CN107496442A - A kind of chlorine dioxide responsive to temperature type spray gel and preparation method thereof - Google Patents
A kind of chlorine dioxide responsive to temperature type spray gel and preparation method thereof Download PDFInfo
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- CN107496442A CN107496442A CN201710740623.6A CN201710740623A CN107496442A CN 107496442 A CN107496442 A CN 107496442A CN 201710740623 A CN201710740623 A CN 201710740623A CN 107496442 A CN107496442 A CN 107496442A
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- 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
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
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- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
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- 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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Abstract
The present invention relates to a kind of chlorine dioxide responsive to temperature type spray gel and preparation method thereof.It is made up of chlorine dioxide matrix, activator, temperature sensing material, gelation temperature conditioning agent and water.Using boric acid as gel conditioning agent, dosage is 0.5% ~ 1%, and this gel is the liquid of free-flowing at 5 DEG C ~ 32 DEG C, at 32 DEG C ~ 40 DEG C, is changed into gel state by liquid, chlorine dioxide can be discharged under two states.The present invention can be with filling to suitable sprayer unit or gel delivery device, to smear or Sprayable is administered, available for preventing and treating enterovirus, influenza virus.
Description
Technical field
The invention belongs to field of medicine preparations, is related to a kind of chlorine dioxide responsive to temperature type spray gel and its preparation side
Method.
Background technology
Chlorine dioxide is a kind of extremely strong oxidant of water solubility, and its oxidability is 2.6 times of chlorine, and it being capable of rapid oxygen
Change decomposing bacteria, virus, the amino acid in protein and many reducing substanceses, can also be with a variety of inorganic ions and organic
Thing is had an effect, and will not produce the organic halogens such as carcinogenic, teratogenesis, mutagenic chloroform, is generally used for making sterilization, drift
In vain, antistaling agent, as products such as oxidant, deodorant, biocide, antistaling agent, bleaching agents.Chlorine Dioxide On Escherichia Coli, wound
The scorching virus of cold bacillus, hepatitis type B virus, tubercle bacillus, green pus liver bacterium, chicken pneumonitis virus, brains, bacteriophage, poliomyelopathy
Killing rates such as malicious (II) is up to 10%.Chlorine dioxide can adsorb and the capsid protein through virus, is reacted with RNA therein, damage
Hinder the assortment of genes into RNA ability, and the Chlorine Dioxide Molecules of high concentration are have accumulated in virus surface, thus two can be greatly reinforced
The inactivating efficacy of chlorine monoxid, in addition, the type of chlorine dioxide infected by influenza I, II type and III type can make it in certain dosage
Inactivation.Chlorine dioxide is to Human enterovirus virus, herpesviral, Newcastle virus, bacteriophage, vaccinia virus, poliovirus
Etc. numerous viruses, there is good killing effect.As can be seen here, chlorine dioxide has wide in terms for the treatment of enterovirus and influenza virus
Wealthy application prospect.
Thermo-sensitive material is Low Molecular-Weight Gel, is generally all to be formed by weaker interaction, such as molecule
Between hydrogen bond, π-π effects, Van der Waals force and hydrophobic effect etc..The change of temperature can influence or destroy these effects, so that
Gel state changes, in liquid during usually less than LCST, in as a form of gel during higher than LCST.When its hydrophilic radical with it is hydrophobic
When the ratio of group is suitable, gel conversion can occur in aqueous.With the rise of temperature, dissolving energy of the water to polymer
Power is reduced, and the interaction between polymer is become as leading role, so as to form gel.After it is used for delivery system, in body
Gel is formed under temperature, medicine can be discharged well and act on human body, so as to play therapeutic action.Chinese patent201510016557.9Thermo-sensitive material is used as using responsive to temperature type water wetted material poloxamer188 and PLURONICS F87 mixing
Material prepares nose temperature-sensitivtype type hydrogel spray, and the wherein content of poloxamer188 is 14%~18%, PLURONICS F87
Concentration be 0%~2%, both total dosages be not more than 20%, the transformation of the way agent be liquid under room temperature (25 DEG C), temperature be 30 DEG C
It is gel state at~35 DEG C；But because body temperature is generally 36.5~37.2 DEG C, this invention can not under the temperature conditionss
Stable gel state is formed, in the prior art, can be by adding polyethylene glycol, Methyl cellulose usually improves gelation temperature,
However, adding polyethylene glycol, methylcellulose can reduce the gelling ability of poloxamer188, therefore, what emphasis of the present invention solved
Problem is on the premise of gelling ability is ensured, expands the temperature range for maintaining gel state, and then improve the glue of poloxamer188
Solidifying temperature, it is allowed to be adapted to body temperature, reaches therapeutic effect.
