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Propylgallate injection, and preparation method and application of propylgallate injection

A technology of injection and propyl gallate, which is applied in the fields of blood diseases, medical formulas, extracellular fluid diseases, etc., can solve problems such as the instability of propyl gallate injection, and achieve stability, small growth of related substances, The effect of increasing production

Active Publication Date: 2017-06-13
SHANDONG WEIZHI BAIKE PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem that the present invention aims to solve is to overcome the defect that propyl gallate injection is usually unstable in the prior art, and provides a kind of propyl gallate injection and its preparation method and application

Method used

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  • Propylgallate injection, and preparation method and application of propylgallate injection
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  • Propylgallate injection, and preparation method and application of propylgallate injection

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Embodiment 1

[0026] Preparation of Propylgallate Injection

[0027] Add 30 L of propylene glycol, 0.4 g of edetate disodium to about 50 L of degassed water for injection, then add 1.2 kg of propyl gallate and mix. Phosphate buffer was added to adjust the pH to about 4.5. Sufficient degassed water for injection was added to make a 1.2% solution (total volume 100 L). Exposure to air was minimized by displacing oxygen with nitrogen. Pass the solution through a 0.2 micron sterile filter. Put the product into a vial or ampoule that minimizes the exposure of oxygen by replacing it with nitrogen to obtain an injection with a residual oxygen content of about 1.5%, and sterilize it at 121°C for 15 minutes.

Embodiment 2

[0029] Preparation of Propylgallate Injection

[0030] Add 40 L of propylene glycol, 0.4 g of edetate disodium to about 50 L of degassed water for injection, then add 1.2 kg of propyl gallate and mix. Phosphate buffer was added to adjust the pH to about 4.5. Sufficient degassed water for injection was added to make a 1.2% solution (total volume 100 L). Exposure to air was minimized by displacing oxygen with nitrogen or other pharmaceutically inert gas. Pass the solution through a 0.2 micron or other sterile filter. Put the product into a vial or ampoule that minimizes the exposure of oxygen by substituting nitrogen or other pharmaceutical inert gas to obtain an injection with a residual oxygen content of about 2%, and sterilize it at 121°C for 15 minutes.

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Abstract

The invention discloses a propylgallate injection, and a preparation method and application of the propylgallate injection. The propylgallate injection comprises the following raw material ingredients: propylgallate, propylene glycol, edetate disodium, a pH (potential of hydrogen) regulator and water for injection, excluding an antioxidant. The preparation method of the propylgallate injection comprises the following steps: (1) adding propylene glycol, edetate disodium and propylgallate into the water for injection, uniformly mixing, then adding the pH regulator till a pH value is 3.0-5.0, (2) purging an injection obtained in step (1) with nitrogen, replacing air, allowing the injection to flow through a sterilization filter, and (3) loading an injection obtained in step (2) into a vial or an ampoule purged by the nitrogen to form an injection with a remaining oxygen content of less than or equal to 5%, and carrying out sterilization. The prepared propylgallate injection can achieve better stability on the premise of not containing the antioxidant.

Description

technical field [0001] The present invention relates to a kind of propyl gallate injection and its preparation method and application. Background technique [0002] Studies have shown that the existing marketed propyl gallate injections have increased related substances, decreased pH values, and unstable injections during storage. Antioxidants (such as sodium bisulfite, sodium metabisulfite, etc.) are added to most injection prescriptions. However, these antioxidants are not stable during storage, and will continuously generate acidic substances to continuously decrease the pH of the preparation. It is not stable in the acidic solution (it is easy to hydrolyze to generate impurities), which causes relatively large side effects of the existing marketed propyl gallate injection. [0003] Therefore, there is an urgent need to find a prescription and a process for producing more stable propyl gallate injection, which can meet the antioxidant requirements of propyl gallate injec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/235A61K47/18A61K47/10A61P9/10A61P7/02A61P9/00
CPCA61K9/0019A61K9/08A61K31/235A61K47/10A61K47/18
Inventor 魏彦君孟勇涛李锋裴晓娜
Owner SHANDONG WEIZHI BAIKE PHARM CO LTD
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