CN110327404A - A kind of xerophthalmia moisturizing spray and preparation method thereof - Google Patents

A kind of xerophthalmia moisturizing spray and preparation method thereof Download PDF

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Publication number
CN110327404A
CN110327404A CN201910625180.5A CN201910625180A CN110327404A CN 110327404 A CN110327404 A CN 110327404A CN 201910625180 A CN201910625180 A CN 201910625180A CN 110327404 A CN110327404 A CN 110327404A
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xerophthalmia
ingredient
moisturizing spray
moisturizing
preserving moisture
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CN110327404B (en
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周铁丽
方人驰
曹建明
陈涛
张秀彩
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Wenzhou Medical University
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/726—Glycosaminoglycans, i.e. mucopolysaccharides
    • A61K31/728—Hyaluronic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
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    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents

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Abstract

The present invention provides a kind of xerophthalmia moisturizing spray, the moisturizing spray mainly includes replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer reparation ingredient, Osmolyte regulator and pH buffer, and the moisturizing spray of every 100 parts by weight includes each component of following parts by weight: replenishing water and preserving moisture ingredient: 0.01 part ~ 0.1 part；Inflammation inhibitor: 0.1 part ~ 0.3 part；Ulcer reparation ingredient: 0.15 part ~ 0.3 part；Osmolyte regulator: 0.6 part ~ 0.9 part；Surplus is ultrapure water, and adjusts pH value to 7.0 ~ 7.5 using pH buffer.The present invention also provides the preparation methods of the moisturizing spray.Moisturizing spray of the invention is exclusively used in alleviating and treating xerophthalmia related symptoms, it passes through dedicated atomization moisturizing instrument, generate micron order atomized drop mild and moist eyeball position, replenishing water and preserving moisture ingredient therein can long time retaining water content, alleviate xerophthalmia symptom, ingredient is safe and non-toxic, and irritation is small, and user's compliance is higher.

