CN108645850A - A kind of swab and its preparation method and application - Google Patents

A kind of swab and its preparation method and application Download PDF

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Publication number
CN108645850A
CN108645850A CN201810507561.9A CN201810507561A CN108645850A CN 108645850 A CN108645850 A CN 108645850A CN 201810507561 A CN201810507561 A CN 201810507561A CN 108645850 A CN108645850 A CN 108645850A
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China
Prior art keywords
swab
hot pressing
pipe
hollow
sampling head
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CN201810507561.9A
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Chinese (zh)
Inventor
叶超华
黄健
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Huizhou Fa Luyuan Gene Technology Co Ltd
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Huizhou Fa Luyuan Gene Technology Co Ltd
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Priority to CN201810507561.9A priority Critical patent/CN108645850A/en
Publication of CN108645850A publication Critical patent/CN108645850A/en
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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G01N21/80Indicating pH value
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045Devices for taking samples of body liquids
    • A61B2010/0074Vaginal or cervical secretions

Abstract

The present invention provides a kind of swabs and its preparation method and application, the swab includes swab head, hollow swab pipe (3) and isolation strip (4), the hollow swab pipe is provided at both ends with the first sampling head (1) and the second sampling head (2), and the isolation strip (4) is arranged in the middle part of hollow swab pipe.Two kinds of detection methods are incorporated on a swab by swab provided by the invention by the way of double end swab, it is simple in structure portable, and the hollow swab pipe of the swab stick in traditional swab is substituted, hollow swab duct occlusion is isolated into not connected two parts using hot-pressing technique, can be used for that liquid is perfused, extruded hollow pipe can make liquid penetrate into sampling head, and the accuracy rate of testing result for detecting vaginal disease is high.

Description

A kind of swab and its preparation method and application
Technical field
The invention belongs to medical supplementary instrument technical field, a kind of swab and its preparation method and application is related generally to.
Background technology
It is getting faster in the rhythm of life of today's society women, the pressure of various work and life causes the female for suffering from gynaecological disease Property is more and more.Bacterial vaginosis BV is suffered from woman vagina caused by flora imbalance and one of gynemetrics's common disease The women of bacterial vaginosis BV, leucorrhea increasing are often accompanied by foreign odor, and this patient is easy to happen metritis, adnexitis, pelvic infecton, palace The diseases such as pregnant, infertile outside, can reduce quality of life, greatly interfere women physically and mentally healthy.Tool is clinical to be proved:Women is weak Acidic environment, intravaginal pH value are about 3.8-4.5, are conducive to kill the various pathogenic bacteria and conditioned pathogen into vagina.PH < 4.5 but when vagina local microenvironment changes, microorganism species growth and breeding and vaginitis occurs, common are trichomonad Property vaginitis, monilial vaginitis and bacterial vaginitis.Trichomonad is detrimental to growth in normal vaginal environment, Growth and breeding is the most active in the environment of PH5.6~6.0.Therefore, when 4.5 values of vagina PH > rise, trichomonad could breed rapidly Growth causes vaginitis.Candida albicans is one of Body normal flora, is widely present in human skin, oral cavity, on genitals mucous membrane. About 10% healthy women and 30% pregnant woman are healthy carrier, without any clinical symptoms, it is seen that in normal genital tract ring In border, candida albicans will not cause a disease.Only when PH > 5.5 or so, growth and breeding is the most active, and can cause a disease.Bacterial vaginosis Inflammation be due to ability of Lactobacillus in human vagina reduce, Gartner bacterium and anaerobic bacteria breeding and caused by mixed infection.Bacterial vaginitis When, pH value is up to 5.0-6.8 or higher.If pH value 6.8-8.1 just considers whether the possibility of cervical lesions, discharges and cure Treat diagnoses and treatment.
In terms of vaginal disease diagnosis, clinically frequently with following methods:1, smear for microscopic examination takes secretion to make smear, shows It is micro- to have seen whether pathogenic bacteria;2, amine test, dropwise addition amine reagent is said if having a fish like smell release in vaginal fluid sample Bright secretion amine content is high;3, biochemical process takes vaginal fluid to make biochemical measurement, and normal women lactate content is high, amber salt Content is low, and vaginal disease patient's measured value is opposite;4, Enzymology method, using the enzyme-specific catalytic mechanism of microorganism, in conjunction with Chromophoric substrate forms enzyme and quickly detects.But above method is both needed to certain detection instrument or means, and testing cost is high, and time-consuming, behaviour Make cumbersome, dedicated technician is needed to operate.
