CN101539546A - Method for systematically detecting quality of polyacrylonitrile (PAN) drug-loading fiber - Google Patents
Method for systematically detecting quality of polyacrylonitrile (PAN) drug-loading fiber Download PDFInfo
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- CN101539546A CN101539546A CN200910050051A CN200910050051A CN101539546A CN 101539546 A CN101539546 A CN 101539546A CN 200910050051 A CN200910050051 A CN 200910050051A CN 200910050051 A CN200910050051 A CN 200910050051A CN 101539546 A CN101539546 A CN 101539546A
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Abstract
The invention relates to a method for systematically detecting the quality of a polyacrylonitrile (PAN) drug-loading fiber. The drug-loading fiber is tested according to the drug-loading rate, the residual quantity of organic solvent, the control release property of an in vitro drug and the distribution of the drug in the fiber. The detection method of the invention can be widely applied to the detection and the control of the quality of various drug-loading fibers, has the capability of fast and accurate detection, and is suitable for wide popularization.
Description
Technical field
The invention belongs to the detection range of drug-loading fibre quality, particularly relate to a kind of systematization detection method of polyacrylonitrile (PAN) drug-loading fibre quality.
Background technology
Along with the particularly development of materialogy and pharmacy of modern science and technology, textile technology constantly develops in the application forward depth direction of pharmacy.Iatric fiber is exactly under this background, appearance be pharmaceutical dosage form in the middle of carrier novel with the fiber.Except traditional various special medicinal function fiber, the development over nearly 20 years has various new iatric fiber launch in the world again, as the anti-heart disease vest of Japanese Kuraray company and stomach drug fiber of Pfizer Inc. etc.
Based on cutaneous penetration, drug-loading fibre can directly be processed into transdermal drug delivery system, also can be processed into medicinal and medical textile such as garments for recovery, medicine footwear, shoe-pad medicated gauze mask, medicine subsides, medicinal bra, medicinal pillow, medicinal underwear, medicinal towel and handkerchief etc.; Medical as surgical sewing thread, wound dresser, hemostasis and anti-inflammation fabric etc.Wherein with drug-loading fibre braiding, be embedded among the fabric or prepare various transdermal drug delivery systems have many advantages as: size is easy to adjust, uses easily and processing, comfortable and can not influence attractive in appearance, permeability and well can not produce bad stimulation etc. to skin.Bright development prospect is arranged, especially for some infants, old man and special disease colony.
Polyacrylonitrile (PAN) fiber is the regenerated fiber that a kind of macromolecule long-chain synthetic polymer forms, and is the light-duty fiber with good draping property, but can produces warming very light fabric.Its elasticity and rebound resilience tool are good, and have excellent anti-sunlight and weather-resistant property, can wash or dry-clean.PAN is often being used the matrix of drug-loading fibre, the preparation drug-loading fibre, and further be processed into transdermal drug delivery system, at dermopathic local medicine-applying system, sanitary antimicrobial textile, antibacterial underwear etc.; The drug-loading fibre preparation that with PAN is base material can be adopted multiple textile technology, mainly comprises wet spinning, dry-wet spinning, high-voltage electrostatic spinning etc.
Though the research about drug-loading fibre increases rapidly at present, but also, there is not the concerned countries standard to comply with not about the drug-loading fibre quality systematization detection method of (comprising existence and the distribution etc. in fiber of residual organic solvent situation, medicine in medicine carrying performance, controlled release properties, the fiber) yet; The conventional method of more dependence relevant speciality detects the performance of fiber.If but after drug-loading fibre further researched and developed into product, quality testing then was necessary with control.Because it is general not high, so inevitable in its quality system check based on the preparation process performance to the mechanical property and the mechanical property requirements of drug-loading fibre.
Summary of the invention
Technical matters to be solved by this invention provides a kind of systematization detection method of polyacrylonitrile (PAN) drug-loading fibre quality, and this detection method can be widely used in the Detection ﹠ Controling of other various drug-loading fibre quality, and can be quick, the accurate detection.
The systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality of the present invention is by the detection system check drug-loading fibre to drug loading, Determination of Residual Organic Solvents, external medicine controlled releasing performance, the indexs such as distribution of medicine in fiber.
Detailed process is as follows:
(1) wet spinning prepares PAN drug-loading fibre Chinese traditional medicine Determination on content
1. get dry drug-loading fibre 100mg-150mg, be dissolved in 2.0ml-3.0ml and contain in the aqueous solution of NaSCN of 50% quality;
2. pipetting the above-mentioned solution of 1.0ml-1.5ml is added drop-wise under stirring condition in the NaOH solution of 45ml-55ml 0.4%-1.0% quality and extracts medicine;
3. get solution after the above-mentioned extraction,, carry out HPLC and analyze through 0.45 μ m membrane filtration.
(2) wet spinning or high-voltage electrostatic spinning legal system are equipped with Determination of Residual Organic Solvents in the PAN drug-loading fibre
1. get drug-loading fibre 1.0g-1.5g; Be dissolved in the 10mL-15ml dimethyl sulfoxide (DMSO) (DMSO);
2. pipetting the above-mentioned solution of 1.0mL-1.5ml slowly is added drop-wise under stirring condition in the NaOH solution of 19mL-20ml 0.4%-1.0% quality and extracts organic solvent;
3. get solution after the above-mentioned extraction,, carry out HPLC and analyze through 0.22 μ m membrane filtration.
(3) wet spinning or high-voltage electrostatic spinning legal system are equipped with PAN drug-loading fibre medicine controlled releasing performance
With reference to Pharmacopoeia of People's Republic of China version regulation in 2005, adopt dissolution method the 2nd subtraction unit, carry out the release in vitro degree and measure.
With physiological saline 250mL-300ml is release medium, and pre-temperature is to (32 ± 0.5) ℃, and the 150mg drug-loading fibre is fixed in two-layer video disc central authorities, again the net dish is placed the beaker bottom, and make video disc parallel with the surfaces of revolution at the bottom of the oar, both are at a distance of (25 ± 2) mm, begin to stir rotating speed 100rmin
-1, take out 5mL respectively at the time of 1h, 2h, 4h, 8h, 24h, 2d, 3d～12d and discharge liquid, and replenish the blank release medium of equivalent immediately, discharge liquid with 0.22 μ m filtering with microporous membrane, discard filtrate just, collect subsequent filtrate 1mL, measure.
(4) wet spinning prepares the distribution of PAN drug-loading fibre Chinese traditional medicine
Drug-loading fibre is placed microslide, and covered is fixed under the polarizing microscope, and polarizer and analyzer quadrature are interlaced, and observes medicine by cross-polarized light and takes record in the distribution situation of fiber surface and the existence and the employing digital camera of drug particles;
Or the high-voltage electrostatic spinning legal system is equipped with the distribution of PAN drug-loading fibre drug-loading fibre Chinese traditional medicine
Microslide is fixed in the aluminium foil fiber to be accepted on the flat board, connect negative pole, carried out electrostatic spinning 10 minutes, take off microslide, covered is fixed under the polarizing microscope, polarizer and analyzer quadrature are interlaced, by the form of cross-polarized light observation drug-loading fibre, and the observed drug particles of possibility, adopt digital camera to take record.
Detection to drug loading: destroy fiber, extraction medicine wherein is by the content of rp-hplc analysis drug-loading fibre Chinese traditional medicine; The detection of Determination of Residual Organic Solvents: after the solvent intersection extraction that can dissolve fiber base material, the rp-hplc analysis method detects Determination of Residual Organic Solvents in the drug-loading fibre; External medicine controlled releasing performance detection: the medicine sustained and controlled release performance that detects drug-loading fibre by external dissolution test; Distribution and the thermodynamic state verification of medicine in fiber: in drug-loading fibre, can evenly distribute and the yardstick of medicine crystal particle etc. by the polarized light microscope observing medicine.
