司