CN206818620U discloses a kind of bacterial vaginosis BV detection swab stick, and the bacterial vaginosis BV detects swab Stick includes barred body and indication end, and the indication end includes two layers of nylon cloth layer, and macromolecule is covered in two layers of nylon cloth layer Polymeric layer carries pH indicator nitrazine yellows in the high polymer layer.The swab stick of the utility model is for bacterium Vaginosis accuracy in detection is high, but the indication end for coating nitrazine yellow is directly entered vagina sampling can cause vaginal irritation, aggravates Colpitis, and only by pH acid-base values detection cannot determine whether centainly to suffer from vaginitis, indicator go bad or it is unstable can Generate false positive.CN201064454Y discloses a kind of vagina acid-base degree fast sampling detection swab, which includes taking Sample head and the mating amine reagent of thief rod, the sampling head are ellipticity, which is located at one end of thief rod.With it is existing The features such as technology is compared, which is conducive to medical practice, is conducive to commercialization and is transported, and safe and reliable, but should Smaller using the novel sampling head, oblong surface sampling amount is few, is unfavorable for late detection, easy tos produce error, and match The amine reagent of set is additive reagent, occupies packaging space, and is unfavorable for transporting and use.
Therefore it provides a kind of simple in structure portable, easy to operate efficient, as a result objective stabilization and accuracy height, facilitate trouble Person's self-test and low-cost detection swab is of great significance and broad mass market foreground.
Invention content
In view of the deficiencies of the prior art and actual demand, the present invention provides a kind of swab, by the way of double end swab Two kinds of detection methods are incorporated on a swab, simple in structure portable, it is complicated for operation to solve existing detection method, expense The defects of height, as a result subjectivity is strong, and the detection external transport brought of liquid is inconvenient, has a extensive future.
For this purpose, the present invention uses following technical scheme:
In a first aspect, the present invention provides a kind of swab, the swab includes swab head, hollow swab pipe 3 and isolation Band 4, the hollow swab pipe are provided at both ends with the first sampling head 1 and the second sampling head 2, and the setting of the isolation strip 4 is wiped hollow In the middle part of sub- pipe.
In the present invention, two kinds of detection methods are incorporated on a swab by the way of double end swab, it is simple in structure just It takes, and the hollow swab pipe of the swab stick in traditional swab is substituted, be isolated into hollow swab duct occlusion using hot-pressing technique Not connected two parts, and detection reagent is poured into respectively in the swab pipe of isolation strip both sides, by way of simply squeezing So that detection liquid is infiltrated through the sampling head after sampling, is changed by color change and taste, objective reaction result, accuracy is high, It avoiding the external transport brought of reagent and preserves inconvenience, doctor and patient can carry out operation detection, easy to operate, meanwhile, it is double The design of sampling head and hollow swab pipe is cost-effective, and market prospects are good.
Preferably, the material of the swab head include any one of medical sponge, flocking or superfine fibre cloth or At least two combination, preferably medical sponge.
Preferably, the length of first sampling head 1 be 10-25mm, such as can be 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm or 25mm.
Preferably, the length of second sampling head 2 be 10-25mm, such as can be 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, 21mm, 22mm, 23mm, 24mm or 25mm.
In the present invention, the selection of the length of first sampling head, 1 and second sampling head 2 is independent, two sampling heads Length can equally can not also be the same, those skilled in the art can be adjusted as needed.
Preferably, first sampling head, 1 and second sampling head 2 is class gourd shape, including spheric end and oval end.
It is a discovery of the invention that class gourd shape makes there is invagination among sampling head, mutually more typical oval sampling head can increase Add sampling amount, reduces the sample loss caused by being contacted with air, while can be during pinch detection liquid penetrates sampling head Play cushioning effect, prevent it is firmly excessive caused by liquid spray.
Preferably, a diameter of 8-13mm of the spheric end of first sampling head 1, for example, can be 8mm, 9mm, 10mm, 11mm, 12mm or 13mm.
Preferably, a diameter of 8-13mm of the spheric end of second sampling head 2, for example, can be 8mm, 9mm, 10mm, 11mm, 12mm or 13mm.
Preferably, the oval end in the sampling head coats hollow swab pipe end point.
The oval end of sampling head coats hollow swab pipe end in the present invention, and hollow swab Guan Zhongyi at this time includes inspection Liquid is surveyed, by adjusting mold shape, sampling head material hot pressing is coated on hollow swab pipe outer end.
Preferably, the material of the hollow swab pipe 3 is polypropylene material.
The present invention carries out the making of hollow swab pipe using polypropylene material, and the material plasticity is strong, safe and non-toxic, is system The good material of standby vagina sampler.
Preferably, the internal diameter of the hollow swab pipe 3 is 3-7mm, such as can be 3mm, 4mm, 5mm, 6mm or 7mm, excellent It is selected as 5mm.
