CN107929314A - A kind of hydrogeneous physiological saline and its preparation method and application - Google Patents

A kind of hydrogeneous physiological saline and its preparation method and application Download PDF

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Publication number
CN107929314A
CN107929314A CN201610893547.8A CN201610893547A CN107929314A CN 107929314 A CN107929314 A CN 107929314A CN 201610893547 A CN201610893547 A CN 201610893547A CN 107929314 A CN107929314 A CN 107929314A
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physiological saline
hydrogeneous
hydrogen
nasal
physiological
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余少卿
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Shanghai Tongji Hospital
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Shanghai Tongji Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0043Nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention provides a kind of hydrogeneous physiological saline and preparation method and purposes, it includes:Physiological saline and the simple substance hydrogen being dissolved in the physiological saline.The preparation method of the hydrogeneous physiological saline is:Prepare physiological saline;At 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline, the hydrogen is reached hypersaturated state in physiological saline, obtains the hydrogeneous nasal nursing liquid.The hydrogeneous physiological saline can be used for preparing nasal wash.The advantage of the invention is that:1st, hydrogen-rich physiological saline by anti-oxidant anti-inflammatory effect, can promote the recovery of schneiderian membrance physiological function, can effectively be applied after the schneiderian membrance functions such as germ infection, allergy, surgery trauma are damaged;2nd, hydrogen-rich brine is used in nasal cavity washing, easy to use, is directly used in the flushing of nasal cavity, can be used for the treatment that the mucous membrane physiological function of the diseases such as rhinitis chronic, nasosinusitis, allergic rhinitis and nose neoplasm is recovered.

