CN102657611B - Sodium pyruvate nasal spray and preparation method thereof - Google Patents
Sodium pyruvate nasal spray and preparation method thereof Download PDFInfo
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- CN102657611B CN102657611B CN201210052155.0A CN201210052155A CN102657611B CN 102657611 B CN102657611 B CN 102657611B CN 201210052155 A CN201210052155 A CN 201210052155A CN 102657611 B CN102657611 B CN 102657611B
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- sodium pyruvate
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- acetone acid
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Abstract
The present invention relates to a nasal spray containing sodium pyruvate and a preparation method thereof, belonging to the field of medical technology, being characterized in that: the nasal spray containing sodium pyruvate comprises the following components: sodium pyruvate, pyruvic acid, an isoosmotic adjusting agent, a preservative and water. Because the sodium pyruvate is capable of alleviating nasal obstruction and inflammation caused by rhinitis, a medical fluid provided in the invention can be made into a nasal spray medical fluid which is capable of entering nasal cavities by adopting a portable spraying device. The nasal spray medical fluid is particularly suitable for cleaning and removing harmful pollutants in nasal passages, paranasal sinuses and mucosal cilia and is capable of being used in nursing after a nasal cavity operation, relieving rhinostegnosis and reducing respiratory tract irritation and risks of infection. By adding the pyruvic acid to form a buffer solution, tingling caused by using the flushing fluid to wash the cavities can be reduced, and inflammation is alleviated. Allergic symptoms can be prevented or gradually alleviated for the people of special professional who often use the product provided in the invention to wash and care nasal cavities.
Description
Technical field
The present invention relates to a kind of nasal spray containing Sodium Pyruvate and preparation method thereof, belong to field of medical technology.
Background technology
Breathing is sustain life basic, and breathe and jointly completed by upper respiratory tract and lower respiratory tract, nasal cavity, nasal sinuses and nasopharynx are the key components of upper respiratory tract, be human body and the Nature carry out mass exchange must through part.Sodium Pyruvate is normal composition all in humans and animals body; it is biological analytic metabolism; Sodium Pyruvate has significant to many cells and multiple organ dysfunction protective effect, particularly to vitals: the ischemia/reperfusion injury reparation of heart, liver, brain and kidney, and has no side effect.
People have selection to the drinking water needed for every day, but be difficult to select to the air needed, dust particularly in air, virus, antibacterial and mycete are caused a disease polluter etc., all without selection, often to propagate and infected with breathing, considerably increase acute and chronic rhinitis, allergic rhinitis, flu, the incidence rate of respiratory tract disease, very large injury is caused to nasal membrane.Some are easily suffered from rhinitis and sinusitis, easily to be caught a cold or the crowd that often contacts with flu patient and the special work post professional population worked under poor environment; need often to carry out cleaning nursing to nasal cavity; progressively alleviate or finally eliminate allergic symptom, protection and regulating action are played to the people often using antibiotic to cause nasal cavity normal flora to lack of proper care.
The present invention treats liquid and makes nasal spray and effectively can remove the pollutant of nasal cavity, alien bacteria, virus, anaphylactogen, pollen, various dust and deleterious particle, avoids or reduces the accumulation of virulence factor on people's upper respiratory tract.And the safety that the present invention has is very high, also there is not risk in life-time service, and extensive use is conducive to improving the disease-resistant and antiallergic ability of nasal cavity, can reduce the sickness rate of the various infectious respiratory diseases such as flu, rhinitis, sinusitis and nasopharyngitis simultaneously.
Summary of the invention
The present invention its objective is and overcomes the deficiencies in the prior art part, provides a kind of based on Sodium Pyruvate coupling acetone acid, the active ingredients such as isoosmotic adjusting agent, antiseptic and water is carried out the nasal cavity that scientific matching makes and washes spray articles for use.
