CN105412045B - A kind of preparation method of benefit arteries and veins health micro-capsule - Google Patents
A kind of preparation method of benefit arteries and veins health micro-capsule Download PDFInfo
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Abstract
The invention discloses a kind of preparation methods of beneficial arteries and veins health micro-capsule, include the following steps：Gelatin is placed in ingredients pot, water is added, being heated at 70 80 DEG C makes Gelatin, obtains gelatin solution, adds erigeron breviscapus dried cream powder, stirring while adding, finally keeps erigeron breviscapus dried cream powder fully miscible in gelatin solution with homogenizer, water phase is made；It takes atoleine to be placed in ingredients pot, adds sorbester p17, be heated to 70 80 DEG C, oil phase is made in mixing；The water phase is slowly added in oil phase, suspension is made；It adds and accounts for 6 8% isopropanol of suspension volume, stand, filtering detaches solid liquid phase, and solid phase is micro-capsule.The present invention can obviously reduce that drawing for preparation is moist, can improve the stability of beneficial arteries and veins health final finished.The preparation method is simple for process, and production cost is low, and energy consumption is low, easily realizes industrialized production.
Description
Technical field
The present invention relates to a kind of pharmaceutical preparation intermediates for treating diseases of cardiovascular and cerebrovascular systems and peripheral neuropathy
Preparation, especially a kind of preparation method of beneficial arteries and veins health micro-capsule.
Background technology
Erigeron breviscapus is the dry of composite family wingceltis object Erigeron breviscapus Erigeron brevisca pus (Vant.) Hand.-Mazz.
Dry herb.Modern pharmacological studies have shown that：(1) erigeron breviscapus has significant anticoagulation, can reduce platelet count and inhibition
Platelet aggregation promotes the effect of Fibrinolytic Activities and internal coagulation function, to have anti thrombotic action；(2) oil lamp is thin
It is pungent to make papaverine, the neure damage of cerebral ischemia is reduced, to the diastole cerebrovascular and anti-cerebral ischemia；(3) erigeron breviscapus can
Improve microcirculation, increase coronary flow and be obviously improved myocardial ischemia, blood brain barrier permeability can be improved, fights Adenosine diphosphate
Glycosides causes platelet aggregation and improves macrophage phagocytic function, has product to the oxygen radical and plasma fibrinolytic activity of coronary heart disease
Pole influences；(4) erigeron breviscapus improves regarding nipple, retina blood circulation by expanding blood vessel, improves the thin of optic ganglion cell
Born of the same parents' pigment oxidation enzymatic activity and active density, Green Tea Extract and reduction Apoptosis, reduce retina blood capillary permeability,
Retina Histopathology changes after improving optic nerve axonal transport and mitigating acute high intraocular pressure, has to optic nerve injury and prevents
And restitution, to have protective effect to green light optic nerve injury.
Because having above-mentioned good drug effect, erigeron breviscapus medicinal material to be used in many Chinese patent drugs, wherein beneficial arteries and veins health series production
Product be with single preparations of ephedrine made of erigeron breviscapus dried cream powder, such as YIMAIKANG PIAN, capsule, soft capsule, dispersible tablet, dripping pill, earliest
YIMAIKANG PIAN prescription record in the 12nd page 160 of the Sanitation Ministry medicine standard Traditional Chinese medicine historical preparation, standard code WS3-B-
2410-97, has promoting blood circulation and removing blood stasis, and having improves brain blood circulation, increases cerebral blood flow (CBF), increases cardiac muscle to the tolerance of ischemic, anoxic,
Improve the effect of microcirculation, clinic loses paralysis, the resistance of eye ground vein after being mainly used for ischemic cerebrovascular disease and cerebral hemorrhage
Plug, coronary heart disease, vasculitic skin disease, rheumatism.Ministry standard preparation method is：Erigeron breviscapus medicinal extract 160g is taken, shallow lake is added
Powder 150g mixings, dry, pulverize at 75 DEG C or less, add dextrin appropriate, and particle is made with 60% ethyl alcohol, tabletting, sugar coating, i.e.,
.
