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Gemcitabine or gemcitabine salt nano-emulsion injecta and preparation method thereof

A technology of gemcitabine and nano-emulsion, which is applied in the field of nano-emulsion injection of gemcitabine or its salt and its preparation, can solve the problem of poor stability of gemcitabine liposomes or nano-microspheres, adverse effects of drug stability and bioavailability, stability It can improve the encapsulation rate and stability, reduce the pain of medication, and reduce the effects of toxic and side effects.

Active Publication Date: 2012-07-25
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

CN101444485B discloses a kind of gemcitabine liposome, and this liposome comprises gemcitabine, phospholipid, cholesterol, but the encapsulation efficiency and dispersibility of this liposome all perform poorly, all have unfavorable to the stability of medicine and bioavailability influences
CN101926779A discloses a gemcitabine solid lipid nanoparticle and a preparation method thereof. The preparation still has the problems of low drug encapsulation efficiency and poor stability, and the drug is partially degraded after storage for about 3 months
[0007] Judging from the current research results, gemcitabine liposomes or nanospheres prepared by existing methods have problems such as poor stability, easy aggregation in aqueous solution, overall erosion or surface degradation, and cannot be practically applied in clinical practice.

Method used

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  • Gemcitabine or gemcitabine salt nano-emulsion injecta and preparation method thereof
  • Gemcitabine or gemcitabine salt nano-emulsion injecta and preparation method thereof
  • Gemcitabine or gemcitabine salt nano-emulsion injecta and preparation method thereof

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Embodiment 1

[0035]

[0036] Preparation method: under the protection of an inert gas, stir 200g of soybean oil for injection to form an oil phase, add 200g of soybean lecithin to 500ml of water for injection, stir to form a water phase, and mix the oil phase and water phase evenly under high-speed stirring , and homogenized by a high-pressure homogenizer to make colostrum, add 10 g of gemcitabine hydrochloride, adjust the pH value to 5.0, add water to set the volume to 1000 ml, and transfer to a high-pressure homogenizer to fully stir until the average particle size is below 40 nm; Packed with nitrogen gas.

Embodiment 2

[0038]

[0039] Preparation method: under the protection of an inert gas, stir 200g of peanut oil for injection to form an oil phase, add 200g of soybean lecithin to 500ml of water for injection, stir to form a water phase, and mix the oil phase and water phase evenly under high-speed stirring. And homogenized by a high-pressure homogenizer to make colostrum, add gemcitabine hydrochloride 10g, adjust the pH value to 5.0, add water to make it 1000ml, transfer it to a high-pressure homogenizer and stir well until the average particle size is below 40nm; filling , Nitrogen-filled packaging.

Embodiment 3

[0041]

[0042] Preparation method: under the protection of an inert gas, stir 200g of sesame oil for injection to form an oil phase, add 200g of soybean lecithin to 500ml of water for injection, stir to form a water phase, and mix the oil phase and water phase evenly under high-speed stirring. And homogenized by a high-pressure homogenizer to make colostrum, add gemcitabine hydrochloride 10g, adjust the pH value to 5.0, add water to make it 1000ml, transfer it to a high-pressure homogenizer and stir well until the average particle size is below 40nm; filling , Nitrogen-filled packaging.

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Abstract

The invention relates to a gemcitabine or gemcitabine salt nano-emulsion injecta and a preparation method of the gemcitabine or gemcitabine salt nano-emulsion injecta. The injecta specifically includes gemcitabine or a gemcitabine salt, oil for injection, a surface active agent and water for injection, wherein the weight ratio of gemcitabine or the gemcitabine salt to the oil for injection to thesurface active agent is 1:(10-100):(10-100), and the average particle size of an emulsion droplet in the emulsion is 1-100nm. The injecta provided by the invention is high in entrapment efficiency and stability and low in side effect.

Description

technical field [0001] The invention relates to a novel preparation of gemcitabine or a salt thereof and a preparation method thereof, in particular to a nanoemulsion injection of gemcitabine or a salt thereof and a preparation method thereof. Background technique [0002] Gemcitabine is a difluoronucleoside antimetabolite anticancer drug that disrupts cell replication. It is a water-soluble analog of deoxycytidine and is an inhibitory substrate for ribonucleotide reductase. , this enzyme is critical for the generation of deoxynucleotides required during DNA synthesis and repair. It has the characteristics of broad anti-tumor spectrum, unique mechanism of action, no cross-resistance with other chemotherapy drugs, and no superposition of toxic reactions. [0003] As a prodrug, gemcitabine is a good substrate for deoxythymidine kinase phosphorylation in the cell, and is converted into the following metabolites under the action of the enzyme: gemcitabine monophosphate (dFdCMP)...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K31/7068A61K47/44A61P35/00
Inventor 宋阳张春红吕爱锋
Owner JIANGSU HANSOH PHARMA CO LTD
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