Gaseous chlorine dioxide is active and unstable, and solution is volatile, general to be inconvenient to compressed gas or concentrate is made, and
Moisture account for exhausted large scale in stable ClO 2 solution, and chlorine dioxide content is low, needs to dilute during use and uses, using,
It is inconvenient to carry.The present invention is directed to disadvantages described above, using netted resistance structure possessed by gel rubber system, slows down chlorine dioxide mother
The association rate of body and activator, chlorine dioxide is set slowly, stably to discharge.Two prepared simultaneously using Thermo-sensitive material
Chlorine monoxid responsive to temperature type spray gel, is stored with solution state, in body temperature when can be sprayed and used by sprayer, and used
Under the conditions of can form gel, slowly discharge chlorine dioxide and act on the virus of human body surface, reach treatment enterovirus and stream
The purpose of Influenza Virus.
The content of the invention
The invention provides a kind of chlorine dioxide responsive to temperature type spray gel, is the liquid of free-flowing at 5 DEG C ~ 32 DEG C
Body, at 32 DEG C ~ 40 DEG C, gel state is changed into by liquid, chlorine dioxide can be discharged under two states, available for treating
Enterovirus and influenza virus.
Specifically, the technical proposal of the invention is realized in this way：
A kind of chlorine dioxide responsive to temperature type spray gel, it is characterised in that by chlorine dioxide matrix, activator, temperature sensing material and
Water forms.
Described temperature sensing material is poloxamer188, and shared weight fraction is 15% ~ 20%
Described gelation temperature conditioning agent is boric acid, and shared weight fraction is 0.5% ~ 1%.
Further, described gelation temperature conditioning agent boric acid, its preferred weight fraction are 0.7 ~ 0.8%
Poloxamer188（Poloxamer407, P407）The nonionic triblock copolymer formed for polyoxyethylene and polyoxypropylene
Thing, it is made up of about 70% ethylene oxide and 30% propylene oxide, it has surface-active, good security；And one
It is liquid to determine the P407 solution of concentration when having low temperature, turns into the reverse thermogelling matter of gel under body temperature, and toxicity is low, stimulates
Small, the good biocompatibility of property.Its gelation temperature is generally 25 DEG C ~ 30 DEG C, and prior art achievement in research shows, is added into gel
Polyethylene glycol, during methylcellulose, although gelation temperature has been lifted, the gelling ability of poloxamer188 can drop
It is low, and we are surprisingly had found by experiment, when adding boric acid, due to introducing electrolyte, can improve poloxamer simultaneously
407 gelation temperature and gelling ability, and boric acid dosage is screened by experiment, make poloxamer188 gelation temperature
32 DEG C ~ 40 DEG C are brought up to, the temperature range is more nearly human body temperature, while in the premise for not increasing poloxamer188 dosage
Under, gelling ability is improved, gel state is added stabilization.
Described chlorine dioxide matrix is sodium chlorate or potassium chlorate, and shared weight fraction is 10 ~ 15%；Described activation
Agent is sodium sulfite or potassium sulfite, and shared weight fraction is 10 ~ 15%.
