Sustained-release microsphere preparation of goserelin composition

A technology of slow-release microsphere preparation and goserelin, which is applied in the direction of drug combination, medical preparations containing active ingredients, peptide/protein components, etc., to reduce toxic and side effects, improve immunity, and stabilize long-term effective concentration Effect

Inactive Publication Date: 2015-03-25
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The preparation can not only treat cancer patients, but also improve the patient's own immunity and improve the therapeutic effect. At the

Method used

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  • Sustained-release microsphere preparation of goserelin composition
  • Sustained-release microsphere preparation of goserelin composition
  • Sustained-release microsphere preparation of goserelin composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Weigh 36g of goserelin, 48g of thymofasin, appropriate amount of gelatin, glycerin and dissolve in distilled water to obtain the inner water phase; weigh 400g of polyhydroxybutyric acid and dissolve in dichloromethane to obtain the oil phase. Prepare 500ml of polyvinyl alcohol solution with a concentration of 5% and 500ml of polyvinyl alcohol solution with a concentration of 0.5%. First transfer the goserelin and thymofasin solution into the dichloromethane solution dissolved in polyhydroxybutyric acid, place it on an emulsifying disperser at room temperature at a speed of 30,000 rpm for 30 seconds, and then mix the obtained W / O emulsion Transfer to 200ml of polyvinyl alcohol solution with a concentration of 5%, place it on an emulsification disperser at a speed of 5000rpm, and milk for 1 minute to obtain a W / O / W type double emulsion, and transfer it to 500ml of 0.5% polyvinyl alcohol solution , placed on a mechanical stirrer, stirred at a low speed of 500rpm for 2 hour...

Embodiment 2

[0024]Weigh 30 g of goserelin, 50 g of thymopentin, appropriate amount of gelatin, and glycerin and dissolve in distilled water to obtain an inner water phase; weigh 400 g of polyvalerate and dissolve in dichloromethane to obtain an oil phase. Prepare 500ml of polyvinyl alcohol solution with a concentration of 5% and 500ml of polyvinyl alcohol solution with a concentration of 0.5%. First move the goserelin and thymopentin solution into the dichloromethane solution dissolved in polyvaleric acid, place it on an emulsifying disperser at room temperature at a speed of 30,000 rpm for 30 seconds, and then mix the obtained W / O emulsion Transfer to 200ml of polyvinyl alcohol solution with a concentration of 5%, place it on an emulsification disperser at a speed of 5000rpm, and milk for 1 minute to obtain a W / O / W type double emulsion, and transfer it to 500ml of 0.5% polyvinyl alcohol solution , placed on a mechanical stirrer, stirred at a low speed of 500rpm for 2 hours, centrifuged, ...

Embodiment 3

[0031] Weigh 80g of goserelin, 120g of thymopentin, appropriate amount of gelatin, glycerin and dissolve in distilled water to obtain the inner water phase; weigh 400g of polyvalonic acid and dissolve in dichloromethane to obtain the oil phase. Prepare 500ml of polyvinyl alcohol solution with a concentration of 5% and 500ml of polyvinyl alcohol solution with a concentration of 0.5%. First move the goserelin and thymopentin solution into the dichloromethane solution dissolved in polyvaleric acid, place it on an emulsifying disperser at room temperature at a speed of 30,000 rpm for 30 seconds, and then mix the obtained W / O emulsion Transfer to 200ml of polyvinyl alcohol solution with a concentration of 5%, place it on an emulsification disperser at a speed of 5000rpm, and milk for 1 minute to obtain a W / O / W type double emulsion, and transfer it to 500ml of 0.5% polyvinyl alcohol solution , placed on a mechanical stirrer, stirred at a low speed of 500rpm for 2 hours, centrifuged ...

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Abstract

The invention belongs to the field of a pharmaceutical preparation, and relates to a sustained-release microsphere preparation of a goserelin composition and a preparation method of the sustained-release microsphere preparation. Specifically, the goserelin composition includes goserelin and a polypeptide composition capable of enhancing immunity, wherein the polypeptide capable of enhancing immunity comprises thymalfasin, thymopentin and thymosin beta4. The sustained-release microsphere consists of 0.1-40% (w/w) of goserelin and polypeptide capable of enhancing immunity in terms of the total weight of the microsphere, 60-99.9% of a biodegradable and biocompatible high polymer material which is 5,000-200,000Dalton in molecular weight in terms of the weight of the microsphere, and 0-10% of other pharmaceutically acceptable accessories in terms of the weight of the microsphere. The sustained-release microsphere disclosed by the invention is 5-20microns in average grain size and encapsulation efficiency is more than 80%. The sustained-release duration of the sustained-release microsphere can last for several days or several months, so that administration frequency is obviously reduced, bioavailability is improved, the toxic and side effects of medicine are reduced, and the sustained-release microsphere is conducive to clinic treatment. The production process of the finished product is good in reproducibility and good in feasibility.

Description

technical field [0001] The invention relates to the technical field of sustained-release microsphere preparations, in particular to a sustained-release preparation containing goserelin and an immunity-enhancing polypeptide and a preparation method thereof. Background technique [0002] After surgery or during chemotherapy and radiotherapy, many tumor patients are accompanied by decreased immunity and are more likely to be infected with other diseases. Therefore, the current clinical treatment of tumors often needs to be combined with immunomodulators for treatment, but they are administered separately, which is troublesome, and the current clinical immunomodulators do not have sustained and controlled release preparations, goserelin sustained release Implants are administered once every 28 days, and immunomodulators are administered twice a week or multiple times. The sustained-release microspheres of the goserelin composition prepared by the present invention can realize an...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K38/09A61K9/16A61P37/04A61P35/00A61K38/08
Inventor 支钦姚志勇李云开舒遂智徐洲文
Owner SHENZHEN JYMED TECH
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