CN102579334A - Nasal drops containing sodium hyaluronate and preparation method thereof - Google Patents

Nasal drops containing sodium hyaluronate and preparation method thereof Download PDF

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Publication number
CN102579334A
CN102579334A CN2012100952570A CN201210095257A CN102579334A CN 102579334 A CN102579334 A CN 102579334A CN 2012100952570 A CN2012100952570 A CN 2012100952570A CN 201210095257 A CN201210095257 A CN 201210095257A CN 102579334 A CN102579334 A CN 102579334A
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CN
China
Prior art keywords
sodium
nasal drop
hyaluronic acid
water
glycerol
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Pending
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CN2012100952570A
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Chinese (zh)
Inventor
李诗标
牛凤菊
许翠萍
张梅雪
张为胜
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Jinan Kangzhong Pharmaceutical Research and Development Co Ltd
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Jinan Kangzhong Pharmaceutical Research and Development Co Ltd
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Priority to CN2012100952570A priority Critical patent/CN102579334A/en
Publication of CN102579334A publication Critical patent/CN102579334A/en
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Abstract

The invention provides nasal drops containing sodium hyaluronate and a preparation method thereof. The nasal drops in a formula comprise the sodium hyaluronate, glycerol, a Ph value buffer agent, an osmotic pressure regulator, a preservative and water. The preparation method comprises the steps of: dissolving the sodium hyaluronate in water according to the basic composition and amount of the formula, adding the glycerol, sodium chloride, the Ph value buffer agent, the preservative and a pharmacological active substance, replenishing water to a set volume, filtering through a millipore filter for sterilization, and performing split packaging to obtain the nasal drops containing the sodium hyaluronate. The nasal drops are mainly used for treating seasonal allergic rhinitis and is free from toxicity and side effect and obvious in curative effect.

