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Ondansetron hydrochloride composition for injection and preparation method thereof

A technology of ondansetron hydrochloride and composition, applied to the ondansetron hydrochloride composition for injection and the field of preparation thereof, can solve the problems such as no improvement, achieve low production cost, uniform and accurate content, and improved resolubility energy effect

Inactive Publication Date: 2012-10-03
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] None of the existing known technologies propose improvements to the above defects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] prescription:

[0054] Ondansetron Hydrochloride 45g

[0055] Mannitol 90g

[0056] Add water for injection to 20Kg

[0057] Preparation:

[0058] Put ondansetron hydrochloride and mannitol in the preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 4.2 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0059] Sterile filtration, packing:

[0060] The prepared ondansetron hydrochloride solution was filtered through a microporous membrane into a sterile room, divided into vials, and half stoppered;

[0061] Vacuum Freeze Drying:

[0062] a. Pre-freezing: put the subpackaged ondansetron hydrochloride liquid into a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ondansetron hydrochloride liquid is completely frozen;

[0063] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the temperat...

Embodiment 2

[0066] prescription:

[0067] Ondansetron Hydrochloride 45g

[0068] Mannitol 450g

[0069] Add water for injection to 20Kg

[0070] Preparation:

[0071] Put ondansetron hydrochloride and mannitol in the preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 4.2 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0072] Sterile filtration, packing:

[0073] The prepared ondansetron hydrochloride solution was filtered through a microporous membrane into a sterile room, divided into vials, and half stoppered;

[0074] Vacuum Freeze Drying:

[0075] a. Pre-freezing: put the subpackaged ondansetron hydrochloride liquid into a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ondansetron hydrochloride liquid is completely frozen;

[0076] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the tempera...

Embodiment 3

[0079] prescription:

[0080] Ondansetron Hydrochloride 90g

[0081] Mannitol 360g

[0082] Add water for injection to 20Kg

[0083] Preparation:

[0084] Put ondansetron hydrochloride and mannitol in the preparation tank, add water for injection, stir to dissolve completely and mix evenly, and adjust the pH value to 4.2 with 0.1mol / L hydrochloric acid and 0.1mol / L sodium hydroxide solution;

[0085] Sterile filtration, packing:

[0086] The prepared ondansetron hydrochloride solution was filtered through a microporous membrane into a sterile room, divided into vials, and half stoppered;

[0087] Vacuum Freeze Drying:

[0088] a. Pre-freezing: put the subpackaged ondansetron hydrochloride liquid into a freeze dryer, lower the temperature of the product to -40°C, and keep warm until the ondansetron hydrochloride liquid is completely frozen;

[0089] b. Refrigeration of the rear box: use the compressor to cool the cold trap of the rear box, and keep the tempera...

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PUM

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Abstract

The invention relates to an ondansetron hydrochloride composition for injection and a preparation method thereof. The composition contains ondansetron hydrochloride and mannitol, and the preparation method comprises: 1) a step of preparation, in which ondansetron hydrochloride and mannitol are filled in a preparation tank according to a weight ratio of 1:(2-10) and added with water for injection,the mixture is stirred till the ondansetron hydrochloride and mannitol are dissolved uniformly, and the solution is mixed uniformly; 2) a step of sterile filtering, filling separately and half plugging; and 3) a step of vacuum freezing and drying. In the invention, the formula is simple, the process is advanced, the quality is uniform and stable, the water is completely dried, and the resoluble performance is high.

Description

technical field [0001] The present invention relates to a composition of ondansetron hydrochloride for injection and a preparation method thereof, and the composition of ondansetron hydrochloride prepared by the method is suitable for treating nausea and vomiting caused by cytotoxic drug chemotherapy and radiotherapy , is also suitable for the prevention and treatment of nausea and vomiting after surgery. Background technique [0002] The chemical name of ondansetron hydrochloride is 1,2,3,9-tetrahydro-9-methyl-3-[(2-methylimidazol-1-yl)methyl]-4-oxocarbazole hydrochloride salt dihydrate. [0003] Its structural formula is: [0004] [0005] Molecular formula: C 18 h 19 N 3 O·HCl·2H 2 o [0006] Molecular weight: 365.83. [0007] Ondansetron is a highly selective serotonin 5HT 3 Receptor antagonists are new powerful antiemetics. It was successfully developed by the British Glaxo company in 1989, and its preparations include tablets and injections. It is suitabl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4178A61K9/08A61P1/08
Inventor 赵小伟叶东胡振
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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