In spite of oral preparation, injection made of above-mentioned a variety of erigeron breviscapus, but due to technology of preparing etc., mostly
Number oral preparations take after there is limit for length when leaching, dissolution rate is low, absorption is poor and bioavilability is relatively low the problems such as, especially
It is its manufactured hard capsule, easily becomes damp and rotten in production and storage process, to influence the performance of drug effect, also directly affect
The effect for the treatment of.In addition, Patients with Cardiovascular/Cerebrovascular Diseases needs long-term treatment, injection is used for a long time and is inconvenient, manufacture and
Medical treatment cost is high, the disadvantage of patient economy burden weight.It is not easy the moisture absorption therefore, it is necessary to prepare, is easy to the intermediate micro-capsule absorbed,
With a variety of demands for meeting clinical treatment and family uses.
Invention content
The present invention in view of the above problems, provides a kind of preparation method of beneficial arteries and veins health micro-capsule.After beneficial arteries and veins health microencapsulation
It is moist to can obviously reduce drawing for former particle, increases mobility of particle, is easy to capsule charge or tabletting, and it is final to improve benefit arteries and veins health
The stability of finished product.The preparation method is simple for process, and production cost is low, and energy consumption is low, easily realizes industrialized production.
In order to achieve the goal above, the present invention uses following technical scheme：
A kind of preparation method of benefit arteries and veins health micro-capsule, includes the following steps：
1. weighing each raw material according to following parts by weight：100 parts of erigeron breviscapus dried cream powder, 100-120 parts of gelatin and water
1000-1200 parts, gelatin is placed in ingredients pot, water is added, being heated at 70-80 DEG C makes Gelatin, obtains gelatin solution, then
Erigeron breviscapus dried cream powder is added, it is stirring while adding, finally keep erigeron breviscapus dried cream powder fully miscible in gelatin with homogenizer
In solution, water phase is made；
2. 100 parts of atoleine is taken to be placed in ingredients pot, 10-20 parts of sorbester p17 is added, is heated to 70-80 DEG C, mixing,
Oil phase is made；
3. the temperature of the control oil phase is 70-80 DEG C, the water phase is slowly added in oil phase, the water by stirring
Mutually and the volume ratio of oil phase is：100:100-120 continues to stir 3-5min, suspension is made；
So that suspension is cooled to 5-7 DEG C rapidly 4. starting circulating chilled water, continues to stir 20-30min, add and account for suspension
The isopropanol of total volume 6-8% stirs 2-4min, stands 20-24h；
5. after stratification, removing supernatant, remainder filtering detaches solid liquid phase, solid phase is micro-capsule, is cleaned with isopropanol
Micro-capsule surface, obtains solids, and solids is dried 24-28h to get beneficial arteries and veins health micro-capsule at 40-50 DEG C.
Above-described erigeron breviscapus dried cream powder, is erigeron breviscapus medicinal substances extract, and preferred preparation method is：Take lamp
Small cup Asarum medicinal materials, are added a concentration of 60-75% ethyl alcohol, and heating and refluxing extraction 2-3 times is 1-2 hours each, filtration, filtrate decompression
It is concentrated into no alcohol taste, is filtered, filtrate is condensed into medicinal extract, dry to get erigeron breviscapus dried cream powder.
Preferably, moisture≤6% of above-described erigeron breviscapus dried cream powder.
Preferably, step 3 described above, the mixing speed of step 4 are 700-900rpm.
The molecular formula of above-described sorbester p17 is C24H44O6, alias is sorbitan mono-oleic acid ester, anhydrous sorbitol oil
Acid esters, (Z)-mono- 9- octadecenic acids Isosorbide Dinitrate, emulsifier S80 and sorbitan monooleate.Sorbester p17 is insoluble in
Water is dissolved in deep fat and organic solvent, is advanced lipophilic emulsifier, is mainly used for medicine, cosmetics, weaving, paint and stone
Oily industry etc. is used as emulsifier, thickener, antirust agent etc..
Micro-capsule made of the preparation method of benefit arteries and veins health micro-capsule described above, the micro-capsule can be used for the production of any dosage form,
It is preferred for the production of capsule, tablet.