The present invention can be widely used in the Detection ﹠ Controling of other various drug-loading fibre quality.
Described drug-loading fibre makes by wet spinning or high-voltage electrostatic spinning.
Beneficial effect
Detection method of the present invention is quick, accurately, is suitable for large range promotion use.
Description of drawings
Fig. 1 wet spinning prepares PAN drug-loading fibre Chinese traditional medicine and analyzes RP-HPLC figure;
Fig. 2 wet spinning prepares Determination of Residual Organic Solvents RP-HPLC figure in the PAN drug-loading fibre;
Fig. 3 wet spinning prepares PAN drug-loading fibre drug release characteristics;
Fig. 4 wet spinning prepares the polarized light microscope observing result that PAN drug-loading fibre Chinese traditional medicine distributes;
The wet spinning of Fig. 5 polarized light microscope observing prepares PAN drug-loading fibre Chinese traditional medicine state.
Embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Embodiment 1
Wet spinning prepares PAN drug-loading fibre Chinese traditional medicine assay
Preparation fiber spinning solution: 1. the 20g brufen is dissolved among the DMAc of 500mL; 2. (12 ℃) are scattered in the 100gPAN fine powder in the DMAc solution that is dissolved with brufen under the room temperature, ultrasonic dispersion 10 minutes; 3. under the 200rpm stirring condition, place 70 ℃ water-bath 24 hours; 4. be cooled to room temperature, spinning liquid solution is limpid, is glassy yellow.
Adopt wet spinning technology to prepare drug-loading fibre: spray silk pressure is 0.03MPa, carries out coagulating bath under the room temperature in 42%DMAc, and prestretched and hot-stretch temperature are respectively 60 and 90 ℃, and stretch rate is 6, and winding speed is 50m/min.Twine fiber 35 ℃ with vacuum 320Pa condition under be dried to constant weight.
The chromatographiccondition chromatographic column is Kromasil 100A C 18 (250mm * 4.6mm, 5 μ m); C-18
The chromatogram pre-service PostLBBM-612111; Moving phase is methanol-water-glacial acetic acid (80: 19: 1/v: v: v) mixed solution; The detection wavelength is 264nm; Column temperature is a room temperature; Flow velocity: 0.8mLmin
-1Filter with syringe filter (0.45 μ m filter membrane) before the sample feeding, sample size is 5 μ L.
The brufen extraction extracts the brufen in the drug-loading fibre as follows in the drug-loading fibre: 1. take by weighing the drug-loading fibre 100mg that is dried to constant weight; 2. the aqueous solution that contains NaSCN50% with 2.0mL is dissolved drug-loading fibre; 3. pipette 1.0mL solution and extract brufen among under stirring condition, slowly being added drop-wise to the NaOH solution of 49mL 0.4%; 4. get extraction back solution,, carry out HPLC and analyze through 0.45 μ m membrane filtration.
It is the 144.77mg/g fiber that the result measures drug-loading fibre Chinese traditional medicine content, and calculates by reinforced, and drug-loading fibre Chinese traditional medicine theoretical content should be the 166.67mg/g fiber, and the loss of spinning process Chinese traditional medicine is 13.14%.Chromatogram as shown in Figure 1, wherein the residence time is SCN at the peak of 3.102min
-1With trace DMAc residual in the drug-loading fibre.
Wet spinning prepares Determination of Residual Organic Solvents in the PAN drug-loading fibre
The chromatographic condition chromatographic column is Kromasil 100A C18 (250mm * 4.6mm, 5 μ m); Moving phase is methanol-water (28: 72); The detection wavelength is 220nm; Column temperature is a room temperature; Flow velocity: 0.8mLmin
-1Filter with syringe filter (0.22 μ m filter membrane) before the sample feeding, sample size is 5 μ L.