Description

A kind of xerophthalmia moisturizing spray and preparation method thereof
Technical field
The present invention relates to eye health protection fields, and in particular to a kind of xerophthalmia moisturizing spray and preparation method thereof.
Background technique
Xerophthalmia is the decline of the tear film stability as caused by many reasons, while with ophthalmic uncomfortable and (or) ocular tissue The general name of a variety of diseases of lesion characteristics.The cardinal symptom of xerophthalmia includes that the dry and astringent tired, eye of eyes has strong foreign body sensation, pain It is burning heat sensation, fear of wind, photophobia, very sensitive etc. to environmental stimuli；More severe case eyes meeting redness, hyperemia, keratinization, corneal epithelium are broken Pi Eryou filiform sticks, and with the passing of time this damage can then cause angle conjunctive disorder, and will affect eyesight.
Under normal circumstances, the therapeutic strategy of xerophthalmia has:
1. eliminating inducement: should be avoided for a long time using computer, contact the dry eyes inducement such as air-conditioning and smoke and dust environment less；Meibomian gland function Energy obstacle person should be noted that cleaning eyelid, using antibiotic etc..
2. the replacement therapy of tear component: applying autoserum or artificial tears, severe patient should be as far as possible using without anti- The artificial tears of rotten agent.
3. extending tear in the residence time of ocular: wet room mirror, silica gel eyeshade, therapeutic corneal contact lens etc. can be worn.
4. other: avoiding taking the drug that can reduce lacrimal secretion, such as hypotensor, antidepressants, atropine analog Deng；The type for having immune factor to participate in can add with immunosuppressor or short-term local use hormone；Operative treatment etc..
Patent CN1456167A provides a kind of artificial tears containing phosphatide, and patent CN1651090A provides one kind and contains There is the ophthalmic administration transmission system of trehalose and Hyaluronic Acid, above therapeutic strategy, which passes through to instill in patient's eye, to play a role, And many patients have a significant discomfort sense to the dropwise addition process of eyedrops and artificial tears in actual operation, patient compliance compared with Difference.It is caused in addition, the ophthalmic administration that current many can be used for xerophthalmia lacks while eyes being kept to moisten while treating xerophthalmia Ophthalmic injuries effect.
Summary of the invention
In order to solve the above technical problems, the present invention provides the xerophthalmia moisturizing sprays that one kind can cooperate atomization moisturizing instrument to use Mist agent has powerful replenishing water and preserving moisture ability, can keep eyeball surface wet for a long time, reduction of patient dry eye symptoms, together When patient's use process will not generate irritation.
In order to solve the above technical problems, the technical solution used in the present invention is: a kind of xerophthalmia moisturizing spray, the guarantor Wet spray agent mainly includes that replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer repair ingredient, Osmolyte regulator and pH buffer, often The moisturizing spray of 100 parts by weight includes each component of following parts by weight:
Replenishing water and preserving moisture ingredient: 0.01 part ~ 0.1 part；
Inflammation inhibitor: 0.1 part ~ 0.3 part；
Ulcer reparation ingredient: 0.15 part ~ 0.3 part；
Osmolyte regulator: 0.6 part ~ 0.9 part；
Surplus is ultrapure water, and adjusts pH value to 7.0 ~ 7.5 using pH buffer.
Further, the replenishing water and preserving moisture ingredient is hyaluronic acid or macrodex.
Further, the inflammation inhibitor is aloe extract or dipotassium glycyrrhizinate.
Further, it is allantoin that the ulcer, which repairs ingredient,.
Further, the Osmolyte regulator is sodium chloride.
Further, the Osmolyte regulator further includes potassium chloride and/or calcium chloride, the potassium chloride and/or calcium chloride with The mass ratio of sodium chloride is 1:10 ~ 15.
Further, the pH buffer is phosphate buffer.
The present invention also provides the preparation method of the xerophthalmia moisturizing spray, preparation process is as follows:
A. it sterilizes to all containers,
B. replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer are mixed and repairs ingredient and Osmolyte regulator,
C. ultrapure water will be added in the mixture in step B to 100 parts by weight, using phosphate buffer adjust pH value to 7.0 ~ 7.5, dissolution is sufficiently stirred under normal temperature and pressure.
The attainable beneficial effect of institute of the invention is:
1. the present invention be free of pungent, administration mode mildly safety, patient be not likely to produce conflict psychology, while can be long when Between keep eyeball wet, alleviate the malaise symptoms of xerophthalmia.
2. major function of the present invention is to keep eye to moisten, but its effective component also has anti-inflammatory, analgesic, antianaphylactic work With, while accelerating skin and cell migration, play the role of a series of ophthalmic injuries caused by treating xerophthalmia.
3. the raw materials used in the present invention is easy to get, preparation is simple, prescription proportion science, easy to promote and utilize and safe and reliable, right Human body is nonirritant.
Specific embodiment
Following case study on implementation is used to explain the present invention, and however, it is not limited to this.Wherein used hyaluronic acid, chlorination Sodium, allantoin etc. are as being commercial product without clearly stating.
The present invention provides a kind of moisturizing spray for xerophthalmia, the moisturizing spray mainly include replenishing water and preserving moisture at Divide, inflammation inhibitor, ulcer reparation ingredient, Osmolyte regulator and pH buffer, the moisturizing spray of every 100 parts by weight include such as The each component of lower parts by weight:
Replenishing water and preserving moisture ingredient: 0.01 part ~ 0.1 part；
Inflammation inhibitor: 0.1 part ~ 0.3 part；
Ulcer reparation ingredient: 0.15 part ~ 0.3 part；
Osmolyte regulator: 0.6 part ~ 0.9 part；
Surplus is ultrapure water, and adjusts pH value to 7.0 ~ 7.5 using pH buffer.
Wherein, the replenishing water and preserving moisture ingredient is hyaluronic acid or macrodex.The inflammation inhibitor is aloe extraction Object or dipotassium glycyrrhizinate.It is allantoin that the ulcer, which repairs ingredient,.The Osmolyte regulator is sodium chloride.The Osmolyte regulator It further include potassium chloride and/or calcium chloride, the mass ratio of the potassium chloride and/or calcium chloride and sodium chloride is 1:10 ~ 15.The pH Buffer is phosphate buffer.
The present invention also provides the preparation method of the xerophthalmia moisturizing spray, preparation process is as follows:
