Ganirelix acetate injection and preparation method thereof

A technology for ganirelix and injection, which is used in pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. It can reduce the steps and time of liquid preparation, improve product quality and curative effect, and the preparation process is simple and easy to operate.

Pending Publication Date: 2022-06-03
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Chinese patent CN 02823490.1 discloses an injection containing LHRH antagonists. The solubility of LHRH antagonists is increased by adding organic acids and surfactants, but the stability of the preparation is poor, and impurities increase significantly after being placed at 25°C for 6 months
[0004] Chinese patent CN 201880009464.5 discloses a composition for the long-term release of gonadotropin-releasing hormone (GnRH) antagonists and a preparation method thereof, which are prepared into hydrogels, microspheres, and implants by adding thermoplastic polymers and organic solvents. Injection and other dosage forms have achieved long-term drug release, but the preparation process is complicated and the technical requirements are high
[0005] According to the existing technology, the dosing process of ganirelix acetate injection is complicated and the stability is poor during storage at room temperature, and the related substances increase more; at the same time, there is no buffer system in the commercially available products, and the pH value of the preparation is prone to fluctuations

Method used

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  • Ganirelix acetate injection and preparation method thereof
  • Ganirelix acetate injection and preparation method thereof
  • Ganirelix acetate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1: the preparation of ganirelix acetate injection is prepared according to the following proportions:

[0027] Ganirelix acetate: 0.3g

[0028] Sodium chloride: 9.0g

[0029] Phosphoric acid: adjust pH to 4.0

[0030] Disodium hydrogen phosphate: 0.2g

[0031] Add water for injection to: 1000g

[0032] Specifically include the following steps:

[0033] Step 1: Weigh 700g of water for injection, add 9g of sodium chloride and stir until completely dissolved, add 0.2g of disodium hydrogen phosphate, continue to stir until dissolved to obtain an auxiliary material solution;

[0034] Step 2: Weigh 250 g of water for injection, adjust the pH value to 4.0 with phosphoric acid, add 0.3 g of ganirelix acetate to dissolve, and obtain a bulk drug solution;

[0035] Step 3: Mix the raw and auxiliary materials, adjust the pH value to 4.0 with phosphoric acid, and fix the weight to 1000g.

Embodiment 2

[0036] Embodiment 2: the preparation of ganirelix acetate injection is prepared according to the following proportions:

[0037] Ganirelix acetate: 0.4g

[0038] Sodium chloride: 6.0g

[0039] Acetic acid: adjust pH to 4.5

[0040] Sodium acetate: 0.2g

[0041] Add water for injection to: 1000g

[0042] Specifically include the following steps:

[0043] Step 1: Weigh 650g water for injection, add 6g sodium chloride and stir until completely dissolved, then add 0.2g sodium acetate, continue stirring until dissolved to obtain an auxiliary material solution;

[0044] Step 2: Weigh 250 g of water for injection, adjust the pH value to 4.5 with acetic acid, add 0.4 g of ganirelix acetate to dissolve, and obtain a bulk drug solution;

[0045] Step 3: Mix the raw and auxiliary materials, adjust the pH value to 4.5 with acetic acid, and fix the weight to 1000g.

Embodiment 3

[0046] Embodiment 3: the preparation of ganirelix acetate injection is prepared according to the following proportions:

[0047] Ganirelix acetate: 0.5g

[0048] Mannitol: 50g

[0049] Acetic acid: adjust pH to 5.0

[0050] Sodium acetate: 0.4g

[0051] Add water for injection to: 1000g

[0052] Specifically include the following steps:

[0053] Step 1: Weigh 600g of water for injection, add 50g of mannitol and stir until completely dissolved, then add 0.4g of sodium acetate, and continue to stir until dissolved to obtain an auxiliary material solution;

[0054] Step 2: Weigh 250 g of water for injection, adjust the pH value to 5.0 with acetic acid, add 0.5 g of ganirelix acetate to dissolve, and obtain a bulk drug solution;

[0055] Step 3: Mix the raw and auxiliary materials, adjust the pH value to 5.0 with acetic acid, and fix the weight to 1000g.

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Abstract

The invention belongs to the field of pharmaceutical preparations, and discloses a ganirelix acetate injection preparation method, which comprises: weighing 0.6-8% by weight of an osmotic pressure regulator, dissolving in 40-70% by weight of water for injection, adding 0.02-0.05% by weight of a buffer agent, and dissolving to obtain an auxiliary material solution; the preparation method comprises the following steps: weighing 25% by weight of water for injection, regulating the pH value of the water for injection to 4.0-5.5 by using a pH regulator, and then adding 0.03%-0.08% by weight of ganirelix acetate for dissolving to obtain a raw material medicine solution; and mixing the raw material medicine solution and the auxiliary material solution, and adjusting the pH value to 4.0-5.5 to obtain the traditional Chinese medicine composition. The preparation process is simple and easy to operate, liquid preparation steps and time are reduced, and the stability of the ganirelix acetate injection is effectively guaranteed.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a ganirelix acetate injection and a preparation process. Background technique [0002] Ganirelix is ​​a synthetic decapeptide that replaces the amino acids at positions 1, 2, 3, 6, 8, and 10 of natural gonadotropin-releasing hormone (GnRH), and is a GnRH antagonist. The naturally occurring gonadotropin-releasing hormone (GnRH) has high antagonistic activity, which controls the action of gonadotropin-releasing hormone and controls the production and secretion of gonadotropins and sex hormones. Ganirelix acetate, also known as Luteinizing Hormone-releasing Hormone, is used in women undergoing assisted reproductive technology controlled ovarian stimulation regimens to treat infertility in women and to prevent premature luteinizing hormone (LH) peaks. [0003] Chinese patent CN 02823490.1 discloses an LHRH antagonist-containing injection. The solubility of the LHRH antagonis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/09A61K9/08A61K47/04A61K47/02A61K47/12A61K47/18A61K47/26A61P15/08
CPCA61K38/09A61K9/08A61K9/0019A61K47/02A61K47/12A61K47/18A61K47/26A61P15/08
Inventor 张婷婷张伟明唐洋明余品香
Owner HYBIO PHARMA
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