Residual organic solvent extracts the content that extracts DMAc in the drug-loading fibre as follows: 1. take by weighing drug-loading fibre 1.0g; 2. dissolve with 10mL DMSO; 3. pipette 1.0mL solution and extract DMAc among under stirring condition, slowly being added drop-wise to the NaOH solution of 19mL 0.4%; 4. get extraction back solution,, carry out HPLC and analyze through 0.22 μ m membrane filtration.
After the result was added to the DMSO drips of solution of drug-loading fibre 0.4% NaOH solution, PAN separated out from aqueous solution immediately, forms milky white precipitate, and medicine, DMSO and DMAc are extracted among the NaOH aqueous solution.Through stratographic analysis, the result of 6 detections contains DMAc 389 μ g for average every gram drug-loading fibre.Chromatogram as shown in Figure 2, wherein huge peak between 3～4min is DMSO the residence time, residence time 13.365min's is the medicine brufen.
Embodiment 3
The high-voltage electrostatic spinning legal system is equipped with Determination of Residual Organic Solvents in the drug-loading fibre
Preparation drug-loading fibre spinning liquid: the 10g Acyclovir is dissolved in the Erlenmeyer flask that fills 1000mL DMAc under 60 ℃ of water-baths; Then 100g PAN fine powder is added wherein, the 250rpm rotating speed stir with 60 ℃ of water bath condition under swelling 24 hours; Be cooled to room temperature and prepare spinning.
The solution that configures is poured in the solution reservoir (5mL syringe), No. 6 injection needles that employing is scabbled are as the kapillary that sprays thread, the positive pole that connects high-voltage power supply, the aluminium foil fiber is accepted the dull and stereotyped negative pole that connects, the solution spray volume is controlled by micro-injection pump, opening power is carried out electrostatic spinning under different technical parameters.
According to trial test, determine that electrospinning process parameter is: flow velocity is 1.0mLh
-1, receiver sheet is 15cm from spinning nozzle distance, voltage 15kV, and environment temperature is (16 ± 1) ℃, ambient humidity is 60 ± 5%.
According to embodiment 2, to analyze with carrying out RP-HPLC after the DMSO extraction, the every gram medicine-loading fibre felt of result contains DMAc 74 μ g, prepares the content of DMAc in the drug-loading fibre far below wet spinning.
Wet spinning prepares PAN drug-loading fibre medicine controlled releasing performance
With reference to Pharmacopoeia of People's Republic of China version regulation in 2005, adopt dissolution method the 2nd subtraction unit, carry out the release in vitro degree and measure.With physiological saline 250mL is release medium, and pre-temperature is to (32 ± 0.5) ℃, and the drug-loading fibre among the 150mg embodiment 1 is fixed in two-layer video disc central authorities, again the net dish is placed the beaker bottom, and make video disc parallel with the surfaces of revolution at the bottom of the oar, both are at a distance of (25 ± 2) mm, begin to stir rotating speed 100rmin
-1, take out 5mL respectively at the time of 1h, 2h, 4h, 8h, 24h, 2d, 3d～12d and discharge liquid, and replenish the blank release medium of equivalent immediately, discharge liquid with 0.22 μ m filtering with microporous membrane, discard filtrate just, collect subsequent filtrate 1mL, measure.
To the time mapping, the results are shown in Figure 3 with cumulative in vitro burst size (Q).Several days the measured value in back there is not variation, final total release amount of medicine is 1.70mg, and brufen content is 2.17mg in the 50mg iatric fiber, therefore the cumulative release degree is 78.34%, iatric fiber has the significantly prominent phenomenon of releasing of initial stage, main cause may be to have drug particles to assemble at fiber surface to exist, and drug-loading fibre can be controlled drug slow release generally.