Preferably, the pipe arm thickness of the hollow swab pipe 3 be 0.4-1mm, such as can be 0.4mm, 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1.0mm, preferably 0.5mm.
Preferably, the length of the hollow swab pipe 3 be 10-18cm, such as can be 10cm, 11cm, 12cm, 13cm, 14cm, 15cm, 16cm, 17cm or 18cm, preferably 14cm.
Preferably, the width of the isolation strip 4 is 1-5mm, such as can be 1mm, 2mm, 3mm, 4mm or 5mm.
Preferably, isolation strip 4 is set to the middle part of hollow swab pipe, and hollow swab pipe is divided into two portions of equidistance Point.
In the present invention, hollow swab pipe extrudes isolation strip by hot pressing mode, by hollow swab pipe be divided into it is completely enclosed every Two parts, and preferably two parts are equally spaced apart, two kinds of detection liquid are poured into the hollow swab pipe of dividing strip both sides respectively, Space and detection liquid dosage are saved, cost is reduced, while easy to use, can be carried around.
Preferably, contain pH detection liquid in the side that isolation strip 4 separates in the hollow swab pipe (3).
Preferably, the pH detections liquid includes methyl red, dimethyl diaminophenazine chloride, phenolsulfonphthalein, bromophenol blue, thymol blue, bromine thyme Phenol is blue or any one of bromocresol green or at least two combination, such as can be methyl red, thymol blue and bromocresol green Combination, methyl red, phenolphthalein is yellow and the combination of bromthymol blue, the combination of methyl red and bromocresol green or methyl red, phenolsulfonphthalein With the combination of thymol blue, the preferably combination of methyl red, phenolsulfonphthalein and thymol blue.
Heretofore described thymol blue is also known as thymol blue.
Preferably, the volume ratio of the methyl red, phenolsulfonphthalein and thymol blue is (2-5):(1-3):(1-3), such as can To be 2:1:1、3:2:1、4:2:3、5:1:2 or 5:3:3.
It is a discovery of the invention that methyl red reagent is used alone, indicated pH testing results are unstable, by coordinating phenolphthalein yellow And thymol blue can be obtained pH instruction results and stablize in amount ranges of the present invention, the pH detections that SOLUTION PROPERTIES is stablized Liquid, accuracy of detection are high.
Preferably, contain amine reagent in the other side that isolation strip 4 separates in the hollow swab pipe 3.
It is a discovery of the invention that pH detections are applied in combination is remarkably improved accuracy of detection with amine reagent experimental method.Meanwhile by amine Reagent is built in hollow swab pipe, amount capable of reducing using, and detection is easy to operate, is not necessarily to other auxiliary devices or tool.
Second aspect, the present invention provides a kind of preparation method preparing swab as described in relation to the first aspect, including walks as follows Suddenly:
(1) hollow swab pipe middle heat press seal is closed, extrudes isolation strip;
(2) the hollow swab pipe that the pH configured detection liquid is poured into isolation strip side, by opening hot pressing closing;
(3) the hollow swab pipe that the amine reagent configured is poured into the isolation strip other side, by opening hot pressing closing;
(4) by medical sponge hot pressing hollow swab pipe the outer end point.
Preferably, the upper mold temperature of step (1) described hot pressing is 100-120 DEG C, for example, can be 100 DEG C, 101 DEG C, 102 DEG C, 103 DEG C, 104 DEG C, 105 DEG C, 107 DEG C, 108 DEG C, 110 DEG C, 112 DEG C, 115 DEG C, 116 DEG C, 118 DEG C or 120 DEG C.
Preferably, the lower die temperature of the hot pressing is 100-120 DEG C, for example, can be 100 DEG C, 101 DEG C, 102 DEG C, 103 DEG C, 104 DEG C, 105 DEG C, 107 DEG C, 108 DEG C, 110 DEG C, 112 DEG C, 115 DEG C, 116 DEG C, 118 DEG C or 120 DEG C.
Preferably, the time of step (1) described hot pressing be 3-5s, such as can be 3s, 3.2s, 3.5s, 3.7s, 3.8s, 4.0s, 4.2s, 4.5s, 4.8s or 5.0s, preferably 3.5s.
It is a discovery of the invention that the hot pressing that hollow swab pipe carries out, i.e., swab pipe is opened after the hot pressing of isolation strip enters liquid with tank The hot pressing of mouth, the best results in the hot pressing temperature and time range, neither will produce leakage will not be such that tubing melts.
Preferably, the pH detection liquid and preparation method thereofs described in step (2) include the following steps:By methyl red solution 1.8- 2.0nmol/L, phenolsulfonphthalein solution 1.3-1.5nmol/L and thymol blue 0.9-1.1nmol/L, according to methyl red, phenolsulfonphthalein and Thymol blue is (2-5) by volume:(1-3):(1-3) mixing shakes up, and is stored in spare in brown bottle.
