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Palonosetron hydrochloride injection and preparation method thereof

A technology for palonosetron and chon injections, which is applied in pharmaceutical formulations, medical preparations with inactive ingredients, drug delivery and other directions, can solve problems such as increasing the pain of patients, achieve enhanced medication compliance, reduce metal ion precipitation, The effect of improving stability

Inactive Publication Date: 2016-05-04
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the approved clinical instructions all stipulate that this product should be administered by single-dose intravenous injection, and the injection time should be more than 30 seconds. Such an administration method greatly increases the pain of the patient's medication.
Therefore, the liquid injection dosage forms of the marketed drugs determine the lack of compliance of their clinical medication

Method used

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  • Palonosetron hydrochloride injection and preparation method thereof
  • Palonosetron hydrochloride injection and preparation method thereof
  • Palonosetron hydrochloride injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] prescription:

[0025] Palonosetron hydrochloride (calculated as palonosetron) 0.075mg (equivalent concentration 0.0015mg / ml)

[0026] Sodium chloride 0.45g

[0027] Add water for injection to 50ml

[0028] Preparation:

[0029] (1) Put the prescribed amount of palonosetron hydrochloride and sodium chloride into the water for injection that has been filled with nitrogen and deoxygenated, stir and dissolve, and the measured pH value should be 5.0;

[0030] (2) Under the protection of continuous nitrogen filling, filter through 0.45μm and 0.22μm filter membranes, fill and seal with plastic packaging;

[0031] (3) Sterilize in a high-pressure water bath at 121°C for 12-15 minutes.

Embodiment 2

[0033] prescription:

[0034] Palonosetron hydrochloride (calculated as palonosetron) 0.075mg (equivalent to 0.00075mg / ml)

[0035] Sodium chloride 0.9g

[0036] Add water for injection to 100ml

[0037] Preparation:

[0038] (1) Put the prescribed amount of palonosetron hydrochloride and sodium chloride into the water for injection that has been filled with nitrogen and deoxygenated, stir and dissolve, and the measured pH value should be 5.5;

[0039] (2) Under the protection of continuous nitrogen filling, filter through 0.45μm and 0.22μm filter membranes, fill and seal with plastic packaging;

[0040] (3) Sterilize in a high-pressure water bath at 121°C for 12-15 minutes.

Embodiment 3

[0042] prescription:

[0043] Palonosetron hydrochloride (calculated as palonosetron) 0.25mg (equivalent concentration 0.005mg / ml)

[0044] Sodium chloride 0.45g

[0045] Add water for injection to 50ml

[0046] Preparation:

[0047] (1) Put the prescribed amount of palonosetron hydrochloride and sodium chloride into the water for injection that has been filled with nitrogen and deoxygenated, stir and dissolve, and the measured pH value should be 6.5;

[0048] (2) Under the protection of continuous nitrogen filling, filter through 0.45μm and 0.22μm filter membranes, fill and seal with plastic packaging;

[0049] (3) Sterilize in a high-pressure water bath at 121°C for 12-15 minutes.

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Abstract

The invention relates to a palonosetron hydrochloride injection and a preparation method thereof. The palonosetron hydrochloride injection is characterized by comprising palonosetron and an osmotic pressure regulator. The preparation is simple in formulation and process, and the quality is stable and easy to control; moreover, the preparation can be applied to direct intravenous drip administration; clinical application is convenient, administration compliance is high, and the safety is high.

Description

technical field [0001] The invention relates to a palonosetron hydrochloride injection and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] The chemical name of Palonosetron Hydrochloride is 2-[1-azabicyclo(2.2.2)oct-3S-yl]-2,3,3aS,4,5,6-hexahydro-1H-benzene And[de]isoquinolin-1-one hydrochloride, molecular formula: C 19 h 24 N 2 O·HCl, molecular weight 332.87. [0003] [0004] Palonosetron hydrochloride was originally developed by the Swiss Helsinn company. It is a new 5-HT3 receptor antagonist developed after ondansetron, granisetron, tropisetron, etc. It binds to 5-HT3 receptors The activity is dozens to hundreds of times stronger than other varieties, with high curative effect, low dosage (0.25mg / day), long half-life in vivo (more than 40 hours), single dose (0.25mg / day) curative effect can reach 5 days, and side effects are relatively low It is characterized by less pain (mainly headache) and can...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/473A61K47/04A61P1/08
CPCA61K9/08A61K9/0019A61K31/473A61K47/02
Inventor 刘绪贵李后涛侯建国王朋郭丽娟
Owner SHANDONG QIDU PHARMA
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