Description

A kind of hydrogeneous physiological saline and its preparation method and application
Technical field
The present invention relates to a kind of hydrogeneous physiological saline and its preparation method and application, belong to field of medical article technology.
Background technology
Physiological saline, physiology or the clinically common osmotic pressure sodium chloride solution equal with animal or human plasma, Its concentration is 0.67~0.70% when being used for amphibian animal, and for mammality and human body when is 0.85~0.90%.Medically, physiology Brine refers to sodium chloride (NaCl, more conventional title method the is brine) solution sterilized.But it is only using intravenous injection When be only it is sterile, other modes physiological saline also be a kind of saline solution.This sterile solution is generally used for vein Injection, rinses contact lenses and nasal douche.Physiological saline also has different application targets in the formula of different purposes.Physiology salt Water also uses in cell biology, molecular biology and Biochemistry Experiment.
When for nasal douche, physiological saline need can by assembled in nasal cavity cause a disease and dirt discharge and Have the function that antibacterial, to reach the effect above, Chinese patent CN105079034A discloses a kind of nasal nursing liquid, the nasal cavity The preparation method of conditioning liquid is:Step 1:Physiological seawater is prepared, the pH value of the physiological seawater is 6.0~8.0, sodium chloride Content is 8.5g/L~9.5g/L;Step 2:Step 1 gained physiological seawater is filtered by filtration system, must be filtered Liquid, the filtration system include primary filter and advanced filter;The primary filter includes stainless steel filter and puts Filter core in stainless steel filter, the filter core material are wood activated charcoal;The advanced filter is filtered including stainless steel Device and the first miillpore filter and the second miillpore filter being placed in stainless steel filter, the retention aperture of first miillpore filter For 1 μm, the retention aperture of second miillpore filter is 0.22 μm;Step 3:By step 2 gained filtered fluid through filling apparatus into After row is filling, irradiation sterilization obtains nasal nursing liquid.The nasal nursing liquid contains the physiological seawater solution after filtering, containing abundant Beneficial mineral matter and trace element, sterilization, anti-inflammatory, antianaphylactic can be played the role of, simultaneously as being filtered, eliminated Some impurity such as anaphylactogen, will not can produce adverse reaction to children especially baby, its osmotic pressure and acid-base value are equal to or closely Nasal cavity osmotic pressure and acid-base value are similar to, solves nasal cavity cleaning technical barrier.
But nasal wash is mainly hypertonic or isotonic physiological saline at present, though with nasal cavity cleaning, promote the surface of a wound The effect of recovery, but without anti-oxidant and anti-inflammatory effect, come for illnesss such as rhinitis chronic, nasosinusitis and allergic rhinitises Say, nasal cavity microenvironment produces a large amount of active oxygens, cause the damage of local mucous membrane, nose physiological function reduces due to the effect of inflammation. Nasal nursing liquid of the prior art there is no method to solve the problems, such as this.
The content of the invention
The present invention provides a kind of hydrogeneous physiological saline and its preparation method and application, in the presence of solving the prior art The above problem.
The present invention is achieved by the following technical solutions:
A kind of hydrogeneous physiological saline, it includes:Physiological saline and the simple substance hydrogen being dissolved in the physiological saline.
Preferably, in the physiological saline, the mass fraction of sodium chloride is 0.5~0.9%.
Preferably, concentration of the simple substance hydrogen in physiological saline is 2~6mmol/L.
A kind of preparation method of hydrogeneous physiological saline as the aforementioned, it includes the following steps:
Prepare physiological saline;
At 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline, makes the hydrogen in life Reach hypersaturated state in reason brine, obtain the hydrogeneous nasal nursing liquid.
A kind of purposes of the hydrogeneous physiological saline in nasal wash is prepared as the aforementioned.
Preferably, including hydrogeneous physiological saline and at least one medically acceptable auxiliary material.
Preferably, the auxiliary material is one or both of osmotic pressure regulator, preservative.
Preferably, the osmotic pressure regulator is selected from boric acid, borax, disodium hydrogen phosphate, citric acid and mannitol At least one of.
Preferably, the preservative is selected from least one of sorbic acid, benzyl carbinol, Phenoxyethanol.
The present invention is realized based on following principle:
Hydrogen molecule (H2) alternatively property antioxidant, there is unique selective antioxidation, selectivity can be passed through Combination and remove toxicity hydroxy radical OH and nitrous acid anion ONOO-, while have no effect on oneself of other bioactivity By base such as superoxide anion and hydrogen peroxide.OH is the most strong free radical of activity, ONOO-Activity also apparently higher than other work Property oxygen, H2Since molecule is small, biomembrane can be easily penetrated, it is most of anti-to reach cytoplasm mitochondria and nucleus etc. The action target spot that oxidant can not be reached effectively, efficiently scavenging capacity is strong and the OH and ONOO of strong toxicity-(such as Fig. 1 institutes Show), therefore, H2With selective clearing oxygen radical OH and ONOO-Bioactivity, possess stronger antiopxidant effect, more preferably Ground, which mitigates cell and the oxidation of tissue, to stimulate, and promotes the recovery of mucous membrane function.
Beneficial effects of the present invention are:
1st, hydrogen-rich physiological saline by anti-oxidant anti-inflammatory effect, can promote the recovery of schneiderian membrance physiological function, can be in disease Effectively application after the schneiderian membrance functions such as bacterium infection, allergy, surgery trauma are damaged;
2nd, hydrogen-rich brine is used in nasal cavity washing, easy to use, is directly used in the flushing of nasal cavity, be can be used for rhinitis chronic, nose The treatment that the mucous membrane physiological function of the diseases such as sinusitis, allergic rhinitis and nose neoplasm is recovered.
Brief description of the drawings
Upon reading the detailed description of non-limiting embodiments with reference to the following drawings, further feature of the invention, Objects and advantages will become more apparent upon:
Fig. 1 is the mechanism principle figure of hydrogen scavenging activated oxygen.
Embodiment
With reference to specific embodiment, the present invention is described in detail.Following embodiments will be helpful to the technology of this area Personnel further understand the present invention, but the invention is not limited in any way.It should be pointed out that the ordinary skill to this area For personnel, without departing from the inventive concept of the premise, various modifications and improvements can be made.These belong to the present invention Protection domain.
1 the present embodiment of embodiment is related to a kind of preparation method of hydrogeneous physiological saline
First, the physiological saline that sodium chloride mass fraction is 0.5% is prepared;