In the present invention, methyl red, phenolphthalein are yellow and thymol blue solution preparation method is according to the record of Chinese Pharmacopoeia, specifically Include the following steps:
0.1g methyl reds are dissolved in the sodium hydroxide of 7.4mL 0.05mol/L by (1 '), and it is spare to be diluted with water to 200mL;
0.1g phenolsulfonphthaleins are dissolved in the sodium hydroxide of 5.7mL 0.05mol/L by (2 '), and it is spare to be diluted with water to 200mL;
0.1g thymol blues are dissolved in the sodium hydroxide of 4.3mL 0.05mol/L by (3 '), and it is standby to be diluted with water to 200mL With.
Preferably, the dosage of step (2) pH detections liquid is 1.5-2.5mL, for example, can be 1.5mL, 1.6mL, 1.7mL, 1.8mL, 1.9mL, 2.0mL, 2.1mL, 2.2mL, 2.3mL, 2.4mL or 2.5mL.
Preferably, the upper mold temperature of opening hot pressing described in step (2) and step (3) is 100-120 DEG C, such as can be 100℃、101℃、102℃、103℃、104℃、105℃、107℃、108℃、110℃、112℃、115℃、116℃、118℃ Or 120 DEG C.
Preferably, the lower die temperature of opening hot pressing described in step (2) and step (3) is 100-120 DEG C, such as can be 100℃、101℃、102℃、103℃、104℃、105℃、107℃、108℃、110℃、112℃、115℃、116℃、118℃ Or 120 DEG C.
Preferably, the time of opening hot pressing described in step (2) and step (3) is 3-5s, for example, can be 3s, 3.2s, 3.5s, 3.7s, 3.8s, 4.0s, 4.2s, 4.5s, 4.8s or 5.0s, preferably 3.5s.
Preferably, the preparation method of step (3) the amine reagent includes the following steps:By potassium iodide 100g-150g, iodine 110g-160g, mercury 100g-150g and 1000ml distilled water heating stirring add distilled water to 2000ml, take again after being completely dissolved It states stoste 500-800ml, 10% sodium hydroxide solution 3000ml-3500ml and distilled water 750ml-1000ml and is made into mixed liquor, Equivalent mixed liquor and 20% potassium hydroxide solution is finally taken to be mixed into amine reagent.
Preferably, step (3) the amine reagent dosage be 1.5-2.5mL, such as can be 1.5mL, 1.6mL, 1.7mL, 1.8mL, 1.9mL, 2.0mL, 2.1mL, 2.2mL, 2.3mL, 2.4mL or 2.5mL.
Preferably, the upper mold hot pressing temperature of step (4) the sponge hot pressing is 155-165 DEG C, such as can be 155 DEG C, 156 DEG C, 157 DEG C, 158 DEG C, 159 DEG C, 160 DEG C, 161 DEG C, 162 DEG C, 163 DEG C, 164 DEG C or 165 DEG C, preferably 160 DEG C.
Preferably, the lower die hot pressing temperature of step (4) the sponge hot pressing is 155-165 DEG C, such as can be 155 DEG C, 156 DEG C, 157 DEG C, 158 DEG C, 159 DEG C, 160 DEG C, 161 DEG C, 162 DEG C, 163 DEG C, 164 DEG C or 165 DEG C, preferably 160 DEG C.
Preferably, the sponge hot pressing preheating temperature described in step (4) is 20-50 DEG C, for example, can be 20 DEG C, 23 DEG C, 25 DEG C, 28 DEG C, 30 DEG C, 35 DEG C, 40 DEG C, 45 DEG C or 50 DEG C.
Preferably, the sponge hot pressing time described in step (4) be 1-3s, such as can be 1s, 1.1s, 1.2s, 1.3s, 1.4s、1.5s、1.6s、1.7s、1.8s、1.9s、2.0s、2.1s、2.2s、2.3s、2.4s、2.5s、2.6s、2.7s、2.8s、 2.9s or 3.0s, preferably 2s.
It is a discovery of the invention that the hot pressing of sponge within the scope of the temperature and time best results, you can so that sponge is moulded Property, and sponge will not be made to melt deformation.
Preferably, step (4) described hot pressing mode is cladding hot pressing, and the length that sponge coats hollow swab pipe is 5- 10mm。
It is a discovery of the invention that sponge coats the infiltration of the effect length detection liquid of hollow swab pipe end point, in the length model The round nose that detection liquid can be made to concentrate on sampling head in enclosing, detection are efficiently quick.