A. it sterilizes to all containers,
B. replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer are mixed and repairs ingredient and Osmolyte regulator,
C. ultrapure water will be added in the mixture in step B to 100 parts by weight, using phosphate buffer adjust pH value to 7.0 ~ 7.5, dissolution is sufficiently stirred under normal temperature and pressure.
The present invention provides a kind of xerophthalmia moisturizing spray, which is different from the hand of existing treatment xerophthalmia Section, but after the atomization by being atomized moisturizing instrument, eyeball position is leniently moistened with micron order drops.It is wrapped in the present invention The ingredient validity contained is through scientific validation, and formula is not identical with other patent family products, replenishing water and preserving moisture ingredient (hyalomitome Acid, macrodex) moisture can be locked for a long time, and moisture is absorbed from air, play moisture-keeping function；Its inflammation inhibitor (aloe extract, dipotassium glycyrrhizinate) can inhibit the development and antiallergy of inflammation；Its ulcer is repaired ingredient (allantoin) and is accelerated The reparation of cellular damage promotes cell growth, cutin-softening albumen, antiulcer；The adjustable intraor extracellular of its Osmolyte regulator Osmotic pressure prevents cell dehydration；Above at subassembly novel and unique, it can be cooperateed with from many aspects after scientific matching and alleviate dry eyes Disease symptom.
The present invention is specifically described with specific embodiment below.
Embodiment 1
A kind of preparation method of xerophthalmia moisturizing spray, the moisturizing spray include hyaluronic acid, aloe extract, allantois Element, sodium chloride, phosphate buffer.
The 100g spray is prepared, weighs each component by following weight:
Hyaluronic acid: 0.01g
Aloe extract: 0.2g
Allantoin: 0.25g
Sodium chloride: 0.9g
Add pure water to 100g,
And pH to 7.0 ~ 7.5 is adjusted using appropriate phosphate buffer.
Wherein preparation process is as follows:
A. it is sterilized in advance to all containers of preparation moisturizing spray,
B. it weighs above each raw material and mixes,
C. it is 100g that ultrapure water to gross mass, which is added, abundant under normal temperature and pressure using phosphate buffer adjusting pH to 7.0 ~ 7.5 Stirring and dissolving.
Embodiment 2
A kind of xerophthalmia moisturizing spray, the moisturizing spray include macrodex, dipotassium glycyrrhizinate, allantoin, sodium chloride, Phosphate buffer.
The 100g spray is prepared, weighs each component by following weight:
Macrodex: 0.03g
Dipotassium glycyrrhizinate: 0.3g
Allantoin: 0.2g
Sodium chloride: 0.7 part
Add pure water to 100g, and adjusts pH to 7.0 ~ 7.5 using appropriate phosphate buffer.
Wherein preparation process is as follows:
A. it is sterilized in advance to all containers of preparation moisturizing spray,
B. it weighs above each raw material and mixes,
C. it is 100g that ultrapure water to gross mass, which is added, abundant under normal temperature and pressure using phosphate buffer adjusting pH to 7.0 ~ 7.5 Stirring and dissolving.
Embodiment 3
A kind of xerophthalmia moisturizing spray, the moisturizing spray include hyaluronic acid, dipotassium glycyrrhizinate, allantoin, sodium chloride, chlorine Change potassium, calcium chloride, phosphate buffer.
The 100g spray is prepared, weighs each component by following weight:
Hyaluronic acid: 0.08g
Dipotassium glycyrrhizinate: 0.1g
Allantoin: 0.3g
Sodium chloride: 0.6g
Potassium chloride: 0.02g
Calcium chloride: 0.03g
Add pure water to 100g, and adjusts pH to 7.0 ~ 7.5 using appropriate phosphate buffer.
Wherein preparation process is as follows:
A. it is sterilized in advance to all containers of preparation moisturizing spray,
B. it weighs above each raw material and mixes,
C. it is 100g that ultrapure water to gross mass, which is added, abundant under normal temperature and pressure using phosphate buffer adjusting pH to 7.0 ~ 7.5 Stirring and dissolving.
Embodiment 4
A kind of xerophthalmia moisturizing spray, the moisturizing spray include macrodex, aloe extract, allantoin, sodium chloride, Potassium chloride, phosphate buffer and pure water.
The 100g spray is prepared, weighs each component by following weight:
Macrodex: 0.1g
Aloe extract: 0.15g
Allantoin: 0.15g
Sodium chloride: 0.55g
Potassium chloride: 0.05g
Adding pure water to gross mass is 100g, and adjusts pH to 7.0 ~ 7.5 using appropriate phosphate buffer.
Wherein preparation process is as follows:
A. it is sterilized in advance to all containers of preparation moisturizing spray,
B. it weighs above each raw material and mixes,
C. it is 100g that ultrapure water to gross mass, which is added, abundant under normal temperature and pressure using phosphate buffer adjusting pH to 7.0 ~ 7.5 Stirring and dissolving.
Embodiment 5
A kind of xerophthalmia moisturizing spray, the moisturizing spray include hyaluronic acid, aloe extract, allantoin, sodium chloride, chlorine Change calcium phosphate buffer and pure water
The 100g spray is prepared, weighs each component by following weight:
Hyaluronic acid: 0.05g
Aloe extract: 0.25g
Allantoin: 0.27g
Sodium chloride: 0.75g
Calcium chloride: 0.05
Add pure water to 100g, and adjusts pH to 7.0 ~ 7.5 using appropriate phosphate buffer.
Wherein preparation process is as follows:
A. it is sterilized in advance to all containers of preparation moisturizing spray liquid,
B. it weighs above each raw material and mixes,
C. it is 100g that ultrapure water to gross mass, which is added, abundant under normal temperature and pressure using phosphate buffer adjusting pH to 7.0 ~ 7.5 Stirring and dissolving.
Application method:
It takes appropriate moisturizing spray to be placed in atomization moisturizing instrument, it is wet that atomization can be carried out after booting to eyeball.
56 are recruited with xerophthalmia or because excess eye-using causes the volunteer of the malaise symptoms such as the dry and astringent, inflammation of eyes to participate in Effect experience.The experience and record that eyeball is wet, after the record instant use of volunteer and after being used for a long time are carried out according to the above method.
Following table is the staining effect of commercially available artificial tears and the embodiment of the present invention:
As can be seen from the above table, the moisturizing spray of the embodiment of the present invention replenishing water and preserving moisture effect, using irritation in terms of Better than similar-type products in the market.
Embodiment described in the invention is merely for exemplary purpose, the protection scope being not intended to limit the invention, Those skilled in the art can be made within the scope of the invention various other replacements, changes and improvements, thus, the present invention is not limited to Above embodiment, and be only defined by the claims.