The formation mechanism of chlorine dioxide is that with activator redox reaction occurs for chlorine dioxide matrix, generates titanium dioxide
Chlorine, the reaction needs to carry out in acid condition, and boric acid is while as gelation temperature conditioning agent, is also chlorine dioxide
Reaction of formation provides sour environment, therefore need not it is possible to additionally incorporate acid reaction in formula and can occur, and reduces formula composition.
In order to prove that boric acid has specificity as the gelation temperature conditioning agent of chlorine dioxide temperature sensitivity spray gel, I
Employ other acidic materials that can be catalyzed chlorine dioxide reaction of formation and prepare chlorine dioxide thermo-sensitive gel, compare gelling temperature
Degree and gelling ability, the results are shown in Table 1.
Influence of the different acid of table 1 to gelation temperature and ability
| Acidic materials | P407 dosages | Gelation temperature | Gelling ability |
| Boric acid | 20% | 32℃~40℃ | ++++ |
| Disodium hydrogen phosphate/dipotassium hydrogen phosphate | 20% | 25℃~30℃ | ++ |
| Acetic acid-acetate buffer | 20% | 25℃~30℃ | ++ |
| Watery hydrochloric acid | 20% | 25℃~30℃ | ++ |
| Citric acid | 20% | 25℃~30℃ | ++ |
| Dilute sulfuric acid | 20% | 25℃~30℃ | + |
| Acetic acid | 20% | 25℃~30℃ | ++ |
Boric acid can improve poloxamer188 while chlorine dioxide reaction of formation is catalyzed it can be seen from the result of table 1
Gelation temperature and gelling ability, and conventional other acid or acidic buffers and acted on without such, it can be seen that,
The hoisting power to gelation temperature and gelling ability of boric acid, realized not by the acid-base value of regulation system, but
Special role of the boric acid to poloxamer, it is the discovery with contingency.
The control of temperature plays the role of key for preparation process, because temperature raises, poloxamer188 is molten in water
The meeting of solution is slack-off, while viscosity increase, can produce substantial amounts of foam in solution, be unfavorable for the preparation of gel, in matching somebody with somebody for the present invention
It is by the temperature control of solution below 25 DEG C during system, such whole process is solution state, can so make chlorine dioxide
Solution and poloxamer188 are sufficiently mixed the performance for uniformly, being advantageous to gelatification.The present invention is being prepared, stir, mixing and filled
The temperature of equipment is preferably controlled in less than 15 DEG C by dress process, and environment temperature is preferably controlled in 20 DEG C or so.
Heretofore described chlorine dioxide responsive to temperature type spray gel, its preparation method, is comprised the following steps that：
Step a：According to formula rate, chlorine dioxide matrix, activator are dissolved in a part of water, it is molten to obtain chlorine dioxide
Liquid.
Step b：Poloxamer188 and boric acid are added in the water of remaining formula ratio, stirring and dissolving, it is molten to obtain thermo-sensitive gel
Liquid.
Further, described coolant-temperature gage is 5 ~ 25 DEG C, preferably 10 ~ 15 DEG C.
Step c：ClO 2 solution and thermo-sensitive gel solution are well mixed, it is filling to produce.
Further, preferably 10 ~ 15 DEG C of described mixing temperature.
Chlorine dioxide responsive to temperature type spray gel in the present invention, during use can with filling to suitable sprayer unit or
In gel delivery device, it is administered with smearing or Sprayable.
Temperature-sensitive spray gel prepared by the present invention coordinates sprayer unit before use, if environment temperature should drop in advance more than 30 DEG C
For temperature to less than 25 DEG C, such temperature can ensure that the state of thermo-sensitive gel is liquid, and spraying forms gel using contact human body
Play a role.
