CN1286528C - Hollow fiber medicine carrier and its preparing method and use - Google Patents
Hollow fiber medicine carrier and its preparing method and use Download PDFInfo
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- CN1286528C CN1286528C CN 200410060615 CN200410060615A CN1286528C CN 1286528 C CN1286528 C CN 1286528C CN 200410060615 CN200410060615 CN 200410060615 CN 200410060615 A CN200410060615 A CN 200410060615A CN 1286528 C CN1286528 C CN 1286528C
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Abstract
The present invention relates to a hollow fiber medicine carrier and a preparation method thereof. The hollow fiber medicine carrier is medicine release material with controllable medicine release and is prepared by utilizing hollow inorganic bioactive fiber or degradable macromolecular fiber as a carrier according to the deposition absorption of medicine in the base body of the hollow fiber carrier. The inorganic bioactive fiber can be prepared by means of a precursor fiber drawing method for inorganic bioactive hollow fiber or electrophoresis deposition, the degradable macromolecular fiber can be prepared by means of a compound coating method and a melting stretching method, and the deposition absorption of medicine in the hollow fiber base body is realized by means of a perfusion method or an immersion method or a hollow adsorption method and vacuum drying or freeze drying at low temperature. The present invention has the advantages of controllable medicine carrying amount, simple operation, simple implantation method of the hollow fiber medicine carrier and controllable medicine release. Meanwhile, a hollow fiber medicine release body can also be used as implantation material or filling material.
Description
Technical field
The present invention relates to doughnut pharmaceutical carrier and its production and application
Background technology
Treatments such as acute and chronic disease can obtain the effective treatment by the release of medicine, have formed multiple drug delivery systems such as tablet, injection, emulsifiable paste, ointment and aerosol at present.Owing to instability, the toxicity of some medicine, have the problem of less therapeutic domain and dissolubility aspect, according to general administering mode, the intravital drug level of people can only be kept the short time, drug level in the blood or in the in-vivo tissue fluctuates bigger up and down, sometimes the medicine maximum tolerated dose that surpasses patient, sometimes be lower than effective dose again, so not only do not have due curative effect, but also may have side effects; Frequent low dose of administration can be regulated blood drug level, avoids above-mentioned phenomenon, but often makes the patient be difficult to accept, and has implemented a lot of difficulties.Therefore, traditional drug delivery system can not satisfy the clinical practice requirement, and the research of may command drug delivery system more and more causes people's attention with application.
The route of administration and the method for pharmaceutical preparation are most important to drug effect.In modern drug-supplying system, microparticulate oral administrations such as microsphere and microcapsule will be subjected to the influence of two kinds of first pass effects, and many medicines lost efficacy because of the first pass effect metabolism greatly.For obtaining excellent curative, have to change oral administration into injection usually and wait other route of administration.But the non-targeted drug by injecting pathway can be evenly distributed in the systemic circulation, before arriving focus, pass through steps such as same protein binding, drainage, metabolism, decomposition, has only small amount of drug just can reach focus.Therefore, prepare the slow-releasing prolonged action drug that can slowly discharge ingredient, improve the utilization rate and the curative effect of medicine and reduce side effects of pharmaceutical drugs, the one, develop suitable drug release Controlled Release System, the effective drug level of control target area, the 2nd, choose the manufacture method of practical carrier material and research pharmaceutical carrier.