In to the research of sodium pyruvate nasal spray, we find that in sodium pyruvate nasal spray prescription, add acetone acid can play good improving effect, its technique effect following points: 1, acetone acid and Sodium Pyruvate form buffer salt system, the effect of stable medicinal liquid can be played, even if be subject to the impact of some factors also can not affect product quality and result of use in preparation, storage, transport, use procedure.2, the pH value range of normal person's nasal cavity is between 6.6 ~ 7.1, Sodium Pyruvate selected by the present invention-acetone acid buffer salt system accurately can control the pH of medicinal liquid a little less than normal value, both medicinal liquid can have been improved in the antibacterial effect of nasal cavity in this scope, reduce again spray to the zest of nasal cavity simultaneously, improve and use this product comfort level.3, this product is while introducing acetone acid, and further optimization formulation increases the viscosity of product, improves and treats the holdup time of liquid in nasal cavity, and entirety increases the effect of rinsing.Define the invention with Sodium Pyruvate and acetone acid conbined usage on this basis.
The present invention includes following component: Sodium Pyruvate, acetone acid, isoosmotic adjusting agent, antiseptic and water.Carry out proportioning according to percentage by weight, adopt Sodium Pyruvate, acetone acid, isoosmotic adjusting agent to be added to the water, stirring and dissolving, add antiseptic and dissolve, adjust ph, to 4-7, is filtered, preparation technology's fill.
Here is according to the present invention spray prepared and the spray do not prepared containing acetone acid with reference to embodiment one, the investigation result of carrying out:
Table one: two prescriptions for investigating:
| Component | Prescription one (containing acetone acid) | Prescription two (not containing acetone acid) |
| Sodium Pyruvate | 0.22% | 0.22% |
| Acetone acid | 0.05% | 0% |
| Sodium chloride | 0.45% | 0.45% |
| Benzalkonium chloride | 0.01% | 0.01% |
| Water | Surplus | Surplus |
Table two: the stability result under 60 DEG C of conditions of two prescriptions
The patient nasal spray of two kinds of prescriptions being given chronic sinusitis or allergic rhinitis uses 2 ~ 3 every day, within 7 days, reporting situations of patient is added up afterwards in use, in 39 triers, having 32 people to think, the spray zest containing acetone acid is less, account for total trier's 82%, all triers all find no allergic phenomena and other are uncomfortable.
Sodium Pyruvate of the present invention and acetone acid its feature of spray after combining is: with the acid-base value of nasal secretions and osmotic pressure consistent; The sensation of pricking produced when reducing flushing liquor nasal irrigation; There is the function of protection nasal mucosa; There is the function removed or to nasal cavity, nasal sinuses and Endonasopharyngeal virus and bacteria inactivation; There is enhancing nose breathing, reduce direct oral cavity and breathe and then improve the function of breathing quality; There is the function of prevention and reduction Secondary cases lower respiratory infection; Have and regulate characteristics of contaminated respiratory droplets hydrogen peroxide and nitric oxide production function; Have and improve pulmonary function, delay the function that Acute pulmonary inflammation increases the weight of; There is the risk reducing lower respiratory tract inflammation and infect.
Nasal spray containing Sodium Pyruvate of the present invention treat liquid to be suitable for crowd be each individuality needing nasal cavity cleaning, especially at Influenza flu season, particularly those easily suffer from the crowd of rhinitis and sinusitis, special operation crowd (as coal, petrochemical industry, fire-fighting, cement industry etc.), suffers from the crowd of chronic obstructive pneumonia, asthmatic patient, respiratory sstem dysfunction patient, flu causes rhinostegnosis, rhinorrhea patient etc.
Detailed description of the invention
embodiment 1
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 22 | 0.22 |
| Acetone acid | 5 | 0.05 |
| Sodium chloride | 45 | 0.45 |
| Benzalkonium chloride | 1 | 0.01 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the benzalkonium chloride that 25-35 DEG C adds recipe quantity, stir, with the sodium hydrate regulator solution pH=6 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.22% of said preparation Sodium Pyruvate, acetone acid 0.05%, is mainly used in cleaning nasal cavity environment.
embodiment 2
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 22 | 0.22 |
| Acetone acid | 5 | 0.05 |
| Potassium chloride | 45 | 0.45 |
| Benzalkonium chloride | 3 | 0.03 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, potassium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the benzalkonium chloride that 25-35 DEG C adds recipe quantity, stir, with the hydrochloric acid conditioning solution pH=5.5 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.22% of said preparation Sodium Pyruvate, acetone acid 0.05%, is mainly used in cleaning nasal cavity environment.
