Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof

A technology of sodium chloride injection and preparation, which is applied in the direction of anti-inflammatory agents, pharmaceutical formulas, non-central analgesics, etc., and can solve the problems of high dosage of acid-base adjustment, low safety, opalescent opacity, etc., and achieve Increase safety and stability, high safety, reduce the effect of dosage

Inactive Publication Date: 2014-02-12
南京帝易医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The present invention mainly solves the problems of too high pH value, too much acid-base adjustment dose and low safety in patent CN201110041127. We set the pH value of ibuprofen sodium chloride injection at 6.0 to 6.5
At the same time, it solves the problem of opalescent turbidity in the patent ZL01823764.9 due to the compatibility of ibuprofen injection

Method used

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  • Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof
  • Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof
  • Ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0036] Embodiment 1: the preparation of ibuprofen sodium chloride injection (4mg / ml)

[0037] Prescription: Ibuprofen 400g

[0038] L-Arginine 310g

[0039] Sodium chloride 850g

[0040] 0.5mol / L L-arginine appropriate amount

[0041] Water for injection up to 100L

[0042] Makes 1000 bottles

[0043] 1) Obtain qualified ibuprofen raw materials, sodium chloride and L-arginine according to the ingredient list;

[0044] 2) Add water for injection with a batch volume of 4% in the batching tank, add the L-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add volume 0.05% (W / V) medicinal activated carbon, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.3, sti...

Embodiment 2

[0049] Embodiment 2: the preparation of ibuprofen sodium chloride injection (4mg / ml)

[0050] Prescription: Ibuprofen 400g

[0051] L-Arginine 330g

[0052] Sodium chloride 820g

[0053] 0.5mol / L L-arginine appropriate amount

[0054] Water for injection up to 100L

[0055] Makes 1000 bottles

[0056] 1) Obtain qualified ibuprofen raw materials, sodium chloride and L-arginine according to the ingredient list;

[0057] 2) Add water for injection with a batch volume of 4% in the batching tank, add the L-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add 0.05% (W / V) medicinal activated carbon by volume, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.4,...

Embodiment 3

[0062] Embodiment 3: the preparation of ibuprofen sodium chloride injection (4mg / ml)

[0063]

[0064] 1) Obtain qualified ibuprofen raw materials, sodium chloride and D-arginine according to the ingredient list;

[0065] 2) Add water for injection with a batch volume of 4% in the batching tank, add the D-arginine of the batch volume, stir and dissolve, add the ibuprofen of the batch volume, stir for 2 hours, add water for injection to 20% of the batch volume, Add sodium chloride and stir to dissolve, add volume 0.05% (W / V) medicinal activated carbon, stir for 30 minutes, filter with titanium rod, add water for injection to 90% of batch volume, add arginine solution to adjust pH to about 6.3, stir well Finally, add water for injection to the full amount, and fine filter with a cartridge filter;

[0066] 3) After the intermediates pass the test, notify the filling section to start filling;

[0067] 4) Put the filled semi-finished product into the sterilization cabinet for ...

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Abstract

The invention provides an ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and a preparation method thereof. The injection contains 1-10 mg/ml of ibuprofen, and injection water, wherein the pH is adjusted to 6.0-6.5 by an acid-base modifier; the dosage of the required acid-base modifier accounts for about 2-6% by weight/volume of the injection; the sodium chloride content of an isoosmotic adjusting agent is 0.70-0.90% by weight/volume. The preparation technology comprises the following steps: firstly, dissolving the acid-base modifier and the ibuprofen; adding the injection water to 20% of total mass; adding sodium chloride to stir and dissolve; adding activated carbon, filtering and decarburizing; adding water to 90% of total mass, adjusting the pH to 6.0-6.5, and adding water to total mass; filtering by 0.45 microns and 0.22 microns of microfiltration membranes; and filling and sealing and sterilizing at 121 DEG C for 8-20 minutes.

Description

technical field [0001] The invention relates to a large-capacity injection of ibuprofen sodium chloride injection with a pH of 6.0-6.5 and a preparation method thereof. Background technique [0002] Ibuprofen, also known as α-methyl-4-(2-methylpropyl)phenylacetic acid, is a non-steroidal anti-inflammatory and analgesic drug with strong anti-inflammatory, anti-rheumatic, antipyretic and analgesic effects , and its efficacy and other effects are greater than aspirin. Ibuprofen has no obvious side effects on the liver and hematopoietic system. Its mechanism of action is the same as other propionic acid derivatives. It is a powerful inhibitor of cyclooxygenase. By inhibiting cyclooxygenase, it can reduce the production and release of prostaglandins. Play anti-inflammatory, antipyretic, analgesic effect. [0003] At present, the formulations of ibuprofen listed at home and abroad include ordinary tablets, chewable tablets, sustained-release tablets, capsules, suspensions, drops...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/192A61P29/00
Inventor 刘小斌陈睿宋季磊别贯银牟丽丽
Owner 南京帝易医药科技有限公司
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