Sodium ferulate ophthalmic preparation and preparation method thereof

A technology of sodium ferulate and ophthalmic preparations, which is applied in the field of sodium ferulate ophthalmic preparations and its preparation, can solve the problems of complicated Chinese medicine ingredients, inaccurate curative effects, and difficult effective inspection, and achieve single ingredients, good performance, High practical effect

Inactive Publication Date: 2019-11-26
陕西省眼科研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the prior art, plants with ferulic acid as the active component are mostly used as the components of traditional Chinese medicines, which makes the components of traditional Chinese medicines complex, the structure is mixed, the curative effect is not exact, and it is difficult to carry out effective testing

Method used

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  • Sodium ferulate ophthalmic preparation and preparation method thereof
  • Sodium ferulate ophthalmic preparation and preparation method thereof
  • Sodium ferulate ophthalmic preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The eye drops of this embodiment include active ingredients, osmotic pressure protectors, osmotic pressure regulators, pH regulators, viscous agents and bacteriostatic agents, and the solvent is water for injection; see Table 1.

[0041] The eye drops of this embodiment are prepared under aseptic conditions, such as figure 1 Shown, the preparation method is:

[0042] Step 1, dissolving the viscous agent sodium hyaluronate in water for injection, and obtaining solution A after refrigeration;

[0043] Step 2, dissolve the bacteriostatic agent ethyl p-hydroxybenzoate in water for injection under heating conditions, stir, then cool, and add active ingredient sodium ferulate, osmotic pressure protecting agent taurine, The osmotic pressure regulator sodium chloride and the pH regulator sodium bicarbonate obtain solution B;

[0044] Step 3: Mix the solution A described in step 1 with the solution B described in step 2, then add water for injection to 1000 mL, stir evenly, f...

Embodiment 2

[0047] This example is the same as Example 1, except that the osmoprotectant is trehalose, carnitine or betaine, or two of trehalose, taurine, carnitine and betaine. The osmotic pressure regulator is glucose; the pH regulator is sodium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, citric acid, sodium citrate, boric acid or borax, or sodium bicarbonate , sodium hydroxide, sodium dihydrogen phosphate, disodium hydrogen phosphate, citric acid, sodium citrate, boric acid and borax; the antibacterial agent is propyl p-hydroxybenzoate, p-hydroxybenzoic acid methyl esters, benzalkonium chloride, benzalkonium bromide, chlorobutanol, thimerosal, chlorhexidine, benzyl alcohol, or benzoic acid;

[0048] The preparation method of the eye drops of this embodiment is the same as that of Example 1.

[0049] The eye drops in this example have an osmotic pressure of 280mOsm / L-290mOsm / L, and a pH value of 6.5-7.5.

Embodiment 3

[0051] The eye drops of this embodiment include active ingredients, osmotic pressure protectors, osmotic pressure regulators and viscous agents, and the solvent is water for injection; the types and contents of raw materials contained in each 1000mL eye drops are shown in Table 1.

[0052] The eye drops of the present embodiment are prepared under aseptic conditions, and the preparation method is:

[0053] Step 1, dissolving the viscous agent sodium hyaluronate in water for injection, and obtaining solution A after refrigeration;

[0054] Step 2, adding the active ingredient sodium ferulate, the osmotic pressure protecting agent trehalose and taurine, and the osmotic pressure regulator glucose to the water for injection to obtain solution B;

[0055] Step 3: Mix the solution A described in step 1 with the solution B described in step 2, then add water for injection to 1000 mL, stir evenly, filter and sterilize through a microporous membrane, and pack aseptically to obtain eye ...

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Abstract

The invention discloses a sodium ferulate ophthalmic preparation which includes eye drops or ophthalmic gels. In the eye drops or the ophthalmic gels, the concentration of active ingredients is 0.01%w / v-1% w / v, the concentration of an osmotic pressure protective agent is 0.05% w / v-5% w / v, the concentration of an osmotic pressure regulator is 0.1% w / v-1% w / v, the concentration of a pH regulator is0% w / v-1% w / v, the concentration of a viscous agent is 0% w / v-1% w / v, and the concentration of a bacteriostatic agent is 0% w / v-0.5% w / v; and the active component is sodium ferulate. In addition, theinvention further provides a method for preparing the sodium ferulate ophthalmic preparation. The sodium ferulate ophthalmic preparation has anti-oxidation and anti-inflammatory effects, targeted treatment of ocular inflammation, hypertonic osmolality, ocular surface damage, and the like of dry eye disease is realized, and the therapeutic effect on other clinical ocular surface diseases with inflammatory reaction is good.

Description

technical field [0001] The invention belongs to the technical field of ophthalmic preparations, and in particular relates to a sodium ferulate ophthalmic preparation and a preparation method thereof. Background technique [0002] Dry eye disease is a common and frequently-occurring disease in ophthalmology, which seriously affects people's quality of life. The international dry eye workshop (DEWS) II issued by the International Tear Film and Ocular Surface Association (TFOS) in 2017 defines dry eye as a condition characterized by tear film homeostasis imbalance. It is a multifactorial ocular surface disease accompanied by ocular discomfort symptoms, tear film instability, increased tear osmotic pressure, ocular surface inflammatory response and injury, and neurological abnormalities are the main pathophysiological mechanisms. [0003] The chemical name of sodium ferulate is sodium salt of 4-hydroxy 3-methoxycinnamic acid, one of the derivatives of cinnamic acid (also known ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/192A61K9/08A61K9/06A61K47/26A61K47/20A61K47/18A61P27/02
CPCA61K31/192A61K9/0048A61K9/08A61K9/06A61K47/26A61K47/20A61K47/183A61P27/02
Inventor 王养正潘士印赵娜李慧明肖湘华朱秀萍段石顽
Owner 陕西省眼科研究所
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