CN103432159A - Nasal cavity air particle blocking agent, production method and application thereof - Google Patents
Nasal cavity air particle blocking agent, production method and application thereof Download PDFInfo
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- CN103432159A CN103432159A CN201310383138XA CN201310383138A CN103432159A CN 103432159 A CN103432159 A CN 103432159A CN 201310383138X A CN201310383138X A CN 201310383138XA CN 201310383138 A CN201310383138 A CN 201310383138A CN 103432159 A CN103432159 A CN 103432159A
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- nasal cavity
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- hydroxybenzoate
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Abstract
The invention relates to a nasal cavity air particle blocking agent and a production method and application thereof. The nasal cavity air particle blocking agent comprises the following components in parts by weight: 1-6 parts of chitosan hydrochloride, 1-15 parts of glycerinum, 1-10 parts of propylene glycol, 1-7 parts of polyoxyethylene (40) hydrogenated castor oil, 0.05-0.2 part of propylparaben, 0.05-0.2 part of aethylparabenum, and 45-75 parts of purified water. The method comprises the following steps of: dissolving chitosan hydrochloride in a part of purified water, and filtering to obtain a solution A; uniformly mixing glycerinum, propylene glycol, polyoxyethylene (40) hydrogenated castor oil, propylparaben and aethylparabenum and heating to obtain a solution B; uniformly mixing the solution A and the solution B; adding the rest of purified water, and regulating the pH value to 5.5-6.5; regulating the osmotic pressure to be isotonic, sterilizing and packaging. The nasal cavity air particle blocking agent has a function of repairing the nasal cavity mucosa cilium system and can be used for treating anaphylactic rhinitis, sneeze, running nose, rhinocnesmus nasal obstruction and other diseases, and daily cleaning disinfection for nasal cavity.
Description
Technical field
The present invention relates to a kind of nasal cavity air atom barrier and production method and purposes.
Background technology
Be full of various microgranules in air, comprise antibacterial, virus, pollen, worm demodicid mite, dust and the less pM2.5 of particle diameter, these mean particle dias differ in size, from 0.02 μ m～400 μ m.Diameter is greater than 10 μ m's, can be stopped and filtration by the nasal cavity vibrissa, and diameter is less than 2 μ m persons, can enter lower respiratory tract by nasal cavity.Some particle matter, during through gland sample body or other lymphoid tissues, can excite immune system response, anaphylaxis occurs.What in these microgranules, diameter was large can be filtered and remove by " mask ", " vibrissa ", but the microgranule in more little micro-footpath can't be eliminated by " mask ", " vibrissa ".Air pollution is more and more serious, and airborne microgranule, anaphylactogen are ubiquitous, wears masks both inconvenient, can not remove fully, and allergic rhinitis, isolated from allergic asthmatic patients, China every year is with 100,000 grades of increases.It is the first-selected principle for the treatment of of allergic rhinitis that department of otorhinolaryngology branch of Chinese Medical Association " diagnosis of allergic rhinitis and treatment guide " (version in 2009) explicitly points out " avoid contact allergy former ".
Therefore in air, microgranule is electronegative, can adsorb and eliminate airborne microgranule by electric charge, and the protection human body do not encroach on by microgranule to be a kind of effective, safety, without the method for other side reactions.
Summary of the invention
Purpose of the present invention provides a kind of nasal cavity air atom barrier and production method and purposes, nasal cavity is smeared or be sprayed on to nasal cavity air atom barrier of the present invention, form the positively charged film of one deck on the nasal membrane surface, energy active adsorption air atom, reduce sensitinogen concentration, allow the sensitization crowd not be exposed under the sensitization source, can also repair nasal membrane cilium systemic-function simultaneously, the diseases such as treatment of allergic rhinitis, sneeze, watery nasal discharge, rhinocnesmus, nasal obstruction, also can be used for nasal cavity daily cleaning disinfection nursing.