Compared with prior art, beneficial effects of the present invention：
1, it is moist will to can obviously reduce drawing for former particle for the method for the present invention after beneficial arteries and veins health microencapsulation, and drug is made to produce and storage
Process is not easy to become damp and rotten, and can improve the stability of beneficial arteries and veins health drug, and micro-capsule good fluidity is conducive to preparation and produces.
2, the method for the present invention will have certain slow controlled release properties, release and conventional YIMAIKANG PIAN after beneficial arteries and veins health micro-capsule
Or beneficial arteries and veins recovering capsule dosage form, compared to being substantially reduced, drug release is slowly and steady, can both prevent drug from inactivating or reducing in stomach
To the irritation of stomach, and the bioavilability of drug can be improved.
3, the present invention has good film forming, emulsification and stability, dosage is few, valence using gelatin as micro-capsule wall material
Lattice are cheap.
4, the encapsulation rate for the beneficial arteries and veins health micro-capsule that the method for the present invention obtains reaches 90% or more, and drugloading rate is more than 40%, micro-capsule
Yield is more than 95%, illustrates that preparation process of the present invention is feasible, reliable.
5, the method for the present invention it is simple for process, easy to operate, energy consumption is low, time saving, production cost is low, industrialization easy to implement
Production.
Specific implementation mode
Below in conjunction with specific implementation mode, the present invention is further described, but is not limited to protection scope of the present invention.
One, the preparation of erigeron breviscapus dried cream powder
Embodiment 1
2000 parts of erigeron breviscapus medicinal material is taken, coarse powder is ground into, 16000 parts of a concentration of 75% ethyl alcohol are added, is heated to reflux and carries
It takes 3 times, 1 hour every time, filtration, filtrate was concentrated under reduced pressure into no alcohol taste at 65 DEG C, filtered, filtrate is condensed into medicinal extract, at 90 DEG C
Under be dried under reduced pressure, moisture is reduced to 6% to get erigeron breviscapus dried cream powder.
Embodiment 2
2000 parts of erigeron breviscapus medicinal material is taken, coarse powder is ground into, 14000 parts of a concentration of 70% ethyl alcohol are added, is heated to reflux and carries
It takes 2 times, 1.5 hours every time, filtration, filtrate was concentrated under reduced pressure into no alcohol taste at 60 DEG C, filtered, filtrate is condensed into medicinal extract, 85
It is dried under reduced pressure at DEG C, moisture is reduced to 5% to get erigeron breviscapus dried cream powder.
Embodiment 3
2000 parts of erigeron breviscapus medicinal material is taken, coarse powder is ground into, 12000 parts of a concentration of 65% ethyl alcohol are added, is heated to reflux and carries
It takes 2 times, 2 hours every time, filtration, filtrate was concentrated under reduced pressure into no alcohol taste at 70 DEG C, filtered, filtrate is condensed into medicinal extract, at 80 DEG C
Under be dried under reduced pressure, moisture is reduced to 5.5% to get erigeron breviscapus dried cream powder.
Two, the preparation of beneficial arteries and veins health micro-capsule
Embodiment 4
A kind of preparation method of benefit arteries and veins health micro-capsule, includes the following steps：
1. weighing each raw material according to following parts by weight：100 parts of 1 erigeron breviscapus dried cream powder of Example, 100 parts of gelatin and
1000 parts of water, gelatin is placed in ingredients pot, and water is added, and being heated at 75 DEG C makes Gelatin, obtains gelatin solution, adds lamp
Small cup asarum dried cream powder, it is stirring while adding, finally keep erigeron breviscapus dried cream powder fully miscible in gelatin solution with homogenizer,
Water phase is made；
2. 100 parts of atoleine is taken to be placed in ingredients pot, 10 parts of sorbester p17 is added, is heated to 70 DEG C, oil is made in mixing
Phase；
3. the temperature of the control oil phase is 70 DEG C, the water phase is slowly added in oil phase by stirring, the water phase and
The volume ratio of oil phase is 100:100, continue to stir 5min, suspension is made；
So that suspension is cooled to 5 DEG C rapidly 4. starting circulating chilled water, continue to stir 20min, adds and account for suspension totality
The isopropanol of product 7% stirs 2min, stands for 24 hours；
5. stratification, removes supernatant, remainder filtering detaches solid liquid phase, solid phase is micro-capsule, is cleaned with isopropanol micro-
Capsule surface, obtains solids, and solids is dried 28h to get beneficial arteries and veins health micro-capsule at 40 DEG C.