The controlled delivery of pharmaceutical agents delivery system is progressively to grow up on the basis of the organic and inorganic material of a series of good biocompatibilities, quite a few pharmaceutical carrier of this type systematic comes from bone grafting material, the medicine of their carryings is extremely extensive, and that has reported has multiple antibiotic, antitubercular agent, antineoplastic agent and urge skeletal growth factor etc.The total characteristics of this type systematic are: (1) is local high dense, and whole body is low dense, and consumption is few, and poisonous side effect of medicine is little; (2) long action time, initial stage release amount height transfers the stable release of low concentration very soon to; (3) replacement or repairing bone defect are kept limbs profile and function.The local recurrence of bone tumor postoperative and the effective ways of serious open fracture accompanying infection treatment and other diseases treatment have been become.This type of pharmaceutical carrier has two classes at present: the one, and organic high molecular polymer is as polymethyl methacrylate (PMMA) and absorbability polyester polyphosphazene polymer lactic acid (PLA), polyglycolic acid (PGA) and PLA and PGA copolymer etc.The polymethyl methacrylate bone cement is to use the earliest and maximum carriers, though can be moulded the shape that needs arbitrarily, excellent mechanical intensity is arranged, the quality densification, but the medicine in the carrier can not discharge fully, and it discharges first quick and back slow, then slowly stablizes after falling suddenly to discharge, and the toxicity of a large amount of heat energy that discharged in polymerization process, residual monomer and unabsorbable material etc. are bigger to the activity influence of contained medicine, need the resistant to elevated temperatures medicine powder of screening as protracted release drug.This type of material can not be degraded, and singly is Drug therapy person and must takes out by second operation.This type systematic mainly carries multiple antibiotic and antitumor drug, can only be used for the repairing and the filling of load-bearing bone, makes it be difficult to become ideal release medium.The biodegradation material that absorbability polyester polyphosphazene polymer lactic acid (PLA), polyglycolic acid (PGA) and PLA and PGA copolymer etc. have certain mechanical strength and forming property, excellent biological compatibility and bone guided activity are arranged, can be new bone good bone support is provided.Degradation in vivo product part is with H
2O and CO
2Discharge, part is participated in tricarboxylic acid cycle, and is nontoxic to human body, and as pharmaceutical carrier release fully, drug release process and carrier degraded are closely related.But as ideal bone grafting drug carrier material, the absorbability macromolecule polyester is difficult to reach simultaneously degradation speed and higher these two requirements of mechanical strength faster.In addition because their lack bone-inducting active, in that coverlet is private when making large segmental bone defect, bone formation rate is slower, and easily produces aseptic inflammation.Second class is biological inorganic calcium phosphate material, as porous bata-tricalcium phosphate ceramic material, calcium phosphate bone cement, porous hydroxyapatite and bioglass material, this class material has excellent biological compatibility and bone guided or osteoinductive energy, can be new bone support is provided, can firmly link to each other with surrounding tissue.As the drug release material, disengaging of medicine can be by the inside and outside Concentraton gradient direct motion diffusion of carrier, and its rate of release is relevant with factors such as carrier micropore size, drug loading, drug solubilities, and contained medicine needn't possess heat stability simultaneously.At present still have some shortcomings during this system repairing bone defect, as poor plasticity, matter is crisp, and resistance to compression, fracture resistance are relatively poor, and it is damaged to be applied to repair load-bearing bone.
In sum, although it is a lot of to serve as the slow releasing carrier of medication material of bone defect repair, and part drug release carrier system obtains commercial development and application, but all there is weak point in varying degrees, no matter the pharmaceutical carrier that uses is medicament capsule at present,, capsule film material or the property implanted microgranule, the dispose procedure of medicine and the dosage of drug release, except that the compatibility of the molecular weight that is subjected to medicine, molecular volume size, water solublity and carrier material influences, also be subjected to the influence of the composition, structure, molecular weight, acid number, degradation speed etc. of carrier material.Medicament capsule,, capsule film material is generally with the gelatin is that primary raw material is prepared from, drug release is fast, Chang Zuowei oral drugs or cavity/canal drug administration suppository.The microgranule of the property implanted reaches the purpose of medicine carrying usually by the surface adsorption of material, the rate of release of medicine is subjected to the shape, particle diameter, surface nature of material itself etc. to influence and discharge the influence of environment, thereby directly has influence on the pharmaceutical requirements amount of focal zone.For this reason, at These characteristics and invention hollow organic polymer and inorganic bioactivity fiber may command discharge pharmaceutical carrier, there is important practical to be worth with the long-acting controllable release that realizes medicine.
Summary of the invention
The objective of the invention is to develop and a kind of doughnut pharmaceutical carrier that can control drug release is provided, effectively control the rate of release of medicine and medicine desired concn at focal zone.
For achieving the above object, technical scheme of the present invention is: with hollow inorganic bioactive fiber or the long and slender dimension of degradable macromolecule is carrier, compound by the deposition absorption of medicine in the doughnut carrier matrix, the doughnut drug release material of preparation drug controllable release.