A kind of nasal cavity air atom barrier, it is characterized in that: by chitosan hydrochlorate, glycerol, propylene glycol, polyoxyethylene (40) castor oil hydrogenated, propyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, purified water, formed, above-mentioned each component by weight
1～6 part of chitosan hydrochlorate, 1～15 part of glycerol, 1～10 part of propylene glycol, 1～7 part of polyoxyethylene (40) castor oil hydrogenated, 0.05～0.2 part of propyl p-hydroxybenzoate, 0.05～0.2 part of ethyl p-hydroxybenzoate, 45～75 parts of purified water, add chitosan hydrochlorate in partial purification water and dissolve, filter to obtain solution A; Glycerol, propylene glycol, polyoxyethylene (40) castor oil hydrogenated, propyl p-hydroxybenzoate, ethyl p-hydroxybenzoate are mixed and heat to obtain solution B, solution A, solution B are stirred evenly, add remaining purified water, adjust pH 5.5～6.5, regulating osmotic pressure oozes for waiting, sterilizing, pack to obtain nasal cavity air atom barrier.
The production method of described nasal cavity air atom barrier, each component by weight, is characterized in that carrying out according to the following steps:
(1) 1～6 part of chitosan hydrochlorate is added in partial purification water and dissolve, filter, filtrate is that solution A is standby;
(2) 1～15 part of glycerol, 1～10 part of propylene glycol, 1～7 part of polyoxyethylene (40) castor oil hydrogenated, 0.05～0.2 part of propyl p-hydroxybenzoate, 0.05～0.2 part of ethyl p-hydroxybenzoate are added together, mix, heat, make to dissolve to obtain solution B;
(3) solution A, solution B are stirred evenly, add remaining purified water, regulating pH value is 5.5～6.5, regulates osmotic pressure and oozes for waiting, and sterilizing, pack to obtain nasal cavity air atom barrier.
Solution A, solution B in step (3) fully stir evenly under 70～80 ℃, and regulating pH value is 5.5～6.5, regulate osmotic pressure and ooze for waiting.
The purposes of described nasal cavity air atom barrier in the medicine of preparation treatment of allergic rhinitis, sneeze, watery nasal discharge, rhinocnesmus, nasal obstruction.
The purposes of described nasal cavity air atom barrier in the medicine of preparation reparation nasal membrane cilium systemic-function.
The purposes of described nasal cavity air atom barrier in the medicine that is prepared in nasal cavity daily cleaning disinfection nursing.
Nasal cavity air atom barrier of the present invention compared with the prior art, has the marked improvement of the following aspects:
1, nasal cavity air atom barrier of the present invention uses the electric charge adsorbent particles, is a kind of physical method, avoids hormone, antiallergic, subtracts the impact of the medicine such as congestion of blood vessel agent on Human Physiology, as the side reaction of drug dependence and medicine.
2, avoided the impact of the filter methods such as " mask ", " nasal cavity thromboembolism " on " expiration flux ".
3, easy to use and stealthy, do not affect work, life, study, social activity of user etc.
4, adult, child, infant all can be used.
5, both available medicine for preparing treatment and the prevention of nasal cavity anaphylactic disease of nasal cavity air atom barrier of the present invention, also can be used for preparing the medicine of the sterilization of nasal cavity daily hygiene, nursing.
The accompanying drawing explanation
Fig. 1 is mild symptoms severe schematic diagram.
The specific embodiment
The invention will be further described in conjunction with the embodiments.
Table 1 is the embodiment of the present invention 1 to 4 raw materials used and proportioning, and each composition of the present invention is all bought and obtained from market.
Raw materials used and the proportioning (unit: Kg) of each embodiment of table 1
The production method of nasal cavity air atom barrier, each component in table 1 and consumption are carried out according to the following steps:
(1) chitosan hydrochlorate is added to partial purification water dissolution, filtration, obtaining filtrate is that solution A is standby.