Embodiment 5
A kind of preparation method of benefit arteries and veins health micro-capsule, includes the following steps：
1. weighing each raw material according to following parts by weight：100 parts of 2 erigeron breviscapus dried cream powder of Example, 120 parts of gelatin and
1000 parts of water, gelatin is placed in ingredients pot, and water is added, and being heated at 70 DEG C makes Gelatin, obtains gelatin solution, adds lamp
Small cup asarum dried cream powder, it is stirring while adding, finally keep erigeron breviscapus dried cream powder fully miscible in gelatin solution with homogenizer,
Water phase is made；
2. 100 parts of atoleine is taken to be placed in ingredients pot, 10 parts of sorbester p17 is added, is heated to 70 DEG C, oil is made in mixing
Phase；
3. the temperature of the control oil phase is 70 DEG C, the water phase is slowly added in oil phase by stirring, the water phase and
The volume ratio of oil phase is：100:120, continue to stir 3min, suspension is made；
So that suspension is cooled to 5 DEG C rapidly 4. starting circulating chilled water, continue to stir 25min, adds and account for suspension totality
The isopropanol of product 8% stirs 2min, stands 22h, obtains standing liquid；
5. stratification, removes supernatant, remainder filtering detaches solid liquid phase, solid phase is micro-capsule, is cleaned with isopropanol micro-
Capsule surface, obtains solids, and solids is dried for 24 hours at 45 DEG C to get beneficial arteries and veins health micro-capsule.
Embodiment 6
A kind of preparation method of benefit arteries and veins health micro-capsule, includes the following steps：
1. weighing each raw material according to following parts by weight：100 parts of 3 erigeron breviscapus dried cream powder of Example, 100 parts of gelatin and
1200 parts of water, gelatin is placed in ingredients pot, and water is added, and being heated at 80 DEG C makes Gelatin, obtains gelatin solution, adds lamp
Small cup asarum dried cream powder, it is stirring while adding, finally keep erigeron breviscapus dried cream powder fully miscible in gelatin solution with homogenizer,
Water phase is made；
2. 100 parts of atoleine is taken to be placed in ingredients pot, 20 parts of sorbester p17 is added, is heated to 80 DEG C, oil is made in mixing
Phase；
3. the temperature of the control oil phase is 80 DEG C, the water phase is slowly added in oil phase by stirring, the water phase and
The volume ratio of oil phase is：100:120, continue to stir 5min, suspension is made；
So that suspension is cooled to 7 DEG C rapidly 4. starting circulating chilled water, continue to stir 30min, adds and account for suspension totality
The isopropanol of product 6% stirs 4min, stands 20h, obtains standing liquid；
5. stratification, removes supernatant, remainder filtering detaches solid liquid phase, solid phase is micro-capsule, is cleaned with isopropanol micro-
Capsule surface, obtains solids, and solids is dried for 24 hours at 50 DEG C to get beneficial arteries and veins health micro-capsule.
Three, the quality evaluation of beneficial arteries and veins health micro-capsule
1. measuring the encapsulation rate of beneficial arteries and veins health micro-capsule
It is detected using ultraviolet spectrophotometry.In the quality/micro-capsule for the flavone compound encapsulated in encapsulation rate=micro-capsule
Content × 100% of encapsulating and non-encapsulated flavone compound.Using rutin as reference substance, it is diluted to 500mg/L.Reality is taken respectively
The beneficial each 50mg of arteries and veins health micro-capsule for applying a 4-6, with 100mL methanol dissolve, then use ultrasonication 30min, filter, take filtrate.
Absorbance is measured at 510nm, then computational envelope rate, the results are shown in Table 1.
The encapsulation rate situation of 1 embodiment 4-6 benefit arteries and veins health micro-capsules of table
| Embodiment | Encapsulation rate (%) |
| Embodiment 4 | 91.25 |
| Embodiment 5 | 93.47 |
| Embodiment 6 | 90.09 |
As can be seen from the table, the encapsulation rate of the beneficial arteries and veins health micro-capsule of the present invention reaches 90% or more.
