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Ziconotide injection and preparation method thereof

A technology for ziconotide and injection, which is applied in the field of ziconotide injection and its preparation, can solve the problems that the preparation method is not involved, and achieve the effects of easy preservation, pollution reduction and obvious effect.

Pending Publication Date: 2021-12-28
杭州澳亚生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In summary, the existing patent ziconotide injection and its preparation method do not involve

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] In this embodiment, the ziconotide injection comprises:

[0050] Active ingredient Ziconotide 0.025mg / ml

[0051] L-methionine 0.05mg / ml

[0052] Sodium chloride 9mg / ml

[0053] The pH regulator is 0.1mol / L hydrochloric acid / sodium hydroxide solution

[0054] The pH value of the injection is 4.8.

[0055] Its preparation method specifically comprises the following steps:

[0056] (1) Add water for injection of 80% of the batch total volume in the batching tank, add the ziconotide of prescription quantity, stir and dissolve;

[0057] (2) Take L-methionine by recipe quantity, add L-methionine in the batching tank, stir until mixed evenly;

[0058] (3) Take sodium chloride by prescription quantity, add sodium chloride in the batching tank, stir and dissolve to mix evenly, obtain medicinal liquid;

[0059] (4) filtering the medicinal liquid obtained in step (3) through a microporous membrane to obtain a filtrate;

[0060] (5) Add dropwise the hydrochloric acid / sodium...

Embodiment 2

[0064] In this embodiment, the ziconotide injection comprises:

[0065] Active ingredient Ziconotide 0.015mg / ml

[0066] L-methionine 0.025mg / ml

[0067] Sodium chloride 7.5mg / ml

[0068] The pH regulator is 0.1mol / L hydrochloric acid / sodium hydroxide solution

[0069] The pH value of the injection is 4.8.

[0070] The preparation method is as in Example 1.

Embodiment 3

[0072] In this embodiment, the ziconotide injection comprises:

[0073] Active ingredient Ziconotide 0.035mg / ml

[0074] L-methionine 0.1mg / ml

[0075] Sodium chloride 10mg / ml

[0076] The pH regulator is 0.1mol / L hydrochloric acid / sodium hydroxide solution

[0077] The pH value of the injection is 4.8.

[0078] The preparation method is as in Example 1.

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PUM

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Abstract

The invention relates to a ziconotide injection and a preparation method thereof. The injection comprises the following components: 0.015-0.035 mg / ml of an active component ziconotide, 0.025-0.1 mg / ml of an antioxidant, 7.5-10 mg / ml of an osmotic pressure regulator and a pH adjusting agent; and the pH value of the injection ranges from 4.5 to 5.0. The prepared injection is stable in quality, and the preparation method is simple.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a ziconotide injection and a preparation method thereof. Background technique [0002] Ziconotide (Ziconotide) is an N-type calcium channel (N-type calcium channel (NCC)) blocker, which is extracted from a toxin secreted by a fish-eating cone snail (Conus magus) in the South Pacific, containing 25 Amino Acids, Peptide Toxoid Synthesis of Three Pairs of Disulfide Bonds. Ziconotide is a polycationic peptide composed of 25 amino acids, which contains basic amino acids including 4 lysines and 2 arginines; the isoelectric point pI is 11.215, the relative molecular mass is 2639.1, and the chemical molecular formula As follows: H-Cys-Lys-Gly-Lys-Gly-Ala-Lys-Cys-Ser-Arg-Leu-Met-Tyr-Asp-Cys-Cys-Thr-Gly-Ser-Cys-Arg-Ser-Gly- Lys-Cys-NH 2 . The 6 cysteine ​​residues in the molecule play an important role in its pharmacological activity through 3 pairs of disulfide-linked struct...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/17A61K47/02A61K47/18A61K47/20A61K47/26A61P25/04
CPCA61K38/1767A61K9/08A61K9/0019A61K47/02A61K47/26A61K47/20A61K47/183A61P25/04
Inventor 黄少峰谷宜洁金甲张洁萍王新星汪赛红孔丽萍楼新韵
Owner 杭州澳亚生物技术股份有限公司
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