Description

Contain nasal drop of hyaluronic acid sodium and preparation method thereof
Technical field
The present invention relates to a kind of nasal drop, be specifically related to nasal drop of hyaluronic acid sodium and preparation method thereof, belong to medical technical field.
Background technology
Hyaluronic acid sodium (SH) claim hyaluronate sodium again; Be extensively to be present in the intravital biological active substances of animal and human; Being to repeat crosslinked and a kind of macromolecule aminoglycan that form by N-acetylglucosamine and D-glucuronic acid, is the main component that constitutes extracellular matrix and intercellular stroma.Along with deepening continuously of research, find the conjugated protein and receptor of SH ability, all bringing into play important effect aspect generation, reparation, cell regulate and control and the angiogenesis of tissue, therefore, SH is in the field of medicaments extensive use.The application of SH in medicine at present is following.
Application in field of ophthalmology: the corneal epithelium wound healing, SH has been developed to into promoting the medicine of corneal wound healing in the treatment xerophthalmia, like SH sodium eye drop at present.Because the SH intramolecularly can be possessed numerous hydrones, thereby has excellent water-retaining property, can protect cornea moist; In cataract operation, SH is used to keep operative space at present, the protection endothelial layer.
Application in the orthopaedics field: osteoarthritis is used for the intra-articular injection treatment osteoarthritis with SH as the articular cartilage protective agent, and obtains good efficacy.Rheumatoid arthritis, the patient carries out joint cavity injection SH, 1 time weekly; Continuous 5 weeks; Clinical parameters such as level to arthralgia, inflammation, synovial fluid volume and several kinds of chemical substances carry out tracking and measuring then, and the result shows the significantly improvement of each item index, and sb.'s illness took a favorable turn.
The application of surgical field: cystitis, SH is to bladder mucosa epithelium healing and to the effect of bladder fiber.The capacity of finding bladder in the treatment group increases to some extent, and the epithelial defect area reduces to some extent.Find also simultaneously that SH can promote the bladder mucosa epithelial wound healing but suppress the growth of bladder fiber.Tissue adhesion, application of SH prevent that tissue adhesion from starting from the nineties in 20th century, and a large amount of experiments and clinical practice show, the biosystem that the adhesion of SH scalable forms, prevention and minimizing postoperative tissue adhesion.
Preserving moisture and protecting skin function: SH has the title of " molecule sponge ", can absorb and keep himself weight 500-1000 water doubly, and generate gel, forms one deck hydration shell, and horny layer is kept moisture-keeping function, prevents xerosis cutis, produces skin care effect.In addition, the SH hydration shell also have ventilative and non-closure property, result produce general closed emollient the skin moistening function that can not compare.SH also can help to prevent that ossein is converted into non-dissolved state by dissolved state through forming glutinous bullet liquid and being filled in the subcutaneous collagen fibre, and with protein complex skin is produced collaborative moisture-keeping function.
Promote the wound healing function: after body received injuries such as wound, operation wound, scald and cold injury, endogenous macromolecule SH was one of main bioactive substance that at first arrives the wound.Under the effect of SH enzyme, SH degrades rapidly, and excites wound to repair gradually.SH can also strengthen the activity of thrombin; The formation of accelerating fibers sludged blood and stopping blooding; And the entering that can promote monocytic pathology phagocytosis and epidermis cell with stick and fibroblasts proliferation and migration; Prevent that inflammation from oozing out, directly promoted growth, differentiation, reconstruction and the structure repair of cell.Simultaneously,, can promote that cell moves, keep the constant of wound circumference skin water environment, for wound healing provides advantage through enlarging the intercellular space because the height of SH is preserved moisture and hydrating capacity.
Pharmaceutical carrier function: SH mainly produces medicament slow release and promotes drug transdermal to absorb two kinds of effects as pharmaceutical carrier.
Summary of the invention
The object of the present invention is to provide a kind of nasal drop that contains hyaluronic acid sodium and preparation method thereof, be mainly used in nasal drop of treatment of allergic rhinitis and preparation method thereof.
A kind of nasal drop that contains hyaluronic acid sodium, the basic comprising of prescription is: hyaluronic acid sodium, glycerol, Ph value buffer agent, osmotic pressure regulator, antiseptic and water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, antiseptic, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription itself promptly can be used for treating treatment of allergic rhinitis; Also can on the basis of basic comprising, add other pharmacological active substancies, like glucocorticoid medicine and antihistamine drug, and Decongestant etc.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, bromo geramine 0.004g; Sodium cromoglicate 1-5g, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Dexamethasone 0.1g, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Ephedrine 0.5-1g, remaining is a water.
The above-mentioned a kind of method for preparing that contains the nasal drop of hyaluronic acid sodium of the present invention is: by the basic comprising and the consumption of the present invention's prescription; After hyaluronic acid sodium put into water dissolving, add glycerol, sodium chloride again, Ph value buffer agent, antiseptic and pharmacological active substance; Mend again and add water to volume; The filtering with microporous membrane degerming, packing promptly gets the present invention.
The nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned is a nasal-cavity administration, splashes into nasal cavity during use.Also available cotton rod dips in gets a little compositions, is applied to the nasal cavity and the bridge of the nose thereof and wing of nose place, and use 2-4 every day, also can reduce access times according to symptom, and using dosage need not particular restriction.
 
