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Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate

A technology of dexamethasone acetate and tropisetron hydrochloride, applied in the field of medicine

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

However, direct use of tropisetron hydrochloride and dexamethasone still has many side effects, such as constipation, headache, dizziness, vertigo, abdominal pain, glucocorticoid syndrome, etc.

Method used

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  • Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate
  • Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate
  • Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Example 1 Preparation of tropisetron hydrochloride freeze-dried powder for injection

[0040] prescription:

[0041]

[0042] making process:

[0043] (1) First add 2800ml of water for injection into the container, and control the temperature at 10°C to 20°C;

[0044] (2) Add 105g of mannitol and stir to dissolve completely;

[0045] (3) Add 7g of tropisetron hydrochloride (press C 17 h 20 N 2 o 2 meter), stir to dissolve completely, and adjust the pH to 4.8 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0046] (4) Add 0.7g of activated carbon for injection, add the remaining water for injection, set the volume to 3500ml, stir and absorb for 30 minutes;

[0047] (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;

[0048] (6) Filling.

[0049] (7) Freeze dr...

Embodiment 2

[0054] Example 2 Preparation of Tropisetron Hydrochloride Injection

[0055] prescription:

[0056]

[0057]

[0058] making process:

[0059] (1) First add 5600ml of water for injection into the container, and control the temperature at 10°C to 20°C;

[0060] (2) Add tropisetron hydrochloride 7g (press C 17 h 20 N 2 o 2 meter), stir to dissolve completely, and adjust the pH to 5.0 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0061] (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;

[0062] (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;

[0063] (6) Filling, sealing, and sterilization.

Embodiment 3

[0064] Example 3 Preparation of Dexamethasone Acetate Injection

[0065] prescription:

[0066]

[0067] making process:

[0068] 1. Dissolve 143g glycerin in 5000ml water for injection, and make water phase at 60°C;

[0069] 2. Dissolve 78g of lecithin for injection and 32.5g of dexamethasone acetate in 650g of soybean oil for injection to make an oil phase;

[0070] 3. Add the oil phase to the water phase, stir and mix evenly, adjust the pH to 5.6 with 0.1mol / L sodium hydroxide solution or 0.1mol / L hydrochloric acid solution, add water for injection to the full amount, and make an emulsion through high-pressure homogenization;

[0071] 4. Then add 3.25g of wetted medicinal charcoal, stir for 30 minutes, filter and decarbonize;

[0072] 5. Filter with a 0.45 μm microporous membrane, fill, 0.5ml / bottle or 1ml / bottle or 5ml / bottle, seal, and sterilize to obtain dexamethasone acetate injection.

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Abstract

The invention relates to a pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate, and particularly relates to a combined application package comprising a tropisetron hydrochloride injection and a dexamethasone acetate injection. When the combined application package is in use, the tropisetron hydrochloride injection and a dexamethasone acetate injection are co-dissolved in normal saline, a Ringer's solution, 5% glucose injection, a fructose solution 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 containing tropisetron hydrochloride and dexamethasone acetate, in particular to a combined application package composed of tropisetron hydrochloride injection and dexamethasone acetate injection, belonging to the technical field of medicine. Background technique [0002] Tropisetron hydrochloride is a highly efficient and highly selective competitive antagonist of peripheral neurons and central nervous system 5-hydroxytryptamine 3 (5-HT3) receptors. Certain substances, including some chemotherapeutic drugs, stimulate the release of serotonin from chromaffin-like cells in the visceral mucosa, which induces the gag reflex with nausea. Tropisetron hydrochloride inhibits the gag reflex mainly by selectively blocking the presynaptic 5-HT3 receptors of peripheral neurons. In addition, its antiemetic effect may also be related to the direct blockade of central 5-HT3 receptors. Inhibition of the stimulati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K47/10A61K9/19A61K9/08A61P35/00A61P1/08A61K31/46
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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