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Medicine composition sustained release micro-sphere preparation for treating osteoporosis and preparing method thereof

A slow-release microsphere preparation and technology of slow-release microspheres, which are applied in drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as no corresponding problems

Inactive Publication Date: 2016-04-20
SHENZHEN JYMED TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there have been combined dosage forms of bisphosphonates or calcitonins and calcium or vitamin D on the market, but as far as teriparatide is concerned, there has not been a corresponding combined dosage form, and teriparatide Peptides are complementary to bisphosphonates, calcitonins, etc. in their mechanism of action. Therefore, teriparatide is now combined with other types of drugs and prepared into injectable sustained-release microspheres , play a long-term sustained-release effect

Method used

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  • Medicine composition sustained release micro-sphere preparation for treating osteoporosis and preparing method thereof
  • Medicine composition sustained release micro-sphere preparation for treating osteoporosis and preparing method thereof
  • Medicine composition sustained release micro-sphere preparation for treating osteoporosis and preparing method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0013] Weigh 20 μg teriparatide, 10 mg alendronate, 5 mg gelatin, 5 mg glycerin, 10 ml 0.5% polyvinyl alcohol solution and dissolve them in distilled water to obtain the inner aqueous phase; weigh 400 mg polylactide and dissolve them in dichloromethane In methane, an oily phase was obtained. First move the water phase into the oil phase, put it on an emulsification disperser at room temperature at a speed of 30000rpm, and emulsify it for 30 seconds, then transfer the obtained W / O emulsion into an aqueous solution of polyvinyl alcohol, place it on an emulsification disperser at a speed of 5000rpm Rotating speed, homogenize the milk for 2 minutes to obtain W / O / W type double emulsion, stir at a low speed of 500rpm at room temperature for 2.5 hours, remove the organic solvent, ultracentrifuge, collect the obtained microspheres, wash with distilled water several times, and then centrifuge again , adding 45 mg of sorbitol, and freeze-drying to obtain sustained-release microspheres o...

Embodiment 2

[0016] Weigh 40 μg teriparatide, 1 mg alendronate, 0.5 mg gelatin, 0.5 mg glycerin, 5 ml 0.5% polyvinyl alcohol solution, dissolve in distilled water to obtain the inner aqueous phase; weigh 10 mg polyglycolide solution In dichloromethane, an oily phase was obtained. First move the water phase into the oil phase, put it on an emulsification disperser at room temperature at a speed of 30000rpm, and emulsify it for 30 seconds, then transfer the obtained W / O emulsion into an aqueous solution of polyvinyl alcohol, place it on an emulsification disperser at a speed of 5000rpm Rotating speed, homogenize the milk for 2 minutes to obtain W / O / W type double emulsion, stir at a low speed of 500rpm at room temperature for 2.5 hours, remove the organic solvent, ultracentrifuge, collect the obtained microspheres, wash with distilled water several times, and then centrifuge again , adding 1.5 mg of mannitol, and freeze-drying to obtain sustained-release microspheres of the pharmaceutical com...

Embodiment 3

[0019] Weigh 10mg teriparatide, 200000IU salmon calcitonin, 30mg gelatin, 30mg glycerin, 20ml0.5% polyvinyl alcohol solution, dissolve in distilled water to obtain the inner water phase; weigh 500mg polylactide-glycolide solution In dichloromethane, an oily phase was obtained. First move the water phase into the oil phase, put it on an emulsification disperser at room temperature at a speed of 30000rpm, and emulsify it for 30 seconds, then transfer the obtained W / O emulsion into an aqueous solution of polyvinyl alcohol, place it on an emulsification disperser at a speed of 5000rpm Rotating speed, homogenize the milk for 2 minutes to obtain W / O / W type double emulsion, stir at a low speed of 500rpm at room temperature for 2.5 hours, remove the organic solvent, ultracentrifuge, collect the obtained microspheres, wash with distilled water several times, and then centrifuge again , adding 30 mg of mannitol, and freeze-drying to obtain sustained-release microspheres of the pharmaceu...

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Abstract

The invention relates to a medicine composition sustained release micro-sphere preparation for treating osteoporosis and a preparing method thereof. The preparation is characterized in that one or more of teriparatide and bisphosphonate, or calcitonin or estrogen are wrapped by a degradable macro-molecule material carrier composed according to a certain proportion, and a sustained release micro-sphere is prepared and used for injection, so that the long-acting sustained release effect is achieved. The sustained release period of the sustained release micro-sphere injection is as long as a few days or a few months, while the number of times for drug use is reduced obviously, complementation of action mechanisms can be achieved by means of the drug combination, adverse drug reaction is reduced, and the preparation is beneficial for clinical treatment.

Description

technical field [0001] The invention relates to the technical field of sustained-release microsphere preparations, in particular to a sustained-release microsphere preparation of a pharmaceutical composition for treating osteoporosis and a preparation method thereof. Background technique [0002] Osteoporosis (Osteoporosis, OP) is a metabolic bone disease that causes bone loss and bone quality decline due to various reasons, resulting in increased bone fragility until fracture occurs. Osteoporosis can be divided into primary and secondary types. Type I primary osteoporosis occurs in postmenopausal women, and type II primary osteoporosis occurs in the elderly. According to survey data, there are about 84 million patients with osteoporosis in my country, and it is estimated that the number will increase to 220 million by the middle of the 21st century, resulting in 1.3-1.6 million fractures. The risk of fractures caused by osteoporosis seriously affects the psychosomatic and ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/29A61K9/19A61K45/06A61P19/10A61K38/23A61K31/565A61K31/663
CPCA61K45/06A61K9/0002A61K9/0019A61K9/1623A61K9/1635A61K9/1647A61K9/19A61K31/565A61K31/663A61K38/23A61K38/29A61K2300/00
Inventor 姚志勇支钦李新宇曹演威周莹
Owner SHENZHEN JYMED TECH
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