(2) glycerol, propylene glycol, polyoxyethylene (40) castor oil hydrogenated, propyl p-hydroxybenzoate, ethyl p-hydroxybenzoate composition are added together, mix, heat, make to dissolve, obtain solution B.
(3) solution A, solution B are fully stirred evenly under 70～80 ℃, add remaining purified water, regulating pH value is 5.5～6.5, regulates osmotic pressure and oozes for waiting, and sterilizing, pack to obtain nasal cavity air atom barrier.
The examining report of " nasal cavity air atom barrier "
| ? | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Acid-base value | pH5.6 | pH5.7 | pH6.0 | pH6.2 |
| Osmotic pressure | 290mosmol/kg | 291mosmol/kg | 292mosmol/kg | 293mosmol/kg |
| Adsorptivity | Positive | Positive | Positive | Positive |
| Biocidal property | Bacteriostasis rate >=75% | Bacteriostasis rate >=85% | Bacteriostasis rate >=90% | Bacteriostasis rate >=95% |
| Cytotoxicity | Nothing | Nothing | Nothing | Nothing |
| Zest | Nothing | Nothing | Nothing | Nothing |
| Sensitization | Nothing | Nothing | Nothing | Nothing |
[0032] " nasal cavity air atom barrier " clinical trial and result with embodiments of the invention 1 preparation
One, clinical trial method:
Random, open, parallel check experiment design that this clinical trial adopts.To there be 2 hospitals, 120 patients to participate in (every hospital's 60 examples).The patient is divided into to two groups at random, and A group (test group 30 examples) is with " nasal cavity air atom barrier ", each every nasal cavity 1-2 spray, every day 4 times, morning WA with 1 time, noon, with 1 time, used in bed 1 time afternoon evening with 1 time, 2 weeks courses for the treatment of.B group (matched group 30 examples), with " nose anaphylactogen barrier " (emulsifiable paste), is put on 2 side nasal cavity by emulsifiable paste, and the emulsifiable paste that length is 0.5cm is smeared in each every nostril, every day 4 times, morning WA with 1 time, noon is with 1 time, with 1 time, use in bed 1 time afternoon evening, 2 weeks courses for the treatment of.A, two groups of whiles of B standby " clarityne sheet (10mg/ sheet) ".The Product labelling of A, B group is removed, pack with identical external packing box, according to random code table, paste random code on packing box.Random administration after patient is selected by selected standard.Tested rear decoding, the data of two groups of A, B have been carried out to statistical analysis, estimated the nasal cavity anaphylactogen and intercept clinical efficacy and the safety of gel to diseases such as allergic rhinitis and rhinocnesmus, nasal obstruction, watery nasal discharge, sneezes.
Two, alternative scope (comprising the selection of matched group in case of necessity), alternative quantity and selection reason:
Classification and calibration principle according to (" guide " 09 edition), for the ease of observation of curative effect with meet the requirement of statistical procedures, select persistence, in-the severe Allergic Rhinitis is study subject, is divided at random two groups, A group (test group) 30 examples, B group (matched group) 30 examples.Two hospitals are totally 120 examples.
1, subject enrollment standard: (before test, essential satisfied the lower all requirements of experimenter, can enter group)
(1) 16--60 year, male or female;
(2) there are the symptoms such as nasal obstruction, sneeze, thin nasal discharge, rhinocnesmus and (containing 2) more than 2 occur, more than symptom continued or be accumulated at 1h every day;
(3) rhinitis paresthesia epilepsy persistent period >=4d/ week, and >=continuous 4 weeks;
(4) quality of life (comprising sleep, daily life, working and learning) is exerted an influence during the rhinitis paresthesia epilepsy;
(5) skin prick test at least one is positive;
(6) signature Informed Consent Form.
2, experimenter's exclusion standard: (before test, the experimenter meets following any one, can not enter group)
(1) pregnancy;
(2) heart disease;
(3) by other drug treatment of allergic rhinitis drug withdrawal but be less than 7d person;
(4) whole body application hormone; Use ACE inhibitor or beta-blocker;
(5) hyperthyroidism;
(6) viral infectious (hepatitis, acquired immune deficiency syndrome (AIDS));
(7) the serious internal disease be completely controlled; Apoplexy was arranged in nearly six months;
(8) cancer; Lose weight>2kg/ the week that can't illustrate;
(9) participating in another clinical research.
