CN106860891A - A kind of benzalkonium bromide sodium choride irrigation and preparation method thereof - Google Patents
A kind of benzalkonium bromide sodium choride irrigation and preparation method thereof Download PDFInfo
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- CN106860891A CN106860891A CN201710118087.6A CN201710118087A CN106860891A CN 106860891 A CN106860891 A CN 106860891A CN 201710118087 A CN201710118087 A CN 201710118087A CN 106860891 A CN106860891 A CN 106860891A
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- benzalkonium bromide
- irrigation
- flushing liquor
- choride
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/18—Liquid substances or solutions comprising solids or dissolved gases
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N33/00—Biocides, pest repellants or attractants, or plant growth regulators containing organic nitrogen compounds
- A01N33/02—Amines; Quaternary ammonium compounds
- A01N33/12—Quaternary ammonium compounds
-
- A—HUMAN NECESSITIES
- A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
- A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- A01N59/00—Biocides, pest repellants or attractants, or plant growth regulators containing elements or inorganic compounds
- A01N59/08—Alkali metal chlorides; Alkaline earth metal chlorides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/14—Quaternary ammonium compounds, e.g. edrophonium, choline
-
- 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
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
-
- 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
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
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- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Epidemiology (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Dentistry (AREA)
- Pest Control & Pesticides (AREA)
- Environmental Sciences (AREA)
- Plant Pathology (AREA)
- Wood Science & Technology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Zoology (AREA)
- Agronomy & Crop Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
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- Agricultural Chemicals And Associated Chemicals (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of benzalkonium bromide sodium choride irrigation, flushing liquor described in per 1000L is made up of following components：40~60g of benzalkonium bromide, 8.55~9.45kg of sodium chloride, balance of water.Quality evaluation result shows that flushing liquor of the present invention is respectively provided with stronger bacteriostasis to Escherichia coli, staphylococcus aureus, to skin, eyes without obvious irritation, and has good stability, with wide potential applicability in clinical practice.
Description
Technical field
The present invention relates to a kind of benzalkonium bromide sodium choride irrigation and preparation method thereof, belong to sterile products field.
Background technology
Benzalkonium bromide is cationic surfactant class wide-spectrum bactericide, is presently the most one of conventional bactericide.It
Bacterial cytoplasm membrane permeability can be changed, make thalline endochylema extravasation, hindered it to be metabolized and play killing action, it is thin to Grain-positive
The inhibitory action of bacterium is notable.Clinically it is used for pre-surgical skin disinfection, mucous membrane and wound disinfection, surgical instrument disinfection etc..But
It is that benzalkonium bromide has obvious excitant to body, once has been reported that and cause allergic conjunctivitis, hypopsia, contact
Property dermatitis, as vaginadouche even have cause death case, limit its extensive use clinically.Therefore, need
In the biological safety for improving benzalkonium bromide preparation.
Benzalkonium bromide belongs to quaternary ammonium salts surfactant, there is incompatibility with many inorganic salts；More there is research table
Bright, if addition of the sodium chloride in 0.1% bromogeramine is more than 1%, stability of solution is substantially reduced, and is occurred in storage mixed
Turbid phenomenon, and muddy with the amount increase for adding aggravate that (such as Dingqing dragon prevents 0.1% bromogeramine muddiness less than 18 DEG C
Formula [J] northwests pharmaceutical journal, 2 (1) in 1987：21~22, referring to the final stages of page 21).In addition, adding sodium chloride
Whether influence can be produced on the sterilization capability of benzalkonium bromide, be also that technical staff cannot know.
So far, there is not yet preparing the relevant report of benzalkonium bromide sodium choride irrigation.
The content of the invention
It is an object of the invention to provide a kind of benzalkonium bromide sodium choride irrigation and preparation method thereof.
The invention provides a kind of benzalkonium bromide sodium choride irrigation, flushing liquor described in per 1000L is made up of following components：
40~60g of benzalkonium bromide, 8.55~9.45kg of sodium chloride, balance of water.
Further, flushing liquor described in every 1000L is made up of following components：It is benzalkonium bromide 50g, sodium chloride 9kg, balance of
Water.
Further, the pH value of the flushing liquor is 4.0~7.0.
Further, the osmotic pressure of the flushing liquor is 260~320mOsmol/kg.
The invention provides a kind of preparation method of the benzalkonium bromide sodium choride irrigation, comprise the following steps：
A, benzalkonium bromide and sodium chloride are weighed, in adding Agitation Tank, with water dissolves and constant volume；
B, refined filtration, filling, sterilizing, obtain final product.
Further, the refined filtration uses a diameter of 0.22um filtering with microporous membrane.