embodiment 3
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 16 | 0.16 |
| Acetone acid | 11 | 0.11 |
| Glucose | 30 | 0.3 |
| Benzalkonium chloride | 25 | 0.25 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, glucose are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to 25-35 DEG C and add benzalkonium chloride, stir, with the hydrochloric acid conditioning solution pH=4.5 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.16% of said preparation Sodium Pyruvate, acetone acid 0.03%, is mainly used in cleaning nasal cavity environment.
embodiment 4
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 8.8 | 0.088 |
| Acetone acid | 2 | 0.02 |
| Sodium chloride | 15 | 0.15 |
| Benzalkonium chloride | 1 | 0.01 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to 25-35 DEG C and add benzalkonium chloride, stir, with the sodium hydrate regulator solution pH=6.5 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.088% of said preparation Sodium Pyruvate, acetone acid 0.02%, is mainly used in cleaning nasal cavity environment.
embodiment 5
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 1 | 0.01 |
| Acetone acid | 1 | 0.01 |
| Sodium chloride | 10 | 0.1 |
| Benzalkonium chloride | 0.01 | 0.0001 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the benzalkonium chloride that 25-35 DEG C adds recipe quantity, stir, with the sodium hydrate regulator solution pH=7.0 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.088% of said preparation Sodium Pyruvate, acetone acid 0.02%, is mainly used in cleaning nasal cavity environment.
embodiment 6
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 32 | 0.32 |
| Acetone acid | 29 | 0.29 |
| Sodium chloride | 60 | 0.6 |
| Ethyl hydroxybenzoate | 10 | 0.1 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the ethyl hydroxybenzoate that 25-35 DEG C adds recipe quantity, stir, with the sodium hydrate regulator solution pH=4.0 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.32% of said preparation Sodium Pyruvate, acetone acid 0.29%, is mainly used in cleaning nasal cavity environment.
embodiment 7
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 41 | 0.41 |
| Acetone acid | 42 | 0.42 |
| Sodium chloride | 80 | 0.8 |
| Benzalkonium chloride | 40 | 0.4 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the benzalkonium chloride that 25-35 DEG C adds recipe quantity, stir, with the hydrochloric acid conditioning solution pH=5.0 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.41% of said preparation Sodium Pyruvate, acetone acid 0.42%, is mainly used in cleaning nasal cavity environment.
embodiment 8
prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 50 | 0.5 |
| Acetone acid | 50 | 0.5 |
| Sodium chloride | 30 | 1 |
| Benzalkonium bromide | 50 | 0.5 |
preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the benzalkonium bromide that 25-35 DEG C adds recipe quantity, stir, with the hydrochloric acid conditioning solution pH=4.5 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.5% of said preparation Sodium Pyruvate, acetone acid 0.5%, is mainly used in cleaning nasal cavity environment.
Embodiment 9
Prescription:
| Supplementary material title | Consumption (gram) | Ratio (%) |
| Sodium Pyruvate | 22 | 0.22 |
| Acetone acid | 5 | 0.05 |
| Sodium chloride | 45 | 0.45 |
| Poly hexamethylene biguanide | 0.2 | 0.002 |
Preparation technology:
The Sodium Pyruvate of recipe quantity, acetone acid, sodium chloride are slowly added respectively in 9500 grams of purified water, be heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to the poly hexamethylene biguanide that 25-35 DEG C adds recipe quantity, stir, with the sodium hydrate regulator solution pH=6 of 0.1mol/l, be settled to full dose 10000 grams with remaining water again, filter, fill and get final product.The content 0.22% of said preparation Sodium Pyruvate, acetone acid 0.05%, is mainly used in cleaning nasal cavity environment.
By preparation embodiment 1 ~ 9, we find: use Sodium Pyruvate (0.01% ~ 0.5%), acetone acid (0.01% ~ 0.5%), osmotic pressure regulator (0.1% ~ 1%), antibacterial (0.0005% ~ 0.5%), wherein osmotic pressure regulator comprises: sodium chloride, potassium chloride, glucose; Antibacterial comprises: benzalkonium chloride, benzalkonium bromide, ethyl hydroxybenzoate, poly hexamethylene biguanide.PH value controls between 4 ~ 7, all can well prepare suitable nasal spray.
