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Dolasetron mesylate containing injection, as well as preparation method and quality control method thereof

A technology for dolasetron mesylate and injections, which is applied in the field of injections containing dolasetron mesylate and its preparation, and can solve problems such as interruption, pain of patients, and cessation of anti-tumor treatment

Inactive Publication Date: 2013-04-03
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, side effects associated with this treatment include severe nausea and vomiting, which is so distressing for some patients that they interrupt or even stop antineoplastic therapy

Method used

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  • Dolasetron mesylate containing injection, as well as preparation method and quality control method thereof
  • Dolasetron mesylate containing injection, as well as preparation method and quality control method thereof
  • Dolasetron mesylate containing injection, as well as preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: the impact of polyhydroxy compound on the stability of dolasetron mesylate injection

[0044] Prescription 1 Prescription 2 Prescription 3 Prescription 4 Prescription 5 Prescription 6 Prescription 7 Prescription 8 dolasetron mesylate 20g 20g 20g 20g 12.5g 12.5g 12.5g 12.5g Mannitol - 38.2g 33.0g 30.0g - 38.2g 30.0g 30.0g Sorbitol - - 5.0g - - - 7.5g - xylitol - - - 7.5g - - - 5.0g Add water for injection to 1000ml 1000ml 1000ml 1000ml 1000ml 1000ml 1000ml 1000ml

[0045]According to the above prescription, take the mannitol, sorbitol or xylitol of the prescription amount respectively, after dissolving completely with the water for injection of 70% of the prescription amount cooled to room temperature, add the dolasetron mesylate of the prescription amount and stir to dissolve ( Concentrated formulation), add 0.05% (W / V) of concentrated formulation volume of medici...

Embodiment 2

[0064] Embodiment 2: the influence of pH value on the stability of dolasetron mesylate injection

[0065] Prescription 2 Prescription 6 dolasetron mesylate 20.0 g 12.5g Mannitol 38.2 g 38.2g Water for Injection Add to 1000ml Add to 1000ml

[0066] According to the above prescription, weigh the prescribed amount of mannitol respectively, completely dissolve it with 70% of the prescribed amount of water for injection cooled to room temperature, add the prescribed amount of dolasetron mesylate and stir to dissolve (concentrated formulation), add the concentrated formulation 0.05% of the volume (W / V) of medicinal activated carbon was stirred evenly, and after standing for 10 minutes to absorb, filter and decarbonize; add water for injection to 95% of the total amount, stir evenly, and adjust the pH value to 0.1mol / L hydrochloric acid solution respectively. 3.0, 3.5, 4.0, 4.5, add water for injection to the full amount, stir evenly; fine fil...

Embodiment 3

[0074] Feeding prescription:

[0075] dolasetron mesylate 20.0 g Mannitol 38.2 g Water for Injection Add to 1000ml

[0076] Weigh the prescribed amount of mannitol, completely dissolve it with 70% of the prescribed amount of water for injection cooled to room temperature, add the prescribed amount of dolasetron mesylate and stir to dissolve (concentrated formulation), add 0.05% of the concentrated formulation volume ( W / V) of medicinal activated carbon, stir evenly, let it stand for 10 minutes for adsorption, filter and decarbonize; add water for injection to 95% of the total amount, stir evenly, adjust the pH to 3.0 with 0.1mol / L hydrochloric acid solution, and add water for injection to Stir the whole amount evenly; take a sample to measure its properties, pH value, content and bacterial endotoxin. After passing the test, fine filter, fill with nitrogen, fill, melt seal, and sterilize with damp heat at 121°C for 12 minutes.

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Abstract

The invention provides a dolasetron mesylate containing injection. The injection comprises dolasetron mesylate, a polyhydroxy compound, a pH regulator and pharmaceutically acceptable auxiliary materials, wherein the polyhydroxy compound serving as a stabilizing agent is one or more of mannitol, xylitol and sorbitol; the pH regulator is one or more of hydrochloric acid, sulfuric acid, phosphoric acid, citric acid, acetic acid, maleic acid, tartaric acid and lactic acid, and the pH value of the injection can be kept in an acceptable range. The invention also provides a preparation method and quality control method of the injection.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to an injection containing dolasetron mesylate, a preparation method and a quality control method thereof. Background technique [0002] Tumor is a common and frequently-occurring disease with a high mortality rate. Over the past 20-30 years, great progress has been made in cancer treatment and care of cancer patients. Aggressive chemotherapy and radiotherapy are still the main effective treatments commonly used by clinicians. However, side effects of this treatment method include severe nausea and vomiting, which makes some patients so painful that they interrupt or even stop the antitumor therapy. [0003] The exact mechanism of how cytostatic drugs such as cisplatin or radiotherapy induce nausea and vomiting is unknown, however it appears to be related to 5-HT located in the gastrointestinal tract 3 related to the receptor. These receptors on the chemoreceptor tri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/439G01N30/36G01N30/06A61P1/08
Inventor 郑伟
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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