A kind of iodixanol injection and preparation method thereof

A technology of iodixanol and injection, which is applied in the preparation of X-ray contrast agents, pharmaceutical formulations, medical preparations of non-active ingredients, etc., can solve the problems of iodixanol's strong hygroscopicity and difficulty in stirring and dissolving, and achieve Avoid easy aggregation and adhesion into agglomerates, enhance shrinkage, and slow down the effect of impact

Active Publication Date: 2018-03-30
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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  • A kind of iodixanol injection and preparation method thereof
  • A kind of iodixanol injection and preparation method thereof
  • A kind of iodixanol injection and preparation method thereof

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 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time 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 Activated carbon, the dosage is 0.2-0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.

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 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time 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 Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.

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 1 / 4 of the boiled water for injection into the liquid mixing tank, cool down to 58-63°C, put in the prescribed amount of sodium tartrate and stir to dissolve for 0.5h, add iodixanol in batches, stir Dissolve; (2) cool down to 35-40°C, add the prescribed amount of sodium chloride into the batching tank, and at the same time add water for injection to the full amount in the batching tank, add phosphoric acid to adjust the pH to 6.5-7.0; (3) add Activated carbon, the dosage is 0.2~0.8wt% of the injection, after stirring for 15min, filter with 0.5μm titanium rod and 0.45μm filter to remove activated carbon; Sign, pack.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses an iodixanol injection and a preparation method thereof. The iodixanol injection of the present invention comprises the following components: iodixanol, sodium chloride, sodium tartrate, adding water for injection to the full amount, and finally adjusting the pH to a suitable pH range with acid. Compared with the prior art, the types and quantities of auxiliary materials added to the iodixanol injection of the present invention are greatly reduced, the viscosity of the injection is further reduced, and the compliance of clinical application by patients is improved. At the same time, through high-temperature sterilization test, low-temperature freeze-thaw test and irritation test, etc., the iodixanol injection of the present invention has stable quality, low blood vessel irritation, and fully meets the requirements of safe drug use.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an iodixanol injection and a preparation method thereof. Background technique [0002] Since the advent of the first iodine contrast agent diatrizoic acid around 1950, there have been more than ten kinds of iodine contrast agents as diagnostic reagents, which are widely used in clinic. According to the permeability, these iodine contrast agents can be divided into three categories : The first type is hypertonic iodine contrast agent, such as diatrizoic acid, diatrizoate meglumine, etc., and its osmotic pressure is 5 to 8 times that of human blood; the second type is low osmotic iodine contrast agent, including ionic dimer (such as Hwxabrix) and non-ionic monomers (such as iodosol, iomeprol, iopentol, ioversol, iopromide, etc.) have an osmotic pressure about twice that of human blood; the third category is isotonic Iodine contrast agent, that is, n...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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