CN112842994A - Preservative-free multi-dose packaged anti-inflammatory eye drops and preparation method thereof - Google Patents

Preservative-free multi-dose packaged anti-inflammatory eye drops and preparation method thereof Download PDF

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Publication number
CN112842994A
CN112842994A CN202110347468.8A CN202110347468A CN112842994A CN 112842994 A CN112842994 A CN 112842994A CN 202110347468 A CN202110347468 A CN 202110347468A CN 112842994 A CN112842994 A CN 112842994A
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mixture
water
inflammatory eye
injection
eye drops
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CN202110347468.8A
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Inventor
童王勇
陈晓忠
陆超
陈敏
吴慧婷
周之寒
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Wenzhou Medical University
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Wenzhou Medical University
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    • A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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    • A61K31/546—Compounds containing 5-thia-1-azabicyclo [4.2.0] octane ring systems, i.e. compounds containing a ring system of the formula:, e.g. cephalosporins, cefaclor, or cephalexine containing further heterocyclic rings, e.g. cephalothin
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Abstract

The invention relates to the technical field of medical pharmacy, and discloses an antiseptic-free multi-dose packaged anti-inflammatory eye drop, which comprises the following components in percentage by weight: 0.001-0.012% (W/V) of bacteriostatic drugs, 0.08-5.2% (W/V) of compound thickening agent, 0.4-3.1% (W/V) of isotonic regulator, a proper amount of ph regulator, and the balance of water for injection, wherein the bacteriostatic drugs are selected from the following components: different from the prior art, the anti-inflammatory eye drop avoids the addition of preservatives, cannot cause eye drop pollution due to microorganism invasion, simultaneously, a plurality of antibacterial drugs are mixed for use, the effect that a human body generates resistance to individual drugs after long-time use is avoided, comfortable experience of a user during use is ensured by means of a proper proportion and a proper isotonic regulator, and the experience effect that irritation is uncomfortable is avoided.