Embodiment 5
The high-voltage electrostatic spinning legal system is equipped with PAN drug-loading fibre medicine controlled releasing performance
Get the drug-loading fibre among the embodiment 3, carry out external medicine dissolution test according to embodiment 4, medicine-loading fibre felt can progressively be controlled drug 120 hours as a result, and 1 hour medicine initial stage, the prominent amount of releasing was 38.5%, 52.6%, after 36 hours, the drug accumulation release is 69.2%.The drug release data of handling in the ultrafine fiber pad 1～12 hour by the Peppas equation gets fit equation and is: lgQ
2=0.1417lgt+1.6753, r=0.9930 illustrates that prominent in the early stage the releasing of medicine then discharges from drug-loading fibre by flooding mechanism.
Wet spinning prepares PAN drug-loading fibre Chinese traditional medicine and distributes
The drug-loading fibre of embodiment 1 is placed microslide, covered, be fixed under the polarizing microscope, polarizer and analyzer quadrature are interlaced, under certain enlargement factor (10 times * shooting of object lens is amplified 10 times), the attachable mechanical stage of continuous mobile polarizing microscope or rotatable stage are observed medicine by cross-polarized light and are taken record in the distribution situation of fiber surface and the existence and the employing digital camera of drug particles.The result as shown in Figure 4, the drug particles on drug-loading fibre surface is uniform state and distributes.
Embodiment 7
The high-voltage electrostatic spinning legal system is equipped with PAN drug-loading fibre drug-loading fibre Chinese traditional medicine and distributes
In embodiment 3, microslide is fixed in the aluminium foil fiber to be accepted on the flat board, connect negative pole again, carried out electrostatic spinning 10 minutes by its condition, carefully take off microslide then, covered, be fixed under the polarizing microscope, polarizer and analyzer quadrature are interlaced, under the high power enlargement factor (63 times * shooting of object lens is amplified 16 times), the attachable mechanical stage of continuous mobile polarizing microscope or rotatable stage, the form of observing drug-loading fibre by cross-polarized light, and the observed drug particles of possibility, adopt digital camera to take record.
The result does not find that tangible drug particles exists, but has luminance difference in the part of fiber as shown in Figure 5, may be because the existence of medicine crystallite causes.The electrospinning process is because solvent volatilizees rapidly, and PAN becomes fine speed fast, greatly suppressed medicine in the phenomenon that fiber becomes crystallization in the fine process and crystallite to be agglomerated into particle, therefore makes the medicine to disperse more evenly in fiber.
Claims (6)
1. the systematization detection method of a polyacrylonitrile (PAN) drug-loading fibre quality comprises drug loading, Determination of Residual Organic Solvents, external medicine controlled releasing performance and the distribution of medicine in fiber.
2. the systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality according to claim 1 is characterized in that: described wet spinning prepares PAN drug-loading fibre Chinese traditional medicine Determination on content, and detailed process is as follows,
1. get dry drug-loading fibre 100mg-150mg, be dissolved in 2.0ml-3.0ml and contain in the aqueous solution of NaSCN of 50% quality;
2. pipette the above-mentioned solution of 1.0ml-1.5ml, under stirring condition, be added drop-wise in the NaOH solution of 45ml-55ml 0.4%-1.0% quality and extract;
3. get solution after the above-mentioned extraction,, carry out the high-efficient liquid phase chromatogram HPLC analysis through 0.45 μ m membrane filtration.
3. the systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality according to claim 1 is characterized in that: described wet spinning or high-voltage electrostatic spinning legal system are equipped with the mensuration of Determination of Residual Organic Solvents in the PAN drug-loading fibre, and detailed process is as follows,
1. get drug-loading fibre 1.0g-1.5g; Be dissolved among the 10mL-15ml dimethyl sulfoxide (DMSO) DMSO;
2. pipette the above-mentioned solution of 1.0mL-1.5ml, under stirring condition, slowly be added drop-wise in the NaOH solution of 19mL-20ml 0.4%-1.0% quality and extract organic solvent;
3. get solution after the above-mentioned extraction,, carry out the high-efficient liquid phase chromatogram HPLC analysis through 0.22 μ m membrane filtration.
