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Lornoxicam composition for injection and preparation process thereof

A technology for lornoxicam and injection, which is applied in the field of lornoxicam injection composition and its preparation, can solve the problems of large side effects, loss of human calcium ions, harm, etc., and achieves wide clinical application, clear and stable solution good sex effect

Active Publication Date: 2007-03-14
ZHEJIANG ZHENYUAN PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, it is well known that EDTA-2Na will complex with calcium ions in blood plasma, resulting in the loss of calcium ions in the human body, which has great side effects and potential harm

Method used

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  • Lornoxicam composition for injection and preparation process thereof
  • Lornoxicam composition for injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] Preparation of injection a

[0077] Lornoxicam 8.6mg

[0078] Arginine 13mg

[0079] Propylene glycol 0.3g

[0080] Sodium dihydrogen phosphate 6mg

[0081] Mannitol 80mg

[0082] Add water for injection to 2ml

[0083] The lornoxicam solution prepared according to the above prescription was filtered through 0.22 μm. Put the same amount of turbidity standard solution in paired glass tubes for turbidimetry, and observe from the horizontal direction under the fluorescent lamp for comparison. Results The lornoxicam solution was not deeper than No. 1 turbidimetric solution.

[0084] Inject 8 ml of lornoxicam solution prepared as above into 150 ml of sodium chloride injection, as a result, a clear solution is obtained immediately, and the clarity is less than No. 1 turbidimetric solution.

[0085] The results showed that using arginine and propylene glycol as co-solvents of lornoxicam to prepare lornoxicam solution can make the clarity of lorno...

Embodiment 2

[0087] Preparation of injection b

[0088] Lornoxicam 8.6mg

[0089] Arginine 12mg

[0090] Ethanol 0.1g

[0091] Lactic acid amount

[0092] Mannitol 80mg

[0093] Add water for injection to 1ml

[0094] The lornoxicam solution prepared according to the above prescription was filtered through 0.22 μm. Put the same amount of turbidity standard solution in paired glass tubes for turbidimetry, and observe from the horizontal direction under the fluorescent lamp for comparison. Results The lornoxicam solution was not deeper than No. 1 turbidimetric solution.

[0095] Inject 8 ml of lornoxicam solution prepared as above into 150 ml of sodium chloride injection, as a result, a clear solution is obtained immediately, and the clarity is less than No. 1 turbidimetric solution.

[0096] The results showed that using arginine and ethanol as co-solvents of lornoxicam to prepare lornoxicam solution could make the clarity of lornoxicam solution meet the requi...

Embodiment 3

[0098] Preparation of injection c

[0099] Lornoxicam 8.6mg

[0100] Lysine 6.0mg

[0101] Macrogol 400 0.15g

[0102] Lactic acid amount

[0103] Mannitol 80mg

[0104] Add water for injection to 5ml

[0105] The lornoxicam solution prepared according to the above prescription was filtered through 0.22 μm. Put the same amount of turbidity standard solution in paired glass tubes for turbidimetry, and observe from the horizontal direction under the fluorescent lamp for comparison. Results The lornoxicam solution was not deeper than No. 1 turbidimetric solution.

[0106] Inject 8 ml of lornoxicam solution prepared as above into 150 ml of sodium chloride injection, as a result, a clear solution is obtained immediately, and the clarity is less than No. 1 turbidimetric solution.

[0107] The results showed that using lysine and polyethylene glycol as co-solvents of lornoxicam to prepare lornoxicam solution can make the clarity of lornoxicam solution m...

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Abstract

The invention provides a lornoxicam injection combination, including injection and freeze-dried powder. The combinations contain 0.86-4.3 weight portion of lornoxicam and pharmaceutically acceptable basic amino acids, and the weight rate of lornoxicam and basic amino acids is 1:0.5-20, the present invention also provides corresponding preparation methods. The said combination has good solubility in solution, high stability and it improves the convenience and safety of clinical use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a composition for lornoxicam injection and a preparation method thereof. Background technique [0002] Lornoxicam, the chemical name is 6-chloro-4-hydroxy-2-methyl-3-(2-pyridinecarbamoyl)-2H-thieno[2,3-e]-1,2-thiazine -1,1-dioxide, a non-steroidal anti-inflammatory analgesic, is a thiazide derivative, has strong analgesic and anti-inflammatory effects, and can be used in obstetrics and gynecology, oral tooth extraction, orthopedic surgery and Acute pain after surgery, moderate to severe pain caused by trauma, acute sciatica and low back pain, advanced cancer pain, can also be used for the treatment of chronic low back pain, osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Parenteral lornoxicam was as effective as morphine, meperidine, and tramadol in relieving postoperative pain, but lornoxicam was better tolerated than morphine and tramadol. In patien...

Claims

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Application Information

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IPC IPC(8): A61K31/542A61K9/08A61K9/19A61P29/00
Inventor 张建军阮建昌俞建生贺燕娜钱帅
Owner ZHEJIANG ZHENYUAN PHARMA CO LTD
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