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Ophthalmic pharmaceutical composition containing cyclosporine and preparation method and application thereof

The technology of a composition and cyclosporine is applied in the directions of drug combination, medical preparation of non-active ingredients, drug delivery, etc. Stable, good stability, reasonable prescription effect

Active Publication Date: 2019-09-17
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, especially for topical ophthalmic use, which are unacceptable
[0007] Although the prior art "Preliminary Study on the Preparation and Stability of Cyclosporine A Ophthalmic Microemulsion" and the patent CN103656617 solved the problem of large eye irritation and instability of ophthalmic preparations made of cyclosporine, there are certain impurities , and the use comfort needs to be improved

Method used

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  • Ophthalmic pharmaceutical composition containing cyclosporine and preparation method and application thereof
  • Ophthalmic pharmaceutical composition containing cyclosporine and preparation method and application thereof
  • Ophthalmic pharmaceutical composition containing cyclosporine and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Embodiment 1: cyclosporine ophthalmic solution 1 and its preparation

[0081] 1) Prescription:

[0082]

[0083] 2) Preparation method:

[0084] (1) Mix medium-chain triglycerides, Tween-80 and propylene glycol, and dissolve them to obtain the first product;

[0085] (2) adding cyclosporine to the above-mentioned first product to dissolve it to obtain the second product;

[0086] (3) adding sodium hyaluronate and sorbitol to the water for injection to dissolve it to obtain the third product;

[0087] (4) Add the second product to the third product under stirring, and mix well;

[0088] (5) Replenish it with water for injection to the full amount, ready to use.

Embodiment 2

[0089] Embodiment 2: cyclosporine ophthalmic solution 2 and its preparation

[0090] 1) Prescription:

[0091]

[0092] 2) Preparation method:

[0093] (1) castor oil, polyoxyethylene hydrogenated castor oil 40 Mix with propylene glycol, make it dissolve, obtain the first product;

[0094] (2) adding cyclosporine to the above-mentioned first product to dissolve it to obtain the second product;

[0095] (3) adding glycerin and mannitol to the water for injection to dissolve it to obtain the third product;

[0096] (4) Add the second product to the third product under stirring, and mix well;

[0097] (5) Replenish it with water for injection to the full amount, ready to use.

Embodiment 3

[0098] Embodiment 3: cyclosporine ophthalmic solution 3 and its preparation

[0099] 1) Prescription:

[0100]

[0101]

[0102] 2) Preparation method:

[0103] (1) Medium-chain triglycerides, polyoxyethylene hydrogenated castor oil 40 and polyethylene glycol 400 Mixing and dissolving to obtain the first product;

[0104] (2) adding cyclosporine to the above-mentioned first product to dissolve it to obtain the second product;

[0105] (3) Adding glycerin and sorbitol to the water for injection is dissolved to obtain the third product;

[0106] (4) Add the second product to the third product under stirring, and mix well;

[0107] (5) Replenish it with water for injection to the full amount, ready to use.

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PUM

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Abstract

The invention belongs to the field of medicines and preparations and relates to an ophthalmic pharmaceutical composition containing cyclosporine, a preparation method and application thereof. Specifically, the ophthalmic pharmaceutical composition containing the cyclosporine is prepared from, by weight, 0.01%-0.5% of cyclosporine, 0.2%-0.9% of an oil phase and 0.1%-5.0% of a surfactant. The ophthalmic solution can be stably stored for 24 months, is good in stability and low in impurity content.

Description

technical field [0001] The invention belongs to the field of drugs and preparations, and relates to an ophthalmic pharmaceutical composition containing cyclosporine, a preparation method and application thereof. 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. The molecular formula for cyclosporine is C 62 h 111 N 11 o 12 , the molecular weight is 1202.63, and its structural formula is shown in the following formula A. [0003] [0004] 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 act...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/13A61K9/107A61K47/14A61K47/44A61P27/02A61P29/00A61P31/02A61P31/10A61P33/00A61P37/06
CPCA61K9/0048A61K9/1075A61K38/13A61K47/14A61K47/44A61P27/02A61P29/00A61P31/02A61P31/10A61P33/00A61P37/06
Inventor 刘继东杨强艾立诚孟维旭付乐
Owner SHENYANG XINGQI PHARM CO LTD
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