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Ganciclovir freeze-dry preparation for injection and preparation method thereof

A technology for ganciclovir and freeze-dried preparations, which is applied in the field of ganciclovir freeze-dried preparations for injection and its preparation, can solve the problems of low solubility of ganciclovir, unstable product quality, and high production costs, and achieve The effects of shortening freeze-drying time, increasing hardware investment, and increasing production capacity

Active Publication Date: 2010-05-26
MAANSHAN BBCA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] 2) During the preparation of the liquid medicine, due to the low solubility of ganciclovir, a large amount of sodium hydroxide needs to be added, and the pH value of the liquid medicine should be controlled at 10.5 to 11.5, so that the ganciclovir can be completely dissolved in sodium salt, but Due to the strong alkalinity of the liquid medicine, it is highly irritating during clinical injection, and the patient feels very uncomfortable due to pain.
[0020] 3) The freeze-drying time exceeds 30 hours in the freeze-drying process, the longer the freeze-drying time, the longer the ganciclovir is in the non-dry state, the more unstable the product quality, the greater the energy consumption, and the higher the production cost

Method used

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  • Ganciclovir freeze-dry preparation for injection and preparation method thereof
  • Ganciclovir freeze-dry preparation for injection and preparation method thereof
  • Ganciclovir freeze-dry preparation for injection and preparation method thereof

Examples

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Effect test

Embodiment 1

[0044]The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 50 g of ganciclovir; 100 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.

[0045] Its preparation method is as follows:

[0046] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.

[0047] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6ml ...

Embodiment 2

[0055] The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 250 g of ganciclovir; 200 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.

[0056] Its preparation method is as follows:

[0057] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.

[0058] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6m...

Embodiment 3

[0066] The ganciclovir freeze-dried preparation for injection of the present invention is prepared from the following components: 50 g of ganciclovir; 100 g of hydroxypropyl-β-cyclodextrin; and 2600 ml of water for injection.

[0067] Its preparation method is as follows:

[0068] 1) Weigh the prescribed amount of hydroxypropyl-β-cyclodextrin, add about 1300ml of water for injection, stir until completely dissolved, add activated carbon with a prepared volume of 0.2%, stir for 30 minutes, filter and decarbonize to obtain the filtrate ①.

[0069] 2) Measure about 1000ml of water for injection, adjust the pH value to 9.0-9.5, add the prescribed amount of ganciclovir, stir well, add the filtrate ①stir quickly to dissolve it completely, add water for injection to the full amount, and adjust the pH value to 8.5 ~9.5, filtered through a sterilizing filter to the storage tank, and after the semi-finished product is qualified, it is divided into 10ml control bottles according to 2.6ml...

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PUM

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Abstract

The invention relates to a Ganciclovir freeze-dry preparation for injection, comprising 50-250 parts of Ganciclovir and 100-200 parts of hydroxypropyl-beta-cyclodextrin. The invention also relates to a preparation method of the Ganciclovir freeze-dry preparation for injection. In the preparation process of the Ganciclovir freeze-dry preparation, Ganciclovir freeze-dry preparation can be dissolved into solvent when the pH value is almost neutral to improve the compliance for clinical application; freeze-dry time is shortened to be 22-26 hours, thus improving product quality, saving energy and lowering consumption.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a ganciclovir freeze-dried preparation for injection and a preparation method thereof. Background technique [0002] In recent years, antiviral drugs have gradually developed and have become one of the most eye-catching and active varieties in the domestic and foreign pharmaceutical markets. Antiviral drugs rank second only to antibiotics in the world's anti-infective drug market, and their sales have continued year after year soared. Anti-herpes virus drugs occupy an important position in the anti-viral drug market. In the anti-herpes virus drug market, the current anti-herpes virus drug has been developed to the third generation, and ganciclovir is the second generation anti-herpes virus drug. [0003] Generic name of ganciclovir freeze-dried preparation: ganciclovir for injection; English name: Ganciclovir for Injection; ingredient: ganciclovir; chemical name is 9-(1,3-dihydroxy-2-pr...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61P31/20A61P31/22A61J3/00
Inventor 尹双青刘永宏
Owner MAANSHAN BBCA PHARMA
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