Description

Preservative-free multi-dose packaged anti-inflammatory eye drops and preparation method thereof
Technical Field
The invention relates to the technical field of medical pharmacy, in particular to a preservative-free multi-dose packaged anti-inflammatory eye drop and a preparation method thereof.
Background
With the continuous development of science and technology, most people in the life nowadays need face the display screen every day, because improper using-way makes people's eyes produce excessive fatigue, receives environmental pollution's influence simultaneously, and this has just caused xerophthalmia or chronic conjunctivitis patient and has increased progressively, and anti-inflammatory eye drop can be fine alleviate people's fatigue in the vision, has reduced people's human burden to can alleviate the pain of eye.
However, since the eye drops are used for multiple times, a small amount of microorganisms cannot enter the eye drop bottle when people open the cover, and after the use of the eye drops is finished, the microorganisms can propagate in the eye drop, the eye drops are polluted by the continuous use of people, preservatives are added in most of the current eye drop prescriptions, but the addition of the preservatives can cause harm to human bodies, so that a multi-dose packaged anti-inflammatory eye drop without preservatives and a preparation method thereof are needed, the injury of the eyes can be well relieved, the addition of the preservatives is avoided, and the eye drops are easier to absorb by the human bodies.
Because various antibacterial and anti-inflammatory drugs are added into the eye drops, the sterilization effect is improved, the proper ph value is convenient for human bodies to use, and the activity of eye cells is improved by matching with an isotonic regulator, so that the human bodies are prevented from being injured, and the addition of preservatives is rejected.
Disclosure of Invention
In order to realize the purpose of the preservative-free eye drop, the invention provides the following technical scheme: the anti-inflammatory eye drops in multi-dose package without preservative comprise the following components in percentage by weight: 0.001-0.012% (W/V) of bacteriostatic drugs, 0.08-5.2% (W/V) of compound thickening agent, 0.4-3.1% (W/V) of isotonic regulator, a proper amount of ph regulator and the balance of water for injection, so that the eye-care liquid can achieve good anti-inflammatory and bactericidal effects on eyes during use, avoids a plurality of potential dangers and avoids damaging the eyes.
As optimization, the fungus inhibiting medicines are selected from the following medicines: in order to achieve anti-inflammatory and anti-bacterial effects on the eye, while avoiding resistance of a small number of patients to individual drugs, cefazolin, a mixture of erythromycin and ofloxacin or a mixture of cefradine, roxithromycin and ciprofloxacin or a mixture of cefuroxime, cefaclor, a mixture of azithromycin and moxifloxacin or ceftriaxone, cefoperazone, tetracycline, acetaminophen, indomethacin and naproxen or cefpirome, doxycycline, aspirin, a mixture of naproxen and diclofenac or ibuprofen, nimesulide, rofecoxib and celecoxib.
Preferably, the compound thickener is a composition of carrageenan and guar gum or a composition of sodium carboxymethylcellulose, modified starch and propylene glycol alginate or a composition of gelatin and complex protein, and in order to ensure safer material selection of the eye drop, the material selection avoids industrial synthesis.
As optimization, the isotonic regulator is selected from the following components: the mixture of glucose and sodium chloride or the mixture of phosphate and citrate or the mixture of mannitol, sorbitol and sodium chloride can accelerate the absorption efficiency of human body, so that the ocular cell homeostasis can be realized when the ocular cell is coated with the eye drop.
As optimization, the ph regulator is selected from: the compound fertilizer is characterized by comprising boric acid, a mixture of borax and acetic acid or a mixture of acetic acid and lactic acid or a mixture of tartaric acid and citric acid or a mixture of malic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium hydroxide, and has the effects of being suitable for the survival of human cells and avoiding the harm to human bodies caused by over-high or over-low ph.
Preferably, the water for injection is distilled water or deionized distilled water, and the water is stored at the temperature of 70-80 ℃ in a circulating way, so as to ensure the cleanliness of the eye drop.
A preparation method of antiseptic-free multi-dose packaged anti-inflammatory eye drops comprises the following specific steps:
s1, weighing 80-100ml of water for injection, sterilizing at 121 ℃, standing and cooling to 70-80 ℃, then weighing 0.0004-0.6g of antibacterial drugs, and dispersing the cooled water for injection for later use to obtain liquid A;
s2, weighing 0.08-0.6g of compound thickening agent, adding 8-10ml of injection water for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 2-3min, adding the liquid A to obtain liquid B, and adjusting the osmotic pressure molar concentration to be 240-340 mosmol/kg;
s3, dissolving a pH regulator with water for injection, and slowly adding the pH regulator into the solution B while inclining downwards at 45-50 degrees, wherein the adjusted pH value is 5.5-7.5 to obtain a liquid C;
s4, adding 10-15ml of injection water into the liquid C for constant volume, and then filtering and sterilizing under heat and pressure;
and S5, filling the liquid obtained in the step 4 into an eye drop bottle, and sealing to obtain a finished product.
Preferably, the eyedrop bottle is an LDPE device bottle, the storage capacity is 10-15ml, and the eyedrop bottle is used for better containing eyedrop.
As optimization, the anti-inflammatory eye drops contain no stabilizer or preservative, so that the injury to a human body is avoided.
The invention has the beneficial effects that: the anti-inflammatory eye drops without the preservative and the preparation method thereof are different from the prior art, the anti-inflammatory eye drops avoid the addition of the preservative, when people use the eye drops for many times, the eye drops cannot be polluted due to the invasion of microorganisms, meanwhile, a plurality of antibacterial drugs are mixed for use, the effect that a human body generates resistance to individual drugs after being used for a long time is avoided, the comfortable experience of a user when the eye drops are used is ensured by depending on a proper proportion and a proper isotonic regulator, and the experience effect that the irritation is uncomfortable is avoided.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The anti-inflammatory eye drops in multi-dose package without preservative comprise the following components in percentage by weight: 0.001-0.012% (W/V) of bacteriostatic drugs, 0.08-5.2% (W/V) of compound thickening agent, 0.4-3.1% (W/V) of isotonic regulator, a proper amount of ph regulator and the balance of water for injection, so that the eye-care liquid can achieve good anti-inflammatory and bactericidal effects on eyes during use, avoids a plurality of potential dangers and avoids damaging the eyes.
