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Peramivir injection and preparation method thereof

A technology of peramivir and injection, applied in the field of traditional Chinese medicine preparations

Inactive Publication Date: 2011-05-18
天津金世制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Isolation of virus from in vitro cell cultures has not been successful due to its small host range

Method used

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  • Peramivir injection and preparation method thereof
  • Peramivir injection and preparation method thereof
  • Peramivir injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] prescription:

[0064] Preparation method: Take peramivir, dissolve it in the prescribed amount of propylene glycol at 60°C, add the prescribed amount of ethanol, stir well, add some water under stirring, then add sorbitol to dissolve, replenish water to 1000ml, and use sterilized vertical melting Filter with a glass funnel, potting, and obtain 500 tubes of 1ml specification peramivir injection. With the sample prepared by this preparation method, the accelerated stability test (appendix 1) proves that there is good stability under test conditions, and all indicators meet the injection standard (Chinese Pharmacopoeia 2000 edition with IU).

[0065] 3 sticks (1.0mg×2ml) of this injection were added to the 5% glucose infusion and sodium chloride infusion of 250 and 500ml specifications, and no abnormal phenomena such as turbidity appeared. Animal hemolysis test (attachment 4), heat source inspection (according to Chinese Pharmacopoeia 2000 Version 1 Appendix XIII I A),...

Embodiment 2

[0067] prescription:

[0068] Preparation:

[0069] Take the prescribed amount of peramivir, dissolve it in the prescribed amount of ethanol and glycerin at room temperature, stir to dissolve, add part of water for injection, stir well, add glucose, stir to dissolve, add water for injection to 1000ml, filter, pour Seal and sterilize to get 200 5ml specification peramivir injections.

Embodiment 3

[0071] prescription:

[0072] Preparation:

[0073] Take the prescribed amount of peramivir, dissolve it in the mixed solution of ethanol and propylene glycol of the prescribed amount at 40°C, add part of the water under stirring, then add glucose, add water for injection to 1000ml after dissolving, filter, pot, and sterilize , to get 500 piperamivir injections of 2ml specification.

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Abstract

The invention discloses a Peramivir injection and a preparation method thereof. The Peramivir injection is composed of Peramivir, non aqueous solvent, cosolvent and water for injection, wherein the weight measurement ratio (g / ml) of the Peramivir to the non aqueous solvent is 1:(10-100), preferably 1:(15-60); the use ratio of the non aqueous solvent in a prescription is 20-60%(v / v), the use ratio of the cosolvent is 1-20% (w / v), and each injection contains 0.5 or 1.0g / ml of the Peramivir. The Peramivir injection provided by the invention is subjected to an accelerated stability test, an animal hemolysis test, an heat source examination, an irritation test and an irritability test, and all tests indicate that the Peramivir injection completely conforms to the standard. The Peramivir injection has the characteristics of stable quality, quick effect and low toxic or side effect, can be used for avoiding the problems that solvent is feculent, medicaments can not be administrated and the like when the injection is diluted to use clinically, and can satisfy the clinical requirement.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine preparations, and relates to a piperamivir injection preparation, more specifically, a piperamivir injection and a preparation method thereof. Background technique [0002] Hepatitis B virus (HBV) is exclusively hepatotropic Virus , in recent years due to nucleic acid Advances in Molecular Hybridization in Extrahepatic Organs cell HBV-DNA can also be detected. Evidence of replication in extrahepatic cells was provided by experimental studies of HBV in Peking ducks. Human HBV may also replicate in extrahepatic cells, which needs to be further studied. There are three types of virus particles in the serum of HBV-infected patients by electron microscopy: ① Dane particles (HBV particles), the coat protein HBsAg, the core contains HBV-DNA and HBV DNAp (DNA-polymerase), HBcAg, HBeAg; ② small spherical particles; ③ tubular particles . The latter two are excess extraviral (HBs...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/196A61P1/16A61P31/20
Inventor 宋富智
Owner 天津金世制药有限公司