Through clinical trial usefulness of the present invention is described below.
Take by weighing hyaluronic acid sodium 0.5g, put into 800ml Ph value and be 5.8 phosphate buffer, after the dissolving; Add glycerol 10g, sodium chloride 9g, bromo geramine 0.004g; After the dissolving, add water to 1000 ml again, the degerming of 0.2um filtering with microporous membrane fully; Packing promptly gets hyaluronic acid sodium collunarium nasal drop of the present invention; Treatment allergic rhinitis 15 examples.Method: the patient blows nasal mucus totally before dripping medicine, when dripping medicine, and patient's layback, head hangs down backward and makes the nostril up, and the hyaluronic acid sodium nasal drop is splashed into the nostril, and every side 2-3 drips, and gently pinches the wing of nose for several times after dripping, and medicinal liquid is fully contacted with bronchia mucosal.Drip medicine 2-4 every day.5 days is a course of treatment.The result: the equal sensory effect of 15 routine patients is remarkable; Watery nasal discharge, nasal obstruction, rhinocnesmus alleviated in the 1st day, and idol has a sneeze symptom, played nasal cavity on the 2nd day and obviously felt unobstructed before than medication; Sneeze, watery nasal discharge, rhinocnesmus symptom do not appear basically; Bottleneck throat also feels comfortable simultaneously, and continuous use is after 5 days, and nasal cavity inspection nasal mucosa does not have edema; Lab testing has only a small amount of epithelial cell and lymphocyte in patient's nasal discharge, during with allergic rhinitis, the more acidophil of appearance, basophilic leukocyte are compared with goblet cell in the nasal discharge, belong to normal range.
Clinical trial can be found out hyaluronic acid sodium collunarium nasal drop, and treatment allergic rhinitis (allergic rhinitis) is nontoxic, has no side effect, and curative effect is obvious.
The specific embodiment
A kind of nasal drop that contains hyaluronic acid sodium, the basic comprising of prescription is: hyaluronic acid sodium, glycerol, Ph value buffer agent, osmotic pressure regulator, antiseptic and water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, antiseptic, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription itself promptly can be used for treating treatment of allergic rhinitis; Also can on the basis of basic comprising, add other pharmacological active substancies, like glucocorticoid medicine and antihistamine drug, and Decongestant etc.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, bromo geramine 0.004g; Sodium cromoglicate 1-5g, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Dexamethasone 0.1g, remaining is a water.
A kind of nasal drop that contains hyaluronic acid sodium that the present invention is above-mentioned; The basic comprising of prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Ephedrine hydrochloride 0.5-1g, remaining is a water.
The above-mentioned a kind of method for preparing that contains the nasal drop of hyaluronic acid sodium of the present invention is: by the basic comprising and the consumption of the present invention's prescription; After hyaluronic acid sodium put into water dissolving, add glycerol, sodium chloride again, Ph value buffer agent, antiseptic and pharmacological active substance; Mend again and add water to volume; The filtering with microporous membrane degerming, packing promptly gets the present invention.
Further specify the present invention below for example.
Embodiment 1
Take by weighing hyaluronic acid sodium 0.05 gram, glycerol 3g, sodium chloride 0.9g, hyaluronic acid sodium put into the water dissolving after, add glycerol, sodium chloride again, mend again and add water to 100ml, the filtering with microporous membrane degerming, packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 2
Take by weighing hyaluronic acid sodium 0.5 gram, ethyl hydroxybenzoate 3g, sodium chloride 0.9g, hyaluronic acid sodium put into the water dissolving after; After adding ethyl hydroxybenzoate, sodium chloride dissolving again, to regulating Ph value to 5, mend again and add water to 100ml with phosphoric acid buffer; The filtering with microporous membrane degerming, packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 3
Take by weighing hyaluronic acid sodium 0.1 gram, phenylmercuric acetate 0.002g, hyaluronic acid sodium put into the water dissolving after; After adding the phenylmercuric acetate dissolving again, to regulating Ph value to 7.5, mend again and add water to 100ml with phosphoric acid buffer; 0.5um the filtering with microporous membrane degerming, packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 4
Take by weighing hyaluronic acid sodium 0.2 gram, glycerol 2g, ethyl hydroxybenzoate 3g, it is after 5.6 borate buffer dissolves aqueous solution that hyaluronic acid sodium is put into 0.9% sodium chloride Ph value; Add glycerol, ethyl hydroxybenzoate again, stir, after boiling sterilization in 20 minutes; Packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 5
Take by weighing hyaluronic acid sodium 0.3 gram, glycerol 1g, sodium chloride 0.5g, bromo geramine 0.004g, sodium cromoglicate 1g; After hyaluronic acid sodium put into water dissolving, add sodium chloride, bromo geramine again, sodium cromoglicate, after the dissolving, to regulating Ph value to 5.5, benefit adds water to 100ml again with borate buffer, the filtering with microporous membrane degerming, packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 6
Take by weighing hyaluronic acid sodium 0.08g, glycerol 2g, sodium chloride 0.8g, sodium benzoate 0.3g, dexamethasone 0.1g; After hyaluronic acid sodium put into water dissolving, add sodium chloride, sodium benzoate, dexamethasone again, after the dissolving, regulate Ph value to 7 with hydrochloric acid, benefit adds water to 100ml again, the filtering with microporous membrane degerming, and packing promptly gets the nasal drop of hyaluronic acid sodium.
Embodiment 7
Take by weighing hyaluronic acid sodium 0.4g, phenylmercuric acetate 0.002g, glycerol 2g, disodiumedetate 0.3g, ephedrine hydrochloride 0.5g; After hyaluronic acid sodium put into water dissolving, add glycerol, disodiumedetate, ephedrine hydrochloride again, it is an amount of to add water; Stir, phosphoric acid buffer adds water to 100ml to regulating Ph value to 6.5; After the sterilization, divide to be filled to dropper, promptly get the nasal drop of hyaluronic acid sodium.