Preferably we find further: embodiment 1 ~ 4,9, and benzalkonium chloride, poly hexamethylene biguanide its consumption when reaching effective fungistatic effect is less, and toxicity is less, and benzalkonium chloride concentration controls 0.01%, and poly hexamethylene biguanide concentration controls 0.002%; Osmotic pressure regulator selects sodium chloride concentration to control, at (0.15% ~ 0.45%), effectively to protect mucosal tissue, and can make the good moistening of medicinal liquid and infiltrate into mucosa; Sodium Pyruvate controls 0.088% ~ 0.22%, acetone acid controls 0.02% ~ 0.11%, the stability to medicinal liquid and the zest to nasal cavity less, modest viscosity, not only effectively increase and treat the holdup time of liquid in nasal cavity, and use in the nasal cavity being adapted at people.PH value controls between 4 ~ 7, all can well prepare the nasal spray met.
Further preferably we find: embodiment 1 and 9, sodium chloride concentration controls 0.45%, and can produce good isotonic effect, Sodium Pyruvate controls 0.22%, and acetone acid controls 0.11%, and stability and curative effect all reach best, and pH value controls between 4 ~ 7.
Claims (2)
1. the preparation method of a sodium pyruvate nasal spray, it is characterized in that, described sodium pyruvate nasal spray comprises following component according to percentage by weight: Sodium Pyruvate 0.22%, acetone acid 0.05%, isoosmotic adjusting agent 0.45%, antiseptic 0.01%, water surplus, described isoosmotic adjusting agent is selected from sodium chloride, glucose or potassium chloride; Described antiseptic is selected from benzalkonium chloride, benzalkonium bromide, ethyl hydroxybenzoate or poly hexamethylene biguanide;
Above-mentioned Sodium Pyruvate, acetone acid, isoosmotic adjusting agent are slowly added in purified water, is heated to 40-50 DEG C of abundant stirring and dissolving, be cooled to 25-35 DEG C and add antiseptic and dissolve, with the sodium hydrate regulator solution pH=6 of 0.1mol/l, filter, fill and get final product.
2. the sodium pyruvate nasal spray that obtains of the preparation method of sodium pyruvate nasal spray as claimed in claim 1, is characterized in that, described sodium pyruvate nasal spray has the purposes of rhinitis and the sinusitis medicine caused because of inflammatory mediator for the preparation of prevention and therapy.
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| CN201210052155.0A CN102657611B (en) | 2012-03-02 | 2012-03-02 | Sodium pyruvate nasal spray and preparation method thereof |
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| CN102657611B true CN102657611B (en) | 2015-01-14 |
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Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103120703A (en) * | 2013-01-06 | 2013-05-29 | 王峥 | Care solution for cleaning nasal cavity and related composition |
| CN103385868A (en) * | 2013-08-02 | 2013-11-13 | 江苏长泰药业有限公司 | Application of sodium pyruvate in preparing medicine for treating chronic obstructive pulmonary disease |
| CN103610671A (en) * | 2013-12-10 | 2014-03-05 | 江苏长泰药业有限公司 | Pyruvic acid medicinal composition and application thereof in preparing medicament for treating lung cancer |
| CN106361699A (en) * | 2016-08-25 | 2017-02-01 | 江苏长泰药业有限公司 | Nasal spray product for treating or preventing cold and application thereof |
| CN106727320A (en) * | 2017-01-13 | 2017-05-31 | 江苏长泰药业有限公司 | A kind of composition for repairing schneiderian membrane, reducing allergic reaction, antiinflammatory action |
| CN109481429B (en) * | 2019-01-22 | 2021-10-01 | 广州蓓思语生物科技有限公司 | Nasal cavity nursing spray |
| CN109806224B (en) * | 2019-03-15 | 2021-05-28 | 江苏长泰药业有限公司 | Olopatadine composition and preparation method thereof |
| CN115721726B (en) * | 2022-07-27 | 2023-10-17 | 江苏长泰药业股份有限公司 | Nasal product for preventing or relieving cold symptoms and preparation method thereof |
| CN115671051B (en) * | 2022-10-24 | 2024-03-05 | 江苏长泰药业股份有限公司 | Sodium pyruvate nasal spray and application thereof |
| CN116236515A (en) * | 2023-03-13 | 2023-06-09 | 青岛大学附属医院 | Nasal cavity nursing liquid and preparation method and application thereof |
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| US20020006961A1 (en) * | 1999-05-14 | 2002-01-17 | Katz Stanley E. | Method and composition for treating mammalian nasal and sinus diseases caused by inflammatory response |
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