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Palonosetron hydrochloride intravenous injection medicinal composition and preparation method thereof

A composition and drug technology, applied in the direction of drug combination, active ingredients of heterocyclic compounds, digestive system, etc., can solve problems such as vascular irritation, decreased blood calcium concentration, and blood coagulation

Inactive Publication Date: 2008-01-16
HAINAN SHENGKE LIFE SCI RES INST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the known palonosetron hydrochloride injection pharmaceutical composition, edetate disodium is used as the metal complexing agent, however, those skilled in the art know that when using the edetate disodium pharmaceutical composition , there is a risk of causing a decrease in blood calcium concentration, disturbance of electrolyte balance in the body, and may induce vascular irritation and coagulation

Method used

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  • Palonosetron hydrochloride intravenous injection medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Palonosetron Hydrochloride Injection

[0024] Specifications: 5ml: 0.25mg (based on palonosetron C 19 h 24 N 2 O meter).

[0025] The prescription is as follows:

[0026] Palonosetron Hydrochloride

280mg (in C 19 h 24 N 2 O counted as 250mg)

Mannitol

207.5g

sodium citrate

9.41g

citric acid

3.89g

Edetate Calcium Sodium

2.5g

Add water for injection to

5000ml

production

1000 sticks (5ml:0.25mg, in C 19 h 24 N 2 O meter)

[0027] a. Weigh 207.5g of mannitol, 3.89g of citric acid, 9.41g of sodium citrate and 2.5g of calcium sodium edetate, add water for injection, stir to dissolve, then add medicinal activated carbon, stir, stand still, and filter Get solution I for subsequent use;

[0028] b. Weigh 280 mg of palonosetron hydrochloride, add it to water for injection, dissolve completely, and obtain solution II for later use;

[0029] c. After mixing solution I and solutio...

Embodiment 2

[0032] Take 56mg of palonosetron hydrochloride, 41.5g of mannitol, 798mg of citric acid and 1882mg of sodium citrate in proportional amounts, dissolve them in an appropriate amount of water for injection, add water for injection to 1000ml, take four portions, each 200ml, respectively Add 0.00%, 0.03%, 0.05%, 0.10% (w / v) calcium sodium edetate, stir to dissolve, and filter with 0.22 μm microporous membrane respectively. Investigate its appearance, pH value, content and related substances. The results are shown in Table 2.

[0033] Table 2 Antioxidant results of different amounts of edetate calcium sodium

[0034] Edetate Calcium Sodium Concentration

Embodiment 3

[0036] Prepare about 0.01mol / L citric acid-sodium citrate buffer solution, 1000ml each of sodium acetate-acetic acid or sodium hydroxide-hydrochloric acid, add the prescribed amount of palonosetron hydrochloride and mannitol respectively, stir and dissolve, and adjust the pH value to about 5.0, filtered with a 0.22 μm microporous membrane, the appearance, content, and determination results of related substances are shown in Table 1.

[0037] Table 3 Investigation results of each test item when pH=5.0

[0038]

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PUM

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Abstract

The invention discloses a drug compound of stable palonosetron hydrochloride for injection, characterized in that the compound contains diamine tetraacetic acid and or the ramification of the diamine tetraacetic acid as complexing agent of metal ion, pH regulator and osmotic pressure regulator.

Description

technical field [0001] The invention relates to a pharmaceutical composition for intravenous administration, which contains palonosetron hydrochloride and a metal ion complexing agent, has good stability and safety and increases clinical acceptability. Background technique [0002] The chemical name of Palonosetron Hydrochloride is (3aS)-2-[(S)-1-azabicyclo[2,2,2]oct-3-yl]-2,3,3a, 4,5,6-hexahydro-1-oxo-1H benzo[de]isoquinoline hydrochloride, its chemical structural formula is: [0003] [0004] Palonosetron is another 5-HT3 receptor antagonist approved for clinical use after ondansetron, granisetron and dolasetron. It was developed by Swiss Helsinn company. Its injection (specification: 0.25mg ) in 2003 under the trade name Aloxi  Marketed in the United States for the prevention of acute and delayed nausea and vomiting associated with initiation and repeat courses of moderately and highly emetogenic chemotherapy. [0005] Palonosetron is a selective 5-HT 3 Receptor a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/47A61K47/12A61K47/18A61P1/08
Inventor 宁美英
Owner HAINAN SHENGKE LIFE SCI RES INST
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