Claims (8)

1. a kind of xerophthalmia moisturizing spray, which mainly includes that replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer are repaired Multiple ingredient, Osmolyte regulator and pH buffer, which is characterized in that the moisturizing spray of every 100 parts by weight includes following parts by weight Each component:
Replenishing water and preserving moisture ingredient: 0.01 part ~ 0.1 part；
Inflammation inhibitor: 0.1 part ~ 0.3 part；
Ulcer reparation ingredient: 0.15 part ~ 0.3 part；
Osmolyte regulator: 0.6 part ~ 0.9 part；
Surplus is ultrapure water, and adjusts pH value to 7.0 ~ 7.5 using pH buffer.
2. xerophthalmia moisturizing spray according to claim 1, which is characterized in that the replenishing water and preserving moisture ingredient is hyalomitome Acid or macrodex.
3. xerophthalmia moisturizing spray according to claim 1, which is characterized in that the inflammation inhibitor is aloe extraction Object or dipotassium glycyrrhizinate.
4. xerophthalmia moisturizing spray according to claim 1, which is characterized in that it is allantois that the ulcer, which repairs ingredient, Element.
5. xerophthalmia moisturizing spray according to claim 1, which is characterized in that the Osmolyte regulator is sodium chloride.
6. xerophthalmia moisturizing spray according to claim 5, which is characterized in that the Osmolyte regulator further includes chlorination The mass ratio of potassium and/or calcium chloride, the potassium chloride and/or calcium chloride and sodium chloride is 1:10 ~ 15.
7. xerophthalmia moisturizing spray according to claim 1, which is characterized in that the pH buffer is phosphate-buffered Liquid.
8. the preparation method of the described in any item xerophthalmia moisturizing sprays of claim 1-7, preparation process are as follows:
A. it sterilizes to all containers,
B. replenishing water and preserving moisture ingredient, inflammation inhibitor, ulcer are mixed and repairs ingredient and Osmolyte regulator,
C. ultrapure water will be added in the mixture in step B to 100 parts by weight, using phosphate buffer adjust pH value to 7.0 ~ 7.5, dissolution is sufficiently stirred under normal temperature and pressure.
CN201910625180.5A 2019-07-11 2019-07-11 Xerophthalmia moisturizing spray and preparation method thereof Active CN110327404B (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112336870A (en) * 2020-12-03 2021-02-09 温州医科大学 Sustained-release system with synergistic effect of various vitamins in eyes and preparation method thereof

Citations (1)

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US20160312176A1 (en) * 2015-04-22 2016-10-27 Grape King Bio Ltd. Cordyceps cicadae mycelium active substances, preparation method, pharmaceutical composition and application thereof

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US20160312176A1 (en) * 2015-04-22 2016-10-27 Grape King Bio Ltd. Cordyceps cicadae mycelium active substances, preparation method, pharmaceutical composition and application thereof

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顾其胜 主编: "《玻璃酸钠生产与临床应用》", 31 May 2012, 上海：上海科学技术出版社 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112336870A (en) * 2020-12-03 2021-02-09 温州医科大学 Sustained-release system with synergistic effect of various vitamins in eyes and preparation method thereof

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