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Cyclosporine ophthalmic emulsion and preparation method thereof
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A cyclosporine and ophthalmic technology, applied in the field of cyclosporine ophthalmic emulsion and preparation thereof, can solve the problems of inapplicability and prolong drug release time, and achieve the effects of enhancing effect, increasing retention and prolonging release time
Active Publication Date: 2022-04-08
WUHAN CONFORM PHARMA CO LTD
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Problems solved by technology
This oral preparation has the characteristics of stable release, but it uses microemulsion technology, which does not have the function of prolonging the release time of the drug. At the same time, it is an oral solid preparation and is not suitable for eye administration.
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Embodiment 1
[0026] The cyclosporine ophthalmic emulsion prepared in the present embodiment, by mass percentage: cyclosporine 0.03%, collagen 2.0%, castor oil 1.4%, glycerin 2.2%, anthocyanin 0.06%, polysorbate 80 0.8%, remaining The amount is double distilled water, and the anthocyanins are ginkgo anthocyanins with a purity of 90%.
[0029] S2. Under nitrogen protection, add 80% by weight of double-distilled water, glycerin, and collagen to the mixed solution I, and shear and emulsify at 10,000 rpm at 70°C for 45 minutes to obtain the mixed solution II;
[0030] S3. Dissolve the anthocyanins in the remaining double-distilled water and mix with the mixed solution II, disperse at 60°C and 5500rpm for 100min, adjust the pH to 6.5-8.0, stir for 40min, and fi...
Embodiment 2
[0032] The cyclosporine ophthalmic emulsion prepared in the present embodiment, by mass percentage: cyclosporine 0.05%, collagen 2.5%, castor oil 1.2%, glycerin 2.0%, anthocyanin 0.05%, polysorbate 80 0.9%, remaining The amount is double distilled water, and the anthocyanins are ginkgo anthocyanins with a purity of 90%.
[0033] The preparation method of the cyclosporine ophthalmic emulsion of this embodiment is the same as that of Embodiment 1.
Embodiment 3
[0035] The cyclosporine ophthalmic emulsion prepared in the present embodiment, by mass percentage: cyclosporine 0.05%, collagen 2.5%, castor oil 1.2%, glycerin 2.0%, anthocyanin 0.08%, polysorbate 80 0.9%, remaining The amount is double distilled water, and the anthocyanins are ginkgo anthocyanins with a purity of 88.5%.
[0036] The preparation method of the cyclosporine ophthalmic emulsion of this embodiment is the same as that of Embodiment 1.
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Abstract
The cyclosporine ophthalmic emulsion disclosed by the invention comprises the following components in mass percentage: 0.01-0.05% cyclosporine, 1.5-3% collagen, 1.2-1.5% castor oil, 1.8-2.5% glycerin, and anthocyanins 0.04-0.08%, polysorbate 800.8-1.2%, and the balance is double distilled water. The cyclosporine ophthalmic emulsion is prepared by high-speed dispersion and shear emulsification. The combined use of collagen and anthocyanin in the above emulsion can effectively enhance the sustained release effect of the drug and increase the residual amount of the drug in the cornea.
Description
technical field [0001] The invention belongs to the technical field of ophthalmic drugs, and in particular relates to cyclosporine ophthalmic emulsion and a preparation method thereof. Background technique [0002] Cyclosporine, also known as cyclosporin A (i.e. Cyclosporin A or Cyclosporine, referred to as CsA), is a non-polar cyclic oligopeptidedrug composed of 11 amino acid residues, soluble in organic solvents, almost insoluble in water. It is mainly used clinically for organ transplantation, anti-rejection therapy after bone marrowtransplantation and the treatment of autoimmune diseases. Studies at home and abroad have shown that it plays a role by inhibiting the aggregation of inflammatory cells and the release of inflammatory factors, reducing the infiltration of lymphocytes in lacrimal gland and conjunctival tissue, and inhibiting the apoptosis of ocular surface tissues such as lacrimal gland and conjunctival goblet cells. Sporins can be used as a local immunomod...
Claims
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