Further, it is described to sterilize in 121 DEG C of moist heat sterilizations 15 minutes.
The invention provides purposes of the benzalkonium bromide sodium choride irrigation in sterile products are prepared.
Further, described sterile products are the medicines for the cleaning of surgical instrument disinfection, skin, the surface of a wound or mucous membrane.
The invention provides a kind of benzalkonium bromide sodium choride irrigation.Quality evaluation result shows, of the invention by specific use
The benzalkonium bromide and sodium chloride for measuring proportioning are prepared into flushing liquor, and product stability is good, Acceleration study and long-term natural reserved reality
Quality is showed no in testing to occur being decreased obviously.In addition, this product not only Escherichia coli, staphylococcus aureus are respectively provided with it is stronger
Bacteriostasis, and to skin, eyes without obvious irritation, security is good, with wide potential applicability in clinical practice.
Obviously, the above of the invention, according to the ordinary technical knowledge and customary means of this area, is not departing from
Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification of other diversified forms can also be made, is replaced or is changed.
The specific embodiment of form, remakes further specifically to the above of the invention by the following examples
It is bright.But this scope for being interpreted as above-mentioned theme of the invention should not be only limitted to following example.It is all based on the above of the present invention
The technology realized belongs to the scope of the present invention.
Brief description of the drawings
Fig. 1 is the process chart of benzalkonium bromide sodium choride irrigation of the present invention.
Specific embodiment
The raw material that is used in the specific embodiment of the invention, equipment are known product, are obtained by buying commercially available prod.
Ingredient requirement：The benzalkonium bromide used in formula, its quality should meet《Pharmacopoeia of People's Republic of China》In " benzene prick
The requirement of bromine ammonium "；The sodium chloride used in formula, its quality should meet《Pharmacopoeia of People's Republic of China》In " sodium chloride " will
Ask；Industrial water is water for injection, and its quality should meet《Pharmacopoeia of People's Republic of China》In " water for injection " requirement.
The preparation of the benzalkonium bromide sodium choride irrigation of the present invention of embodiment 1
1st, product formula
2nd, prescription is produced
| Benzalkonium bromide | 150g |
| Sodium chloride | 27.0kg |
| Water for injection | Add to 3000L |
3rd, process route
(1) prepare：Benzalkonium bromide, the sodium chloride of recipe quantity are weighed, in the Agitation Tank of the existing appropriate water for injection of addition,
Under stirring, continuation water for injection is settled to 3000L is completely dissolved it.
(2) refined filtration：With a diameter of 0.22um filtering with microporous membrane.
(3) intermediate detection：Including proterties, benzalkonium bromide content and pH value.PH value is 4.5~6.5.
(4) it is filling：Below 60 DEG C, per packed 3000ml or 2000ml.
(5) seal：Welding cap.
(6) sterilize：121 DEG C of moist heat sterilizations 15 minutes.
(7) lamp inspection：By it is straight, horizontal, fall three-step approach, every bag of lamp inspection.
(8) packaging, full inspection, storage.
Beneficial effects of the present invention are proved below by way of experimental example.
The quality evaluation of the benzalkonium bromide sodium choride irrigation of the present invention of experimental example 1
1st, proterties
Take the product prepared according to embodiment 1 to be estimated under natural light, be colourless supernatant liquid.
2nd, pH value
Press《Pharmacopoeia of People's Republic of China》Annex《PH value determination method》Detection, pH value is 4.0~7.0.
3rd, osmotic pressure molar density
This product is taken, is pressed《Pharmacopoeia of People's Republic of China》Annex《Osmotic pressure molar density inspection technique》Detection is 260~
320mOsmol/kg。
4th, loading amount
This product is taken, is pressed《Pharmacopoeia of People's Republic of China》Annex《Minimum loading capacity examination method》Detection, average loading amount is no less than
Sign loading amount, 97% of each container loading amount no less than sign loading amount.
5th, benzalkonium bromide content
According to《Pharmacopoeia of People's Republic of China》Annex《High performance liquid chromatography》Determine.
Chromatographic condition and system suitability octadecylsilane chemically bonded silica are filler；With 0.02mol/L heptan
Alkyl sulfonic acid sodium solution (contains 0.1% triethylamine, pH to 3.5)-acetonitrile (35 is adjusted with phosphoric acid：65) it is mobile phase；Flow velocity is 1.0ml/
Min, 35 DEG C of column temperature, Detection wavelength is 210nm, and number of theoretical plate is calculated by benzalkonium bromide peak and should be not less than 5000.