Claims (7)

1. a nasal drop that contains hyaluronic acid sodium is characterized in that the basic comprising of filling a prescription is: hyaluronic acid sodium, glycerol, Ph value buffer agent, osmotic pressure regulator, antiseptic and water.
2. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 1; It is characterized in that the basic comprising of filling a prescription is: in the 100ml nasal drop; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, antiseptic, remaining is a water.
3. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 1 or claim 2, it is characterized in that on the basis of prescription basic comprising, adding other pharmacological active substance glucocorticoid medicine and antihistamine drugs, and Decongestant.
4. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 3; It is characterized in that nasal drop in 100ml; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid regulate Ph value 5-7.5, bromo geramine 0.004g; Sodium cromoglicate 1-5g, remaining is a water.
5. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 3; It is characterized in that nasal drop in 100ml; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Dexamethasone 0.1g, remaining is a water.
6. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 3; It is characterized in that nasal drop in 100ml; Wherein glass acid 0.05-0.5g, glycerol 0-3g, sodium chloride 0-0.9g, phosphoric acid buffer to or borate buffer to or hydrochloric acid is regulated Ph value 5-7.5, antiseptic is an amount of; Ephedrine 0.5-1g, remaining is a water.
7. according to a kind of nasal drop that contains hyaluronic acid sodium of claim 1 or claim 2 or claim 3 or claim 4 or claim 5 or claim 6, its characteristic in method for preparing is: by the basic comprising and the consumption of the present invention prescription, hyaluronic acid sodium put into the water dissolving after; Add glycerol, sodium chloride again; Ph value buffer agent, antiseptic and pharmacological active substance are mended and are added water to volume, filtering with microporous membrane degerming; Packing promptly gets the present invention.
CN2012100952570A 2012-03-31 2012-03-31 Nasal drops containing sodium hyaluronate and preparation method thereof Pending CN102579334A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103120703A (en) * 2013-01-06 2013-05-29 王峥 Care solution for cleaning nasal cavity and related composition
CN104906029A (en) * 2015-05-22 2015-09-16 中山瑞福医疗器械科技有限公司 Nasal cavity preparation and preparing method and application thereof
CN109276715A (en) * 2017-07-20 2019-01-29 西安力邦医药科技有限责任公司 Antiallergy nasal medicine composition, preparation method and the application of humectant
CN111265590A (en) * 2020-01-21 2020-06-12 华熙生物科技股份有限公司 Hyaluronic acid freeze-drying preparation for nasal spray and preparation method and application thereof
WO2022261723A1 (en) * 2021-06-17 2022-12-22 Pant Harshita Compositions and uses thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1148504A (en) * 1996-03-29 1997-04-30 马三科 Fibrin freeze-dried drops and preparation method thereof
CN102579482A (en) * 2012-03-30 2012-07-18 济南康众医药科技开发有限公司 Medicinal composition for treating allergic rhinitis

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1148504A (en) * 1996-03-29 1997-04-30 马三科 Fibrin freeze-dried drops and preparation method thereof
CN102579482A (en) * 2012-03-30 2012-07-18 济南康众医药科技开发有限公司 Medicinal composition for treating allergic rhinitis

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103120703A (en) * 2013-01-06 2013-05-29 王峥 Care solution for cleaning nasal cavity and related composition
CN104906029A (en) * 2015-05-22 2015-09-16 中山瑞福医疗器械科技有限公司 Nasal cavity preparation and preparing method and application thereof
CN109276715A (en) * 2017-07-20 2019-01-29 西安力邦医药科技有限责任公司 Antiallergy nasal medicine composition, preparation method and the application of humectant
CN111265590A (en) * 2020-01-21 2020-06-12 华熙生物科技股份有限公司 Hyaluronic acid freeze-drying preparation for nasal spray and preparation method and application thereof
WO2022261723A1 (en) * 2021-06-17 2022-12-22 Pant Harshita Compositions and uses thereof

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Application publication date: 20120718