2nd, at 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline obtained to step 1 and is passed through In the physiological saline, the hydrogen is reached hypersaturated state in physiological saline, obtain the hydrogeneous nasal nursing liquid, this When, concentration of the simple substance hydrogen in physiological saline is 6mmol/L.
2 the present embodiment of embodiment is related to a kind of preparation method of hydrogeneous physiological saline
First, the physiological saline that sodium chloride mass fraction is 0.9% is prepared;
2nd, at 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline obtained to step 1 and is passed through In the physiological saline, the hydrogen is reached hypersaturated state in physiological saline, obtain the hydrogeneous nasal nursing liquid, this When, concentration of the simple substance hydrogen in physiological saline is 6mmol/L.
3 the present embodiment of embodiment is related to a kind of preparation method of hydrogeneous physiological saline
First, the physiological saline that sodium chloride mass fraction is 0.7% is prepared;
2nd, at 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline obtained to step 1 and is passed through In the physiological saline, the hydrogen is reached hypersaturated state in physiological saline, obtain the hydrogeneous nasal nursing liquid, this When, concentration of the simple substance hydrogen in physiological saline is 6mmol/L.
4 the present embodiment of embodiment is related to a kind of method that nasal wash is prepared using hydrogeneous physiological saline
Hydrogeneous physiological saline 100ml prepared by Example 1, adds 0.05g boric acid and 0.08g sorbic acids, is slowly stirred After mixing, nasal wash is obtained.
5 the present embodiment of embodiment is related to a kind of method that nasal wash is prepared using hydrogeneous physiological saline
Hydrogeneous physiological saline 100ml prepared by Example 2, adds 0.06g boraxs, 0.07 benzyl carbinol, is slowly stirred mixed After closing uniformly, nasal wash is obtained.
6 the present embodiment of embodiment be related to nasal wash washing treat allergic rhinitis when the effect of detect
Early-stage preparations:Nasal wash prepared by Example 4, will meet 60 patients of diagnosis of allergic rhinitis standard Random packet, every group of 30 people, (all patients sign informed consent form to two groups of patients.) in data such as gender, age and medical histories Compare, difference is statistically meaningless (P ﹥ 0.05), there is comparativity.A groups:Hydrogen-rich physiological saline group;B groups:Physiological saline group (control group).Two groups of uses use 50ml disposable syringes, to ensure the cleaning of washing instrument and wash one's hands and face quantifying for liquid.
Wash one's hands and face liquid:A groups are filled with hydrogen in the infusion physiological saline of 100ml dresses, reach hypersaturated state;B groups are with defeated The physiological saline that liquid is filled with 100ml.
Washing method:Liquid is washed one's hands and face with 100ml every time, washes one's hands and face bilateral nasal cavity.Each 1 time of morning and evening daily, continued treatment 4 weeks.Tool Body operating method:Patient is first blown except the secretion in nasal cavity, then takes a low level of lying on the back, and 50ml is extracted with 50ml disposable syringes Liquid is washed one's hands and face, side nasal cavity is slowly injected into from all angles, flow to after pharynx nasalis the discharge that sits up;Opposite side nasal cavity is washed one's hands and face with method.
Observed content:1) observe and record two groups of patients and receive the pretherapy and post-treatment various symptoms of nasal cavity washing and sign score. Symptom includes once sneezing number, blows the symptoms such as nose number, nasal obstruction and rhiocnesmus daily;Sign is primarily to see concha and schneiderian membrance The degree of swelling.2) the pretherapy and post-treatment eosinophil count of nasal secretion.
Efficacy evaluation:Foundation《The principle of reatment and suggested design (2004) of allergic rhinitis》Record symptom score and body Sign score, and then carry out efficacy determination.And receive the sum of pretherapy and post-treatment sings and symptoms score according to every patient is calculated, adopt The effect for the treatment of is evaluated with therapeutic index and total effective rate two indices.Therapeutic index=(sings and symptoms total score before treatment- Sings and symptoms total score after treatment)/treatment before sings and symptoms total score × 100%.Effective is therapeutic index >=66%, is effectively For therapeutic index 26%~65%, invalid is therapeutic index≤25%.Total effective rate=(effective patient's number+effective patient number)/ Every group of total patient's number.
Statistical procedures:Analyzed using SPSS17.0 statistical softwares, measurement data is represented with x ± s, and two groups are compared use T is examined, with P<0.05 is statistically significant for difference.
As a result
Two groups of pretherapy and post-treatment symptoms, sign are scored and difference comparsion of always scoring
A groups (hydrogen-rich physiological saline group) are always scored respectively with the sings and symptoms before B groups (physiological saline group) treatment (12.35 ± 1.27), (11.95 ± 1.04) point, no significant difference (P>0.05).After treating 4 weeks, the symptom of A groups and Sign is always scored divides for (6.33 ± 1.21), and the sings and symptoms total score of B groups is (8.23 ± 1.51) point, compared with before treatment, Statistically significant (the P of difference<0.05).After treatment, component A value is significantly lower than B groups, the statistically significant (P of difference< 0.05).Pretherapy and post-treatment two groups of patient symptoms and sign total score difference comparsion, the sings and symptoms total score of A groups decline degree bigger, Statistically significant (the P of difference<0.05).It is shown in Table 1.
1 two groups of pretherapy and post-treatment symptoms of table, sign is scored and difference comparsion of always scoring
The comparison of 2.2 two groups of therapeutic indexs and total effective rate
A groups total effective rate 83.33%, B groups total effective rate are significantly better than B groups (P for the therapeutic effect of 66.67%, A groups< 0.05).It is shown in Table 2.
2 two groups of curative effects of table compare
Find out from result of study, the sings and symptoms total score of A groups declines degree bigger, the statistically significant (P of difference< 0.05);The total effective rate of A groups treatment is higher than B groups, and difference is statistically significant (P < 0.05), all illustrates that hydrogen plays necessarily Effect.In order to increase comparativity, the disposable syringes of 50ml are selected, it is controllable to become standard per side nasal cavity 50ml.In order to increase Holdup time of the liquid in nasal cavity is washed one's hands and face to increase the action time of hydrogen, we allow patient lies supine's head low level, are extracted with syringe Nasal cavity is slowly injected into from all angles afterwards, pharynx nasalis is flow to and spues again.And this kind washing method, it can be likely to occur to avoid flushing Nosebleed, pain etc. adverse reaction, two groups of this research do not occur adverse reaction.
In conclusion only presently preferred embodiments of the present invention, be not used for limiting the scope that the present invention is implemented, it is all according to The equivalent changes and modifications carried out by shape, construction, feature and spirit described in scope of the invention as claimed, should all be included in this In the right of invention.