The third aspect, a kind of swab as described in relation to the first aspect are used to prepare in the drug or reagent of detection vaginal disease Purposes.
Swab application method and explanation:The leukorrhea that intravaginal is asked for the sampling head of pH detection liquid one end, after taking-up, uses hand The hollow swab pipe for detecting liquid containing pH is squeezed, so that pH detection liquid is penetrated on the spongy top after sampling, according to saying for detection colour atla Bright observation sampling head color change, red indicate pH<4.5, for feminine gender;Salmon pink, orange colour or yellow indicate pH>4.5, for sun Property;Bluish violet indicates pH>7.0, for the positive;
Wherein, the individual of the pH testing results positive asks for intravaginal leukorrhea using the sampling head of amine reagent one end, takes out Afterwards, the hollow swab pipe containing amine reagent is squeezed with hand, in the spongy top after making amine reagent penetrate sampling, generates fish bad smell, It then determines positive.
Compared with prior art, the present invention has the advantages that:
(1) two kinds of detection methods are incorporated on a swab by swab provided by the invention by the way of double end swab, It is simple in structure portable, and the hollow swab pipe of the swab stick in traditional swab is substituted, using hot-pressing technique by hollow swab pipe Closing is isolated into not connected two parts, can be used for being perfused liquid, and extruded hollow pipe can make liquid penetrate into sampling head, be used for The accuracy rate of testing result for detecting vaginal disease is high, can be not only used for bacterial vaginitis, trichomonas vaginitis and beads The diagnosis of bacterium property vaginitis can also indicate that cervicitis lesion, the more common swab of detection range are wider;
(2) easy to operate, can be used for patient and check oneself, can be used for doctor assist detection, whole process rapidly and efficiently, and When avoiding a sample for two kinds of detections, sample be exposed in air for a long time may caused by sample losses and rotten;
(3) it is complicated for operation to solve existing detection method, costly, as a result subjectivity is strong, detects the external fortune brought of liquid It the defects of defeated inconvenient, has a extensive future.
Description of the drawings
Fig. 1 is the structural schematic diagram of the swab of the present invention, wherein 1 is the first sampling head, 2 be the second sampling head, and 3 be hollow Swab pipe, 4 be isolation strip.
Specific implementation mode
Further to illustrate the present invention technological means and its effect taken, below by way of specific implementation mode come into One step illustrates technical scheme of the present invention, but the present invention is not limited in scope of embodiments.
Embodiment 1
As shown in Figure 1, a kind of swab includes swab head, hollow swab pipe 3 and isolation strip 4, the hollow swab pipe It is provided at both ends with the first sampling head 1 and the second sampling head 2, the isolation strip 4 is arranged in the middle part of hollow swab pipe.
(1) the hollow swab pipe of polypropylene material, pipe range 14cm, internal diameter 5mm, pipe thickness 0.5mm, in centre are selected Position hot pressing goes out the isolation strip of 3mm, 102 DEG C of hot pressing upper mold temperature, and lower die temperature is 102 DEG C, hot pressing 3.5s, it is ensured that closing is not leaked Liquid;
(2) by methyl red 1.9nmol/L, phenolsulfonphthalein 1.4nmol/L and 1.0nmol/L thymol blue according to 2:1:1 body Product shakes up than mixing, is stored in that brown bottle is spare, and 2mL pH configure are detected the hollow swab that liquid pours into isolation strip side Pipe is closed swab tube opening hot pressing, 102 DEG C of hot pressing upper mold temperature, and lower die temperature is 102 DEG C, hot pressing 3.5s, it is ensured that closing is not Leakage;
(3) the amine reagent that 2mL has been configured is poured into the hollow swab pipe of the isolation strip other side, by swab tube opening hot pressing Closing, 102 DEG C of hot pressing upper mold temperature, lower die temperature are 102 DEG C, hot pressing 3.5s, it is ensured that closing no leakage;
(4) it is 15mm to select material of the medical sponge as swab head, design 1 length of the first sampling head, and second takes The length of sample head 2 is 15mm, and sampling head spheric end diameter 10mm, oval end cladding hot pressing is in hollow swab pipe the outer end point, sea The length that silk floss coats hollow swab pipe is 8mm, and sponge hot pressing upper mold temperature is 160 DEG C, and lower die hot pressing temperature is 160 DEG C, hot pressing 2s。
Embodiment 2
As shown in Figure 1, a kind of swab includes swab head, hollow swab pipe 3 and isolation strip 4, the hollow swab pipe It is provided at both ends with the first sampling head 1 and the second sampling head 2, the isolation strip 4 is arranged in the middle part of hollow swab pipe.
