Iron proteinsuccinylate oral solution and preparation method thereof

A technology of iron protein succinate and oral solution, which is applied in the field of medicine, can solve problems such as unsuitable plastic bottle packaging materials, achieve the effects of reducing production costs and quality risks, good taste and smell, and long-term stable quality

Inactive Publication Date: 2018-11-23
WUHAN LEADPHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The more commonly used sterilization method is high temperature terminal sterilization, but the plastic bottle packaging material is not suitable for this method

Method used

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  • Iron proteinsuccinylate oral solution and preparation method thereof
  • Iron proteinsuccinylate oral solution and preparation method thereof
  • Iron proteinsuccinylate oral solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] A kind of iron protein succinate oral solution, every 1500mL described oral solution is prepared from the raw material of following formula:

[0036]

[0037] The method for preparing 1500mL iron protein succinate oral solution according to above-mentioned raw material formula, its step is:

[0038] 1. Add ferric protein succinate (80 mesh) into 900ml of purified water, then add glycerin, stir at 55-65°C, add 4mol / L sodium hydroxide solution while stirring, and control the pH value to 6.0-6.2 (thermal measurement ), continue to stir until iron protein succinate is completely dissolved, then add sorbitol, sodium methylparaben, sodium propylparaben, sucralose and peach essence in sequence, stir to dissolve, and adjust with 4mol / L sodium hydroxide solution When the pH value reaches 7.0-7.5 (thermal measurement), add purified water to 1500mL and stir well;

[0039] 2. Filter the solution obtained in step 1 with a 5 μm microporous membrane, quantitatively fill it in a lo...

Embodiment 2-3

[0041] The only difference between Examples 2-3 and Example 1 is that the raw material iron protein succinate has a different mesh size. In Example 2, the particle size of iron protein succinate is 100 mesh, and in Example 3, the particle size of iron protein succinate is 150 mesh. .

[0042] The iron protein succinate oral solution prepared by embodiment 1-3 is carried out quality inspection, and investigation result is as shown in table 1:

[0043] Table 1 The results of each index investigation of iron protein succinate oral solution

[0044]

[0045]

[0046] Wherein, "iron content" refers to the ratio of the actual amount of iron in the oral solution to the labeled amount, and the explanation will not be repeated below.

[0047] It can be seen from Table 1 that the iron content in Example 1 is slightly lower, so it can be seen that iron protein succinate needs to be pulverized, and the particle size should be controlled at not less than 100 mesh.

Embodiment 4-7

[0049] The raw materials and the preparation method of the 1500mL iron protein succinate oral solution prepared by Examples 4-7 are the same as in Example 2, but the quality of some raw materials added is different, as shown in Table 2:

[0050] Table 2

[0051] raw material

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Abstract

The invention discloses an iron proteinsuccinylate oral solution and a preparation method thereof. Each 1500mL of the oral solution contains 60-130g of iron proteinsuccinylate and 40-240g of glycerinum. The preparation method of the oral solution comprises the steps that 1, iron proteinsuccinylate is added into purified water accounting for 50-70% of the volume of the prepared iron proteinsuccinylate oral solution, glycernium is added and stirred at the temperature of 55-65 DEG C, a pH conditioning agent is added while stirring is conducted, the pH value is controlled to be between 6.0 and 6.2, stirring is conducted continuously till iron proteinsuccinylate is completely dissolved, a stabilizer, a preservative, an essence corrigent and a sweet corrigent are sequentially added and stirred to be dissolved, the pH conditioning agent is used to condition the pH value to be 7.0-7.5, the purified water is added to achieve constant volume, and the mixture is stirred to be uniform; and 2, thesolution obtained in the step 1 is filtered, the filtrate is filled quantitatively, and sterilized, and the iron proteinsuccinylate oral solution is obtained. The oral solution is good in mouth feel,and has the good solubleness and stability. The preparation method of the oral solution is simple and easy to operate.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a ferric protein succinate oral solution and a preparation method thereof. Background technique [0002] Iron protein succinate is a kind of macromolecular protein complexed iron, its molecular weight reaches 5000KD, and its structural formula is as follows: [0003] [0004] Iron protein succinate oral solution made from iron protein succinate is a product developed by Italian Panmark Pharmaceuticals in the 1980s. It was launched in Italy in 1987 and has been sold in more than 20 countries around the world, including Spain, Portugal, and Greece. In 2009, it was approved to enter China. The indications are the treatment of absolute and relative iron deficiency anemia, due to insufficient iron intake or malabsorption, acute or chronic blood loss, and infection in patients of various ages. The treatment of invisible or dominant iron-deficiency anemia caused by it, and the trea...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/17A61K9/08A61K47/10A61P7/06
CPCA61K9/0053A61K9/08A61K38/1709A61K47/10
Inventor 邵健谢树伟徐旻明陈蔚江
Owner WUHAN LEADPHARM TECH CO LTD
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