2. measuring the drugloading rate of beneficial arteries and veins health micro-capsule
The beneficial each 5g of arteries and veins health micro-capsule for weighing embodiment 4-6 respectively adds 50ml water ultrasound 20min, and petroleum ether (60-90 is added
DEG C) extraction 2 times, each 50ml is carried out, filtration merges petroleum ether layer, is placed on single port bottle revolving, is then placed on 105 DEG C of drying
Case is dried, and the single port bottle of drying is placed in vacuum desiccator, is cooled to room temperature, is weighed, and calculates micro-capsule the inside lamp in single port bottle
The weight of small cup asarum dried cream powder, according to formula：Erigeron breviscapus dried cream powder weight/benefit arteries and veins health micro-capsule inside drugloading rate (%)=micro-capsule
Weight × 100%, calculates drugloading rate, and result of calculation is shown in Table 2.
The drugloading rate situation of 2 embodiment 4-6 benefit arteries and veins health micro-capsules of table
| Embodiment | Drugloading rate (%) |
| Embodiment 1 | 43.03 |
| Embodiment 2 | 46.78 |
| Embodiment 3 | 41.94 |
3. measuring the release of micro-capsule
4-6 of embodiment of the present invention samples and commercially available beneficial arteries and veins recovering capsule, commercially available YIMAIKANG PIAN are taken respectively, according to Chinese Pharmacopoeia
2015 editions drug release determination methods (the first methods of annex XD), according to the release of 2.4 the method time-and-motion study benefit arteries and veins health micro-capsules.It is molten
Go out condition：It 37 ± 0.5 DEG C, rotating speed 80rpm, is sampled respectively in 10min, 20min, 40min, 80min.According to entrapment efficiency determination side
Method detects general flavone content, and reagent addition finishes beginning timing, and 10min starts to measure, and METHOD FOR CONTINUOUS DETERMINATION 80min, measurement result is such as
Shown in table 3.
3 drug release rate situation of table
| 10min | 20min | 40min | 80min | |
| Embodiment 4 | 12.5 | 25.8 | 38.7 | 50.4 |
| Embodiment 5 | 11.5 | 22.7 | 36.4 | 48.5 |
| Embodiment 6 | 12.2 | 24.4 | 39.4 | 53.9 |
| Commercially available benefit arteries and veins recovering capsule | 56.8 | 65.4 | 76.2 | 90.7 |
| Commercially available YIMAIKANG PIAN | 45.3 | 55.8 | 68.7 | 82.9 |
As can be seen from the table, beneficial arteries and veins health micro-capsule release is slower than using commercially available capsule and tablet made of common preparation method,
Its slow controlled-release effect is apparent.
Four, the preparation of beneficial arteries and veins recovering capsule
Embodiment 7
The beneficial arteries and veins health micro-capsule 3.2kg of Example 4, adds starch 2.8kg, adds appropriate talcum powder, is uniformly mixed, and is packed into
Capsule is to get beneficial arteries and veins recovering capsule.
Embodiment 8
The beneficial arteries and veins health micro-capsule 3.2kg of Example 5, adds starch 2.8kg, adds appropriate talcum powder, is uniformly mixed, and is packed into
Capsule is to get beneficial arteries and veins recovering capsule.
Five, the preparation of YIMAIKANG PIAN
Embodiment 9
The 1.6kg of the beneficial arteries and veins health micro-capsule of Example 6 adds starch 1.5kg, then adds dextrin appropriate, is made of 60% ethyl alcohol
Particle, tabletting, sugar coating is to get YIMAIKANG PIAN.
Six, determination of moisture
7-9 of the embodiment of the present invention and commercially available YIMAIKANG PIAN, beneficial arteries and veins recovering capsule are taken, stability test case is set, in 40 DEG C of temperature
± 2 DEG C, carry out 6 months accelerated tests under the conditions of relative humidity 75% ± 5%, according to《Chinese Pharmacopoeia》One annex of version in 2015
It is examined under moisture item, refers to table 4.
