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A kind of glatiramer acetate microsphere and preparation method thereof

A technology of glatiramer acetate and microspheres, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, peptide/protein components, etc., which can solve frequent problems, achieve stable disease conditions, stable quality, and reduce the frequency of medication.

Active Publication Date: 2016-07-06
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Frequent and long-term administration and its side effects bring a lot of pain and inconvenience to patients
[0006] At present, patents on glatiramer acetate mainly focus on the development and research of its preparation method, such as Chinese patent CN102844325A, US patents 7,495,072 and 7,049,399, but there are few reports on the change of its dosage form

Method used

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  • A kind of glatiramer acetate microsphere and preparation method thereof
  • A kind of glatiramer acetate microsphere and preparation method thereof
  • A kind of glatiramer acetate microsphere and preparation method thereof

Examples

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preparation example Construction

[0059] Another aspect of the present invention provides a method for preparing glatiramer acetate microspheres, the method comprising:

[0060] (1) Add glatiramer acetate and protective agent to water for injection, stir until the drug is completely dissolved, and set aside.

[0061] (2) Weigh the polymer carrier and dissolve it in an organic solvent for use.

[0062] (3) Mix the solutions prepared in steps (1) and (2), and add emulsifiers to prepare W / O colostrum.

[0063] (4) The W / O colostrum in step (3) is added to an aqueous solution containing polyvinyl alcohol to prepare a W / O / W double emulsion.

[0064] (5) Slowly stir the W / O / W double emulsion in step (4), evaporate the organic solvent, and then filter, wash, centrifuge, collect, and freeze-dry to obtain glatiramer acetate microspheres.

[0065] among them

[0066] The protective agent in step (1) is selected from one of mannitol, gelatin, hypromellose (HPMC, viscosity not greater than 10cp), sodium carboxymethyl cellulose (NaCMC...

Embodiment

[0075] In order to further understand the present invention, the present invention will be described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are intended to illustrate and do not limit the present invention.

[0076] Raw materials

[0077] Glatiramer acetate (from Shenzhen Hanyu Pharmaceutical Co., Ltd., batch 20111109)

[0078] PLGA (purchased from Jinan Daigang Biotechnology Co., Ltd.)

[0079] Hypromellose (purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd.)

[0080] Sodium carboxymethyl cellulose (purchased from Anhui Shanhe Pharmaceutical Excipients Co., Ltd.)

[0081] Polyvinyl alcohol (purchased from Xi'an Zaolutang Pharmaceutical Group Rehabilitation Medicine Co., Ltd.)

[0082] Span 80 (purchased from Xi'an Yuelai Pharmaceutical Technology Co., Ltd.)

[0083] Polyvinylpyrrolidone (purchased from Shandong Liaocheng Ahua Pharmaceutical Co., Ltd.)

[0084] Mannitol (purchased from Qingdao Mingyue Sea...

preparation Embodiment 1

[0096] (1) Add 6g glatiramer acetate and 0.5g HPMC to 200ml water for injection, stir to completely dissolve the drug, and set aside.

[0097] (2) Weigh 70g of polymer carrier PLGA (the ratio of lactic acid to glycolic acid is 60:40) and dissolve it in 500ml of dichloromethane.

[0098] (3) Mix the prepared solutions of (1) and (2), add 0.2% (g / ml) Span 80 and stir with a homogenizer to make W / O colostrum.

[0099] (4) Pour the W / O colostrum into 15L of an aqueous solution containing 0.3% (g / ml) polyvinyl alcohol (PVA), and make a W / O / W double emulsion at a rotation speed of 6000r / min.

[0100] (5) Slowly stir the above emulsion for 4 hours, evaporate the organic solvent to prepare semi-solid microspheres, filter, wash 3 times with water, collect by centrifugation (3000r / min), disperse with 100ml of 6% mannitol solution, and freeze dry. 125.65 g of freeze-dried microspheres were obtained.

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Abstract

The invention relates to an acetic acid copaxone microsphere and a preparation method thereof. The preparation method is simple in process, and the encapsulation efficiency of the prepared acetic acid copaxone microsphere is high and stable in quality.

Description

Technical field [0001] The invention relates to a medicinal microsphere and a preparation method thereof, in particular to a glatiramer acetate microsphere and a preparation method thereof. Background technique [0002] Glatiramer acetate (Glatiramer acetate, abbreviated as GA) is the acetate of an artificial peptide, which contains a mixture of four randomly polymerized natural amino acids: L-glutamic acid, L-alanine, L-lysine and L-tyrosine. The average molecular weight of glatiramer acetate is 5,000-9,000 Daltons. [0003] Glatiramer acetate (trade name ) Is developed and manufactured by Israel Teva Pharmaceutical (TEVA) Industry Co., Ltd. It was approved by the US FDA in 1996 for the treatment of multiple sclerosis. There are two products: injection water injection and freeze-dried powder injection, both of which are used for subcutaneous injection. [0004] In Western countries with more multiple sclerosis patients, Both the efficacy and tolerability of the drug have been f...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K38/16A61P25/28A61P37/02
Inventor 王博郑春莲刘建马亚平袁建成
Owner HYBIO PHARMA
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