Ramosetron hydrochloride injection and preparation method thereof

A technology of ramosetron hydrochloride and injection, applied in the field of medicine, can solve the problems that activated carbon cannot effectively remove pyrogens, particles and viruses, affect the color and clarity of the injection, unstable illumination of the solution, etc., so as to ensure product quality , clarity and color improvement

Inactive Publication Date: 2014-01-29
无锡紫杉药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The use of activated carbon in the above invention cannot effectively remove pyrogens, particles and viruses in the liquid medicine, and will affect the color and clarity of the injection. In addition, activated carbon will also adsorb ramosetron hydrochloride in the injection, affecting the quality of the injection. The stability of the ingredients in the solution, and the solution still has light instability, which is easy to increase the adverse reaction of the product

Method used

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  • Ramosetron hydrochloride injection and preparation method thereof
  • Ramosetron hydrochloride injection and preparation method thereof
  • Ramosetron hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Injection formula: main ingredient ramosetron hydrochloride 5.1g

[0035] Freeze-dried matrix agent glycine 680g

[0036] Water for injection to 17000ml

[0037] The preparation method of above-mentioned injection is as follows, figure 1 For the flow chart of the preparation method of ramosetron hydrochloride for injection:

[0038] (a) put about 80% fresh water for injection of the total amount in the batching barrel, add the glycine of formula quantity, stir to make dissolving completely;

[0039] (b) Add the precisely weighed formula amount of ramosetron hydrochloride, gradually add in portions, and stir to make it all dissolve. Adjust the pH value to 4.7, and perform ultrafiltration for the obtained medicinal solution;

[0040] (c) Add water for injection to a sufficient amount, turn on magnetic stirring and stir for 15 minutes, sterilize through two 0.22μm microporous membranes connected in series, press to the receiving tank of the filling station, adjust the ...

Embodiment 2

[0045] Injection formula: main ingredient ramosetron hydrochloride 5.1g

[0046] Freeze-dried matrix glycine 2040g

[0047] Water for injection to 34000ml

[0048] The preparation method of above-mentioned injection is as follows:

[0049] (a) Put about 70% fresh water for injection of the total amount in the batching tank, add the glycine of the formula amount, stir to dissolve completely;

[0050] (b) Add the precisely weighed formula amount of ramosetron hydrochloride, gradually add in portions, and stir to make it all dissolve. Adjust the pH value to 3.5, and perform ultrafiltration for the obtained medicinal solution;

[0051] (c) Add water for injection to a sufficient amount, turn on magnetic stirring and stir for 15 minutes, sterilize through two 0.22μm microporous membranes connected in series, press to the receiving tank of the filling station, adjust the filling volume, and fill it in a brown bottle , half stopper;

[0052] (d) Pre-freezing: insert temperature an...

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Abstract

The invention relates to a ramosetron hydrochloride injection and a preparation method thereof. The ramosetron hydrochloride injection comprises the following components in parts by weight: 1 part of ramosetron hydrochloride, 50-500 parts of glycine and 2,000-6,000 parts of injection water. In the preparation method, a pyrogen is removed by using ultrafiltration; compared with the use of active carbon, the preparation method has the advantages that the pyrogen, micro-particles, viruses and the like in liquid medicine can be effectively removed through ultrafiltration with molecular weight cutoff of 10,000, and the clarity and the color of the intermediate are improved to a certain extent compared with the active carbon, no adsorption effect is caused to the ramosetron hydrochloride, serving as a main ingredient of the product, like the active carbon, and the need of multiple adjustment due to inaccurate content in a blending process is avoided.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to ramosetron hydrochloride injection and a preparation method thereof. Background technique [0002] Ramosetron hydrochloride, chemical name: (-)-(R)-5-[(1-methyl-1H-indol-3-yl)carbonyl]-4,5,6,7-tetrahydro- 1H-benzimidazole hydrochloride, the molecular formula is C 17 h 17 N 3 O·HCl, the molecular weight is 315.80. The structural formula is as follows: [0003] [0004] Ramosetron hydrochloride has 5-HT3 receptor antagonism, and has significant prevention and treatment of nausea, vomiting and other gastrointestinal symptoms caused by anti-malignant drug treatment. It has a large clinical dosage. Research on ramosetron hydrochloride injection Also more. Disclosed a kind of preparation method of ramosetron hydrochloride injection as CN102038637A, it comprises the following steps: (a) take water for injection as solvent, the ramosetron hydrochloride of effective dosage is ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/4184A61K47/18A61P1/08
Inventor 李春洲史健飞张勇朱震
Owner 无锡紫杉药业股份有限公司
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