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Recombinant human basic fibroblast growth factor instant gel preparation and preparation method thereof

A technology of fibroblasts and growth factors, applied in the direction of non-active ingredient medical preparations, medical preparations containing active ingredients, drug combinations, etc., can solve the problems of reducing bioavailability and administration cycle, and improve the ease of use Effects of usability and bioavailability, prolonged dosing period, and prolonged residence time

Active Publication Date: 2017-09-15
ZHUHAI ESSEX BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

thereby reducing its bioavailability and dosing cycle

Method used

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  • Recombinant human basic fibroblast growth factor instant gel preparation and preparation method thereof

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Embodiment 1

[0019] This embodiment provides recombinant human basic fibroblast growth factor instant gel preparation, including the following components: recombinant human basic fibroblast growth factor 5.0 mg, carbomer 9400.1 g, hypromellose (E4M) 0.1g, glycerin 0.1g, chlorobutanol 0.001g, appropriate amount of hydrochloric acid solution, add water for injection to 1000ml.

[0020] This embodiment also provides a preparation method of recombinant human basic fibroblast growth factor instant gel preparation, comprising the following steps:

[0021] A1: Add 5.0 mg of recombinant human basic fibroblast growth factor into the container;

[0022] A2: Add 0.1g of glycerin and 0.001g of chlorobutanol, and stir;

[0023] A3: Add 0.1 g of hydroxypropyl methylcellulose (E4M), and stir until a transparent solution is formed;

[0024] A4: Sprinkle carbomer 9400.1g into the container in batches, stir while adding, and keep stirring until the swelling is completely dispersed;

[0025] A5: Add water...

Embodiment 2

[0027] This embodiment provides recombinant human basic fibroblast growth factor instant gel preparation, including the following components: recombinant human basic fibroblast growth factor 30.0mg, carbomer 9400.3g, hypromellose (E4M) 1g, 2.5g glycerin, 0.1g chlorobutanol, appropriate amount of hydrochloric acid solution, add water for injection to 1000ml.

[0028] The preparation method of the instant gel preparation of recombinant human basic fibroblast growth factor provided in this example is the same as that in Example 1.

Embodiment 3

[0030] This embodiment provides recombinant human basic fibroblast growth factor instant gel preparation, including the following components: recombinant human basic fibroblast growth factor 40.0mg, carbomer 94020g, hypromellose (E4M) 50g , 20.0 g of glycerin, 10.0 g of chlorobutanol, an appropriate amount of hydrochloric acid solution, and water for injection was added to 1000 ml.

[0031] The preparation method of the instant gel preparation of recombinant human basic fibroblast growth factor provided in this example is the same as that in Example 1.

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Abstract

The invention provides an instant gel preparation of recombinant human basic fibroblast growth factor, which comprises the following components according to the weight ratio: 5.0×10-3-40×10-3 parts of recombinant human basic fibroblast growth factor, Poloxamer 2‑50 parts. The instant gel preparation of recombinant human basic fibroblast growth factor provided by the invention can prolong the retention time in eyes and improve the bioavailability.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a recombinant human basic fibroblast growth factor instant gel and a preparation method thereof. Background technique [0002] Basic Fibroblast Growth Factor (basic Fibroblast Growth Factor, bFGF) is a single-chain polypeptide composed of 146 amino acids, with a molecular weight of 17KD. biological activity. It is also a normal physiological component of corneal tissue, and it is distributed in all thicknesses of normal corneal tissue. Under normal conditions, bFGF mainly exists in the interstitium in the form of no or low activity. When the cornea is damaged, rFGF can stimulate the proliferation and migration of corneal epithelial cells, accelerate corneal epithelial regeneration and promote wound healing. Clinical trials have shown that bFGF eye preparations can delay and alleviate corneal epithelial reshedding damage to a certain extent. [0003] The dosage forms of reco...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K9/06A61K47/10A61K47/32A61K47/38A61P27/02
Inventor 曲伟许岩杨波方海洲郑赞顺
Owner ZHUHAI ESSEX BIO PHARMA
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