Described hollow inorganic bioactive fiber is bioactivity calcium phosphate doughnut, hydroxyapatite doughnut, bio-vitric doughnut and mangneto heating hollow composite fibre.
Described Biodegradable high-molecular doughnut is to can be used for the degradable poly lactic acid that body is implanted into or the copolymer doughnut of polyglycolic acid, polylactic acid and polyglycolic acid.
The deposition absorption of described medicine in the doughnut carrier matrix is meant doughnut and to be used for human body deposition absorption chronic and the acute illness medicine compound, and it comprises solvent evaporation method, spray drying method, fusion method, hollow absorption method, perfusion, infusion process, it is compound directly to mix the shaping method to suppress or the direct mixing cured method of forming or pack.
Described controllable release is for utilizing materials such as pH responsive type, thermosensitive type, ultrasonic trigger-type, magnetic trigger-type or device drug delivery system is exerted one's influence and being controlled.
The preparation of presoma fiber elongation method or electrophoretic deposition is adopted in the preparation of the biological activity mangneto heating hollow composite fibre that the present invention is used.
1. the preparation process of presoma fiber elongation method is: the preparation of (1) phosphorous even colloidal sol: is to be dissolved in hot water at 1～4: 1 sodium alginate and tetrasodium pyrophosphate by sodium alginate and tetrasodium pyrophosphate mass ratio, and stirred, make it be dissolved as colloidal sol fully, regulate pH value to 6～8 of colloidal sol with acetic acid, add mangneto heating ferrite additive, left standstill 1～5 hour at 50～90 ℃ then, obtain evenly bubble-free phosphorous colloidal sol; Tetrasodium pyrophosphate and additive mass ratio are 10: 0～3 in the wherein phosphorous colloidal sol, described ferrite additive is meant: spinel-type MFe2O4, carbuncle type R3Fe5O12, Magnetoplumbate-type MFe12O19 material any, wherein M is an iron family element, and R is a rare earth element; (2) preparation of precursor fibre: the CaCl2 solution of modulation 0.4mol/L, phosphorous colloidal sol is carried out wire drawing, washing, drying obtain the dry precursor fiber then; (3) with precursor fibre heat treatment in air, heat treatment temperature is 500～1200 ℃, and heat treatment time is 0.2～1.5 hour, promptly gets biological activity mangneto heating hollow composite fibre (referring to Fig. 1).
2. electrophoretic deposition prepares doughnut, the steps include: that (1) calcium phosphorous compound suspension makes the electrophoretic deposition medium, the suspension solids content is 20～60g/L, mangneto heating ferrite additive concentration is 0.5wt%～3wt%, its system is deposition used pulse voltage: 20～80V, and pulse current 20～80mA, sedimentation time are that 0.5～2min (2) is with precursor fibre high-temperature process in air, heat treatment temperature is 800～1200 ℃, and heat treatment time is 0.2～1.5 hour.
The used bio-vitric doughnut of the present invention can be by the preparation of glass tubing drawing process.
The preparation of fusion drawn method and compound cladding process is adopted in the preparation of the Biodegradable high-molecular doughnut that the present invention is used.
1. the preparation process of fusion drawn method is: (1) utilizes melt rheometer with the temperature acquisition required hollow degradable macromolecule fiber of degradable macromolecule at 60～140 ℃.
2. the preparation process of compound cladding process is: (1) is dissolved in the organic solvent wiring solution-forming with Biodegradable high-molecular, organic solvent comprises: one or more in acetone, dichloromethane, chloroform, ethyl acetate, 1.4 dioxane, organic solvent: organic polymer (volume ratio)=2.5～0.5: 1; (2) organic solution that macromolecule is made into is coated on the presoma surface, and used presoma is glass fibre or carbon fiber; (3) doughnut that will be coated with macromolecule organic solution places vacuum drying oven or frozen drying case evaporative removal organic solvent, and the vacuum drying inside and outside differential pressure is-0.06～-0.1MPa, 10～50 ℃ of true temps, time are 2～24 hours; The frozen drying condition: degree of hollowness is less than 13 handkerchiefs, temperature-40～0 ℃, 2～24 hours time.