(1) the hollow swab pipe of polypropylene material, pipe range 10cm, internal diameter 3mm, pipe thickness 0.4mm, in centre are selected Position hot pressing goes out the isolation strip of 1mm, 100 DEG C of hot pressing upper mold temperature, and lower die temperature is 100 DEG C, hot pressing 5s, it is ensured that closing is not leaked Liquid;
(2) by methyl red 1.8nmol/L, phenolsulfonphthalein 1.5nmol/L and 0.9nmol/L thymol blue according to 3:1:2 body Product shakes up than mixing, is stored in that brown bottle is spare, 1.5mL pH configure are detected liquid pours into the hollow of isolation strip side and wipe Son pipe, swab tube opening hot pressing is closed, 100 DEG C of hot pressing upper mold temperature, and lower die temperature is 100 DEG C, hot pressing 5s, it is ensured that closing is not Leakage;
(3) the amine reagent that 1.5mL has been configured is poured into the hollow swab pipe of the isolation strip other side, by swab tube opening heat Press seal closes, 100 DEG C of hot pressing upper mold temperature, and lower die temperature is 100 DEG C, hot pressing 5s, it is ensured that closing no leakage;
(4) it is 10mm to select material of the medical sponge as swab head, design 1 length of the first sampling head, and second takes The length of sample head 2 is 10mm, and sampling head spheric end diameter 8mm, oval end coats hot pressing in hollow swab pipe the outer end point, sponge The length for coating hollow swab pipe is 5mm, and sponge hot pressing upper mold temperature is 165 DEG C, and lower die hot pressing temperature is 165 DEG C, hot pressing 1s.
Embodiment 3
As shown in Figure 1, a kind of swab includes swab head, hollow swab pipe 3 and isolation strip 4, the hollow swab pipe It is provided at both ends with the first sampling head 1 and the second sampling head 2, the isolation strip 4 is arranged in the middle part of hollow swab pipe.
(1) the hollow swab pipe of polypropylene material, pipe range 18cm, internal diameter 7mm, pipe thickness 0.1mm, in centre are selected Position hot pressing goes out the isolation strip of 3mm, 120 DEG C of hot pressing upper mold temperature, and lower die temperature is 120 DEG C, hot pressing 3s, it is ensured that closing is not leaked Liquid;
(2) by methyl red 2.0nmol/L, phenolsulfonphthalein 1.3nmol/L and 1.1nmol/L thymol blue according to 4:2:1 body Product shakes up than mixing, is stored in that brown bottle is spare, 2.5mL pH configure are detected liquid pours into the hollow of isolation strip side and wipe Son pipe, swab tube opening hot pressing is closed, 120 DEG C of hot pressing upper mold temperature, and lower die temperature is 120 DEG C, hot pressing 3s, it is ensured that closing is not Leakage;
(3) the amine reagent that 2.5mL has been configured is poured into the hollow swab pipe of the isolation strip other side, by swab tube opening heat Press seal closes, 120 DEG C of hot pressing upper mold temperature, and lower die temperature is 120 DEG C, hot pressing 3s, it is ensured that closing no leakage;
(4) it is 25mm to select material of the medical sponge as swab head, design 1 length of the first sampling head, and second takes The length of sample head 2 is 25mm, and sampling head spheric end diameter 13mm, oval end cladding hot pressing is in hollow swab pipe the outer end point, sea The length that silk floss coats hollow swab pipe is 10mm, and sponge hot pressing upper mold temperature is 155 DEG C, and lower die hot pressing temperature is 155 DEG C, hot pressing 3s。
Embodiment 4
Compared with Example 1, other than isolation strip hot pressing temperature is 90 DEG C, other conditions are the same as embodiment 1.The results show that The swab isolation strip that embodiment 4 is prepared cannot play the role of closing isolation, and the detection liquid at hollow swab pipe both ends occurs Mixing influences swab use.
Embodiment 5
Compared with Example 1, other than isolation strip hot pressing temperature is 130 DEG C, other conditions are the same as embodiment 1.The results show that The swab that embodiment 5 is prepared causes hollow swab pipe deformation even to fuse since isolation strip hot pressing temperature is excessively high, influences to wipe Son uses.
Embodiment 6
Compared with Example 1, other than sponge hot pressing temperature is 150 DEG C, other conditions are the same as embodiment 1.The results show that real The swab that example 6 is prepared is applied, sponge hot pressing is not molded, and easy cracking falls off after placing a period of time.
Embodiment 7
Compared with Example 1, other than sponge hot pressing temperature is 170 DEG C, other conditions are the same as embodiment 1.The results show that real The swab that example 6 is prepared is applied, sponge melts blackening, influences swab normal use.
Embodiment 8
Compared with Example 1, it is made of methyl red and bromocresol green in addition to pH reagents, ratio 2:Except 1, other conditions With embodiment 1.
