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Injection of palonosetron and preparation process thereof

A technique for palonosetron and injection, which is applied in the field of intravenous injection in which palonosetron hydrochloride is an active ingredient, can solve the problems of stability and high cost, achieve simple and feasible production technology, improve stability, and be easy to use. The effect of industrial production

Active Publication Date: 2009-01-28
SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention provides a stable injection solution containing palonosetron or its pharmaceutically acceptable salt in order to solve the shortcomings of the prior art in terms of stability and high cost

Method used

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  • Injection of palonosetron and preparation process thereof
  • Injection of palonosetron and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1 Preparation of Palonosetron Hydrochloride Injection

[0029] (1) Specific research process and experimental results of component screening

[0030] According to the water-soluble nature of palonosetron hydrochloride, water for injection was used as the solvent to prepare the following five components, and the composition of components 3 and 4 was similar to that of commercially available products. The specific composition of components and the results of the investigation of influencing factors are shown in Table 1.

[0031] Table 1 Palonosetron hydrochloride component screening table

[0032]

Components

component 1

component 2

Component 3

Component 4

Component 5

Component 6

(commercial prescription)

Palonosetron hydrochloride (g)

0.28

0.28

0.28

0.28

0.28

0.28

Citric acid (g)

-

25.5

4.2

0.8 ...

Embodiment 2

[0037] Embodiment 2 stability test

[0038] The palonosetron hydrochloride injection samples (components 1 to 5) and foreign commercially available injection formulation samples (component 6) prepared in Example 1 were placed in an oven with influencing factors at 60°C for 10 days, and observed and compared The changes of their appearance and impurity amount on the 0th day, the 5th day and the 10th day were used to 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 the commercially available products, the appearance and amount of impurities of the injection samples prepared in Example 1 had no significant changes 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.

[0039] Table 2 The results of the determination of related subst...

Embodiment 3

[0042] Embodiment 3 Pharmacological experiment

[0043] According to the requirements of the "Measures for the Administration of Drug Registration", we have conducted special safety tests on palonosetron hydrochloride injection such as allergy, hemolysis and local irritation.

[0044] In the guinea pig systemic active allergy test (ASA), 24 FMMU guinea pigs were randomly divided into negative control group, positive control group and palonosetron hydrochloride low and high dose groups (0.019 and 0.058mg / kg. bw, the dosage is converted according to 1 and 3 times of the planned dosage for one clinical intravenous injection respectively). Intraperitoneal injection, once every other day, for three consecutive times. Animals in each group were challenged on the 12th day after the last injection. Results The guinea pigs in the negative control group had no obvious allergic reaction symptoms, all the guinea pigs in the positive control group died, and the guinea pigs in the low and h...

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PUM

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Abstract

The invention discloses an injection of Palonosetron, which comprises medicinal salts of Palonosetron and medicinal auxiliary materials, as well as water for injection, the medicinal auxiliary material being sodium chloride. The concentration of Palonosetron in the injection is 0.01-20mg / ml, preferably 0.05mg / ml, the range of pH of the injection is 6.00-8.00. The preparing process consists of charging a definite quantity of water for injection into raw materials, carrying out hyperfiltration, removing thermal source, filter membrane filtration, encapsulating and sterilizing.

Description

technical field [0001] The invention relates to a stable and simple drug intravenous injection solution, in particular to palonosetron or a pharmaceutically acceptable salt thereof, which uses sodium chloride as an auxiliary material, especially palonosetron hydrochloride as an active ingredient of intravenous fluids. 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. Palonosetron hydrochloride is white or off-white crystalline powder, odorless and tasteless. Dissolved in water, insoluble in ethanol. Palonosetron hydrochloride injection is a colorless or almost colorless clear solution. Palonosetron hydrochloride is the latest efficient and highly selective 5-hydroxytryptamine 3 receptor antagonist developed by Mgi Pharma Inc. of Switzerland and its partner Hnelsinn Healthcare Sa. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/473A61K9/08A61K47/02A61P1/08
Inventor 唐田曲伟张德福吴永福李勇李靖
Owner SHENZHEN NEPTUNUS PHARMA RES INST CO LTD
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