Chlorine dioxide responsive to temperature type spray gel utilizes the reverse thermogelling of the gel of poloxamer188 in the present invention
Matter, gelation temperature is improved by gelation temperature conditioning agent, poloxamer188 is turned within the temperature range of body temperature is adapted to
Become gel-like state.The characteristics of combining response type and slow released ClO 2 preparation, fluid storage state gives birth to chlorine dioxide
It is higher into reaction efficiency, and gel use state can realize sustained release purpose, also, either spraying is made using still smearing
With both of which is very convenient, can effectively treat enterovirus and influenza virus.
Embodiment
With reference to embodiment, the present invention will be further described, but following examples are not as the limit to the present invention
System.
Embodiment 1
Formula：Poloxamer188 15%, boric acid 0.5%, sodium chlorate 10%, sodium sulfite 10%, purified water 64.5%.
Preparation method：Sodium chlorate, sodium sulfite are dissolved in the water of half formula ratio, obtain ClO 2 solution；Will
Poloxamer188 and boric acid are added in the water of remaining formula ratio, stirring and dissolving under the conditions of 15 DEG C, obtain thermo-sensitive gel solution；Will
ClO 2 solution and thermo-sensitive gel solution are well mixed, filling to produce.
Embodiment 2
Formula：Poloxamer188 15%, boric acid 1.0%, sodium chlorate 15%, sodium sulfite 15%, purified water 54%.
Preparation method：Sodium chlorate, sodium sulfite are dissolved in the water of half formula ratio, obtain ClO 2 solution.Will
Poloxamer188 and boric acid are added in the water of remaining formula ratio, stirring and dissolving under the conditions of 15 DEG C, obtain thermo-sensitive gel solution.Will
ClO 2 solution and thermo-sensitive gel solution are well mixed, filling to produce.
Embodiment 3
Formula：Poloxamer188 20%, boric acid 1.0%, sodium chlorate 10%, sodium sulfite 10%, purified water 59%.
Preparation method：Sodium chlorate, sodium sulfite are dissolved in the water of half formula ratio, obtain ClO 2 solution.Will
Poloxamer188 and boric acid are added in the water of remaining formula ratio, stirring and dissolving under the conditions of 10 DEG C, obtain thermo-sensitive gel solution.Will
ClO 2 solution and thermo-sensitive gel solution are well mixed, filling to produce.
Embodiment 4
Formula：Poloxamer188 20%, boric acid 0.5%, sodium chlorate 15%, sodium sulfite 15%, purified water 49.5%.
Preparation method：Sodium chlorate, sodium sulfite are dissolved in the water of half formula ratio, obtain ClO 2 solution.Will
Poloxamer188 and boric acid are added in the water of remaining formula ratio, stirring and dissolving under the conditions of 10 DEG C, obtain thermo-sensitive gel solution.Will
ClO 2 solution and thermo-sensitive gel solution are well mixed, filling to produce.
Testing example 1
The measure of gelation temperature：
Sample is placed in water-bath, agitating paddle is placed in sample, is at the uniform velocity stirred, temperature is set to 10 respectively, 15,20,25,
30th, 35,40,45 DEG C, observe sample state after every temperature stirring 5min, determine and record be changed into by solution state it is solidifying
Temperature during gluey state.
Chlorine dioxide thermosensitive in situ gel is prepared referring additionally to method in Chinese patent 201510016557.9, for control
Group, determine gelation temperature.
The control group of table 2 and the contrast of embodiment gelation temperature
| Sample | Control group | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| Gelation temperature（℃） | 32.0 | 32.8 | 34.7 | 37.6 | 36.0 |
Using embodiment 1, embodiment 2, embodiment 3, embodiment 4, control group is contrasted, determines the gelling of chlorine dioxide thermo-sensitive gel
Temperature.As a result it can be seen that the embodiment of the present invention can both reach the gelation temperature requirement of control group, temperature range has also been made
Expand, it is possible to achieve higher gelation temperature, and then closer human body temperature.
