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Pharmaceutical composition containing tropisetron hydrochloride and dexamethasone acetate

A technology of tropane hydrochloride and composition, applied in the field of medicine

Inactive Publication Date: 2014-09-10
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 injection for injection

[0040] prescription:

[0041]

[0042] Preparation Process:

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

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

[0045] (3) Add 7g of tropisetron hydrochloride (press C 17 H 20 N 2 O 2 Calculate), stir to dissolve completely, 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, dilute to 3500ml, stir and absorb for 30 minutes;

[0047] (5) The solution is coarsely filtered and decarbonized, filtered through a 0.45μm cartridge filter, and then sterilized and filtered with a 0.22μm microporous membrane until the visible foreign matter is qualified;

[0048] (6) Filling.

[0049] (7) Freeze drying

[0050] ① During the pre-freezing perio...

Embodiment 2

[0054] Example 2 Preparation of Tropisetron Hydrochloride Injection

[0055] prescription:

[0056]

[0057]

[0058] Preparation Process:

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

[0060] (2) Add 7g of tropisetron hydrochloride (press C 17 H 20 N 2 O 2 Calculate), stir to dissolve completely, 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, dilute to 7000ml, stir and absorb for 30 minutes;

[0062] (5) The solution is coarsely filtered and decarbonized, filtered through a 0.45μm cartridge filter, and then sterilized and filtered with a 0.22μm 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] Preparation Process:

[0068] 1. Dissolve 143g of glycerol in 5000ml of water for injection, and make the water phase at 60℃;

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

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

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

[0072] 5. Filter with 0.45μm microporous membrane, fill, 0.5ml / piece or 1ml / piece or 5ml / piece, 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 effective and highly selective competitive antagonist of peripheral neurons and central nervous system serotonin 3 (5-HT3) receptors. Certain substances, including some chemotherapeutics, can stimulate the chromaffin-like cells of the visceral mucosa to release serotonin, thereby inducing the vomiting reflex accompanied by nausea. Tropisetron hydrochloride mainly inhibits the vomiting reflex by selectively blocking the presynaptic 5-HT3 receptors of peripheral neurons. In addition, its antiemetic effect may also be directly blocking the central 5-HT3 receptors. It is related to the inhibition of th...

Claims

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Application Information

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Patent Type & Authority Patents(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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