Stable palonosetron injection liquid and its preparation method

A technology of palonosetron and injection, which is applied in the field of drug intravenous injection and can solve the problems of insufficient stability of palonosetron hydrochloride solution and the like

Active Publication Date: 2006-08-30
YAOPHARMA CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the research results of Example 3 of PCT patent application WO2004067005, Palonosetron hydrochloride solution adjusted to isotonicity with sodium chloride is not stable enough, not as good as mannitol

Method used

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  • Stable palonosetron injection liquid and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Palonosetron hydrochloride injection formula (prescription) is shown in Table 1

[0033] prescription ingredients

1

2

3

4 (commercial prescription)

palonox hydrochloride

Joan

xylitol

Sorbitol

Sodium chloride

Mannitol

EDTA

citric acid

Sodium citrate

PH value

Add water for injection to

0.28mg

250mg

-

-

6.4mg

5mg

3.73

5ml

0.28mg

-

250mg

-

6.4mg

5mg

3.75

5ml

0.28mg

-

-

45mg

6.4mg

5mg

3.75

5ml

0.28mg

207mg

2.5mg

7.8mg

18mg

5.10

5ml

[0034] Preparation Process:

[0035] Weigh xylitol, citric acid, and trisodium citrate according to the amount of prescription 1, add an appropriate amount of water for injection to dissolve, add an appropriate amount of activated carbon for needles, heat...

Embodiment 2

[0039] Stability test

[0040]Palonosetron hydrochloride injection samples (prescription 1, 2, 3,) and foreign commercially available injection formulation samples (prescription 4) prepared in Example 1 were placed in a 60°C influencing factor oven, placed for 10 days, Observe and compare their appearance and changes in the amount of impurities on the 0th day, the 5th day and the 10th day, and investigate the thermal stability of the preparation. The related substances on the 0th day, the 5th day and the 10th day were determined by high performance liquid chromatography. The results showed that compared with foreign commercially available products, the injection samples prepared in Example 1 had no obvious changes in appearance and impurity amount after being placed at 60°C for 5 days and 10 days, indicating that they had better thermal stability. See Table 2 for specific data.

[0041] prescription number

[0042] Conclusion: adopt the injection sample prepared by...

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Abstract

A high-stability injection of Paluonosiqiong is prepared from Paluonosiqiong or its medicinal salt, and the additive for injection chosen from citrate buffer solution, xylitol, sorbitol and sodium chloride. It has low cost.

Description

Technical field: [0001] The invention relates to a stable drug intravenous injection, in particular to a palonosetron or a pharmaceutically acceptable salt thereof, with xylitol, sorbitol or sodium chloride as auxiliary materials, especially palonosetron hydrochloride Joan becomes the active ingredient in an intravenous solution. Background technique: [0002] The chemical structural formula of Palonosetron Hydrochloride is: [0003] [0004] The chemical name is 2-[(S)-1-azabicyclo[2,2,2]octan-3-yl]-2,3,3a(S),4,5,6-hexahydro-1H- Benzisoquinolin-1-one hydrochloride. [0005] Palonosetron hydrochloride is white or off-white crystalline powder, odorless and tasteless. Dissolved in water, insoluble in ethanol. [0006] Palonosetron hydrochloride injection is a colorless or almost colorless clear solution. [0007] Palonosetron hydrochloride is a 5-hydroxytryptamine 3 receptor antagonist developed by Helsinn Healthcare Company in Switzerland, and its injection (water inj...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/473A61K9/08A61K47/10A61P1/08
Inventor 宗太丽牟才华
Owner YAOPHARMA CO LTD
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