Claims (9)

  1. A kind of 1. hydrogeneous physiological saline, it is characterised in that including:Physiological saline and the simple substance being dissolved in the physiological saline Hydrogen.
  2. 2. hydrogeneous physiological saline as claimed in claim 1, it is characterised in that in the physiological saline, the quality point of sodium chloride Number is 0.5~0.9%.
  3. 3. hydrogeneous physiological saline as claimed in claim 1 or 2, it is characterised in that the simple substance hydrogen is dense in physiological saline Spend for 2~6mmol/L.
  4. 4. a kind of preparation method of hydrogeneous physiological saline as claimed in claim 1, it is characterised in that include the following steps:
    Prepare physiological saline;
    At 20 DEG C, hydrogen of the purity not less than 99.9999% is passed through in the physiological saline, makes the hydrogen in physiology salt Reach hypersaturated state in water, obtain the hydrogeneous nasal nursing liquid.
  5. A kind of 5. purposes of the hydrogeneous physiological saline in nasal wash is prepared as claimed in claim 1.
  6. 6. nasal wash as claimed in claim 5, it is characterised in that including hydrogeneous physiological saline and at least one medically Acceptable auxiliary material.
  7. 7. nasal wash as claimed in claim 6, it is characterised in that the auxiliary material is osmotic pressure regulator, in preservative One or two.
  8. 8. nasal wash as claimed in claim 7, it is characterised in that the osmotic pressure regulator is selected from boric acid, borax, phosphorus At least one of sour disodium hydrogen, citric acid and mannitol.
  9. 9. nasal wash as claimed in claim 7, it is characterised in that the preservative is selected from sorbic acid, benzyl carbinol, benzene oxygen At least one of ethanol.
CN201610893547.8A 2016-10-13 2016-10-13 A kind of hydrogeneous physiological saline and its preparation method and application Pending CN107929314A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019055748A1 (en) * 2017-09-14 2019-03-21 Miz Company Limited Hydrogen-containing composition
CN110151783A (en) * 2019-02-02 2019-08-23 复旦大学附属妇产科医院 A kind of peritoneal fluid recurred for preventing endometriosis
CN110464736A (en) * 2019-09-06 2019-11-19 深圳市罗湖区人民医院 A kind of application of composition, hydrogen physiological saline for treating bladder cancer
CN112156073A (en) * 2020-09-07 2021-01-01 厦门市壳聚糖生物科技有限公司 Hydrogen-rich physiological seawater nasal spray and preparation method thereof
CN114159464A (en) * 2020-09-10 2022-03-11 三鑫三淼(北京)生物科技有限公司 Nasal wash and method for preparing nasal wash

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019055748A1 (en) * 2017-09-14 2019-03-21 Miz Company Limited Hydrogen-containing composition
CN110151783A (en) * 2019-02-02 2019-08-23 复旦大学附属妇产科医院 A kind of peritoneal fluid recurred for preventing endometriosis
CN110464736A (en) * 2019-09-06 2019-11-19 深圳市罗湖区人民医院 A kind of application of composition, hydrogen physiological saline for treating bladder cancer
CN112156073A (en) * 2020-09-07 2021-01-01 厦门市壳聚糖生物科技有限公司 Hydrogen-rich physiological seawater nasal spray and preparation method thereof
CN114159464A (en) * 2020-09-10 2022-03-11 三鑫三淼(北京)生物科技有限公司 Nasal wash and method for preparing nasal wash

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