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A kind of stable flurbiprofen axetil pharmaceutical composition

A technology of flurbiprofen axetil and composition, which is applied in the field of stability of flurbiprofen axetil and its emulsification stability, can solve problems such as increasing potential safety hazards, and achieve the effects of prolonging shelf life, excellent stability, and reducing degradation

Active Publication Date: 2018-01-02
WISDOM PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Both patents CN102188393B and CN104188905A solve the above problems by changing the prescription, but considering the safety of the clinical use of injections, although increasing the types of excipients may improve the in vitro stability of the preparation, it also increases the potential safety hazard in the body

Method used

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  • A kind of stable flurbiprofen axetil pharmaceutical composition
  • A kind of stable flurbiprofen axetil pharmaceutical composition
  • A kind of stable flurbiprofen axetil pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064]

[0065] The general steps for emulsion preparation are described below:

[0066] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0067] (2) Take soybean oil, heat it to 65°C, add phosphatidylcholine, phosphatidylethanolamine and flurbiprofen axetil, stir and dissolve, and use it as the oil phase;

[0068] (3) Under high-speed shearing, add the oil phase into the water phase at 65°C, the high-speed shearing speed is 10000rpm, and the time is 10min to form colostrum;

[0069] (4) Disodium hydrogen phosphate citrate buffer solution (the molar ratio of disodium hydrogen phosphate to citric acid is 4:1) to adjust the pH value of the colostrum to 6.0-6.5, and add water for injection to the full amount;

[0070] (5) Transfer the colostrum to a high-pressure homogenizer for emulsification, the homogenization pressure is 1000 bar, and 3 cycles;

[0071] (6) Filtration: filter the essence milk through a 0.45 μm mi...

Embodiment 2

[0074]

[0075] The general steps for emulsion preparation are described below:

[0076] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0077] (2) Take soybean oil, heat it to 65°C, add phosphatidylcholine, phosphatidylethanolamine and flurbiprofen axetil, stir and dissolve, and use it as the oil phase;

[0078] (3) Under high-speed shearing, add the oil phase into the water phase at 65°C, the high-speed shearing speed is 10000rpm, and the time is 10min to form colostrum;

[0079] (4) Disodium hydrogen phosphate citrate buffer solution (the molar ratio of disodium hydrogen phosphate to citric acid is 4:1) to adjust the pH value of the colostrum to 6.0-6.5, and add water for injection to the full amount;

[0080] (5) Transfer the colostrum to a high-pressure homogenizer for emulsification, the homogenization pressure is 1000 bar, and 3 cycles;

[0081] (6) Filtration: filter the essence milk through a 0.45 μm mi...

Embodiment 3

[0084]

[0085] The general steps for emulsion preparation are described below:

[0086] (1) Take water for injection, heat it to 65°C, add glycerin to dissolve it, and use it as the water phase;

[0087] (2) Take soybean oil, heat it to 65°C, add phosphatidylcholine, phosphatidylethanolamine, phosphatidylglycerol and flurbiprofen axetil, stir to dissolve, and use it as the oil phase;

[0088] (3) Under high-speed shearing, add the oil phase into the water phase at 65°C, the high-speed shearing speed is 10000rpm, and the time is 10min to form colostrum;

[0089] (4) Disodium hydrogen phosphate citrate buffer solution (the molar ratio of disodium hydrogen phosphate to citric acid is 4:1) to adjust the pH value of the colostrum to 6.0-6.5, and add water for injection to the full amount;

[0090] (5) Transfer the colostrum to a high-pressure homogenizer for emulsification, the homogenization pressure is 1000 bar, and 3 cycles;

[0091] (6) Filtration: filter the essence milk...

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Abstract

The invention provides a stable flurbiprofen axetil medicine composition which comprises flurbiprofen axetil with the weight / volume percent of 0.1-1% w / v, phosphatidyl choline with the weight / volume percent of 0.4-1.6% w / v, phosphatidyl ethanolamine with the weight / volume percent of smaller than or equal to 0.18% w / v, injection oil with the weight / volume percent of 10-30% w / v and injection water. The composition has good stability, the content of hydrolyzed impurity flurbiprofen is relatively low, and the shelf life of the composition is prolonged from 18 months to 24 months as compared with that of products sold in the market.

Description

technical field [0001] The invention relates to a stable flurbiprofen axetil pharmaceutical composition and a preparation method thereof, in particular to the stability of the active ingredient flurbiprofen axetil and the emulsification stability thereof. Background technique [0002] Flurbiprofen axetil is a prodrug of flurbiprofen, which can be used for analgesia after surgery and various cancers. Flurbiprofen axetil injection is a non-steroidal targeted analgesic, which reduces the synthesis of prostaglandins by inhibiting cyclooxygenase (COX) in the spinal cord and the periphery, and reduces the hyperalgesia state caused by surgical trauma. Fat emulsion preparations have stronger drug effects, faster onset and longer duration, and are less likely to cause adverse reactions such as gastric mucosal damage. It is used for postoperative analgesia. The advantage is that it has no central inhibitory effect, does not affect the recovery of patients under anesthesia, and can be...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K31/222A61P29/00
Inventor 林静文其他发明人请求不公开姓名
Owner WISDOM PHARM CO LTD
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