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Nano ganciclovir freeze-drying preparation for injection and preparation method thereof

A technology of ganciclovir and freeze-dried preparations, applied in the field of ganciclovir nanocapsule freeze-dried preparations for injection and their preparation, can solve the problems of vascular tissue irritation and other problems, achieve elimination of vascular irritation, increase absorption, The effect of reducing toxic side effects

Active Publication Date: 2013-10-09
上海华源药业(宁夏)沙赛制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Ganciclovir is insoluble in water and dissolves in sodium hydroxide solution. The pH value of the existing injection is about 12, which is strongly alkaline and is more irritating to vascular tissue. Therefore, the preparation of ganciclovir nanocapsules for injection is freeze-dried Preparations have important clinical significance

Method used

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  • Nano ganciclovir freeze-drying preparation for injection and preparation method thereof
  • Nano ganciclovir freeze-drying preparation for injection and preparation method thereof
  • Nano ganciclovir freeze-drying preparation for injection and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0032] 1. Preparation of ganciclovir nanocapsule lyophilized preparation for injection (3000ml volume)

[0033] Prescription: ganciclovir 250g, dextran 4010g, hydroxypropyl-β-cyclodextrin 30g, polyethylene glycol-polylactic acid block copolymer (number average molecular weight 1000) 60g, mannitol 30g, sodium sulfite 1g, water for injection Set the volume to 3000ml.

[0034] Preparation:

[0035] ⑴Preparation: After treating the containers and pipes used for dosing, wash them with water for injection; wash vials and rubber stoppers according to conventional methods, sterilize them, and dry them for later use.

[0036] (2) Dosing: Add 80% of the prescription amount of water for injection (2400ml) into the liquid mixing tank (temperature 50-60°C), first weigh the prescribed amount of dextran 40, solubilizer, and sodium sulfite into the liquid mixing tank, and stir until dissolved Weigh the ganciclovir of prescription quantity, add in the above-mentioned liquid medicine, stir unti...

Embodiment 2

[0076] 1. Preparation of ganciclovir nanocapsule lyophilized preparation for injection (3000ml volume)

[0077] Prescription: ganciclovir 250g, dextran 4015g, hydroxypropyl-β-cyclodextrin 40g, polyethylene glycol-polylactic acid block copolymer (number average molecular weight 1000) 70g, mannitol 60g, sodium sulfite 3g, water for injection Set the volume to 3000ml.

[0078] Preparation:

[0079] ⑴Preparation: After treating the containers and pipes used for dosing, wash them with water for injection; wash vials and rubber stoppers according to conventional methods, sterilize them, and dry them for later use.

[0080] (2) Dosing: Add 80% of the prescription amount of water for injection (2400ml) into the liquid mixing tank (temperature 50-60°C), first weigh the prescribed amount of dextran 40, solubilizer, and sodium sulfite into the liquid mixing tank, and stir until dissolved ; Weigh the ganciclovir of prescription quantity, add in the above-mentioned medicinal liquid, stir...

Embodiment 3

[0105] 1. Preparation of ganciclovir nanocapsule lyophilized preparation for injection (3000ml volume)

[0106] Prescription: Ganciclovir 125g, dextran 4020g, hydroxypropyl-β-cyclodextrin 20g, polyethylene glycol-polylactic acid block copolymer (number average molecular weight 2000) 40g, mannitol 40g, sodium sulfite 2g, water for injection Set the volume to 3000ml.

[0107] Preparation:

[0108] ⑴Preparation: After treating the containers and pipes used for dosing, wash them with water for injection; wash vials and rubber stoppers according to conventional methods, sterilize them, and dry them for later use.

[0109] (2) Dosing: Add 80% of the prescription amount of water for injection (2400ml) into the liquid mixing tank (temperature 50-60°C), first weigh the prescribed amount of dextran 40, solubilizer, and sodium sulfite into the liquid mixing tank, and stir until dissolved ; Weigh the ganciclovir of prescription quantity, add in the above-mentioned medicinal liquid, stir...

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Abstract

The invention discloses a nano ganciclovir freeze-drying preparation for injection and a preparation method thereof. The nano ganciclovir freeze-drying preparation for injection comprises the following components in parts by weight: 100-400 parts of ganciclovir, 10-50 parts of dextran 40, 5-50 parts of solubilizer, 10-100 parts of nano carrier material and 10-80 parts of freeze-drying skeleton agent. The preparation method comprises the following steps of: sequentially adding dextran 40, solubilizer, ganciclovir, nano carrier material and freeze-drying skeleton agent into water for injection to be dissolved, filtering a solution step by step, and carrying out freeze-drying, thus a freeze-drying preparation is obtained. According to the preparation method, no activated carbon is introduced, thus a risk that damage is done to a human body when activated carbon particles are introduced into the preparation as the activated carbon is used is avoided; besides, pH of the nano ganciclovir freeze-drying preparation for injection is 6-8 and close to that of plasma, and local irritation produced to the human body owning to overhigh alkalinity is avoided.

Description

technical field [0001] The invention relates to a ganciclovir nanocapsule freeze-dried preparation for injection and a preparation method thereof. Background technique [0002] Ganciclovir (GCV), whose chemical name is 9-(1,3-dihydroxy-2-propoxy)-guanine, is a guanosine derivative and is a broad-spectrum anti-herpes virus drug, especially The activity against human cytomegalovirus is particularly strong, and it has become the drug of choice for the prevention and treatment of cytomegalovirus infection. The principle is that GCV is rapidly phosphorylated by virus-encoded protein kinase (thymidine kinase, TK) to monophosphate GCV after entering the cell, and then generates diphosphate and triphosphate GCV through the action of cellular kinase. GCV triphosphate exerts its antiviral effect by inhibiting viral replication by competitively inhibiting viral DNA polymerase and incorporating into viral DNA chains to block the elongation of viral DNA. Ganciclovir is insoluble in wat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/522A61K47/40A61K47/34A61P31/22
Inventor 芦莉娜刘伟强
Owner 上海华源药业(宁夏)沙赛制药有限公司
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