Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition

A kind of technology of tropisetron hydrochloride and tropisetron hydrochloride, which is applied in the field of medicine

Inactive Publication Date: 2015-08-12
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The applicant already has a patent application CN201310332615.X for combining tropisetron hydrochloride and fructose, which discloses a pharmaceutical composition comprising tropisetron hydrochloride injection and fructose injection, characterized in that tropisetron hydrochloride Injections include Tropisetron Hydrochloride Injection and Tropisetron Hydrochloride for Injection, which is a sterile injection prepared by adding an appropriate amount of auxiliary materials to Tropisetron Hydrochloride or a sterile freeze-dried preparation made by adding an appropriate amount of excipients ; Fructose injection is a sterile injection prepared by adding an appropriate amount of auxiliary materials; yet further studies have found that because there are only tropisetron hydrochloride and fructose in the composition, there are also some defects, such as not being suitable for postoperative burns Fluid replacement therapy for patients requiring sodium or energy in insulin resistant states such as infections

Method used

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  • Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition
  • Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition
  • Tropisetron hydrochloride and fructose-sodium chloride containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 Preparation of Tropisetron Hydrochloride for Injection

[0041] prescription:

[0042]

[0043] Preparation Process:

[0044] (1) First add 2800ml of water for injection into the container, and control the temperature at 10°C to 20°C;

[0045] (2) Add 35g xylitol and 70g glycine, stir and dissolve completely;

[0046] (3) Add tropisetron hydrochloride 7g (press C 17 h 20 N 2 o 2 meter), stir and dissolve completely, and adjust the pH to 5.1 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0047] (4) Add 0.7g activated carbon for injection, add the remaining water for injection, set the volume to 3500ml, stir and absorb for 30 minutes;

[0048] (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;

[0049](6) Filling, 1ml / bottle and 2.5ml / bottle.

[00...

Embodiment 2

[0060] Example 2 Preparation of Tropisetron Hydrochloride Injection

[0061] prescription:

[0062]

[0063] Preparation Process:

[0064] (1) First add 5600ml of water for injection into the container, and control the temperature at 10°C to 20°C;

[0065] (2) Add 35g xylitol and 70g glycine, stir and dissolve completely;

[0066] (3) Add tropisetron hydrochloride 7g (press C 17 h 20 N 2 o 2 meter), stir and dissolve completely, and adjust the pH to 5.0 with 1mol / L sodium hydroxide solution or 1mol / L hydrochloric acid solution;

[0067] (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;

[0068] (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;

[0069] (6) Filling, 2ml / bottle and 5ml / bottle, sealing...

Embodiment 3

[0074] Example 3 Preparation of Fructose Sodium Chloride Injection

[0075] prescription:

[0076]

[0077] Preparation Process:

[0078] (1) Concentrated formulation: add 30L of water for injection into the concentrated formulation tank, add 10kg of fructose and 0.9kg of sodium chloride, stir to dissolve them, add 100g of moistened medicinal charcoal, stir for 30 minutes, filter and decarbonize, Filter into the dilute formulation tank, rinse the concentrated formulation tank with water for injection several times, and filter into the dilute formulation tank;

[0079] (2) Dilute preparation: add 90L of water for injection to the dilute preparation tank, adjust the pH value to 3.8 with 0.1mol / L hydrochloric acid solution, add 100g of wetted medicinal charcoal, stir for 30 minutes, filter and decarbonize, Add water for injection to 100L;

[0080] (3) finely filter with a microporous membrane of 0.22 μm, fill, 250ml / bottle and 500ml / bottle, seal;

[0081] (4) Sterilizati...

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PUM

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Abstract

The invention provides a pharmaceutical composition of a tropisetron hydrochloride injection and a fructose-sodium chloride injection, and particularly provides a composite application package comprising a tropisetron hydrochloride injection and a fructose-sodium chloride injection. When in use, after the tropisetron hydrochloride injection is dissolved in the fructose-sodium chloride injection, the obtained product is applied to intravenous infusion, so that the pharmaceutical composition not only has an effect of treating postoperative nausea and vomiting, but also can replenish energy and body fluids to a human body.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing tropisetron hydrochloride and fructose sodium chloride, in particular to a pharmaceutical composition composed of tropisetron hydrochloride injection and fructose sodium chloride 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 stimu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/14A61K9/08A61K9/19A61P1/08A61P13/12A61P1/12A61P1/00A61K31/46A61K31/7004
Inventor 陶灵刚
Owner HAINAN LINGKANG PHARMA CO LTD
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