Determination method takes this product stoste as need testing solution, and precision measures 20 μ l, injects liquid chromatograph, records chromatogram
Figure；The another benzalkonium bromide that takes is appropriate, and solution of every 1ml containing about the μ g of benzalkonium bromide 50 is quantitatively diluted to water, is measured in the same method, by external standard
Method is obtained final product with calculated by peak area.
The sign content of benzalkonium bromide is 50mg/L, and this product benzalkonium bromide content is 40mg/L~60mg/L.
6th, microbiological indicator
This product is taken, is pressed《Pharmacopoeia of People's Republic of China》Annex《Sterility Test》Middle membrane-filter procedure detection, aseptic life
It is long.
7th, bacteriostasis property (stripping property)
7.1 test organisms are prepared with bacterium solution
7.1.1 test organisms：Escherichia coli, staphylococcus aureus.
7.1.2 prepared by bacteria suspension：Take Escherichia coli, the staphylococcus aureus slant culture to nutrient broth in 3~5 generations
In culture medium, 30~35 DEG C are cultivated 18~24 hours；Bacterium solution after culture is diluted with 0.03mol/L phosphate buffers (will
The concentration asked is：With 100 μ L drops in 5mL aqua sterilisas), as experiment bacterium solution.Bacterial count recovered is 1*104~9*104cfu/
ml。
7.1.3 contrast with the preparation of 0.005% benzalkonium bromide flushing liquor：Sodium chloride is added without, remaining same embodiment of operation
1。
7.2 operating procedures
Take each by test liquid (flushing liquor of embodiment 1 or 0.005% benzalkonium bromide flushing liquor) and control sample liquid (aqua sterilisa)
5mL, then the μ L of above-mentioned experiment bacterium solution 100 are taken, add to mixed in test liquid and control sample liquid respectively, after mixing, making respectively
During with 2,5,10,20min, the examination that 0.5mL puts into the phosphate buffers of 0.03mol/L containing 4.5mL is drawn respectively with aseptic straw
In pipe, fully mix, make appropriate dilution, then take wherein 2-3 dilution factor, 0.5mL is drawn respectively, be placed in two plates, use
Let cool after dissolving to 40~45 DEG C of nutrient agar (EHEC, staphylococcus aureus use) about 15mL and make to incline
Note, rotates plate, makes its full and uniform, and flat board is overturn after agar solidification, and bacterium cultivates 48h, does viable bacteria bacterium in 30 DEG C~35 DEG C
Fall to counting.
Experiment is repeated 3 times, and bacteriostasis rate is calculated by formula following equation：X=(A-B)/A*100%
In formula：X --- bacteriostasis rate, %；
A --- control sample average colony number；
B --- tested sample average clump count.
7.3 results
| By test solution | Escherichia coli bacteriostasis rate | Staphylococcus aureus bacteriostasis rate |
| The flushing liquor of embodiment 1 | 100% | 100% |
| 0.005% benzalkonium bromide flushing liquor | 100% | 100% |
Result above shows that benzalkonium bromide sodium choride irrigation of the present invention has to Escherichia coli, staphylococcus aureus
The addition for having stronger bacteriostasis, a large amount of sodium chloride does not reduce its bacteriostasis.
8th, toxicologic index
More than 8.1 Skin Irritation Test
8.1.1 test method
By the Ministry of Public Health《Disinfection technology standard》(2002) Part II《Sterile products inspection technology specification》In " sterilization produce
Corresponding test method is carried out in product toxicological experiment technical specification ".
8.1.2 sample preparation
Sample is the flushing liquor stoste of embodiment 1.Control uses purified water.
8.1.3 result
Benzalkonium bromide sodium choride irrigation is to the multiple skin wound repair scoring of rabbit
Note：*Daily every animal integral mean value=∑ (every the erythema and oedema total mark of animal 14d)/animal subject
×14.
Experimental result：Benzalkonium bromide sodium choride irrigation of the present invention refers to the acute irritation that rabbit intact skin repeatedly stimulates
Number top averages are 0, and excitant is suitable with pure water, show its to skin without obvious stimulation, security is good.
8.2 acute eye irritation tests
8.2.1 test method
By the Ministry of Public Health《Disinfection technology standard》(2002) Part II《Sterile products inspection technology specification》In " sterilization produce
Corresponding test method is carried out in product toxicological experiment technical specification ".
8.2.2 sample preparation
Sample is the flushing liquor stoste of embodiment 1.Control uses physiological saline.
8.2.3 result
Benzalkonium bromide sodium choride irrigation is to rabbit eye irritant test result
*Average score means that 24h, 48h and 72h score sum divided by observing time hop count 3.
