Cyclosporins A emulsion preparations for eyes and preparation thereof

A technology of cyclosporine and cyclosporine, which is applied in the direction of medical preparations containing active ingredients, cyclic peptide components, and pharmaceutical formulas, and can solve problems such as high process requirements

Inactive Publication Date: 2008-08-20
南京医科大学附属南京第一医院
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation method is a shear-high-pressure homogenization process, which requires relatively high process requirements and has no additional effects

Method used

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  • Cyclosporins A emulsion preparations for eyes and preparation thereof
  • Cyclosporins A emulsion preparations for eyes and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] A

[0048] Preparation method: Weigh each component according to the composition of the prescription, and follow the operation steps as 1) steam distill 100g of chrysanthemum or 60g of honeysuckle, collect 1000ml of distillate, separate the upper oily liquid, concentrate the remaining liquid to 400ml, and mix with the oily liquid Mix well; 2) Put hydroxypropyl methylcellulose (HPMC) into appropriate amount of water, heat to 80-90°C, stir, disperse and cool to room temperature; 3) Add appropriate amount of chrysanthemum and honeysuckle concentrate to HPMC solution 4) Dissolve cyclosporine A in the oil phase; 5) Mix evenly with emulsifier and glycerin; 6) Slowly add the mixture obtained in 3) to the obtained cyclosporin A mixture , ultrasonic shear emulsification, 1 to 5 minutes; 7) Use a pH regulator to adjust the pH value to 7.2 to 7.8; 8) Add the prescribed amount of purified water to make up to a sufficient amount, and then filter it with a 0.45um sterile...

Embodiment 2

[0050] A

[0051] Preparation method: weigh each component according to the composition of the prescription, steam distill 50g of chrysanthemum and 20g of honeysuckle according to step 1), collect 1000ml of distillate, separate the upper oily liquid, concentrate the remaining liquid to 400ml, and mix well with the oily liquid ,; 2) Put hydroxypropyl methylcellulose (HPMC) into an appropriate amount of water, heat to 80-90°C, stir, disperse and cool to room temperature; 3) Add appropriate amount of chrysanthemum and honeysuckle concentrate to the HPMC solution, Mix well and set aside; 4) Dissolve cyclosporin A in the oil phase; 5) Mix evenly with emulsifier and glycerin; 6) Slowly add the mixture obtained in 3) to the obtained cyclosporine A mixture, and ultrasonically Shear emulsification, 1-5 minutes; 7) Use a pH regulator to adjust the pH value to 7.2-7.8; 8) Add the prescribed amount of purified water to make up to a sufficient amount, and then filter through a...

Embodiment 3

[0053] A

[0054] Preparation method: weigh each component according to the composition of the prescription, steam distill 50g of chrysanthemum and 20g of honeysuckle according to step 1), collect 1000ml of distillate, separate the upper oily liquid, concentrate the remaining liquid to 400ml, and mix well with the oily liquid ,; 2) Put hydroxypropyl methylcellulose (HPMC) into an appropriate amount of water, heat to 80-90°C, stir, disperse and cool to room temperature; 3) Add appropriate amount of chrysanthemum and honeysuckle concentrate to the HPMC solution, Mix well and set aside; 4) Dissolve cyclosporin A in the oil phase; 5) Mix evenly with emulsifier and glycerin; 6) Slowly add the mixture obtained in 3) to the obtained cyclosporine A mixture, and ultrasonically Shear emulsification, 1-5 minutes; 7) Use a pH regulator to adjust the pH value to 7.2-7.8; 8) Add the prescribed amount of purified water to make up to a sufficient amount, and then filter through a...

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Abstract

The invention provides a cyclosporine A emulsion preparation for eye use, which is characterized in that the components and the proportion of the weight of contents are: cyclosporine A: 0.05 to 0.5%; cellulose thickening agent: 0.3 to 2%; chrysanthemum or the extract with honeysuckle: 0.3 to 6%; oil phase: 0.25 to 7.0%; solubilizing agent emulsifier: 0.1 to 5.0%; glycerol: 1 to 4%; pH adjuster: proper amount; the allowance is purified water. The preparation method comprises the following steps: the cellulose thickening agent is added into water of proper amount, heated to 80 to 90 DEG C and stirred, dispersed and cooled to ambient temperature; the chrysanthemum or the extraction with honeysuckle is added to the cellulose solution, mixed well for later use; the cyclosporine A is dissolved in the oil phase; the mixed liquid is added to the obtained cyclosporine mixed liquid; then the ultrasonic, shearing and emulsification is made for 1 to 5 minutes; the pH value is adjusted to 7.2 to 7.8 by the pH adjuster; after the prescription amount of purified water is added to the full dose, finished product is obtained.

Description

technical field [0001] The invention relates to the field of medicine and its preparation, in particular to an ophthalmic emulsion preparation and a composite emulsion preparation of cyclosporin A and a preparation method thereof. Background technique [0002] Cyclosporin A is a non-polar cyclic oligopeptide with immunosuppressive activity, mainly used for anti-rejection therapy of autoimmune diseases and organ suppression. Cyclosporine can selectively inhibit immunocompetent cells, especially T lymphocytes. It has the effect of inhibiting the production of lymphokines, γ-interferon, interleukin-2, and the release of T cell growth factors; as described in US Patent No. 4,839,342; cyclosporine is effective in the treatment of dry corneas with immunoregulatory causes This condition is effective in patients with conjunctivitis (KCS or dry eye). Cyclosporin A is the main component of a group of cyclosporine polypeptides. Generally speaking, commercially available cyclosporine ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K38/13A61K47/44A61P27/02A61P37/02A61K36/35
Inventor 肖大伟钱薇
Owner 南京医科大学附属南京第一医院
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