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Pharmaceutical composition of ondansetron hydrochloride and dexamethasone

A technology of ondansetron hydrochloride and ondansetron hydrochloride, applied in the field of medicine, can solve problems such as unclear mechanism of action

Inactive Publication Date: 2013-11-20
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ondansetron hydrochloride can still inhibit opioid-induced nausea, and its mechanism of action is unclear

Method used

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  • Pharmaceutical composition of ondansetron hydrochloride and dexamethasone
  • Pharmaceutical composition of ondansetron hydrochloride and dexamethasone
  • Pharmaceutical composition of ondansetron hydrochloride and dexamethasone

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of Ondansetron Hydrochloride Freeze-dried Powder for Injection

[0036] prescription:

[0037]

[0038] Preparation Process:

[0039] (1) First add 5600ml water for injection into the container;

[0040] (2) Add 14g of ondansetron hydrochloride (calculated as ondansetron) and 350g of mannitol, stir to dissolve completely, and adjust the pH to 3.6 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0041] (4) Add 1.4g of activated carbon for injection, add the remaining water for injection, set the volume to 7000ml, stir and absorb for 30 minutes;

[0042] (5) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0043] (6) Filling, 1ml / bottle or 2ml / bottle or 4ml / bottle.

[0044] (7) Freeze drying

[0045] ① During the pre-freezing period, lower th...

Embodiment 2

[0049] Example 2 Preparation of Ondansetron Hydrochloride Injection

[0050] prescription:

[0051]

[0052] Preparation Process:

[0053] (1) First add 5600ml water for injection into the container;

[0054] (2) Add 14 g of ondansetron hydrochloride (calculated as ondansetron), stir to dissolve completely, and adjust the pH to 3.5 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0055] (4) Add 1.4g of activated carbon for injection, add the remaining water for injection, set the volume to 7000ml, stir and absorb for 30 minutes;

[0056] (5) The solution is decarbonized by coarse filtration, coarsely filtered through a 0.45 μm cartridge filter, and then sterilized and filtered with a 0.22 μm microporous membrane until the visible foreign matter is qualified;

[0057] (6) Filling, 1ml / bottle or 2ml / bottle or 4ml / bottle, seal and sterilize.

Embodiment 3

[0058] Example 3 Preparation of Dexamethasone Sodium Phosphate Injection

[0059] prescription:

[0060]

[0061] Preparation Process:

[0062] (1) Add 500ml of water for injection into the beaker, add 2g of sodium bisulfite and 300ml of propylene glycol, stir to dissolve, then add 1g of dexamethasone sodium phosphate, stir to completely dissolve, use 0.1mol / L hydrochloric acid solution or 0.1 mol / L sodium hydroxide solution to adjust the pH to 7.8, then add 0.5g of wetted medicinal charcoal, add water for injection to 1000ml, stir for 30 minutes, filter and decarbonize; fine filter with a 0.22μm microporous membrane, Filling, 1ml / bottle, sealing; autoclave at 121°C for 15 minutes, quickly spray to cool down, take out the cabinet, and naturally cool to room temperature.

[0063] (2) Add 500ml of water for injection into the beaker, add 2g of sodium bisulfite and 300ml of propylene glycol, stir to dissolve, then add 2g of dexamethasone sodium phosphate, stir to completel...

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PUM

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Abstract

The invention relates to a pharmaceutical composition of ondansetron hydrochloride and dexamethasone, and particularly relates to a combined application package comprising an ondansetron hydrochloride injection and an injection containing dexamethasone. When the combined application package is in use, the ondansetron hydrochloride injection and the injection containing dexamethasone are co-dissolved in normal saline, a Ringer's solution, 5% glucose injection and the like for intravenous infusion, so that a curative effect of stopping vomit can be increased.

Description

technical field [0001] The invention relates to a pharmaceutical composition of ondansetron hydrochloride and dexamethasone, in particular to a combined application package of ondansetron hydrochloride injection and the injection containing dexamethasone, belonging to the technical field of medicine. Background technique [0002] Ondansetron hydrochloride is a potent and highly selective 5-HT3 receptor antagonist with strong antiemetic effect. Chemotherapy drugs and radiation therapy can cause the small intestine to release 5-HT, which activates the afferent branch of the vagus nerve through the 5-HT3 receptor and triggers the gag reflex. Ondansetron hydrochloride blocks the triggering of this reflex. The excitation of the afferent branch of the vagus nerve can also cause the release of 5-HT in the Postrema area at the bottom of the fourth ventricle, which can be strengthened through the central mechanism. Ondansetron hydrochloride is effective against nausea and vomiting ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K47/10A61P1/08A61K31/4178
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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