4. the systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality according to claim 1 is characterized in that: described wet spinning or high-voltage electrostatic spinning legal system are equipped with PAN drug-loading fibre medicine controlled releasing performance, and detailed process is as follows:
With physiological saline 250mL-300ml is release medium, and pre-temperature is to 32 ℃ ± 0.5 ℃, and the 150mg drug-loading fibre is fixed in two-layer video disc central authorities, places the container bottom, and makes video disc parallel with the surfaces of revolution at the bottom of the oar and at a distance of 25 ± 2mm, begins stirring, rotating speed 100rmin
-1, take out 5mL respectively at the time of 1h, 2h, 4h, 8h, 24h, 2d, 3d～12d and discharge liquid, replenish the described blank release medium of equivalent immediately, discharge liquid with 0.22 μ m filtering with microporous membrane, discard filtrate just, collect subsequent filtrate, measure.
5. the systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality according to claim 1 is characterized in that: described wet spinning prepares PAN drug-loading fibre Chinese traditional medicine and distributes, and detailed process is as follows,
Drug-loading fibre is fixed under the polarizing microscope, polarizer and analyzer quadrature are interlaced, observe medicine by cross-polarized light and take record in the distribution situation of fiber surface and the existence and the employing digital camera of drug particles;
Or the high-voltage electrostatic spinning legal system is equipped with the distribution of PAN drug-loading fibre drug-loading fibre Chinese traditional medicine
Microslide is fixed in the aluminium foil fiber to be accepted on the flat board, connect negative pole, carried out electrostatic spinning 10-15 minute, be fixed under the polarizing microscope, polarizer and analyzer quadrature are interlaced, by the form of cross-polarized light observation drug-loading fibre, and the observed drug particles of possibility, adopt camera to take record.
6. the systematization detection method of a kind of polyacrylonitrile (PAN) drug-loading fibre quality according to claim 1 is characterized in that: described drug-loading fibre is various drug-loading fibres.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105040119A (en) * | 2015-06-08 | 2015-11-11 | 浪莎针织有限公司 | Preparation method for polyacrylonitrile nanometer electrospinning fibrous membrane for slow-release anti-herpes virus drugs |
| CN109473146A (en) * | 2018-10-31 | 2019-03-15 | 哈尔滨工业大学（深圳） | A kind of multi-layer planar controlled drug delivery systems optimization method and system |
| CN113050568A (en) * | 2017-02-22 | 2021-06-29 | 苏州普力玛智能电子有限公司 | Quality monitoring method and system for false-twisted yarns |
-
2009
- 2009-04-27 CN CN200910050051A patent/CN101539546A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105040119A (en) * | 2015-06-08 | 2015-11-11 | 浪莎针织有限公司 | Preparation method for polyacrylonitrile nanometer electrospinning fibrous membrane for slow-release anti-herpes virus drugs |
| CN113050568A (en) * | 2017-02-22 | 2021-06-29 | 苏州普力玛智能电子有限公司 | Quality monitoring method and system for false-twisted yarns |
| CN113050568B (en) * | 2017-02-22 | 2022-03-15 | 苏州普力玛智能电子有限公司 | Quality monitoring method and system for false-twisted yarns |
| CN109473146A (en) * | 2018-10-31 | 2019-03-15 | 哈尔滨工业大学（深圳） | A kind of multi-layer planar controlled drug delivery systems optimization method and system |
| CN109473146B (en) * | 2018-10-31 | 2021-06-11 | 哈尔滨工业大学（深圳） | Method and system for optimizing multi-layer flat-plate drug controlled release system |
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Application publication date: 20090923 |