Doughnut preparation of drug carriers step of the present invention is:
(1) with solvent and contained medicament mixed, be mixed with the solution or the suspension that contain medicine 1wt%～5wt%, and stirred 3～10 hours, solvent for use be in acetone, dichloromethane, chloroform, ethyl acetate, 1.4 dioxane organic solvents or the distilled water one or more; (2) doughnut for preparing is soaked in above-mentioned solution, one or more of employing perfusion or infusion process or vac sorb method, two-port and micropore fibre wall on of medicine by doughnut entered the doughnut deposition, hollow absorption inside and outside differential pressure is-0.06～-0.1MPa; (3) used solvent is removed in vacuum drying or lyophilization, and the vacuum drying inside and outside differential pressure is-0.06～-0.1MPa, 30～50 ℃ of true temps, time are 2～24 hours; The frozen drying condition: degree of hollowness is less than 13 handkerchiefs, temperature-40～0 ℃, time: 2～24 hours; (4) repeat above-mentioned steps repeatedly, to required year medication amount (referring to Fig. 2).
The application of the doughnut drug carrier material that the present invention is prepared can be by the operative treatment implantation or as the interventional therapy appliance material.
The doughnut pharmaceutical carrier that the present invention is prepared, it is the sustained release system of one as medicine and bioactive substance, can improve utilization rate, safety and the effectiveness of medicine.Medicine can be positioned and be discharged into the position, lesion, improves therapeutic effect and reduces dosage.
The carrier material and the used medicine of bio-medical doughnut pharmaceutical carrier are closely related, the present invention utilizes the doughnut material to be carrier, carrier material requires to have excellent biological compatibility, and local organization is had no adverse effects, non-immunogenicity, has certain mechanical strength and support effect.According to different materials, choose different technologies of preparing and form the different doughnut structure in fine aperture of diameter, wall thickness and fibre wall.Because doughnut has distinctive advantages such as loading density is big, simple in structure, specific area is big on version, adsorption technology that can be by said medicine and material and lyophilization and vacuum drying technique are adsorbed in contained medicine in the hollow cellulose bodies, and the adsorbance of the size control medicine of the concentration of parameter, solution and suspension by control absorption, vacuum, fiber is made the medicament carrier system of certain dosage form through the port shutoff.Thereby the control medicine makes the dosage of medicine according to design in the intravital rate of release of people, slowly discharges in vivo by certain speed in the time range that requires, to reach the purpose of effective treatment.The effect of alternating magnetic field is outside descended because the rate of release of the raising may command medicine of heat to mangneto heating doughnut material.Doughnut medicament carrier system of the present invention can be separately or bunchy or implant by the block that Binder Materials is prepared into high voidage, high compactedness.The tube wall of medicine by doughnut obtains discharging, because the degraded of material, reduces the resistance of drug release at the middle and late stage of drug release, guarantees the constant release of medicine.To specific case, in the doughnut preparation process, obtain the carrier system that functional may command discharges by adding proper additive, control the release of medicine effectively.
The present invention makes full use of distinctive advantage the structures such as the doughnut loading density is big, simple in structure, inner ratio surface area is big, rationally choose different biomaterials as carrier according to different medicines and case, technology of preparing by different materials, form the doughnut that tube wall contains micropore, utilize perfusion or infusion process or vac sorb method and vacuum drying and hypothermic lyophilization technology, realize the medicine carrying of medicine.System component, aperture, the pore structure of fibre wall and the distribution of pore of control doughnut material, and the external environment that is applied influence, thereby the continual and steady release of control medicine.
Description of drawings
Fig. 1 presoma fiber elongation method prepares the sketch map of doughnut
Fig. 2 doughnut medicine-carrying method and process sketch map
Fig. 3 root canal is filled with doughnut pharmaceutical carrier sketch map
Fig. 4 bone tuberculosis and bone defect repair doughnut pharmaceutical carrier sketch map
Number in the figure is represented: 1 sodium alginate soln, and 2 calcium chloride solutions, 3 precursor fibre, 4 doughnuts, 5 contain the solution or the suspension of medicine, 6 absorption medicines, 7 doughnut pharmaceutical carriers, 8 doughnut pharmaceutical carrier embedded materials, P pressure.