The fungus inhibiting medicines are selected and used as follows: in order to achieve anti-inflammatory and sterilization of eyes and avoid resistance of a few patients to individual drugs so as to achieve more comprehensive treatment effect, the compound thickening agent is a composition of carrageenan and guar gum or a composition of sodium carboxymethylcellulose, modified starch and propylene glycol alginate or a composition of gelatin and complexing protein, in order to ensure that the material selection of the eye drop is safer, the material selection avoids industrial synthesis, accelerate the absorption effect of the human body of the patient after use, the isotonic regulator is selected from: the absorption efficiency of a human body is accelerated by a mixture of glucose and sodium chloride or a mixture of phosphate and citrate or a mixture of mannitol, sorbitol and sodium chloride, so that the internal environment of eye cells is stable when the eye cells are smeared with the eye drop, and the effect of dehydration wrinkles or water absorption and swelling cracks caused by uneven internal and external pressure of the eye cells is avoided.
The ph regulator is selected from: boric acid, borax and acetic acid mixture or acetic acid and lactic acid mixture or tartaric acid and citric acid mixture or malic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium hydroxide mixture, in order to be suitable for the existence of human cells, avoid the effect of harm to human body caused by too high or too low ph, and simultaneously, in order to rapidly mix various raw materials, improve the treatment effect of the medicine, the water for injection is distilled water or deionized distilled water, and the application circulating storage temperature is 70 ℃ -80 ℃ for storage, in order to ensure the cleanliness of the eye drop and simultaneously avoid the microorganisms in the water for injection from multiplying, the eye drop bottle is an LDPE device bottle, the storage amount is 10-15ml, in order to better hold the eye drop and be convenient for the user to squeeze, the anti-inflammatory eye drop does not contain a stabilizer and a preservative, and avoids the damage to the human body, the eye drop is safer and causes less harm to human body.
A preparation method of antiseptic-free multi-dose packaged anti-inflammatory eye drops comprises the following specific steps:
s1, weighing 80-100ml of water for injection, sterilizing at 121 ℃, standing and cooling to 70-80 ℃, then weighing 0.0004-0.6g of antibacterial drugs, and dispersing the cooled water for injection for later use to obtain liquid A;
s2, weighing 0.08-0.6g of compound thickening agent, adding 8-10ml of injection water for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 2-3min, adding the liquid A to obtain liquid B, and adjusting the osmotic pressure molar concentration to be 240-340 mosmol/kg;
s3, dissolving a pH regulator with water for injection, and slowly adding the pH regulator into the solution B while inclining downwards at 45-50 degrees, wherein the adjusted pH value is 5.5-7.5 to obtain a liquid C;
s4, adding 10-15ml of injection water into the liquid C for constant volume, and then filtering and sterilizing under heat and pressure;
and S5, filling the liquid obtained in the step 4 into an eye drop bottle, and sealing to obtain a finished product.
The first embodiment is as follows:
a preparation method of antiseptic-free multi-dose packaged anti-inflammatory eye drops comprises the following specific steps:
s1, weighing 80ml of injection water, sterilizing at 121 ℃, standing and cooling to 70 ℃, weighing 0.0004g of antibacterial drugs, and dispersing the cooled injection water for later use to obtain liquid A;
s2, weighing 0.08g of compound thickening agent, adding 8ml of water for injection for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 2min, adding the liquid A to obtain liquid B, and adjusting the osmotic pressure molar concentration to 240 mosmol/kg;
s3, dissolving a pH regulator with water for injection, and slowly adding the pH regulator into the solution B while inclining downwards at 45 degrees, wherein the adjusted pH value is 5.5, so as to obtain a liquid C;
s4, adding 10ml of injection water into the liquid C for constant volume, and then filtering and sterilizing under heat and pressure;
and S5, filling the liquid obtained in the step 4 into an eye drop bottle, and sealing to obtain a finished product.
Example two:
a preparation method of antiseptic-free multi-dose packaged anti-inflammatory eye drops comprises the following specific steps:
s1, weighing 90ml of injection water, sterilizing at 121 ℃ and then standing and cooling to 70-80 ℃, then weighing 0.2g of antibacterial drugs, and adding the antibacterial drugs into the cooled injection water for dispersion to obtain liquid A for later use;
s2, weighing 0.3g of compound thickening agent, adding 9ml of water for injection for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 2.4min, adding the liquid A to obtain a liquid B, and adjusting the osmotic pressure molar concentration to 300 mosmol/kg;
s3, dissolving a pH regulator by using water for injection, and slowly adding the pH regulator into the solution B by inclining downwards at 48 degrees, wherein the adjusted pH value is 6, so as to obtain a liquid C;
s4, adding 112ml of injection water into the liquid C for constant volume, and then carrying out filtration and autoclaving sterilization;
and S5, filling the liquid obtained in the step 4 into an eye drop bottle, and sealing to obtain a finished product.
Example three:
a preparation method of antiseptic-free multi-dose packaged anti-inflammatory eye drops comprises the following specific steps:
s1, weighing 100ml of water for injection, sterilizing at 121 ℃ and then standing and cooling to 80 ℃, then weighing 0.6g of antibacterial drugs, and adding the antibacterial drugs into the cooled water for injection to disperse for later use to obtain liquid A;
s2, weighing 0.6g of compound thickening agent, adding 10ml of water for injection for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 3min, adding the liquid A to obtain a liquid B, and adjusting the osmotic pressure molar concentration to 340 mosmol/kg;
s3, dissolving a pH regulator with water for injection, and slowly adding the pH regulator into the solution B by inclining downwards at 50 degrees, wherein the adjusted pH value is 7.5, so as to obtain a liquid C;
s4, adding 15ml of injection water into the liquid C for constant volume, and then carrying out filtration, autoclaving and sterilization;
and S5, filling the liquid obtained in the step 4 into an eye drop bottle, and sealing to obtain a finished product.
In conclusion, the antiseptic-free multi-dose packaged anti-inflammatory eye drop and the preparation method thereof are different from the prior art, the anti-inflammatory eye drop avoids the addition of an antiseptic, when people use the eye drop for multiple times, the eye drop is not polluted due to the invasion of microorganisms, meanwhile, a plurality of antibacterial drugs are mixed for use, the effect that a human body generates resistance to individual drugs after long-time use is avoided, the comfortable experience of a user during use is ensured by means of the proper proportion and the proper isotonic regulator, and the experience effect of uncomfortable irritation is avoided.
The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any person skilled in the art should be able to cover the technical scope of the present invention and the equivalent alternatives or modifications according to the technical solution and the inventive concept of the present invention within the technical scope of the present invention.

