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Quinine dihydrochloride injection and preparation method thereof

A technology of quinine dihydrochloride and injection, which is applied in the field of medicine, can solve the problems of easily exceeding the standard of heat source and bacterial content, non-conformance, complicated preparation process, etc., so as to avoid pre-sterilization treatment, save energy consumption, and reduce by-products. Effect

Inactive Publication Date: 2018-11-20
JIANGSU PENGYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation process of traditional quinine dihydrochloride injection is complicated, and the content of heat source and bacteria is easy to exceed the standard, which no longer meets the increasingly stringent standard control

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The quinine dihydrochloride injection consists of the following components in parts by mass: 100 parts of quinine dihydrochloride, 0.05 parts of mannitol, 0.01 part of sodium hydroxide, 0.01 part of maleic acid, 0.03 parts of propylene glycol and 400 parts of water for injection.

Embodiment 2

[0024] The quinine dihydrochloride injection consists of the following components in parts by mass: 100 parts of quinine dihydrochloride, 0.8 parts of mannitol, 0.3 parts of sodium hydroxide, 0.3 parts of maleic acid, 0.5 parts of propylene glycol and 4000 parts of water for injection.

Embodiment 3

[0026] The quinine dihydrochloride injection consists of the following components in parts by mass: 100 parts of quinine dihydrochloride, 0.2 parts of mannitol, 0.08 parts of sodium hydroxide, 0.05 parts of maleic acid, 0.3 parts of propylene glycol and 1800 parts of water for injection.

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PUM

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Abstract

The invention discloses a quinine dihydrochloride injection comprising the following components in parts by mass: 100 parts of quinine dihydrochloride, 0.05-0.8 part of mannitol, 0.01-0.3 part of sodium hydroxide, 0.01-0.3 part of maleic acid, 0.03-0.5 part of propylene glycol and 400-4000 parts of injection water. Moreover, the invention also discloses a preparation method of the quinine dihydrochloride injection. The formula is scientific in design; through the stabilizer propylene glycol, the co-solvent mannitol and the pH adjusters sodium hydroxide and maleic acid, the preparation of the whole formula is more rigorous and the by-products are as less as possible; and by adopting multi-stage temperature control sterilization, the bacteria that possibly be present in the mixed solution are effectively inactivated to meet the quality standards of the injection.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to quinine dihydrochloride injection and a preparation method thereof. Background technique [0002] Quinine is a quinoline derivative that can bind to the DNA of malaria parasites to form a complex, inhibit DNA replication and RNA transcription, thereby inhibiting protozoan protein synthesis, and its effect is weaker than that of chloroquine. In addition, quinine can reduce the oxygen consumption of Plasmodium, inhibit the phosphorylase in Plasmodium and interfere with its glucose metabolism. Quinine also causes agglutination of malarin, but it develops slowly, rarely forms large clumps, and is often accompanied by cell death. Electron microscope observation showed that the nucleus and outer membrane of the protozoa were swollen, and there were small vacuoles, and blood cell particles aggregated in the small vacuoles, which was different from the pigment agglutination of chloro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/49A61K47/10A61K47/02A61K47/12A61L2/04A61P33/06
CPCA61K9/0019A61K9/08A61K31/49A61K47/02A61K47/10A61K47/12A61L2/0023A61P33/06
Inventor 蒋锋周健陈梦琦
Owner JIANGSU PENGYAO PHARMA