Gadobutrol injection and preparation method thereof

A technology for gadobutrol and injection, which is applied in the field of gadobutrol injection and its preparation, can solve the problems of strong irritation, many side effects, and high content of free gadolinium, and achieve the effect of less irritation and less side effects

Active Publication Date: 2017-05-10
SHANDONG WEIZHI BAIKE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The technical problem solved by the present invention is to overcome the defects of high free gadolinium content in the existing gadobutrol injection and

Method used

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  • Gadobutrol injection and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] A preparation method of gadobutrol injection, comprising the steps of:

[0040] (1) Add 70% of the prescription amount of fresh water for injection into the preparation equipment, add 0.537 g of disodium hydrogen phosphate, stir and dissolve at a controlled temperature of 40-50 ° C, and obtain the mixed solution A;

[0041] (2) Add 0.513 g of Calcium Sodium Cobutrol and 604.720 g of Gadobutrol to Mixed Solution A, stir and dissolve at a controlled temperature of 40-50° C. to obtain Mixed Solution B;

[0042] (3) Dilute the mixed solution B with the remaining prescription amount of water, set the volume to 1000mL, measure the pH value to 7.40, and obtain gadobutrol injection, and determine the content of free gadolinium in the injection to be 0.0008mg / mL.

Embodiment 2

[0044] A preparation method of gadobutrol injection, comprising the steps of:

[0045] (1) Add fresh water for injection of 75% of the prescription amount into the preparation equipment, add 0.358 g of disodium hydrogen phosphate, stir and dissolve at a controlled temperature of 40-50 ° C, and obtain the mixed solution A;

[0046] (2) Add 0.514 g of Calcium Sodium Cobutrol and 604.720 g of Gadobutrol to Mixed Solution A, stir and dissolve at a controlled temperature of 40-50° C. to obtain Mixed Solution B;

[0047] (3) Dilute the mixed solution B with the remaining prescription amount of water, set the volume to 1000mL, and measure the pH value to 6.80 to obtain gadobutrol injection. The free gadolinium content in the injection was determined to be 0.0008mg / mL.

Embodiment 3

[0049] A preparation method of gadobutrol injection, comprising the steps of:

[0050] (1) Add 70% of the prescription amount of fresh water for injection into the preparation equipment, add 0.537 g of disodium hydrogen phosphate, stir and dissolve at a controlled temperature of 40-50 ° C, and obtain the mixed solution A;

[0051] (2) Add 0.515 g of Calcium Sodium Cobutrol and 604.721 g of Gadobutrol to Mixed Solution A, stir and dissolve at a controlled temperature of 40-50° C. to obtain Mixed Solution B;

[0052] (3) Dilute the mixed solution B with the remaining prescription amount of water, set the volume to 1000mL, measure the pH value to 7.46, and obtain gadobutrol injection, and determine the free gadolinium content in the injection solution to be 0.0008mg / mL.

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Abstract

The invention discloses a gadobutrol injection and a preparation method thereof. The gadobutrol injection is prepared from the following ingredients including gadobutrol, calcobutrolsodium, pH regulators and water, wherein the pH value of the injection is 6.7 to 8.0; and the pH regulators are phosphates. The preparation method comprises the following steps of (1) uniformly mixing the phosphates with partial water to obtain a mixed solution A; (2) uniformly mixing the calcobutrolsodium and the gadobutrol with the mixed solution A to obtain a mixed solution B; and (3) diluting the mixed solution B by rest partial water to obtain the gadobutrol injection. The gadobutrol injection uses the specially selected pH regulators; the pH value of the injection can be regulated; and the stability of the injection in the sterilization process and the long-time placement process can be maintained, i.e., the free gadolinium content is controlled to be at a low level.

Description

technical field [0001] The invention relates to the field of magnetic resonance imaging contrast agents, in particular to a gadobutrol injection and a preparation method thereof. Background technique [0002] Gadolinium-containing magnetic resonance imaging (MRI) contrast agent is used to improve the contrast of the image and visualize abnormal tissues or affected areas in various parts of the body. It is mainly used for MRI examinations of the head, spine and whole body. The contrast agent is Injected into the human body by intravenous injection. [0003] Gadolinium-containing contrast agents have become the most clinically used MRI contrast agents, and gadobutrol is the sixth gadolinium-based contrast agent approved by the US Food and Drug Administration (FDA) for central nervous system resonance imaging. However, the FDA issued a notice on its website in May 2007, requiring companies to add a new black-box warning to all gadolinium-containing MRI contrast agents, warning...

Claims

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Application Information

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IPC IPC(8): A61K49/10A61K49/18A61K47/24
Inventor 魏彦君孟勇涛邢艳平裴晓娜李锋
Owner SHANDONG WEIZHI BAIKE PHARM CO LTD
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