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Topotecan hydrochloride lipidosome nano preparation and preparing method thereof

A technology of topotecan hydrochloride and nano-preparation, applied in the preparation of topotecan hydrochloride liposome nano-preparation, topotecan hydrochloride liposome nano-preparation field, can solve the problem that is not suitable for the treatment of large-scale samples, and the processing capacity is small , will dilute the original liposome and other problems, to achieve the effect of improving distribution in the body, large replacement efficiency, and easy industrial production

Inactive Publication Date: 2015-07-15
SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The problem with these two methods is that the amount of processing is small, which will dilute the concentration of the original liposome, so it is only suitable for a small amount of laboratory applications, not suitable for the processing of large-scale samples

Method used

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  • Topotecan hydrochloride lipidosome nano preparation and preparing method thereof
  • Topotecan hydrochloride lipidosome nano preparation and preparing method thereof
  • Topotecan hydrochloride lipidosome nano preparation and preparing method thereof

Examples

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Embodiment 1 to 12

[0045] Take phospholipids, cholesterol, PEG-DSPE (Shanghai Aiweite Pharmaceutical Technology Co., Ltd., batch number B20204), dissolve them ultrasonically in 5ml of absolute ethanol in a 65°C water bath, inject them into 400ml of gradient regulator aqueous solution preheated to 65°C, The high-speed stirring speed was set at 200-600rpm to obtain the first product, and then homogenized under high pressure at 20,000psi for 4 times to obtain blank liposomes. Filter the blank liposomes through tangential flow, and use deionized water as the replacement liquid to replace the liposomes. After blank liposome extracorporeal water phase, mix with 40ml topotecan hydrochloride aqueous solution (2mg / ml), incubate at a certain temperature for 15min, take it out, let it cool, and obtain it. The types, quantities, and key process parameters of the components of the topotecan hydrochloride liposome nano-preparation in Examples 1 to 12 are operated according to Tables 1, 2, and 3.

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Abstract

The invention provides a preparing method of a topotecan hydrochloride lipidosome nano preparation and the topotecan hydrochloride lipidosome nano preparation prepared by the same, wherein the method comprises the following steps: a), dissolving phospholipid, cholesterol and a modification material in ethanol to obtain an organic phase, injecting the organic phase into an aqueous solution containing a gradient regulator, stirring, and homogenizing to form a blank liposome; b) with adopting of a tangential flow filtration method, utilizing deionized water to replace the ionic gradient regulator in the aqueous phase outside the blank liposome, and thus forming an ion concentration gradient of the aqueous phases inside and outside the blank liposome; c) taking topotecan hydrochloride, mixing with the blank liposome formed in the step b), incubating under a temperature higher than a phospholipid phase transition temperature, and thus obtaining the topotecan hydrochloride liposome nano preparation. The method is simple to operate, has less time-consuming, has the quality easy to control, and is suitable for industrialized mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a preparation method of topotecan hydrochloride liposome nano-preparation and the topotecan hydrochloride liposome nano-preparation prepared by the method. The method is simple in operation, less time-consuming, easy to control in quality, and is suitable for industrial mass production. Background technique [0002] Topotecan (Topotecan, TPT) is a new semi-synthetic derivative of camptothecin, which has curative effects on a variety of tumors, such as non-small cell lung cancer, liver cancer, gastric cancer, blood lymphoma, etc. It is a DNA topoisomerase I Inhibitor of (Topo I), topotecan and its active metabolites cause DNA single-strand breaks through the stable combination with DNA-Topo-1 complex, causing irreversible DNA damage and death. [0003] At present, the domestic marketed product is topotecan hydrochloride injection, which has strong anticancer...

Claims

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Application Information

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IPC IPC(8): A61K9/127A61K31/4745A61P35/00A61J3/00
Inventor 李亚平顾王文许磊磊
Owner SHANGHAI INST OF MATERIA MEDICA CHINESE ACAD OF SCI
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