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Reduced carboxy alkyl dextriferron injection and preparation method thereof

A technology of iron dextran and carboxyalkyl, which is applied in the field of injection containing reduced carboxyalkyl iron dextran and its preparation, and can solve iron dextran allergic reactions, multiple administration times, and long administration time, etc. problems, achieve low immunogenicity, good effect, and reduce the number of administrations

Inactive Publication Date: 2016-06-29
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In order to overcome the defects of existing traditional intravenous injections, especially iron dextran is prone to allergic reactions, causing patients to experience skin itching, edema, asthma, and even side effects such as blood pressure drop and cardiac arrest, and at the same time overcome the adverse effects of iron sucrose in clinical application. The number of times of medicine is many, the amount of single administration is small, and the shortcoming of administration time is long. One of the purposes of this application is to provide reduced carboxyalkyl dextran iron injection

Method used

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  • Reduced carboxy alkyl dextriferron injection and preparation method thereof
  • Reduced carboxy alkyl dextriferron injection and preparation method thereof
  • Reduced carboxy alkyl dextriferron injection and preparation method thereof

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Effect test

Embodiment 1

[0098] The preparation of embodiment 1 sorbitol carboxyalkyl ether dextran iron particles

[0099] Preparation of sorbitol carboxyalkyl ether dextran

[0100]The dextran of 50g is dissolved in the purified water of 50g, after stirring it to dissolve completely, add 20g concentration and be the NaOH solution of 50% and the sodium borohydride of 10.4g (test 1 # ) or 11.3g potassium borohydride (test 2 # ) for reduction or catalytic hydrogenation (Test 3 # ~6 # ) for reduction, see Table 1 for details, react at room temperature, then add 34g concentration of 50% NaOH solution and halogenated alkanoic acid such as 27.6g chloroacetic acid or 31.8g bromoacetic acid to carry out carboxyalkylation reaction, after 12h, add 4M hydrochloric acid The reaction was terminated at pH 7.0, and a white product was obtained by precipitation. test 1 # The infrared spectrum of the reaction product is shown in figure 2 As shown, it conforms to the infrared spectrum of sorbitol carboxymethy...

Embodiment 2

[0108] The preparation of embodiment 2 sorbitol carboxyalkyl ether dextran iron injection

[0109] Test 1 in embodiment 1 # ~Experiment 6 # The prepared sorbitol carboxyalkyl ether dextran iron was dissolved in an appropriate amount of water for injection according to the prescription amount shown in Table 3. Add 0.05-0.2% (w / v) activated carbon, adjust the pH value of the solution to 5.5-6.5 with 1M hydrochloric acid solution under stirring, and then keep the drug solution at 60-70°C for 20-30 minutes. Then use 1M sodium hydroxide solution to adjust the pH value of the solution to 10.0-11.5, continue to keep the medicinal solution at a temperature of 60-70° C. for 10-15 minutes, and then filter and decarbonize. Add water for injection to the full amount of the prescription, check the pH value of the solution, and adjust the pH value of the solution to the range of 10.0 to 11.5 with an acid-base regulator if necessary; filter the liquid medicine with 0.4 μm and 0.22 μm micro...

Embodiment 3

[0112] Embodiment 3 test

[0113] Visible foreign object detection:

[0114] Injection 1 # ~ Injection 6 # After cold and heat cycle treatment, according to the second part of the Pharmacopoeia of the People's Republic of China (in this application, it can be referred to as "the second part of the Chinese Pharmacopoeia 2010" or similar abbreviation) appendix IXH of the first method (light inspection) in the foreign matter inspection method of the 2010 edition method) (this method may also be referred to as "light inspection method" or similar abbreviation in this application), and also inspect superparamagnetic iron oxide (Ferumoxytol), high-molecular-weight iron dextran, low-molecular-weight iron dextran, sucrose Iron and sodium ferric gluconate were tested, and the detection rate of visible foreign matter is shown in Table 4. Compared with existing products, the obtained embodiment of the present application has significantly lower detection rate of visible foreign matt...

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Abstract

The present application provides a reduced carboxyalkyl dextran iron injection, which comprises reduced carboxyalkyl dextran iron as an active ingredient, an optional acid-base regulator and water for injection. The present application also provides a preparation method of reduced carboxyalkyl dextran iron injection. The injection provided by the present application has a lower detection rate of visible foreign matter than the iron injection obtained in the prior art, and has good properties such as good physical stability and / or good chemical stability.

Description

technical field [0001] The present application relates to an iron-containing injection, in particular to an injection containing reduced carboxyalkyl dextran iron and a preparation method thereof. Background technique [0002] As we all know, iron is an essential trace element for the human body. Iron deficiency due to insufficient intake, limited utilization or other reasons is quite common. Iron deficiency anemia is the most widely distributed nutritional deficiency disease in the world today. Therefore, in addition to active dietary adjustment and increasing the intake of iron-rich foods, research on various iron supplements and iron-fortified foods is also necessary. Anemia is the number one disease in the world. According to the statistics of the World Health Organization (WHO), about 1 / 4 of the world's population (1.6 billion people) suffers from anemia in varying degrees. [0003] There are many causes of anemia, among which iron deficiency anemia (IDA) is mainly cau...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/716A61P3/02A61P7/06
CPCA61K9/08A61K9/0019A61K31/716
Inventor 李立忠王勇苏志强荣航姚荷云武晋
Owner SHANXI PUDE PHARMA CO LTD
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