Penciclovir freeze dried and method of manufacturing the same

A technology of freeze-dried powder injection and penciclovir is applied in the field of medicine to achieve the effects of solving poor bioavailability, good finished product molding, and ensuring safety and convenience.

Active Publication Date: 2008-01-23
ZHEJIANG JIANFENG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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  • Penciclovir freeze dried and method of manufacturing the same

Examples

Experimental program
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Effect test

Embodiment 1

[0027] Get 250g of penciclovir, dissolve with 5% sodium hydroxide solution until clarification (control pH value 11.0); 100g of low-molecular-weight d-glucoside is prepared into a 10% solution with water for injection, add 0.5% activated carbon, and boil for 30min , cooling and filtering. Mix the above two solutions, add 0.5% activated carbon, stir for 30 minutes, filter, take a sample to measure the content, add water for injection to the specified volume, and measure the pH value. Put the packaged products into the freeze dryer for freeze-drying (the freeze-drying curve is shown in Figure 1), pre-freeze for 3 hours after entering the box, the shelf temperature is -40°C, the product temperature is -25°C, and the vacuum pump is turned on. Sublimation begins, and the temperature of the product during the sublimation stage is controlled at -18°C (the eutectic point of the product is about -9°C). After the water line reaches the bottom, the temperature of the product slowly rises...

Embodiment 2

[0029] Get 300g of penciclovir, dissolve with 5% sodium hydroxide solution to clarification (control pH value 11.0); 120g of low-molecular-weight d-glucoside, first prepare 10% solution with water for injection, add 0.5% active carbon, boil for 30min , cooling and filtering. Mix the above two solutions, add 0.5% activated carbon, stir for 30 minutes, filter, take a sample to measure the content, add water for injection to the specified volume, and measure the pH value. Put the packaged products into the freeze dryer for freeze-drying, and pre-freeze for 4 hours after entering the box. The temperature of the shelf is -45°C, and the temperature of the product is -25°C. Turn on the vacuum pump and the product starts to sublimate. 20°C (the eutectic point of the product is about -9°C), after the water line reaches the bottom, the temperature of the product slowly rises to about 37°C, the temperature of the shelf is 40°C, keep it warm for 10 hours, and press the plug out of the box...

Embodiment 3

[0031] Get 400g of penciclovir, dissolve with 5% sodium hydroxide solution until clarification (controlling pH value 11.0); 160g of low-molecular-weight d-glucoside is prepared into a 10% solution with water for injection, add 0.5% activated carbon, and boil for 30min , cooling and filtering. Mix the above two solutions, add 0.5% activated carbon, stir for 30 minutes, filter, take a sample to measure the content, add water for injection to the specified volume, and measure the pH value. Put the packaged products into the freeze dryer for freeze-drying, and pre-freeze for 5 hours after entering the box. The shelf temperature is -50°C, the product temperature is -30°C, and the vacuum pump is turned on. The product starts to sublime, and the product temperature is controlled at - 20°C (the eutectic point of the product is about -9°C), after the water line reaches the bottom, the temperature of the product slowly rises to about 37°C, the temperature of the shelf is 41°C, keep it w...

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Abstract

The invention relates to the technical field of medical technology, in particular to a penciclovir lyophilized royal jelly powder injection and its preparation method, which comprises penciclovir and excipient. The powder injection is made by making penciclovir into penciclovir sodium salt, add the excipient and then freeze out. The weight ratio of the penciclovir and the excipient is: 1:0.2 to 3; the excipient comprises low molecular dextran. The invention resolves the problem of defective water-solubility in the prior art. Besides, with the freezing out technology and by adding low molecular dextran as the excipient, the invention enhances the solubility and stability of penciclovir, resolves the problem of low biologic utilization rate of penciclovir and ensures the safety and convenience of medication. What is more, the invention also provides the preparation method for the penciclovir lyophilized royal jelly powder injection.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a penciclovir freeze-dried powder injection and a preparation method thereof. Background technique [0002] Penciclovir (molecular formula: C 10 h 15 N 5 o 3 ) is a nucleoside antiviral drug. It has inhibitory effect on type I and type II herpes simplex virus in vitro. In virus-infected cells, viral thymidine kinase (TK) phosphorylates this product into penciclovir monophosphate, and then the cellular kinase Converts penciclovir monophosphate to penciclovir triphosphate. In vitro experiments show that penciclovir triphosphate and deoxyguanosine triphosphate competitively inhibit herpes simplex virus polymerase, thereby selectively inhibiting herpes simplex virus DNA synthesis and replication. [0003] The prodrug (prodrug) of penciclovir (PCV) is famciclovir (FCV), which is converted into PCV with antiviral activity through enzymatic action in vivo. At present, it has bee...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/522A61K47/36A61P31/12
Inventor 蒋晓萌黄金龙施存元
Owner ZHEJIANG JIANFENG PHARM CO LTD
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