Embodiment 9
Compared with Example 1, other than pH reagents do not add phenolphthalein Huang, other conditions are the same as embodiment 1.
Embodiment 10
Compared with Example 1, other than pH reagents do not add thymol blue, other conditions are the same as embodiment 1.
Embodiment 11
Compared with Example 1, in addition to only carrying out pH detections, without amine test outside, other conditions are the same as embodiment 1.
Crowd tests
Select 160 vaginal disease volunteers, including bacterial vaginitis patient 45, trichomonas vaginitis patient 35 Name, monilial vaginitis patient 43 and virus in patients with cervicitis 37.Wiping using embodiment 1-3 and embodiment 8-11 respectively Son is detected, and counts the detection accuracy of vaginal disease.
Detection method:
(1) swab is taken out, the leukorrhea of intravaginal is asked for the sampling head of pH detection liquid one end, after taking-up, is contained with hand extruding The hollow swab pipe for having pH detection liquid makes pH detection liquid penetrate on the spongy top after sampling, illustrates to observe according to detection colour atla Sampling head color change, red indicate pH<4.5, for feminine gender, show that vagina has self purification;Salmon pink, orange colour or yellow table Show pH>4.5, for the positive, prompt colpitis;Bluish violet indicates pH>7.0, indicate cervical disease;
(2) intravaginal leukorrhea is asked for the sampling head of amine reagent one end again, after taking-up, is squeezed containing in amine reagent with hand Empty swab pipe makes amine reagent penetrate in the spongy top after sampling, and generates fish bad smell, then can determine whether according to patient symptom and sign Whether bacillary, trichomonad, monilial vaginitis or Cervicitis are suffered from.Testing result is shown in Table 1.
1 vaginal disease Detection accuracy of table
Comparing embodiment 1 and embodiment 4-7 is it is found that hot pressing temperature controls, excessively high or mistake most important to hollow swab pipe It is low all swab to be made to be molded.Comparing embodiment 1 and embodiment 8-11 are it is found that the composition of pH reagents and with comparing various vagina diseases The influence of the detection accuracy rate of disease, pH detections liquid of the present invention is preferably constituted and is matched rationally, and is worked in coordination, pH detections Liquid stable components, instruction result accuracy rate is high, and pH detection methods are used alone and still will produce false positive, inspection must be cooperateed with amine reagent It surveys, the detection accuracy rate of bacterial vaginitis, trichomonas vaginitis and monilial vaginitis is up to 100%, while the present invention The swab of offer can be used to detect instruction cervicitis, and accuracy rate is up to 97%, and detection type is wider, and application value is big.
To sum up, two kinds of detection methods are incorporated into a swab by swab provided by the invention by the way of double end swab On, it is simple in structure portable, and the hollow swab pipe of the swab stick in traditional swab is substituted, using hot-pressing technique by hollow swab Duct occlusion is isolated into not connected two parts, and pours into detection reagent respectively in the swab pipe of isolation strip both sides, passes through letter The mode singly squeezed makes detection liquid infiltrate through the sampling head after sampling, is changed by color change and taste, objectively reaction knot Fruit, accuracy is high, avoids the external transport brought of reagent and preserves inconvenience, and doctor and patient can carry out operation detection, operate Simply, meanwhile, the design of double sampling heads and hollow swab pipe is cost-effective, and market prospects are good.
Applicant states that the present invention illustrates the method detailed of the present invention, but the present invention not office by above-described embodiment It is limited to above-mentioned method detailed, that is, does not mean that the present invention has to rely on above-mentioned method detailed and could implement.Technical field Technical staff it will be clearly understood that any improvement in the present invention, equivalence replacement and auxiliary element to each raw material of product of the present invention Addition, the selection etc. of concrete mode, all fall within protection scope of the present invention and the open scope.

Claims (10)

1. a kind of swab, which is characterized in that the swab includes swab head, hollow swab pipe (3) and isolation strip (4), institute It states hollow swab pipe and is provided at both ends with the first sampling head (1) and the second sampling head (2), isolation strip (4) setting is wiped hollow In the middle part of sub- pipe.
2. swab according to claim 1, which is characterized in that the material of the swab head includes medical sponge, plants Any one of suede or superfine fibre cloth or at least two combination, preferably medical sponge;
Preferably, the length of first sampling head (1) is 10-25mm;
Preferably, the length of second sampling head (2) is 10-25mm.
3. swab according to claim 1 or 2, which is characterized in that first sampling head (1) and the second sampling head (2) For class gourd shape, including spheric end and oval end;
Preferably, a diameter of 8-13mm of the spheric end of first sampling head (1);
Preferably, a diameter of 8-13mm of the spheric end of second sampling head (2);
Preferably, the oval end in the sampling head coats hollow swab pipe end point.
