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A kind of preparation method of ramosetron hydrochloride injection

A technology of ramosetron hydrochloride and injection, which can be applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, pharmaceutical formulas, etc., and can solve the risk that the quantity of related substances and adverse drug reactions cannot be effectively controlled. Increase, light, thermal instability and other problems, to achieve the effect of easy operation, simple method, improve stability

Inactive Publication Date: 2012-02-15
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because ramosetron hydrochloride is unstable to light and heat, it is easily oxidized
In the production process, even if conventional antioxidants such as sodium bisulfite are added, the amount of related substances in the finished product cannot be effectively controlled.
[0003] It is well known that the risk of adverse drug reactions increases with the increase in related substances

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Process formula: active ingredient ramosetron hydrochloride 0.23g

[0015] Stabilizer Lactic acid 2g

[0016] Osmotic pressure regulator sodium chloride 9g

[0017] Water for injection 1000ml

[0018] Preparation method: Under the condition of air cleanliness level 10000 and 100, the whole process is protected from light. First, dissolve lactic acid in 800ml water for injection, then add sodium chloride and stir to dissolve, then add ramosetron hydrochloride and stir to dissolve Finally, make up the volume to 1000ml, add 0.1% activated carbon and stir for 30 minutes, decarbonize, control the pH at 4.0-5.0, filter through a 0.22 μm cartridge filter, fill, and seal to obtain ramosetron hydrochloride injection.

Embodiment 2

[0020] Process formula: active ingredient ramosetron hydrochloride 0.23g

[0021] Stabilizer sodium acetate 4.5g

[0022] Osmotic pressure regulator sodium chloride 9g

[0023] Water for injection 1000ml

[0024] Under the conditions of air cleanliness level 10000 and 100, the whole process shall be protected from light. First, dissolve the effective dose of stabilizer sodium acetate in 80% volume of water for injection, adjust the pH to 4.5 with acetic acid, and then add sodium chloride and stir Dissolve, then add ramosetron hydrochloride and stir to dissolve, make up the volume, add 0.25% activated carbon and stir for 20 minutes, remove the activated carbon, control the pH at 4.0-5.0, filter through a 0.22 μm cartridge filter, fill, seal, and obtain Ramosetron Hydrochloride Injection.

Embodiment 3

[0025] Example 3 Ramosetron Hydrochloride Injection was produced according to conventional preparation methods.

[0026] Process formula: active ingredient ramosetron hydrochloride 0.23g

[0027] Stabilizer sodium bisulfite 2g

[0028] Osmotic pressure regulator sodium chloride 9g

[0029] Water for injection 1000ml

[0030] Under the conditions of air cleanliness level 10000 and 100, first dissolve sodium bisulfite in 80% volume of water for injection, adjust the pH to 4.5 with hydrochloric acid, then add sodium chloride and stir to dissolve, then add ramoxet hydrochloride After stirring and dissolving the agar, make up the volume, add 0.25% activated carbon and stir for 20 minutes, remove the activated carbon, control the pH at 4.0-5.0, filter through a 0.22 μm cartridge filter, fill and seal to obtain ramosetron hydrochloride injection.

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PUM

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Abstract

The invention provides a preparation method of ramosetron hydrochloride injection, which comprises the following steps: (a) using water for injection as a solvent, an effective dose of ramosetron hydrochloride as an active ingredient, and lactic acid or sodium acetate as a stable (b) in a clean, light-proof environment, dissolve the stabilizer in about a predetermined amount of water for injection, then add an osmotic pressure regulator to adjust isotonicity, after dissolving, add the active ingredient of the drug; after stirring and dissolving, make up the volume (c) adding 0.05-0.25% activated carbon and stirring for 20-30 minutes, removing the activated carbon, controlling the pH at 4.0-5.0, filtering, filling and sealing. The method of the invention is simple and easy to operate, can effectively reduce the quantity of related substances in the ramosetron hydrochloride injection, and improve the stability of the ramosetron hydrochloride injection.

Description

technical field [0001] The invention relates to a preparation method of a pharmaceutical preparation, in particular to a preparation method of ramosetron hydrochloride injection. technical background [0002] Ramosetron hydrochloride (ramosetron hydrochloride) belongs to the 5-HT3 receptor antagonist, and it is also the most effective antiemetic drug so far. Because the drug has an effective and significant therapeutic effect on nausea and vomiting caused by chemotherapy, and compared with similar drugs on the market before, the dosage is small and the action time is long. Therefore, it is favored by clinicians and patients. However, because ramosetron hydrochloride is unstable to light and heat, it is easily oxidized. In the production process, even if conventional antioxidants such as sodium bisulfite are added, the amount of related substances in the finished product cannot be effectively controlled. [0003] It is well known that with the increase of related substance...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/4184A61K47/12A61P1/08
Inventor 张西果李晓斌路玉锋赵霞刘书睿
Owner NORTH CHINA PHARMA COMPANY