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Iohexol injection and preparation method thereof

A technology of injection and iohexol, applied in the preparation of X-ray contrast agents, etc., can solve problems such as low yield, adverse reactions, and product instability, so as to improve production yield, improve product stability, and reduce preparation time Effect

Inactive Publication Date: 2015-01-28
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, although the contrast effect of iohexol is remarkable and the sales volume is very large, the product is unstable due to the drug itself being easily affected by polyvalent metal ions, and it is prone to problems such as yellowing of the color and increased visible foreign matter, resulting in low yield in the production process. low
At present, the production yield of domestic enterprises is lower than 95%.
In addition, the existing iohexol injection is prone to allergies and many adverse reactions

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] Components: 75.5g of iohexol, 120mg of tromethamine, 10mg of calcium sodium edetate, and dilute to 100ml with water for injection. In mass production, the one-time preparation volume of iohexol injection is 25L.

[0014] Preparation method: 1) first add 1 / 3 of boiling water for injection into the batching tank, cool down to 60°C, add iohexol and dissolve; 2) turn on the cooling, add calcium sodium edetate and tromethamine into the batching tank Alcohol, add water for injection to the full amount in the batching tank at the same time, stir; 3) adjust the pH to 7.34 with 1mol / L hydrochloric acid, and circulate through the high level tank for 20 minutes; Wet the injection solution, stir for 15 minutes after adding, filter and remove carbon with 0.5μm titanium rod and 0.45μm filter in turn, and put it into a stainless steel barrel; 5) Send samples to test the content, related substances, and the content of calcium and sodium edetate , color, and fill the medicinal solution...

Embodiment 2

[0016] Components: 75.5g of iohexol, 120mg of tromethamine, 10mg of calcium sodium edetate, and dilute to 100ml with water for injection. In mass production, the one-time preparation volume of iohexol injection is 25L.

[0017] Preparation method: 1) first add 1 / 3 of boiling water for injection into the batching tank, cool down to 65°C, add iohexol and dissolve; 2) turn on the cooling, add calcium sodium edetate and tromethamine into the batching tank Alcohol, add water for injection to the full amount in the batching tank at the same time, stir; 3) adjust the pH to 7.34 with 1mol / L hydrochloric acid, and circulate through the high level tank for 20 minutes; The injection is wetted, stirred for 15 minutes after adding, and then filtered with a 0.5um titanium rod and a 0.45μm filter to remove carbon, and poured into a stainless steel barrel; 5) Send samples to test the content, related substances, and the content of calcium sodium edetate , color, and fill the medicinal soluti...

Embodiment 3

[0019] Components: 75.5g iohexol, 120mg trometamol, 10mg calcium sodium edetate, 20mg (5Z,7E)-4,4-dimethyl-5-ethanonyl-5,7-nonadiene Dilute sodium chloride and water for injection to 100ml. In mass production, the one-time preparation volume of iohexol injection is 25L.

[0020] Preparation method: 1) first add 1 / 3 of boiling water for injection into the batching tank, cool down to 60°C, add iohexol and dissolve; 2) turn on the cooling, add calcium sodium edetate, (5Z, 7E)-4,4-dimethyl-5-ethanonyl-5,7-nonadienoate sodium, tromethamine, while adding water for injection to the full amount in the batching tank, stirring; 3) with 1mol / L hydrochloric acid to adjust the pH to 7.34, and circulate through the high-level tank for 20 minutes; 4) Take 0.8wt% activated carbon of the injection, wet it with the cooled injection in advance, stir for 15 minutes after adding, and then use 0.5um titanium rod, 0.45μm filter to remove carbon, and put it into a stainless steel bucket; 5) send s...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and relates to an iohexol injection and a preparation method thereof. The iohexol injection comprises the following constituents in parts by weight: 50-85 parts of iohexol, 0.05-0.25 part of a stabilizer, 0.01-0.05 part of a chelating agent, and 80-100 parts of water for injection, and is prepared by mixing the constituents, and at last using hydrochloric acid with a concentration of 1 mol / L to regulate the pH value to be 7.0-7.4. Compared to the prior art, the iohexol injection adopts the chelating agent with appropriate amount to avoid complexation between the basic remedy and polyvalent metal ions, so as to increase the product stability, ensure that the injection in each batch is undifferentiated in the color, obviously reduce the visible foreign matters and greatly increase the production yield as the product cannot be influenced by the polyvalent metal ions during the preparation process; the preparation duration can be shortened as the injection is prepared with water at 60-65 DEG C; after low-temperature adsorption, the carbon is removed to avoid that the novel visible foreign matter appears as the injection is recrystallized due to cooling after high-temperature adsorption and filling, so as not to cause low yield.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an iohexol injection and a preparation method thereof. Background technique [0002] Iohexol, chemical name 5-[N-(2,3-dihydroxypropyl)acetamido]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri Iodo-1,3-phthalamide. Iohexol is a water-soluble X-CT contrast agent launched by Nycomyn in Norway in the 1980s. Iohexol injection with it as the main component is widely used in blood vessels and intrabody injections of adults and children. Partial CT-enhanced radiography, intravenous urography, arthrography, endoscopic retrograde cholangiopancreatography, percutaneous transhepatic cholangiography, hernia or fistula tract radiography, gastrointestinal tract radiography, "T" duct radiography, etc. , therefore, it is considered to be one of the best non-ionic X-CT contrast agents. [0003] At present, although the contrast effect of iohexol is remarkable and the s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K49/04
Inventor 吴荣翠李明丽石井岗李清涛
Owner CISEN PHARMA
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