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Preparation method of ramosetron hydrochloride for injection

A technology for ramosetron hydrochloride and injection, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and medical formulas, etc. Product sterility and other issues, to achieve the effect of eliminating influence, improving stability, and accurate volume determination

Inactive Publication Date: 2018-11-13
CHENGDU TONGDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing preparation method of ramosetron hydrochloride for injection is difficult to guarantee its bactericidal effect and the sterility of the product, resulting in unstable product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A preparation method of ramosetron hydrochloride for injection, comprising the following steps:

[0027] S1. Add 800ml of water for injection and 50g of mannitol into the concentrated preparation tank, heat to above 60°C, and stir until the mannitol dissolves;

[0028] S2. Add 0.1 g of activated carbon to the concentrated preparation tank for stirring and adsorption, and pour the solution in the concentrated preparation tank into the thin preparation tank through a titanium rod filter, the pore size of the titanium rod filter is 0.45um;

[0029] S3, add 100ml of water for injection in the dilute preparation tank, cool to normal temperature, add 0.3g ramosetron hydrochloride, stir until dissolving; add phosphoric acid solution to adjust, and control the pH of the liquid to be 3.8;

[0030] S4. Add 100ml of water for injection to the solution obtained in step S3, stir and mix evenly, add phosphoric acid solution to adjust, control the pH value of the medicinal solution to...

Embodiment 2

[0040] A preparation method of ramosetron hydrochloride for injection, comprising the following steps:

[0041] S1. Add 800ml of water for injection and 50g of mannitol into the concentrated preparation tank, heat to above 60°C, and stir until the mannitol dissolves;

[0042] S2. Add 0.1 g of activated carbon to the concentrated preparation tank for stirring and adsorption, and pour the solution in the concentrated preparation tank into the thin preparation tank through a titanium rod filter, the pore size of the titanium rod filter is 0.45um;

[0043] S3, add 100ml water for injection in the dilute preparation tank, cool to normal temperature, add 0.3g ramosetron hydrochloride, stir until dissolving; add and adjust with phosphoric acid solution, the pH value of control liquid medicine is 4.2;

[0044] S4. Add 100ml of water for injection to the solution obtained in step S3, stir and mix evenly, add phosphoric acid solution to adjust, control the pH value of the medicinal solu...

Embodiment 3

[0054] A preparation method of ramosetron hydrochloride for injection, comprising the following steps:

[0055] S1. Add 800ml of water for injection and 50g of mannitol into the concentrated preparation tank, heat to above 60°C, and stir until the mannitol dissolves;

[0056] S2. Add 0.1 g of activated carbon to the concentrated preparation tank for stirring and adsorption, and pour the solution in the concentrated preparation tank into the thin preparation tank through a titanium rod filter, the pore size of the titanium rod filter is 0.45um;

[0057] S3, add 100ml of water for injection in the dilute preparation tank, cool to normal temperature, add 0.3g ramosetron hydrochloride, stir until dissolving; add phosphoric acid solution to adjust, and control the pH value of the liquid to 4;

[0058] S4, add 100ml water for injection in the solution gained in step S3, stir and mix evenly, add and adjust with phosphoric acid solution, the pH value of control medicinal liquid is 4, ...

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PUM

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Abstract

The invention discloses a preparation method of ramosetron hydrochloride for injection. The preparation method comprises the following steps: adding water soluble mannitol for injection in a concentrated mixing tank, and heating and stirring till the mannitol is dissolved; adding activated carbon in the concentrated mixing tank for stirring and absorption, injecting a solution in the concentratedmixing tank into a dilute mixing tank; adding water for injection in the dilute mixing tank for cooling, adding ramosetron hydrochloride and stirring till dissolution; adding water for injection in the solution till total dispensing volume and uniformly stirring and mixing to prepare a ramosetron hydrochloride product; freeze-drying and sterilizing the ramosetron hydrochloride product. The ramosetron hydrochloride for injection, prepared by the preparation method disclosed by the invention, is subjected to tertiary the third-stage sterilization filtration to fully ensure the sterility of the product.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical production, and is specifically a preparation method of ramosetron hydrochloride for injection. Background technique [0002] At present, ramosetron hydrochloride has been made into various pharmaceutical dosage forms for clinical treatment. Among them, ramosetron hydrochloride for injection is the most commonly used and has a large market demand. In the production process of pharmaceutical preparations, ramosetron hydrochloride for injection is made into ramosetron hydrochloride freeze-dried powder for injection. The existing preparation method of ramosetron hydrochloride freeze-dried powder for injection includes: stirring and dissolving ramosetron hydrochloride, excipients and water for injection, and then freeze-drying to prepare ramosetron hydrochloride freeze-dried powder for injection. However, the existing preparation method of ramosetron hydrochloride for injection is difficult to...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K31/4184A61P1/08
CPCA61K9/0019A61K9/08A61K31/4184A61K47/26A61P1/08
Inventor 吴照军徐平俊李晓琳
Owner CHENGDU TONGDE PHARMA
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