Claims (9)

1. A preservative-free multi-dose packaged anti-inflammatory eye drop is characterized in that: the anti-inflammatory eye drops comprise the following components in percentage by weight: 0.001-0.012% (W/V) of bacteriostatic drug, 0.08-5.2% (W/V) of compound thickening agent, 0.4-3.1% (W/V) of isotonic regulator, proper amount of ph regulator and the balance of water for injection.
2. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the fungus inhibiting medicines are selected and used as follows: cefazolin, a mixture of erythromycin and ofloxacin or a mixture of cefradine, roxithromycin and ciprofloxacin or a mixture of cefuroxime, cefaclor, a mixture of azithromycin and moxifloxacin or ceftriaxone, cefoperazone, tetracycline, paracetamol, indomethacin and naproxen or a mixture of cefpirome, doxycycline, aspirin, a mixture of naproxen and diclofenac or ibuprofen, nimesulide, rofecoxib and celecoxib.
3. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the compound thickener is a composition of carrageenan and guar gum or a composition of sodium carboxymethylcellulose, modified starch and propylene glycol alginate or a composition of gelatin and complexing protein.
4. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the osmotic adjusting agent is selected from: glucose and sodium chloride mixture or phosphate and citrate mixture or mannitol, sorbitol and sodium chloride mixture.
5. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the ph regulator is selected from: boric acid, borax and acetic acid mixture or acetic acid and lactic acid mixture or tartaric acid and citric acid mixture or malic acid, sodium dihydrogen phosphate, disodium hydrogen phosphate and sodium hydroxide mixture.
6. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the water for injection is distilled water or deionized distilled water, and the water is stored at the temperature of 70-80 ℃ in a circulating manner.
7. The method for preparing antiseptic-free multi-dose packaged anti-inflammatory eye drops as claimed in claim 1, comprises the following steps:
(1) weighing 80-100ml of water for injection, sterilizing at 121 ℃, standing and cooling to 70-80 ℃, then weighing 0.0004-0.6g of antibacterial drugs, and adding the cooled water for injection to disperse for later use to obtain liquid A;
(2) weighing 0.08-0.6g of compound thickening agent, adding 8-10ml of water for injection for dispersion, adding an isoosmotic adjusting agent, stirring clockwise for 2-3min, adding the liquid A to obtain a liquid B, and adjusting the osmotic pressure molar concentration to be 340 mosmol/kg;
(3) dissolving a pH regulator with water for injection, and slowly adding the pH regulator into the solution B while inclining downwards at 45-50 degrees, wherein the adjusted pH value is 5.5-7.5 to obtain a liquid C;
(4) adding 10-15ml of injection water into the liquid C for constant volume, and then filtering and sterilizing under hot pressure;
(5) and (4) filling the liquid obtained in the step (4) into an eye drop bottle, and sealing to obtain a finished product.
8. The method of claim 7, wherein the anti-inflammatory eye drop is prepared by the following steps: the eye drop bottle is an LDPE device bottle, and the storage capacity is 10-15 ml.
9. The preservative-free multi-dose packaged anti-inflammatory eye drops according to claim 1, wherein: the anti-inflammatory eye drops do not contain stabilizers and preservatives.
CN202110347468.8A 2021-03-31 2021-03-31 Preservative-free multi-dose packaged anti-inflammatory eye drops and preparation method thereof Pending CN112842994A (en)

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CN107753424A (en) * 2017-12-01 2018-03-06 北京诺康达医药科技有限公司 A kind of multiple-unit container anti-inflammatory eye drops without preservative and preparation method thereof
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