A temperature-sensitive gel damage repair preparation and its application

A temperature-sensitive, damage-repairing technology that can be used in sensory diseases, aerosol delivery, medical preparations with inactive ingredients, etc.

Active Publication Date: 2021-10-08
FORTUNEROCK (CHINA) CO LTD +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, although the fusion protein injection can ensure the better efficacy of the fusion protein, it is not suitable for external administration, such as dry eye, keratitis, and corneal injury (the general term for cornea and conjunctival injury). Corneal repair after surgery is also It is a common clinical disease that requires drug intervention. At the same time, the administration of skin and epidermis damage is not suitable for injection, and it is suitable for external administration
However, traditional topical administration, such as eye drops and topical skin sprays for the eyes, is in the form of water, and after administration, only a small part of the drug can be absorbed locally, and most of the drug flows with gravity. Non-medication sites, which not only lead to the loss of drug efficacy, but also cause serious waste of drugs, which brings certain difficulties to the evaluation of drug efficacy and the determination of clinical treatment methods

Method used

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  • A temperature-sensitive gel damage repair preparation and its application
  • A temperature-sensitive gel damage repair preparation and its application
  • A temperature-sensitive gel damage repair preparation and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] A kind of preparation formula three containing rHSA / EGF

[0063] In view of the fact that adding glycerol or adding CMC at the same time in Comparative Example 1 and Comparative Example 2 did not significantly improve the stability of the fusion protein, for this reason, glycine plus poloxamer was used as a protein stability and to increase the viscosity of eye drops. The preparation formula excipients, see Table 3 for details.

[0064] Table 3 A formulation three containing rHSA / EGF

[0065]

[0066] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time points for appearance inspection, biological activity measurement and protein electrophoresis detection.

[0067] The results are shown in Table 4.

[0068]

[0069] When testing, the...

Embodiment 2

[0079] A kind of thermosensitive type gel formulation formula five

[0080] In order to achieve the goal that the eye drops are in a liquid state at 0-35°C and in a gel state above 35°C (significantly reducing the fluidity of the eye drops), on the basis of formulation 4, the poloxamer 188 and the consumption of poloxamer 407, specifically see Table 6.

[0081] Table 6 Temperature-sensitive gel preparation formula five

[0082] Component No. name Dosage use 1 rHSA / EGF 0.2mg / mL API 2 Glycine 2% stabilizer 3 Poloxamer 188 6% thickener 4 Poloxamer 407 16.5% thickener 5 100mM PB to a final concentration of 10mM buffer

[0083] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time points...

Embodiment 3

[0086] A kind of temperature-sensitive gel formulation formulation formulation six

[0087] In order to achieve the goal that the eye drops are in a liquid state at 0-35°C and in a gel state (no fluidity) above 35°C, on the basis of formulation five, further adjusting Poloxamer 188 and Poloxamer For the amount of 407, see Table 7 for details.

[0088] Table 7 temperature-sensitive gel preparation formulation formulation six

[0089] Component No. name Dosage use 1 rHSA / EGF 0.2mg / mL API 2 Glycine 2% stabilizer 3 Poloxamer 188 6% thickener 4 Poloxamer 407 18% thickener 5 100mM PB to a final concentration of 10mM buffer

[0090] Prepare 4ml / bottle×10 bottles of samples. According to the method described in Comparative Example 1, it was placed in an accelerated test box with a temperature of 25°C and a humidity of 70% to accelerate the stability inspection for 14 days, and samples were taken according to time poi...

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Abstract

The invention provides a temperature-sensitive gel damage repair preparation and application thereof, belonging to the technical field of biomedical preparations. The preparation includes 0.01-5mg / mL rHSA / EGF, 1.9%-2.6% glycine, 3.9%-6.2% poloxamer 188, 16.3%-18.2% poloxamer 407 and 0.5-100mM PB buffer. As an active ingredient, rHSA / EGF is beneficial to improve the repair of corneal and conjunctival damage, prevent, alleviate and treat dry eye syndrome, and at the same time guide the growth of skin cells and the repair of damaged skin; and the excipients can not only ensure the structural stability of the active ingredient, maintain Drug activity, while keeping the preparation in water form at 0~35°C, and gelatinous at ≥35°C, making the preparation stay longer in the application area, making it easier for the active ingredient to be released slowly, thereby improving the efficacy of the active ingredient Utilization rate, shorten medication time, improve repair speed.

Description

technical field [0001] The invention belongs to the technical field of biomedical preparations, and in particular relates to a temperature-sensitive gel damage repair preparation and its application. Background technique [0002] Dry eye can be called keratoconjunctival sicca (KCS) or xerophthalmia. The tear film instability and ocular surface damage caused by the quantity or quality of tears and abnormal fluid dynamics can lead to ocular symptoms and visual dysfunction, and long-term development can cause corneal epithelial damage. Common symptoms include eye dryness, foreign body sensation, and eye dryness syndrome. The patient's conjunctival goblet cell density decreases, the nucleus-to-plasma ratio increases, epithelial cells become squamous, corneal epithelial conjunctiva, and damage are urgently needed. Eye conjunctiva repair. Dry eye disease is now beginning to rejuvenate, that is, due to the application of computers and mobile phones among young people, a large num...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/38A61K9/06A61K9/08A61K47/18A61P27/02A61P17/02A61K38/18
CPCA61K38/385A61K38/1808A61K9/06A61K9/08A61K9/0048A61K9/0014A61K47/183A61P27/02A61P17/02A61K2300/00
Inventor 于在林富岩杨小楠富俞淞万园侯琼朱涛陈颖
Owner FORTUNEROCK (CHINA) CO LTD
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