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Ophthalmic composition, its preparation method and use

一种组合物、眼药的技术，应用在眼科学领域，能够解决不能在白天施用等问题

Inactive Publication Date: 2019-01-11
COMPREHENSIVE DRUG ENTERPRISES +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some tear substitutes are opaque and therefore cannot be applied during the day

Method used

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  • Ophthalmic composition, its preparation method and use
  • Ophthalmic composition, its preparation method and use
  • Ophthalmic composition, its preparation method and use

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0134] Preparation method of ophthalmic composition

[0135] In one embodiment, the preparation method of the ophthalmic composition of the present invention comprises;

[0136] 1) prepare lipid nanodispersion and gel matrix separately,

[0137] Wherein the preparation of the lipid nanodispersion comprises:

[0138] i) mixing an oil phase dispersion containing solid lipids, liquid lipids and an oil phase emulsifier dispersed in an organic solvent with water or an aqueous phase solution containing a water phase emulsifier dissolved in water to obtain a pre-emulsion (preemulsion), the temperature of the oil phase dispersion is preferably 60°C to 90°C, the temperature of the water or aqueous phase solution is preferably 60°C to 90°C, and the mixing time is preferably 3-10 minutes;

[0139] ii) homogenizing the pre-emulsion, the homogenization is preferably carried out in a pressure range of 500-1500 bar for 6-20 cycles;

[0140] iii) removing the organic solvent in the homog...

Embodiment 1

[0170] Embodiment 1: single factor experiment

[0171] To understand how ingredients affect the particle size and PDI of lipid nanodispersions, single factor experiments were performed. On the basis of basic formulations, solid lipids (yellow petrolatum: lanolin = 8:1, w / w), liquid lipids (MCT), surfactants (EPC, poloxamer 188 )concentration.

[0172] Preparation:

[0173] To prepare lipid nanodispersions, high-pressure homogenization was performed. First, solid lipid, liquid lipid (MCT) and EPC composed of yellow petrolatum and lanolin (8:1, w / w) were dissolved in 20 mL of ethanol at 75 °C as the oil phase. Then 100 mL of water (75° C.) containing 0.5% of poloxamer 188 was prepared as the aqueous phase. after using Under the condition of WERKE stirring at 1000rpm, slowly pour the oil phase into the water phase. After 5 minutes of continuous stirring a pre-emulsion was obtained. Nanoemulsions were then prepared by homogenizing the pre-emulsion using an AST homogenizer...

Embodiment 2

[0200] Embodiment 2: the selection of liquid lipid

[0201] The properties of lipid nanodispersions are compared to select better liquid lipids for final formulations. Using the method described above, lipid nanodispersions were prepared using MCT (lipid nanodispersion N) or castor oil (lipid nanodispersion O) with the following formulation:

[0202]

[0203] result:

[0204] Table 6 Properties of lipid nanodispersions N and O

[0205]

[0206] The data in Table 6 shows that the particle size of the formulation prepared with castor oil was much larger than that of the formulation prepared with MCT. Lipid nanodispersion O is therefore less desirable than lipid nanodispersion N. The |zeta potential| of lipid nanodispersion N is much larger than the |zeta potential| of lipid nanodispersion O. Therefore, lipid nanodispersion N generally has better stability compared to lipid nanodispersion O. Such as Figure 4 As shown, Lipid Nanodispersion N (left bottle) has a...

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Abstract

The present invention is directed to an ophthalmic composition, method for preparing the same, and use of the same. The ophthalmic composition includes a mixture of lipid nano-dispersion and gel substrate, wherein the lipid nano-dispersion includes a first lipid, a second lipid, and emulsifier; in which the first lipid exists in form of solid lipid as staring material, and the second lipid exists in form of liquid lipid as staring material. The ophthalmic composition can better reduce the symptoms of dry eye, and is safe, convenient and economical to use, and can be used during daytime without blocking of vision.

Description

technical field [0001] The present invention relates to the field of ophthalmology. In particular, the present invention relates to ophthalmic compositions, processes for their preparation and related uses. Background technique [0002] Dry eye syndrome (DES), also known as keratoconjunctivitis sicca, keratitis sicca, or Xerophthalmia, is a disorder of the tear film caused by tear deficiency or excessive tear evaporation. Common eye diseases. This disorder causes damage to the ocular surface between the eyelids along with ocular symptoms. Typical symptoms of dry eye are dryness, burning and constant irritation. Many people with dry eye may experience mild discomfort without long-term effects. However, if the condition does not improve or becomes severe, eye damage can result, resulting in impaired vision and even blindness. [0003] Current regimens for the treatment of dry eye include avoidance of irritants, stimulation and replacement of tears, increased tear retentio...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/127A61P27/02
CPCA61K9/0048A61K9/06A61K9/1075A61K47/10A61K47/32A61P27/02A61K47/14A61K47/24A61K47/38A61K47/44
Inventor 魏刚李德晃张文见陆伟跃刘耀南林顺潮
Owner COMPREHENSIVE DRUG ENTERPRISES
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