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Iodixanol injection and method for preparing same

An iodixanol and injection technology, which is used in the preparation of X-ray contrast agents, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Improves compliance, reduces viscosity, enhances shrinkage

Active Publication Date: 2015-12-02
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention also provides a new method for preparing the injection, which can effectively solve the problem that iodixanol has strong hygroscopicity and is difficult to stir and dissolve

Method used

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  • Iodixanol injection and method for preparing same
  • Iodixanol injection and method for preparing same
  • Iodixanol injection and method for preparing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Injection prescription:

[0027]

[0028] In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.

[0029] Preparation method: (1) Add a quarter of the boiling water for injection into the liquid mixing tank, cool to 58~63℃, put in the prescription amount of sodium tartrate and stir to dissolve for 0.5h, then put in iodixanol in batches and stir Dissolve; (2) Cool down to 35~40℃, add the prescription amount of sodium chloride to the batching tank, and add water for injection to the full amount in the batching tank, add tartaric acid to adjust the pH to 7.2-7.4; (3) Add again Activated carbon, the dosage is 0.2-0.8wt% of the injection, after stirring for 15 minutes, use 0.5μm titanium rod and 0.45μm filter to remove the activated carbon; (4) Finally, sterilize (115℃, 30min), light inspection, paste Sign, package.

Embodiment 2

[0031] Injection prescription:

[0032]

[0033] In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.

[0034] Preparation method: (1) Add a quarter of the boiling water for injection into the liquid mixing tank, cool to 58~63℃, put in the prescription amount of sodium tartrate and stir to dissolve for 0.5h, then put in iodixanol in batches and stir Dissolve; (2) Cool down to 35~40℃, add the prescription amount of sodium chloride to the batching tank, and add water for injection to the full amount in the batching tank, add tartaric acid to adjust the pH to 7.2-7.4; (3) Add again Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, use 0.5μm titanium rod and 0.45μm filter to remove the activated carbon; (4) Finally, sterilize (115℃, 30min), light inspection, paste Sign, package.

Embodiment 3

[0036] Injection prescription:

[0037]

[0038] In the scale-up production according to the above ratio, the one-time preparation volume of iodixanol is 20L.

[0039] Preparation method: (1) Add a quarter of the boiling water for injection into the liquid mixing tank, cool to 58~63℃, put in the prescription amount of sodium tartrate and stir to dissolve for 0.5h, then put in iodixanol in batches and stir Dissolve; (2) Cool down to 35~40℃, add the prescribed amount of sodium chloride into the batching tank, and at the same time add water for injection to the full volume, add phosphoric acid to adjust the pH to 6.5-7.0; (3) Add again Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, use 0.5μm titanium rod and 0.45μm filter to remove the activated carbon; (4) Finally, sterilize (115℃, 30min), light inspection, paste Sign, package.

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Abstract

The invention belongs to the technical field of medicine preparations, and discloses iodixanol injection and a method for preparing the same. The iodixanol injection comprises iodixanol, sodium chloride and sodium sulphate. The method includes adding the balance water for injection into the iodixanol, the sodium chloride and the sodium sulphate to obtain mixed liquid; regulating the mixed liquid by the aid of acid until the pH (potential of hydrogen) of the mixed liquid is within an appropriate pH range. Compared with the prior art, the iodixanol injection and the method have the advantages that the types and the quantities of excipients added into the iodixanol injection are greatly reduced, the viscosity of the injection is further lowered, and accordingly the application compliance of clinical patients can be improved; as studied via high-temperature sterilization testes, low-temperature freezing and thawing experiments, irritation tests and the like, the iodixanol injection is stable in quality and low in vascular irritation, and requirements on safe medication can be completely met.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to an injection of iodixanol and a preparation method thereof. Background technique [0002] Since the advent of the first iodine contrast agent, Pantoconic acid, around 1950, there have been more than a dozen iodine contrast agents as diagnostic reagents, which are widely used in clinical practice. These iodine contrast agents can be divided into three categories according to their permeability. : The first category is hypertonic iodine contrast agents, such as diatrizoic acid, diatrizoate meglumine, etc., whose osmotic pressure is 5-8 times that of human blood; the second category is hypotonic iodine contrast agents, including ionic dimers (Such as Hwxabrix) and non-ionic monomers (such as iodothanol, iomeprol, iopentol, ioverol, iopromide, etc.), the osmotic pressure is about twice that of human blood; the third type is isotonic Iodine contrast agent, t...

Claims

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Application Information

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IPC IPC(8): A61K49/04A61K9/08A61K47/12
Inventor 郭璇章晓骅徐丹朱春霞田舟山包玉胜闵涛
Owner NANJING CHIA TAI TIANQING PHARMA
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