Experimental result：The highest that benzalkonium bromide sodium choride irrigation of the present invention is reacted rabbit eyes acute irritation stimulates and refers to
Number averages be 0, excitant is suitable with physiological saline, show its to eyes without obvious stimulation, security is good.
9th, benzalkonium bromide sodium choride irrigation stability
9.1 accelerated tests
To pack 3 months in 37 DEG C~40 DEG C insulating boxs of (packaging material is five-layer coextrusion transfusion bag) intact sample, keep phase
To humidity >=75%.
Detection project：Proterties, pH value, osmotic pressure molar density, benzalkonium bromide content, bacteriostasis property, observation product storage
Front and rear mass change.
Testing result
Experimental result：Proterties, pH value, osmotic pressure molar density, the bacteriostasis property of flushing liquor of the present invention have without significant change
Effect composition benzalkonium bromide content rate of descent≤10%.
Result above shows, flushing liquor of the present invention is up-to-standard through 37 DEG C of accelerated tests 3 months, can place at room temperature to
It is few 2 years, illustrate its good stability.
9.2 natural reserveds
Packaging (packaging material is five-layer coextrusion transfusion bag) intact sample is positioned over room temperature environment, was taken by 0,3,6,12 months
Sample is determined.
Detection project：Proterties, pH value, osmotic pressure molar density, benzalkonium bromide content, bacteriostasis property, microbiological indicator, see
Examine the mass change before and after product storage.
Testing result
Experimental result：Proterties, pH value, osmotic pressure molar density, the bacteriostasis property of flushing liquor of the present invention have without significant change
Effect composition benzalkonium bromide content rate of descent≤10%, microbiological indicator is asepsis growth.
Result above shows that flushing liquor of the present invention is placed in room temperature environment and has no within 12 months that being decreased obviously occurs in quality, and is said
Bright its good stability.
Claims (9)
1. a kind of benzalkonium bromide sodium choride irrigation, it is characterized in that：Flushing liquor described in per 1000L is made up of following components：Benzene is pricked
40~60g of bromine ammonium, 8.55~9.45kg of sodium chloride, balance of water.
2. benzalkonium bromide sodium choride irrigation as claimed in claim 1, it is characterized in that：Flushing liquor is by following described in per 1000L
Component is constituted：Benzalkonium bromide 50g, sodium chloride 9kg, balance of water.
3. benzalkonium bromide sodium choride irrigation as claimed in claim 1, it is characterized in that：The pH value of the flushing liquor be 4.0~
7.0。
4. benzalkonium bromide sodium choride irrigation as claimed in claim 1, it is characterized in that：The osmotic pressure of the flushing liquor is 260
~320mOsmol/kg.
5. the preparation method of benzalkonium bromide sodium choride irrigation described in a kind of Claims 1 to 4 any one, it is characterized in that：Bag
Include following steps：
A, benzalkonium bromide and sodium chloride are weighed, in adding Agitation Tank, with water dissolves and constant volume；
B, refined filtration, filling, sterilizing, obtain final product.
6. preparation method as claimed in claim 5, it is characterized in that：The refined filtration uses a diameter of 0.22um miillpore filters mistake
Filter.
7. preparation method as claimed in claim 5, it is characterized in that：It is described to sterilize in 121 DEG C of moist heat sterilizations 15 minutes.
8. purposes of the benzalkonium bromide sodium choride irrigation in sterile products are prepared described in Claims 1 to 4 any one.
9. purposes as claimed in claim 8, it is characterized in that：Described sterile products are for surgical instrument disinfection, skin, wound
Face or the medicine of mucous membrane cleaning.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710118087.6A CN106860891A (en) | 2017-03-01 | 2017-03-01 | A kind of benzalkonium bromide sodium choride irrigation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710118087.6A CN106860891A (en) | 2017-03-01 | 2017-03-01 | A kind of benzalkonium bromide sodium choride irrigation and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107812180A (en) * | 2017-10-31 | 2018-03-20 | 华仁药业股份有限公司 | A kind of stomach signet ring cell cancer operative incision flushing liquor and preparation method |
| CN108096276A (en) * | 2018-03-08 | 2018-06-01 | 上海宁璋医疗器械有限公司 | A kind of debridement healing washing lotion and its application |
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| CN107812180B (en) * | 2017-10-31 | 2020-06-16 | 华仁药业股份有限公司 | Gastric ring cell cancer operation incision flushing fluid and preparation method thereof |
| CN108096276A (en) * | 2018-03-08 | 2018-06-01 | 上海宁璋医疗器械有限公司 | A kind of debridement healing washing lotion and its application |
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