3, the experimenter rejects standard: (in test, the experimenter meets following any one, exits this clinical research)
(1) serious or persistence anaphylaxis person appear;
(2) experimenter requires to exit clinical trial person;
(3) researcher is thought and should not be continued to participate in this clinical trial investigator.
4, alternative quantity and selection reason:
This test employing is random, open, the design of parallel check experiment.All statistical test all adopt two-sided test t check or χ
2check.By two class mean t, check to calculate, as α=0.05, power of a test β=0.2, sample standard deviation S=1, calculate allowable error δ=1, and the required case load of two-sided test is 17 examples, considers to come off case, answer actual 30 examples that complete, test group, matched group respectively complete 30 examples, amount to 60 routine cases.
Three, the evaluation methodology of clinical performance and statistical processing methods:
Adopt visual simulation scale (Visual analogue scale, VAS) to carry out respectively the clinical efficacy evaluation to the overall symptom before and after treatment and nose classification symptom.
Method is to use a scale that is about 10cm, indicates l0 scale, and two ends are respectively " 0 " and " l00 ", and " 0 " means asymptomatic, and " l00 " represents that symptom is obvious or seriously, and quality of life is exerted an influence.Allow patient mark the relevant position that can represent own distress level on scale.The position that the doctor marks according to patient, by dipstick metering its length, by every 1mm 1 minute, record length also judged, and take " 0～20mm " as " nothing ", and " 20～40mm " is " slightly ", and " 40～100mm " is " middle severe ", as shown in Figure 1.
1, point system: by every 1mm 1 minute, often take 1 " clarityne sheet (10mg/ sheet) " and count 1 minute.
2, the front evaluation for the treatment of: tested rear decoding, the overall symptom before A, two groups of sexes of B, age, treatment and nose classification symptom are carried out respectively to the check of average sided t.Get α=0.05 level, if P >=0.05, two component value there was no significant differences; If P<0.05, two component values are that significant difference is arranged; If P<0.01, two component values have utmost point significant difference.
3, the average for the treatment of post-evaluation: A and B number of components is carried out the sided t check.Get α=0.05 level, if P<0.05, two component values are that significant difference is arranged; If P<0.01, two component values have utmost point significant difference.
4, untoward reaction evaluation: calculate respectively the adverse reaction rate of A, B group, and relatively carry out in twos χ
2check, get α=0.05 level, if P<0.05, two component values are that significant difference is arranged; If P<0.01, two component values have utmost point significant difference.
Four, clinical test results
" nasal cavity air atom barrier " compares with effectiveness and the safety of the medicine that list marketing, hospital are being used, and P<0.05, have significant difference, illustrates that " nasal cavity air atom barrier " is safe and effective.
Claims (6)
1. a nasal cavity air atom barrier, it is characterized in that: by chitosan hydrochlorate, glycerol, propylene glycol, polyoxyethylene (40) castor oil hydrogenated, propyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, purified water, formed, above-mentioned each component by weight
1～6 part of chitosan hydrochlorate, 1～15 part of glycerol, 1～10 part of propylene glycol, 1～7 part of polyoxyethylene (40) castor oil hydrogenated, 0.05～0.2 part of propyl p-hydroxybenzoate, 0.05～0.2 part of ethyl p-hydroxybenzoate, 45～75 parts of purified water, add chitosan hydrochlorate in partial purification water and dissolve, filter to obtain solution A; Glycerol, propylene glycol, polyoxyethylene (40) castor oil hydrogenated, propyl p-hydroxybenzoate, ethyl p-hydroxybenzoate are mixed and heat to obtain solution B, solution A, solution B are stirred evenly, add remaining purified water, adjust pH 5.5～6.5, regulating osmotic pressure oozes for waiting, sterilizing, pack to obtain nasal cavity air atom barrier.
