Preparation method of ciclosporin ophthalmic solution

An ophthalmic solution, cyclosporine technology, applied in the direction of cyclopeptide components, pharmaceutical formulations, sensory diseases, etc., to achieve the effect of improving compliance and tolerance, reducing irritation, and good stability

Inactive Publication Date: 2014-03-26
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Oil-based formulations often have many disadvantages, esp

Method used

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  • Preparation method of ciclosporin ophthalmic solution
  • Preparation method of ciclosporin ophthalmic solution
  • Preparation method of ciclosporin ophthalmic solution

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0033] Embodiment 1 cyclosporine ophthalmic solution 1 and its preparation

[0034] The prescription involved in this patent is as follows:

[0035] 1) Prescription:

[0036]

[0037] 2) Preparation method:

[0038] (1) Cyclosporin is added to medium-chain triglycerides to dissolve it;

[0039] (2) add benzalkonium chloride in aqueous phase, make it dissolve;

[0040] (3) Add mannitol to the water phase to dissolve it;

[0041] (4) polyoxyethylene hydrogenated castor oil 40 Add n-butanol and glycerol to the water phase to dissolve them;

[0042] (5) Under stirring, add the oil phase to the water phase and mix well;

[0043] (6) Replenish with water to the full amount, ready to serve.

Embodiment 2

[0044] Embodiment 2 cyclosporine ophthalmic solution 2 and its preparation

[0045] 1) Prescription:

[0046]

[0047] 2) Preparation method:

[0048] (1) Cyclosporin is added to medium-chain triglycerides to dissolve it;

[0049] (2) add benzalkonium bromide in aqueous phase, make it dissolve;

[0050] (3) Add sorbitol to the water phase to dissolve it;

[0051] (4) Add Tween-80, propylene glycol and sodium hyaluronate to the water phase to dissolve them;

[0052] (5) Under stirring, add the oil phase to the water phase and mix well;

[0053] (6) Replenish with water to the full amount, ready to serve.

Embodiment 3

[0054] Embodiment 3 cyclosporine ophthalmic solution 3 and its preparation

[0055] 1) Prescription:

[0056]

[0057] 2) Preparation method:

[0058] (1) Cyclosporin is added to the phthalate to dissolve it;

[0059] (2) add cetrimonium bromide in aqueous phase, make it dissolve;

[0060] (3) Add mannitol to the water phase to dissolve it;

[0061] (4) polyoxyethylene hydrogenated castor oil 40 Add propylene glycol and glycerin to the water phase to dissolve it;

[0062] (5) Under stirring, add the oil phase to the water phase and mix well;

[0063] (6) Replenish with water to the full amount, ready to serve.

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PUM

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Abstract

The invention relates to an ophthalmic solution which comprises ciclosporin. Due to adoption of a micro emulsion technique, the problem of solubility of ciclosporin in water is solved. The ophthalmic solution is applicable to ophthalmic preparations, and has the characteristics of small irritation and good stability. The ophthalmic solution provided by the invention is reasonable in formula and stable in process, and is applicable to industrial production and clinical application.

Description

technical field [0001] The invention relates to an ophthalmic preparation, which is an ophthalmic solution containing cyclosporine and a preparation method thereof. The ophthalmic preparation has little irritation and good stability. Background technique [0002] Cyclosporine is a white or off-white powder, odorless. It is easily soluble in methanol, ethanol or acetonitrile, easily soluble in ethyl acetate, soluble in acetone or ether, and almost insoluble in water. [0003] Molecular formula: C 62 h 111 N 11 o 12 ; [0004] Molecular weight: 1202.63. [0005] [0006] Cyclosporine is a new type of potent immunosuppressant, characterized by high efficiency and low toxicity. It can inhibit the proliferation of T lymphocytes and B lymphocytes, and can selectively affect the immune system to achieve the suppression of the immune system. In addition, cyclosporine also has a variety of biological and physiological activities such as anti-inflammation, anti-infection, a...

Claims

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Application Information

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IPC IPC(8): A61K38/13A61K9/08A61P27/02
Inventor 刘继东唐海杨宇春艾立诚
Owner SHENYANG XINGQI PHARM CO LTD
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