Testing example 2
Chlorine dioxide thermosensitive in situ gel infected by influenza Disinfection Effect is investigated：
Mdck cell is passaged to 96 orifice plates, after growing up to individual layer, adds 100 μ L (10TCID50) influenza virus liquid absorption 2h（37℃
CO2Incubator）After take out, suction out the solution in each hole, chlorine dioxide thermosensitive in situ gel added or spray into, after reacting certain time
Cultivated in 33 DEG C of insulating boxs, 4 ~ 5d of Continuous Observation, observe mdck cell whether there is lesion under inverted microscope, if without lesion,
Show that virus is inactivated.It is blank control group to set simultaneously and do not add chlorine dioxide gel group.
The chlorine dioxide thermosensitive in situ gel infected by influenza Disinfection Effect of table 3
| Sample | Blank control | Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 |
| The type of influenza virus I | + | - | - | - | - |
| The type of influenza virus II | + | - | - | - | - |
| The type of influenza virus III | + | - | - | - | - |
Note：+ represent that virus is not inactivated；- represent that virus is inactivated
Using embodiment 1, embodiment 2, embodiment 3, embodiment 4, blank control group is contrasted, investigates and three kinds of influenza viruses is gone out
Active fruit, as a result it can be seen that infected by influenza of the embodiment of the present invention has disinfective action.
Claims (7)
- A kind of 1. chlorine dioxide responsive to temperature type spray gel for containing boric acid as gelation temperature conditioning agent.
- 2. a kind of chlorine dioxide temperature spray gel containing boric acid according to claim 1, be by chlorine dioxide matrix, Activator, temperature sensing material, gelation temperature conditioning agent and water composition.
- 3. gelation temperature conditioning agent according to claim 2 is boric acid, shared weight fraction is 0.5% ~ 1%.
- 4. gelation temperature conditioning agent boric acid according to claim 3, further, its preferred weight fraction is 0.7% ~ 0.8%。
- 5. a kind of chlorine dioxide responsive to temperature type spray gel according to claim 2, it is characterised in that described is temperature sensitive Material is poloxamer188, and shared weight fraction is 15% ~ 20%.
- A kind of 6. chlorine dioxide responsive to temperature type spray gel according to claim 5, it is characterised in that described dioxy It is sodium chlorate or potassium chlorate to change chlorine parent, and shared weight fraction is 10 ~ 15%；Described activator is sodium sulfite or sulfurous Sour potassium, shared weight fraction are 10 ~ 15%.
- 7. a kind of chlorine dioxide responsive to temperature type spray gel according to claim 6, it is characterised in that preparation can fill Be filled in suitable sprayer unit or gel delivery device, with smear or Sprayable be administered, for prevent and treat enterovirus and Influenza virus.
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| CN105380957A (en) * | 2015-12-04 | 2016-03-09 | 天津坤健生物制药有限公司 | Acetylcysteine gel, and preparation method and application thereof |
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2017
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Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007036107A1 (en) * | 2005-09-27 | 2007-04-05 | Genescience Pharmaceuticals Co., Ltd | An exterior-applied formulation and its preparation methods and uses |
| CN101199855A (en) * | 2006-12-13 | 2008-06-18 | 天津药业研究院有限公司 | Skinniness hormone packing matter water solution and application thereof |
| CN102068404A (en) * | 2009-11-25 | 2011-05-25 | 中国人民武装警察部队医学院 | Nimesulide temperature sensitive hydrogel and preparation method thereof |
| WO2012079146A1 (en) * | 2010-10-26 | 2012-06-21 | Oral Delivery Technology Ltd. | Nitric oxide amino acid esters for improving vascular circulation, and prophylaxis or treatment of a condition associated with impaired blood circulation |
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| CN105147595A (en) * | 2015-08-18 | 2015-12-16 | 吉林大学 | Pemirolast potassium temperature sensitive hydrogel and preparation method thereof |
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