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Ganciclovir injection and preparation process thereof

A ganciclovir, preparation technology, applied in the field of ganciclovir injection and its preparation, can solve the problems of solubility increase, glass flake dissolution, poor solubility, etc., and achieve good compatibility, visible foreign matter and insoluble particles Falling effect

Active Publication Date: 2016-12-07
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the solubility of ganciclovir in water is poor and slightly soluble in water, but the solubility increases with the increase of pH value. The pH value of ganciclovir injection currently on the market is between 10.5 and 11.5.
However, the liquid medicine contained in the glass ampoule often causes the dissolution of the glass flakes, especially the alkaline flakes.

Method used

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  • Ganciclovir injection and preparation process thereof
  • Ganciclovir injection and preparation process thereof
  • Ganciclovir injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] prescription:

[0015]

[0016] crafting process:

[0017] The preparation method is:

[0018] (1) Add 1 / 10 of the amount of ganciclovir sodium hydroxide under stirring with water for injection, stir to dissolve, slowly pour the prescription amount of ganciclovir, and stir to completely dissolve. Adjust the pH to 11.2 with sodium hydroxide.

[0019] (2) Add 0.3% (w / v) activated carbon and stir for 10 minutes, without adding water for injection to the full amount, filter and circulate for 15 minutes, sample and test the content and pH value after passing, then use three-in-one equipment to make plastic PP ampoules and fill ,seal. Sterilize at 115°C for 30 minutes. Pack and inspect the lamp after passing the inspection.

Embodiment 2

[0021] prescription:

[0022]

[0023] The preparation method is:

[0024] (1) Add the prescription amount of sodium hydroxide under stirring with water for injection, stir to dissolve, slowly pour the prescription amount of ganciclovir, and stir to dissolve completely. Adjust the pH to 11.2 with sodium carbonate.

[0025] (2) Add 0.3% (w / v) activated carbon and stir for 10 minutes, without adding water for injection to the full amount, filter and circulate for 15 minutes, sample and test the content and pH value after passing, then use three-in-one equipment to make plastic PP ampoules and fill ,seal. Sterilize at 115°C for 30 minutes. Pack and inspect the lamp after passing the inspection.

Embodiment 3

[0027] prescription:

[0028]

[0029] The preparation method is:

[0030] (1) Add the prescription amount of sodium hydroxide under stirring with water for injection, stir to dissolve, slowly pour the prescription amount of ganciclovir and motherwort A, and stir to dissolve completely. Adjust the pH to 11.2 with sodium carbonate.

[0031] (2) Add 0.3% (w / v) activated carbon and stir for 10 minutes, without adding water for injection to the full amount, filter and circulate for 15 minutes, sample and test the content and pH value after passing, then use three-in-one equipment to make plastic PP ampoules and fill ,seal. Sterilize at 115°C for 30 minutes. Pack and inspect the lamp after passing the inspection.

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Abstract

The invention belongs to the technical field of medicine preparation, and particularly relates to a ganciclovir injection and a preparation process thereof. The ganciclovir injection comprises ganciclovir and a pH modifier. According to the ganciclovir injection, water for injection is adopted as a solvent, and a plastic ampoule is adopted as an inner packaging container in direct contact with the ganciclovir injection. The mechanism that the ganciclovir injection is prone to generate muddy sediment is deeply analyzed and studied, and the essence reason for easily generated unqualified visible foreign matter and increase of insoluble particles is found. Compared with the prior art, when the ganciclovir injection is prepared, a plastic container packaging material is selected, medicine liquid and the packaging material both have good compatibility, and therefore the visible foreign matter and the insoluble particles are remarkably reduced.

Description

Technical field [0001] The invention belongs to the technical field of medicine preparation, and specifically relates to a ganciclovir injection and a preparation process thereof. Background technique [0002] Ganciclovir is the second-generation nucleoside antiviral drug developed by Syntex Pharmaceuticals in the United Kingdom. After the drug enters the cell, the kinase of the virus induces the production of triphosphate, which competitively inhibits the DNA polymerase of the virus and terminates the growth of the viral DNA chain. In recent years, with the continuous deepening of clinical application, ganciclovir has been widely used in various diseases. However, ganciclovir has poor solubility in water and is slightly soluble in water. However, as the pH value increases, the solubility increases. The currently marketed ganciclovir injection has a pH value between 10.5 and 11.5 and is filled in glass ampoules. However, the liquid medicine contained in the glass ampoule often ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/522A61P31/12A61J1/05
Inventor 薛晓霞卢秀莲杜振新袁洪雨
Owner CISEN PHARMA
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