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Preparation method of raw medicine of environment-friendly iron sucrose

A green and environmentally friendly, iron sucrose technology, applied in the preparation of sugar derivatives, chemical instruments and methods, disaccharides, etc., can solve the problems of wide precipitation area, high production cost, poor specificity, etc., and achieve simple and environmentally friendly process routes, production equipment Simple, effective production process control

Inactive Publication Date: 2013-04-24
CHANGZHOU VOCATIONAL INST OF ENG +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are many deficiencies in the current domestic iron sucrose preparation process: first, the design of the process route is complicated and the investment in equipment is large; Failed to effectively meet the standard treatment of iron sucrose API products according to the standards stipulated in the Pharmacopoeia. The commonly used ethanol segmental precipitation method separates high, medium and low molecular weight, and then selects suitable molecular weight iron sucrose for compounding to obtain qualified molecular weight of iron sucrose. This operation process is very cumbersome
Due to its wide precipitation area and poor specificity, some active ingredients are easily removed, and this method consumes a large amount of ethanol, which is likely to bring ethanol into iron sucrose
Such an operation process has high requirements on equipment, and a lot of equipment needs to be added, and the iron sucrose with too high molecular weight will be discarded, so the production cost is relatively high

Method used

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  • Preparation method of raw medicine of environment-friendly iron sucrose
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] A preparation method of iron sucrose raw material medicine, has the following steps:

[0018] (1) By weight percentage, FeCl 3 ·6H 2 06Kg, add 300L of purified water, put into the reaction kettle and stir the solution, control the temperature in the kettle to 14°C; 2 CO 3 3.72Kg, dissolved in 60L of pure water, pumped in Na with a peristaltic pump 2 CO 3 to FeCl 3 ·6H 2 In the O solution, the feeding time is 1 hour, and after the feeding is completed, continue to stir for 1 hour and then centrifuge to obtain Fe(OH) 3 Raw clay, Fe(OH) 3 Add 400L of pure water to the original clay, stir and wash for 1 hour, repeat centrifugal washing 4 times to obtain Fe(OH) 3 Clay, weighed 19.6Kg, measured Fe(OH) 3 The content of Fe in the cement is 5.20%;

[0019] (2) Weigh 15.0Kg of sucrose and add to Fe(OH) 3 In the cement, stir evenly, adjust the pH to 11.60 with 6M NaOH solution, stir for half an hour, heat to 110°C, react for 10 hours, and cool to room temperature;

[0...

Embodiment 2

[0022] A preparation method of iron sucrose raw material medicine, has the following steps:

[0023] (1) By weight percentage, FeCl 3 ·6H 2 06Kg, add 300L of purified water, drop into the reaction kettle and stir the solution, control the temperature in the kettle to 12°C; 2 CO 3 3.66Kg, dissolved in 60L of pure water, pumped in Na with a peristaltic pump 2 CO 3 to FeCl 3 ·6H 2 In the O solution, the feeding time is 1 hour, and after the feeding is completed, continue to stir for 1 hour and then centrifuge to obtain Fe(OH) 3 Raw clay, Fe(OH) 3 Add 400L of pure water to the original clay, stir and wash for 1 hour, repeat centrifugal washing 4 times to obtain Fe(OH) 3 Clay, weighed 20.4Kg, measured Fe(OH) 3 The content of Fe in the cement is 4.98%;

[0024] (2) Weigh 14.4Kg of sucrose and add to Fe(OH) 3 In the cement, stir evenly, adjust the pH to 11.50 with 6M NaOH solution, stir for half an hour, heat to 110°C, react for 10 hours, and cool to room temperature;

[...

Embodiment 3

[0027] A preparation method of iron sucrose raw material medicine, has the following steps:

[0028] (1) By weight percentage, FeCl 3 ·6H 206Kg, add 300L of purified water, drop into the reaction kettle and stir the solution, control the temperature in the kettle to 10°C; 2 CO 3 3.69Kg, dissolved in 60L of pure water, pumped in Na with a peristaltic pump 2 CO 3 to FeCl 3 ·6H 2 In the O solution, the feeding time is 1 hour, and after the feeding is completed, continue to stir for 1 hour and then centrifuge to obtain Fe(OH) 3 Raw clay, Fe(OH) 3 Add 400L of pure water to the original clay, stir and wash for 1 hour, repeat centrifugal washing 4 times to obtain Fe(OH) 3 Clay, weighed 18.5Kg, measured Fe(OH) 3 The content of Fe in the cement is 5.24%;

[0029] (2) Weigh 14.2Kg of sucrose and add to Fe(OH) 3 In the cement, stir evenly, adjust the pH to 11.70 with 6M NaOH solution, stir for half an hour, heat to 110°C, react for 10 hours, and cool to room temperature;

[0...

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Abstract

The invention relates to the technical field of a raw medicine preparation, and particularly relates to a preparation method of the raw medicine of environment-friendly iron sucrose. The weight-average molecular weight (Mw) of the raw medicine of the environment-friendly iron sucrose obtained by the technical scheme is 34000-60000, and the distribution coefficient (MW / Mn) is less than 1.7. The exceeding chloride Cl<-> in an iron sucrose solution is removed by selecting an anion exchange resin, and the content of Cl<-> in products is controlled at between 0.012% and 0.025%. The products are qualified by titratable alkali indexes after the products are processed by a cation exchange resin. The residual large particle impurities in the iron sucrose solution are filtered out by selecting a 0.8mu m filter membrane. The preparation method is simple and environment-friendly in technology route, high in product yield, good in quality, simple in production equipment, and easy to operate and the whole production process is easy to control, so the preparation method is suitable for scale production.

Description

technical field [0001] The invention relates to the technical field of raw material medicine preparation, in particular to a method for preparing a green and environment-friendly iron sucrose raw material medicine. Background technique [0002] About 200 million people in my country suffer from iron deficiency anemia and iron malnutrition, and the incidence rate is as high as 15-20%. Children and women are high-risk groups, and those with severe anemia are especially pregnant women, cancer patients, receiving dialysis and transplantation, and others. Patients undergoing surgery need to receive safe, fast and efficient iron supplementation. Iron sucrose is a new type of intravenous iron supplement. Compared with other types of iron supplements, it has a safe, fast and effective iron supplementation treatment effect, and its side effects are far lower than those of other dosage forms such as iron dextran. Iron preparations, iron sucrose, have become the fastest growing product...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H3/04C07H1/00
Inventor 李东升庞靖周勇赵雷王平
Owner CHANGZHOU VOCATIONAL INST OF ENG
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