The specific embodiment
Embodiment 1: referring to Fig. 1
Adopting presoma fiber elongation method and medicine vac sorb legal system to be equipped with root canal fills with hollow biologic inorganic fiber pharmaceutical carrier and packing material.Concrete technology is as follows:
1. with mass ratio 2.3: 1 sodium alginate (Na-Alg) and tetrasodium pyrophosphate (Na
4P
2O
7) be dissolved in the hot water, stirred, make it be dissolved as colloidal sol fully, the pH value to 7 with acetic acid adjusting colloidal sol left standstill in 75 ℃ temperature chamber 1.5 hours then, obtained evenly bubble-free phosphorous colloidal sol.(2) phosphorous colloidal sol is at the CaCl of 0.4mol/L
2Carry out wire drawing in the solution, as Fig. 1, washing, drying obtain the dry precursor fiber then.(3) with precursor fibre high-temperature process in air, heat treatment temperature: 900 ℃, heat treatment time: 0.5 hour.Obtain hollow biologic inorganic fiber.
2. be mixed with the Metronidazole Compound suspension of 10wt%～20wt%, the doughnut for preparing is soaked in above-mentioned solution, adopt the vac sorb method, medicine enters the doughnut deposition by the two-port and the micropore on the fibre wall of doughnut, the inside and outside differential pressure of vac sorb :-0.06～-0.1MPa. then degree of hollowness be less than the condition of 13 handkerchiefs, temperature-40 ℃ under lyophilization, remove used solvent, obtain required root canal and fill doughnut pharmaceutical carrier and packing material.
Adopt electrophoretic deposition to prepare inorganic hollow fibers, medicine is filled in doughnut after, be modulated into filling material of bone with inorganic-bone cement with biological, be used for bone tuberculosis and bone defect repair.Concrete technology is as follows:
1. choose the hydroxyapatite suspension and make the electrophoretic deposition medium, ethanol is as suspension, and suspension solids content: 25g/L adds 0.5% magnetic glass.
2. choosing carbon fiber is presoma, prepares the bioactivity calcium phosphate coating at its surperficial electrophoretic deposition.The used pulse voltage of electrophoretic deposition: 30V, pulse current: 50mA, sedimentation time: 30s
3. with precursor fibre high-temperature process in air, heat treatment temperature: 1000 ℃, heat treatment time: 0.5 hour.
4. rifampicin is incorporated in the agitator cup, in 50 ℃ of water-baths, dissolves; Adopt rifampicin vac sorb method in the doughnut for preparing, then complex carrier is taken out, frozen drying realizes that medicine deposits in doughnut; With calcium phosphate bone cement the doughnut carrier modulation is become the medicine carrying packing material, obtain required bone tuberculosis and bone defect repair doughnut pharmaceutical carrier and packing material.
Embodiment 3
Adopt the fusion drawn legal system to be equipped with the Biodegradable high-molecular doughnut, medicine is filled in doughnut after, be modulated into filling material of bone with inorganic-bone cement with biological, be used for oncotherapy.Concrete technology is as follows:
1. utilize melt rheometer that degradable poly lactic acid is carried out fusion under 115 ℃ temperature.Melt forms doughnut and obtains required hollow degradable macromolecule fiber through the traction stretching through hollow air blowing type spinning head.
2. amycin is added in the agitator cup and dissolve, adopt the vac sorb method in the doughnut for preparing, then complex carrier is taken out, the multiple low-temperature lyophilization realizes that medicine deposits in doughnut; With calcium phosphate bone cement the doughnut carrier modulation is become the medicine carrying packing material, obtain the required oncotherapy doughnut pharmaceutical carrier that is used for.
Embodiment 4
Adopt compound cladding process legal system to be equipped with inorganic hollow fibers, medicine is filled in doughnut after, be modulated into filling material of bone with inorganic-bone cement with biological, be used for bone tuberculosis treatment.Concrete technology is as follows:
1. be dissolved in the organic solvent ethyl acetate with an amount of Biodegradable high-molecular polylactic acid with according to glycolic, and, be coated on glass fibre then 0.5% spinel type ferrite material mixing.Place frozen drying case frozen drying to remove organic solvent the doughnut after the demoulding.