2. the production method of nasal cavity air atom barrier according to claim 1, each component by weight, is characterized in that carrying out according to the following steps:
(1) 1～6 part of chitosan hydrochlorate is added in partial purification water and dissolve, filter, filtrate is that solution A is standby;
(2) 1～15 part of glycerol, 1～10 part of propylene glycol, 1～7 part of polyoxyethylene (40) castor oil hydrogenated, 0.05～0.2 part of propyl p-hydroxybenzoate, 0.05～0.2 part of ethyl p-hydroxybenzoate are added together, mix, heat, make to dissolve to obtain solution B;
(3) solution A, solution B are stirred evenly, add remaining purified water, regulating pH value is 5.5～6.5, regulates osmotic pressure and oozes for waiting, and sterilizing, pack to obtain nasal cavity air atom barrier.
3. the production method of nasal cavity air atom barrier according to claim 2, is characterized in that solution A, the solution B in step (3) fully stirs evenly under 70～80 ℃, and regulating pH value is 5.5～6.5, regulates osmotic pressure and ooze for waiting.
4. the purposes of nasal cavity air atom barrier according to claim 1 in the medicine of preparation treatment of allergic rhinitis, sneeze, watery nasal discharge, rhinocnesmus, nasal obstruction.
5. nasal cavity air atom barrier according to claim 1 is repaired the purposes in the medicine of nasal membrane cilium systemic-function in preparation.
6. the purposes of nasal cavity air atom barrier according to claim 1 in the medicine that is prepared in nasal cavity daily cleaning disinfection nursing.
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| CN201310383138.XA CN103432159B (en) | 2013-08-28 | 2013-08-28 | Nasal cavity air particle blocking agent, production method and application thereof |
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| CN103432159B CN103432159B (en) | 2015-07-22 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018176898A1 (en) * | 2017-03-31 | 2018-10-04 | Wang jiu yao | Method for treating allergic airway inflammation |
| CN108721610A (en) * | 2018-06-25 | 2018-11-02 | 济南瑞丰生物工程有限公司 | A kind of nasal cavity wetting agent of chitosan-containing and preparation method thereof |
| CN109172639A (en) * | 2018-09-18 | 2019-01-11 | 李同信 | Nasal cavity allergen barrier and its preparation method and application |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1419940A (en) * | 2001-11-19 | 2003-05-28 | 吴天祥 | Medical ointment, film and tincture |
| US6749869B1 (en) * | 1997-09-26 | 2004-06-15 | Ecolab | Acidic aqueous chlorite teat dip providing shelf life, sanitizing capacity and tissue protection |
| CN101766585A (en) * | 2009-01-07 | 2010-07-07 | 吴天祥 | Medical paste film |
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2013
- 2013-08-28 CN CN201310383138.XA patent/CN103432159B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6749869B1 (en) * | 1997-09-26 | 2004-06-15 | Ecolab | Acidic aqueous chlorite teat dip providing shelf life, sanitizing capacity and tissue protection |
| CN1419940A (en) * | 2001-11-19 | 2003-05-28 | 吴天祥 | Medical ointment, film and tincture |
| CN101766585A (en) * | 2009-01-07 | 2010-07-07 | 吴天祥 | Medical paste film |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018176898A1 (en) * | 2017-03-31 | 2018-10-04 | Wang jiu yao | Method for treating allergic airway inflammation |
| CN108721610A (en) * | 2018-06-25 | 2018-11-02 | 济南瑞丰生物工程有限公司 | A kind of nasal cavity wetting agent of chitosan-containing and preparation method thereof |
| CN109172639A (en) * | 2018-09-18 | 2019-01-11 | 李同信 | Nasal cavity allergen barrier and its preparation method and application |
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| Publication number | Publication date |
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| CN103432159B (en) | 2015-07-22 |
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