Leuprorelin medicinal composition injection type hypodermic implantation agent

A technology of leuprolide and implants, applied in the directions of drug combination, drug delivery, hydrocarbon compound active ingredients, etc., can solve problems such as body damage, poor patient compliance, etc.

Inactive Publication Date: 2016-05-04
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Ordinary implants need to be implanted with a small local incision through surgery, but the surgery will cause greater damage to the body, and the patient's compliance is poor

Method used

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  • Leuprorelin medicinal composition injection type hypodermic implantation agent
  • Leuprorelin medicinal composition injection type hypodermic implantation agent
  • Leuprorelin medicinal composition injection type hypodermic implantation agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Get 0.7g PLGA (20000 Daltons), join in appropriate amount of dichloromethane, stir and make it dissolve completely, make 2% PLGA organic solution, with 0.08g pharmaceutical composition (leuprolide: ginsenoside rh2=1 : 1) Add to the organic solution, spray dry at 25°C, 0.3MPa to prepare microcapsules; dissolve Poloxamer 407 (30,000 Daltons) in water at a low temperature of 5°C to fully swell to a solution state to make a hydrogel solution; adding microcapsule powder into the hydrogel solution, mixing evenly, adding trehalose, and freeze-drying to prepare a leuprolide pharmaceutical composition injection-type subcutaneous implant.

Embodiment 2

[0033] Take 1g PLA (30000 Daltons), add it to an appropriate amount of ethyl acetate, stir to make it completely dissolved, and make a 5% PLGA organic solution, mix 0.1g of the pharmaceutical composition (leuprolide: lycopene=4: 1) Add to the organic solution, spray dry at 25°C and 0.3MPa to prepare microcapsules; under the low temperature condition of 5°C, dissolve PLA-PEG-PLA (30,000 Daltons) with water to fully swell to a solution state, Prepare a hydrogel solution; add microcapsule powder into the hydrogel solution, mix evenly, add sorbitol, and freeze-dry to prepare a leuprolide pharmaceutical composition injection-type subcutaneous implant.

Embodiment 3

[0035] Get 4g PLGA (30000 Daltons), join in appropriate amount of dichloromethane, stir to make it dissolve completely, make 10% PLGA organic solution, 0.1g pharmaceutical composition (leuprolide: coix seed oil=2: 1) adding to the organic solution, spraying and drying at 25°C and 0.3MPa to prepare microcapsules; at a low temperature of 10°C, dissolving Poloxamer 407 (50,000 Daltons) in water to fully swell to a solution state, Prepare a hydrogel solution; add microcapsule powder into the hydrogel solution, mix evenly, add trehalose, and freeze-dry to prepare a leuprolide pharmaceutical composition injection-type subcutaneous implant.

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Abstract

The invention relates to a leuprorelin medicinal composition injection type hypodermic implantation agent. The leuprorelin medicinal composition injection type hypodermic implantation agent is characterized in that medicine active ingredients are leuprorelin, plant extract and hormone or resistance hormone active medicine cooperating with leuprorelin; in addition, an implantation agent is injected subcutaneously in a liquid mode, under the effect of the body temperature, the solution is changed into gel, and then the effect of controlled release of multiple sex hormone dependent diseases is exerted. Through the implantation agent prepared through the method, on the one hand, the use amount is reduced while the medicine effect is kept, toxic and side effects are reduced, and medicine use safety and compliance are improved; on the other hand, the medicine is slowly released in the body, and the long-acting effect of treating the sex hormone dependent diseases is achieved.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a leuprolide pharmaceutical composition injection-type subcutaneous implant and a preparation method thereof. Background technique [0002] Leuprorelin (Leuprorelin / Leuprolideacetate, LA), as a gonadotropin-releasing hormone antagonist, is a polypeptide drug that can stimulate the pituitary gland to secrete gonadotropins and induce reproductive organs to produce steroids. Long-term large-scale use will inhibit the secretion of gonadotropins from the pituitary gland and the production of testicular or ovarian steroids, and can treat or alleviate a variety of sex hormone-dependent diseases such as prostate cancer, endometriosis, uterine fibroids, and precocious puberty. [0003] Long-term large-scale medication of LA has hidden dangers of drug accumulation and many side effects, such as allergic-like symptoms, bone pain, feminization of male breasts, cardiovascular dis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/09A61K9/00A61P15/00A61P5/06A61K31/704A61K31/01A61K36/8994A61K36/185A61K31/167A61K31/277A61K31/138A61K31/57A61K31/58A61K36/28A61K31/56A61K31/357A61K31/567A61K31/4196
CPCA61K38/09A61K9/0019A61K9/19A61K31/01A61K31/138A61K31/167A61K31/277A61K31/357A61K31/4196A61K31/56A61K31/567A61K31/57A61K31/58A61K31/704A61K36/185A61K36/28A61K36/8994A61K47/10A61K47/34A61K2300/00
Inventor 支钦李新宇曹演威吴丽芬
Owner SHENZHEN JYMED TECH
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