4 determination of moisture result table of table
| 0 month | January | 2 months | March | June | |
| Embodiment 7 | 4.8% | 4.9% | 5.1% | 5.3% | 5.4% |
| Embodiment 8 | 4.6% | 4.8% | 4.9% | 5.0% | 5.1% |
| Embodiment 9 | 5.0% | 5.2% | 5.4% | 5.5% | 5.6% |
| Commercially available benefit arteries and veins recovering capsule | 6.8% | 7.2% | 7.8% | 8.0% | 9.2% |
| Commercially available YIMAIKANG PIAN | 6.5% | 7.0% | 7.4% | 7.8% | 8.1% |
Test result shows：Beneficial arteries and veins recovering capsule and tablet prepared by the present invention, with commercially available beneficial arteries and veins recovering capsule and beneficial arteries and veins health
Piece is compared, drug draw it is moist be substantially reduced, solve the problems, such as that drug easily becomes damp and rotten in production and storage process.
The specific implementation of the invention is not to be limited to these illustrations for the above content, and technology belonging to the present invention is led
For the those of ordinary skill in domain, without departing from the inventive concept of the premise, a number of simple deductions or replacements can also be made,
It all shall be regarded as belonging to present invention scope of patent protection determined by the appended claims.
Claims (2)
1. a kind of preparation method of benefit arteries and veins health micro-capsule, which is characterized in that include the following steps：
(1) each raw material is weighed according to following parts by weight：100 parts of erigeron breviscapus dried cream powder, 100-120 parts of gelatin and water
1000-1200 parts, gelatin is placed in ingredients pot, water is added, being heated at 70-80 DEG C makes Gelatin, obtains gelatin solution, then
Erigeron breviscapus dried cream powder is added, it is stirring while adding, finally keep erigeron breviscapus dried cream powder fully miscible in gelatin with homogenizer
In solution, water phase is made；
（2）It takes 100 parts of atoleine to be placed in ingredients pot, adds 10-20 parts of sorbester p17, be heated to 70-80 DEG C, mixing is made
At oil phase；
（3）Control the oil phase temperature be 70-80 DEG C, stirring, the water phase is slowly added in oil phase, the water phase and
The volume ratio of oil phase is：100:100-120 continues to stir 3-5min, suspension is made；
（4）Starting circulating chilled water makes suspension be cooled to 5-7 DEG C rapidly, continues to stir 20-30min, adds that account for suspension total
The isopropanol of volume 6-8% stirs 2-4min, stands 20-24h；
（5）Supernatant is removed, remainder filtering detaches solid liquid phase, solid phase is micro-capsule, cleans micro-capsule surface with isopropanol, obtains
Solids is dried 24-28h to get beneficial arteries and veins health micro-capsule by solids at 40-50 DEG C；
Moisture≤6% of the erigeron breviscapus dried cream powder；
The step（3）、（4）Mixing speed be 700-900rpm.
2. micro-capsule made of a kind of preparation method of beneficial arteries and veins health micro-capsule as described in claim 1, it is characterised in that：The micro-capsule is used
In the production of capsule, tablet.
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|---|---|---|---|---|
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| CN1775868A (en) * | 2005-11-24 | 2006-05-24 | 山东省科学院生物研究所 | A kind of water-dispersible capsanthin microcapsule and preparation method thereof |
| CN1853660A (en) * | 2004-08-13 | 2006-11-01 | 贵阳云岩西创药物科技开发有限公司 | Erigeron breviscapus preparation and making method thereof |
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2015
- 2015-12-15 CN CN201510936600.3A patent/CN105412045B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1626208A (en) * | 2004-08-13 | 2005-06-15 | 贵阳云岩西创药物科技开发有限公司 | Preparation of fleabane and preparation method |
| CN1853660A (en) * | 2004-08-13 | 2006-11-01 | 贵阳云岩西创药物科技开发有限公司 | Erigeron breviscapus preparation and making method thereof |
| CN1775868A (en) * | 2005-11-24 | 2006-05-24 | 山东省科学院生物研究所 | A kind of water-dispersible capsanthin microcapsule and preparation method thereof |
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| Title |
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| Matrix Polyelectrolyte Microcapsules: New System for Macromolecule Encapsulation;Dmitry V. Volodkin etal;《Langmuir the Acs Journal of Surfaces & Colloids》;20040413;第20卷(第8期);3398-406 * |
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