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Lornoxicam freeze-dried injection and preparation method thereof

A technology of freeze-dried powder injection and lornoxicam, which is applied in the direction of freeze-dried delivery, anti-inflammatory agent, powder delivery, etc. The problem of poor product resolubility and other problems can be solved, and the effect of low difficulty in rejecting waste, good freeze-drying and forming, and uniform and stable quality can be achieved.

Active Publication Date: 2009-11-18
HAINAN JINRUI PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] When the present inventor was studying lornoxicam injection composition and preparation method thereof, in combination with the preparation and stability research of the prescription disclosed in WO9809654A and injection lornoxicam " [see Fu Guiying et al. The preparation and stability research of Xicam ", Chinese pharmacy, 2005,16 (9): 671-673] preparation method prepares lornoxicam freeze-dried powder injection, finds that its freeze-dried product resolubility is not good, the solution before freezing The appearance is turbid, the clarity of the freeze-dried powder injection is not good, and the formability of the powder injection is not ideal

Method used

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  • Lornoxicam freeze-dried injection and preparation method thereof
  • Lornoxicam freeze-dried injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] (1) Prescription:

[0063] Lornoxicam 8.6g

[0064] Mannitol 50.0g

[0065] Tromethamine 12.0g

[0066] EDTA0.2g

[0067] Activated carbon 1.0g

[0068] Water for injection 2000ml

[0069] 0.5mol / l sodium hydroxide solution appropriate amount (pH regulator)

[0070] 0.5mol / l hydrochloric acid solution appropriate amount (pH regulator)

[0071]

[0072] Makes 1000 bottles

[0073] (2) Preparation process:

[0074] 1) Take mannitol, tromethamine and EDTA in the liquid preparation tank, add water for injection to 80% preparation amount, then add lornoxicam, when adding lornoxicam, the solution temperature in the liquid preparation tank is controlled at 4°C ;

[0075] 2) After adding lornoxicam, adjust the pH value to 10.5 with sodium hydroxide solution while stirring, and then adjust the pH value to 8.5 with hydrochloric acid solution to obtain a clear solution;

[0076] 3) Add activated carbon to the clear solution,...

Embodiment 2

[0079] (1) Prescription:

[0080] Lornoxicam 8.6g

[0081] Mannitol 30.1g

[0082] Tromethamine 12.0g

[0083] EDTA0.129g

[0084] Activated carbon 1.0g

[0085] Water for injection 2000ml

[0086] 0.5mol / l sodium hydroxide solution appropriate amount (pH regulator)

[0087] 0.5mol / l hydrochloric acid solution appropriate amount (pH regulator)

[0088]

[0089] Makes 1000 bottles

[0090] (2) Preparation process:

[0091] 1) Take mannitol, tromethamine and EDTA in the liquid preparation tank, add water for injection to 80% preparation amount, then add lornoxicam, when adding lornoxicam, the solution temperature in the liquid preparation tank is controlled at 2°C ;

[0092] 2) After the addition of lornoxicam is completed, adjust the pH value to 11.5 with sodium hydroxide solution while stirring, and then adjust the pH value to 9.5 with hydrochloric acid solution to obtain a clear solution;

[0093] 3) Add activated carbon...

Embodiment 3

[0096] (1) Prescription:

[0097] Lornoxicam 8.6g

[0098] Mannitol 73.1g

[0099] Tromethamine 12.0g

[0100] EDTA0.215g

[0101] Activated carbon 1.0g

[0102] Water for injection 2000ml

[0103] 0.5mol / l sodium hydroxide solution appropriate amount (pH regulator)

[0104] 0.5mol / l hydrochloric acid solution appropriate amount (pH regulator)

[0105]

[0106] Makes 1000 bottles

[0107] (2) Preparation process:

[0108] 1) Take mannitol, tromethamine and EDTA in the liquid preparation tank, add water for injection to 80% preparation amount, then add lornoxicam, and control the solution temperature in the liquid preparation tank at 6°C when adding lornoxicam ;

[0109] 2) After the addition of lornoxicam is completed, adjust the pH value to 11 with sodium hydroxide solution while stirring, and then adjust the pH value to 9.0 with hydrochloric acid solution to obtain a clear solution;

[0110] 3) Add activated carbon to the...

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PUM

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Abstract

The invention relates to a lornoxicam freeze-dried powder injection and a preparation method thereof. The powder injection includes lornoxicam, mannitol and trometamol, and also includes EDTA and a pH regulator, the dosage of the mannitol is 3.5-8.5 grams per gram of lornoxicam, and the dosage of the EDTA is 0.015- 0.025 g / g Lornoxicam. In the present invention, EDTA is used to replace EDTA-disodium salt, and the dosage of EDTA and mannitol is screened at the same time, the clarity of the prepared lyophilized product after reconstitution has been significantly improved, and the formability is good; in addition, the present invention Two kinds of pH regulators are selected. In the preparation process, first use one pH regulator to adjust the solution to a pH value range, then use another pH regulator to adjust the solution to another pH value range, and freeze it. The drying process is strictly controlled, and the stability of the prepared freeze-dried powder injection is significantly improved, and the reconstitution property is good.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lornoxicam freeze-dried powder injection and a preparation method thereof. Background technique [0002] Lornoxicam, the chemical name is 6-chloro-4-hydroxy-2-methyl-3-(2-pyridineaminocarboxamide)-2H-thieno[2,3-e]-1,2-thiazine -1,1-Dichloride, a thiazide derivative, has strong analgesic and anti-inflammatory effects, and can be used to treat acute and chronic pain caused by inflammation, such as postoperative pain, arthritis, rheumatism, Soft tissue injury, etc. After intramuscular injection, lornoxicam is rapidly and completely absorbed, reaching the peak plasma concentration after 0.4 hours, without first-pass effect. There is no significant difference in the pharmacokinetic parameters of lornoxicam when it is administered continuously to the elderly, when the liver and kidney function is not seriously impaired, or when it is used in combination with antacids. In...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/542A61K47/10A61P29/00
Inventor 王小树
Owner HAINAN JINRUI PHARMA CO LTD
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