Goserelin implant preparation and preparation method thereof

A technology of implants and preparations, applied in the directions of anti-inflammatory agents, pharmaceutical formulations, non-central analgesics, etc., can solve the problems of sudden drug release phenomenon, complex manufacturing process, high production cost, and achieve a flat release curve and a long release cycle. , The effect of low solvent residue

Pending Publication Date: 2022-03-22
NANJING ANGGU PHARMA TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to solve the problem that the manufacturing process of goserelin implants in the prior art is complicated, the production cost is high, and the drug burst release phenomenon is prone to occur at the end of the release cycle, and the proposed goserelin implants Formulation and its preparation method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] The goserelin implant preparation proposed by the present invention has a raw material ratio of 8 parts of dimethylformamide, 1.5 parts of oxidized proline, 4 parts of dimethyl sulfoxide, and 7 parts of dioxane solution. , 30 parts of lactic acid, 40 parts of glycolic acid, 10 parts of simethicone.

[0025] The preparation method of goserelin implant preparation, the method comprises the following steps:

[0026] S1, placing dimethylformamide and dimethyl sulfoxide in the raw material in a stirrer, and preparing a mixed solvent under neutralization and stirring at a temperature of 0°C;

[0027] S2, suspending the oxidized proline in a mixed solvent, adding dioxane solution, and stirring for 5 minutes to obtain a clear goserelin solution;

[0028] S3, mixing and stirring lactic acid 1 and glycolic acid in the raw materials to obtain a mixed solution;

[0029] S4, injecting simethicone into the mixture, agglomerating to form microsphere embryos;

[0030] S5, transferri...

Embodiment 2

[0034] The goserelin implant preparation proposed by the present invention has a raw material ratio of 7 parts of dimethylformamide, 0.8 parts of oxidized proline, 3 parts of dimethyl sulfoxide, and 4 parts of dioxane solution. , 11 parts of lactic acid, 24 parts of glycolic acid, 7 parts of simethicone.

[0035] The preparation method of the goserelin implant preparation is the same as in Example 1.

Embodiment 3

[0037] The goserelin implant preparation proposed by the present invention has a raw material ratio of 8 parts of dimethylformamide, 0.9 parts of oxidized proline, 2.7 parts of dimethyl sulfoxide, and 4 parts of dioxane solution. , 15 parts of lactic acid, 22 parts of glycolic acid, 4 parts of simethicone.

[0038] The preparation method of the goserelin implant preparation is the same as in Example 1.

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PUM

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Abstract

The invention discloses a goserelin implant preparation and a preparation method thereof.The implant preparation is prepared from, by weight, 3-8 parts of dimethylformamide, 0.8-1.5 parts of oxidized proline, 2-4 parts of dimethyl sulfoxide, 3-7 parts of dioxane solution, 10-30 parts of lactic acid, 20-40 parts of glycolic acid and 3-12 parts of dimeticone. The goserelin sustained-release microsphere is low in solvent residue and has a long-acting sustained-release effect, and the goserelin sustained-release microsphere is fused with a goserelin solution, so that the goserelin sustained-release microsphere has the effects of small burst release effect, smooth release curve, long release period and the like.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a goserelin implant preparation and a preparation method thereof. Background technique [0002] Implants are a kind of sterile solid preparations made of drugs and auxiliary materials for value into the body. Implants are generally implanted into the body using a special syringe, or they can be implanted by surgical incision. The released drug is absorbed directly into the blood circulation through subcutaneous absorption or cavity absorption, thus avoiding the first-pass effect, high bioavailability, and a long acting time, even up to several years. Goserelin is currently the most researched drug. Gonadotropin-releasing hormone analogues are widely used in the treatment of premenopausal patients with hormone receptor-positive breast cancer. The drug acts as a medical castrate, reducing the patient's estrogen to postmenopausal levels. Goserelin is indicated for many diseases,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/09A61K9/08A61P35/00A61P15/00A61P29/00
CPCA61K38/09A61K9/08A61K47/34A61P35/00A61P15/00A61P29/00
Inventor 程浩杨松靳志红
Owner NANJING ANGGU PHARMA TECH
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