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Method for preparing nadroparin calcium

A technology of nadroparin calcium and heparin sodium, which is applied in the field of preparation of nadroparin calcium, can solve problems such as unstable product quality, achieve the effects of reducing the risk of pH reduction, good stability, and ensuring controllability

Inactive Publication Date: 2019-05-14
HEBEI CHANGSHAN BIOCHEM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the above method, some measures to increase the stability of the product have been considered, but metal ions are not controlled, and the residual free calcium content is not controlled, so although the raw material of nadroparin calcium produced meets the regulations and standards, the use of The injection after preparation of this raw material still has the risk of unstable product quality

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  • Method for preparing nadroparin calcium
  • Method for preparing nadroparin calcium
  • Method for preparing nadroparin calcium

Examples

Experimental program
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Effect test

Embodiment 1

[0028] Embodiment 1: as figure 1 Shown, the preparation method of nadroparin calcium of the present invention comprises following technological process:

[0029] a. Degradation

[0030] Take 3 kg of heparin sodium fine product, add purified water to dissolve it, and then make a constant volume of 30 L. When the temperature of the liquid is adjusted to 20°C, use 20% hydrochloric acid solution to adjust the pH value to 2.0. Weigh 75 g of sodium nitrite and add purified water to dissolve it to a constant volume. 500ml was added to the above-mentioned heparin sodium aqueous solution at a uniform speed for 60 minutes, then kept at 20°C and stirred for 2 hours to obtain a heparin sodium degradation solution;

[0031] b. Restore

[0032] After adjusting the pH value of the above-mentioned heparin sodium degradation solution to 8.5 with 3mol / L sodium hydroxide solution, add 25 g of sodium borohydride at room temperature, stir for 24 hours, adjust the pH value to 4.0 with 20% hydroch...

Embodiment 2

[0045] Embodiment 2: the difference between this embodiment and embodiment 1 is:

[0046] a. Degradation

[0047] Take 3 kg of heparin sodium fine product, add purified water to dissolve it, and then make a constant volume of 20 L. When the temperature of the liquid is adjusted to 19°C, use 20% hydrochloric acid solution to adjust the pH to 3.0. Weigh 90 g of sodium nitrite and add purified water to dissolve it to a constant volume. 500ml was added to the above-mentioned heparin sodium aqueous solution at a uniform speed for 55 minutes, and then kept at a temperature of 19°C, and stirred for 2 hours to obtain a heparin sodium degradation solution;

[0048] b. Restore

[0049] After adjusting the pH value of the heparin sodium degradation solution to 9.0 with 3M sodium hydroxide solution, add 30 g of sodium borohydride at room temperature, stir for 20 hours, adjust the pH value to 4.3 with 20% hydrochloric acid solution, stir for another 30 minutes, and then use 3M sodium hydr...

Embodiment 3

[0062] Embodiment 3: the differences between this embodiment and embodiment 1 are:

[0063] a. Degradation

[0064] Take 3 kg of heparin sodium fine product, add purified water to dissolve it, and then make a constant volume of 15 L. Adjust the temperature of the liquid to 18°C ​​and adjust the pH value to 3.5 with 20% hydrochloric acid solution. Weigh 105 g of sodium nitrite and add purified water to dissolve it to a constant volume. 420ml was added to the above-mentioned heparin sodium aqueous solution at a uniform speed for 50 minutes, then kept at 18°C ​​and stirred for 2 hours to obtain a heparin sodium degradation solution;

[0065] b. Restore

[0066] After adjusting the pH value of the heparin sodium degradation solution to 9.5 with 3M sodium hydroxide solution, add 35 g of sodium borohydride at room temperature, stir for 15 hours, adjust the pH value to 4.5 with 20% hydrochloric acid solution, stir for another 30 minutes, and then use 3M sodium hydroxide Adjust the ...

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Abstract

The invention discloses a method for preparing nadroparin calcium. The method for preparing the nadroparin calcium includes the steps of adopting heparin sodium as the raw material to conduct variousprocesses such as degradation, reduction, removal of metal ions, calcium transfer, nanofiltration, oxidation, ultrafiltration, nanofiltration, membrane filtration and freeze drying to prepare the nadroparin calcium. The method for preparing the nadroparin calcium has the advantages that with the raw material of the nadroparin calcium filled into injection, the yellowing of the solution is improvedsignificantly, the risks of turbidity and pH (potential of hydrogen) reduction in the nadroparin calcium injection are reduced, and the controllability of the pH of the injection prepared from the raw material of the nadroparin calcium is guaranteed; with the raw material going through 6-month accelerated stability test and 24-month long-term stability test after the prepared raw material is filled into the injection, the stability of the product is good, the test results are in accordance with the regulations and standards, the safety of the product, high biological activity and good productquality are ensured in clinical use, and the risk of adverse reactions is reduced; the prepared nadroparin calcium-filled injection has good stability in various aspects such as color, clarity and pHvalue; the method of significant social and economic benefits is simple and suitable for commercial production.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a preparation method of nadroparin calcium. Background technique [0002] Nadroparin Calcium is produced from heparin sodium through the process of degradation, reduction, decolorization, calcium conversion, sterilization, filtration and drying. Compared with heparin, it has a longer half-life, better antithrombotic effect, and weaker bleeding tendency , convenient administration and so on. Compared with common sodium salt-type heparin products, calcium salt-type nadroparin calcium has the advantages of reducing local hematoma and significantly improving pain conditions during subcutaneous injection. Therefore, currently, heparin products are more inclined to be made into calcium salt products. When nadroparin calcium is used clinically, the most widely used dosage form is nadroparin calcium injection, i.e. an aqueous solution of nadroparin calcium. Nadroparin calcium injection is cl...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 高飞赵焕荣田志鹏史云飞康伟白文举高树华
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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