A kind of octreotide acetate freeze-dried powder injection and preparation method thereof

A technology of octreotide acetate and freeze-dried powder injection, which is applied in freeze-dried delivery, powder delivery, pharmaceutical formulation and other directions, can solve problems such as excessive bacterial and impurity content, and achieve improved resolubility, good therapeutic effect, and good biocompatibility Effect

Active Publication Date: 2019-12-31
国药集团成都信立邦生物制药有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The problem to be solved by the present invention is technical problems such as excessive bacteria and impurity content easily occurring in the existing octreotide acetate freeze-dried powder injection

Method used

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  • A kind of octreotide acetate freeze-dried powder injection and preparation method thereof
  • A kind of octreotide acetate freeze-dried powder injection and preparation method thereof
  • A kind of octreotide acetate freeze-dried powder injection and preparation method thereof

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Embodiment 1-4

[0029] A kind of octreotide acetate freeze-dried powder injection and preparation method thereof, comprises the steps:

[0030] (1) Under the protection of nitrogen, add mannitol into water, stir and dissolve evenly, then add carboxymethyl chitosan and hydroxypropyl-β-cyclodextrin, stir and dissolve evenly to obtain solution I;

[0031] (2) Under the protection of nitrogen, add octreotide acetate into solution I, stir and dissolve evenly, add acetic acid and glycinamide, adjust the pH of the solution to 4.5, and obtain solution II;

[0032] (3) In a sterile room, filter solution II with a 10nm ultrafiltration membrane under nitrogen protection, then fill it into a vial under nitrogen protection, and freeze-dry under vacuum conditions: pre-freeze at -50°C for 2 hours, The first drying at -15°C for 6 hours and the second drying at 28°C for 8 hours gave octreotide acetate freeze-dried powder injection.

[0033] Using the same preparation method, 4 groups of octreotide acetate fr...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and particularly relates to an octreotide acetate lyophilized powder injection and a preparation method thereof. The octreotide acetate lyophilized powder injection includes carboxymethyl chitosan and hydroxypropyl-beta-cyclodextrin, and a pH buffering agent is acetic acid and glycinamide. The carboxymethyl chitosan can inhibit thegrowth of bacteria in a product; hydroxypropyl-beta-cyclodextrin can improve the resolubility of the product, and can play the role of a lyophilization protectant together with mannitol to improve the stability of the product; In addition, the carboxymethyl chitosan and hydroxypropyl-beta-cyclodextrin can form a weak gel in a solution, which plays a role in sustained release of octreotide acetate. The octreotide acetate lyophilized powder obtained by the invention has low bacteria and impurities content, and the stability and resolubility are also superior to that of the traditional products.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an octreotide acetate freeze-dried powder injection and a preparation method thereof. Background technique [0002] Freeze-dried powder injection is to add raw materials to some excipients and solvents in a sterile environment, dissolve them through a series of processing, and then freeze-dry the solution to obtain dry and sterile powder preparations, which can maximize the Maintain the performance of the raw material; used for subcutaneous injection, and can avoid the defects of decreased drug stability and drug reduction caused by the patient's gastrointestinal environment when taken orally, so it is widely used in the field of medicine. [0003] Octreotide acetate freeze-dried powder injection is usually a kind of drug obtained by dissolving octreotide acetate in water, adding a freeze-drying protective agent, a pH regulator, etc., and then freeze-drying it. Injecti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/08A61K9/19A61K47/36A61K47/40A61K47/26A61K47/12A61K47/18A61P35/00
Inventor 孙杰
Owner 国药集团成都信立邦生物制药有限公司
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