4. according to claim 1-3 any one of them swabs, which is characterized in that the material of the hollow swab pipe (3) is poly- Propylene material;
Preferably, the internal diameter of the hollow swab pipe (3) is 3-7mm, preferably 5mm;
Preferably, the pipe arm thickness of the hollow swab pipe (3) is 0.4-1mm, preferably 0.5mm;
Preferably, the length of the hollow swab pipe (3) is 10-18cm, preferably 14cm.
5. according to claim 1-4 any one of them swabs, which is characterized in that the width of the isolation strip (4) is 1-5mm;
Preferably, isolation strip (4) are set to the middle part of hollow swab pipe, and hollow swab pipe is divided into two portions of equidistance Point.
6. according to claim 1-5 any one of them swabs, which is characterized in that isolation strip (4) in the hollow swab pipe (3) Contain pH detection liquid in the side of separation;
Preferably, the pH detections liquid includes methyl red, dimethyl diaminophenazine chloride, phenolsulfonphthalein, bromophenol blue, thymol blue, Bromothymol blue Any one of bromocresol green or at least two combination, the preferably combination of methyl red, phenolsulfonphthalein and thymol blue;
Preferably, the volume ratio of the methyl red, phenolsulfonphthalein and thymol blue is (2-5):(1-3):(1-3).
7. according to claim 1-6 any one of them swabs, which is characterized in that isolation strip (4) in the hollow swab pipe (3) Contain amine reagent in the other side of separation.
8. a kind of preparing the method such as claim 1-7 any one of them swabs, which is characterized in that include the following steps:
(1) hollow swab pipe middle heat press seal is closed, extrudes isolation strip;
(2) the hollow swab pipe that the pH configured detection liquid is poured into isolation strip side, by opening hot pressing closing;
(3) the hollow swab pipe that the amine reagent configured is poured into the isolation strip other side, by opening hot pressing closing;
(4) by medical sponge hot pressing hollow swab pipe the outer end point.
9. according to the method described in claim 8, it is characterized in that, the upper mold temperature of step (1) described hot pressing is 100-120 ℃;
Preferably, the lower die temperature of the hot pressing is 100-120 DEG C;
Preferably, the time of step (1) described hot pressing is 3-5s, preferably 3.5s;
Preferably, the pH detection liquid and preparation method thereofs described in step (2) include the following steps:By methyl red solution 1.8-2.0nmol/ L, phenolsulfonphthalein solution 1.3-1.5nmol/L and thymol blue 0.9-1.1nmol/L, according to methyl red, phenolsulfonphthalein and thymol blue It is by volume (2-5):(1-3):(1-3) mixing shakes up, and is stored in spare in brown bottle;
Preferably, the dosage of step (2) the pH detections liquid is 1.5-2.5mL;
Preferably, the upper mold temperature of opening hot pressing described in step (2) and step (3) is 100-120 DEG C;
Preferably, the lower die temperature of opening hot pressing described in step (2) and step (3) is 100-120 DEG C;
Preferably, the time of opening hot pressing described in step (2) and step (3) is 3-5s, preferably 3.5s;
Preferably, the preparation method of step (3) the amine reagent includes the following steps:By potassium iodide 100g-150g, iodine 110g- 160g, mercury 100g-150g and 1000ml distilled water heating stirring add distilled water to 2000ml, take above-mentioned original again after being completely dissolved Liquid 500-800ml, 10% sodium hydroxide solution 3000ml-3500ml and distilled water 750ml-1000ml are made into mixed liquor, finally Equivalent mixed liquor and 20% potassium hydroxide solution is taken to be mixed into amine reagent;
Preferably, step (3) the amine reagent dosage is 1.5-2.5mL;
Preferably, the upper mold hot pressing temperature of step (4) the sponge hot pressing is 155-165 DEG C, preferably 160 DEG C;
Preferably, the lower die hot pressing temperature of step (4) the sponge hot pressing is 155-165 DEG C, preferably 160 DEG C;
Preferably, the sponge hot pressing preheating temperature described in step (4) is 20-50 DEG C;
Preferably, the sponge hot pressing time described in step (4) is 1-3s, preferably 2s;
Preferably, step (4) described hot pressing mode is cladding hot pressing, and the length that sponge coats hollow swab pipe is 5-10mm.
10. a kind of be used to prepare such as claim 1-7 any one of them swabs in the drug or reagent of detection vaginal disease Purposes.
CN201810507561.9A 2018-05-24 2018-05-24 A kind of swab and its preparation method and application Pending CN108645850A (en)

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