2. isoniazid is utilized the vac sorb method to be deposited in the doughnut for preparing, complex carrier is taken out, with the shutoff of doughnut two ends, obtain required bone tuberculosis treatment doughnut pharmaceutical carrier with calcium phosphate bone cement.
Claims (3)
1, doughnut pharmaceutical carrier, it is characterized in that it is a carrier with the hollow inorganic bioactive fiber, by the deposition absorption of medicine in the doughnut carrier matrix, and the drug release material of the drug controllable release that makes, its described hollow inorganic bioactive fiber is a biological activity mangneto heating hollow composite fibre.
2, pharmaceutical carrier as claimed in claim 1, it is characterized in that described biological activity mangneto heating hollow composite fibre prepares with the presoma fiber elongation method, the steps include: the preparation of (1) phosphorous even colloidal sol: is to be dissolved in hot water at 1～4: 1 sodium alginate and tetrasodium pyrophosphate by sodium alginate and tetrasodium pyrophosphate mass ratio, and stirred, make it be dissolved as colloidal sol fully, regulate pH value to 6～8 of colloidal sol with acetic acid, add mangneto heating ferrite additive, leave standstill l～5 hour at 50～90 ℃ then, obtain evenly bubble-free phosphorous colloidal sol; Tetrasodium pyrophosphate and additive mass ratio are 10: 0～3 in the wherein phosphorous colloidal sol, described ferrite additive is meant: spinel-type MFe2O4, carbuncle type R3Fe5O12, Magnetoplumbate-type MFe12O19 material any, wherein M is an iron family element, and R is a rare earth element; (2) preparation of precursor fibre: the CaCl2 solution of modulation 0.4mol/L, phosphorous colloidal sol is carried out wire drawing, washing, drying obtain the dry precursor fiber then; (3) with precursor fibre heat treatment in air, heat treatment temperature is 500～1200 ℃, and heat treatment time is 0.2～1.5 hour, promptly gets biological activity mangneto heating hollow composite fibre.
3, pharmaceutical carrier as claimed in claim 1, it is characterized in that described biological activity mangneto heating hollow composite fibre prepares with electrophoretic deposition, its method is: (1) makes the electrophoretic deposition medium with the calcium phosphorous compound suspension, its suspension solids content is 20～60g/L, and mangneto heating ferrite additive concentration is 0.5wt%～3wt%; (2) with the carbon fiber be presoma, prepare the bioactivity calcium phosphate coating at its surperficial electrophoretic deposition, the used pulse voltage of electrophoretic deposition is 20～80V, and pulse current is 20～80mA, and sedimentation time is 0.5～2min; (3) with precursor fibre heat treatment in air, heat treatment temperature is 800～1200 ℃, and heat treatment time is 0.2～1.5 hour.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410060615 CN1286528C (en) | 2004-07-22 | 2004-07-22 | Hollow fiber medicine carrier and its preparing method and use |
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| CN 200410060615 CN1286528C (en) | 2004-07-22 | 2004-07-22 | Hollow fiber medicine carrier and its preparing method and use |
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| CN1286528C true CN1286528C (en) | 2006-11-29 |
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Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1957695B1 (en) * | 2005-12-07 | 2011-02-09 | Ramot at Tel-Aviv University Ltd. | Drug-delivering composite structures |
| CN103469610A (en) * | 2013-09-16 | 2013-12-25 | 吴江市海丰喷织有限公司 | Multi-purpose anti-bacterial fabric |
| CN106390207A (en) * | 2016-08-29 | 2017-02-15 | 上海交通大学 | Application of porous titanium alloy in medical science as carrier |
| CN107641970B (en) * | 2017-11-01 | 2020-10-16 | 南召东方蚕丝绸开发有限公司 | Animal fiber containing microcapsule and preparation method thereof |
| CN108066766B (en) * | 2017-12-04 | 2021-08-31 | 北京派尔特医疗科技股份有限公司 | Method and system for carrying medicine through wire material microporous ceramic layer |
| CN110780059B (en) * | 2019-10-15 | 2021-07-13 | 河海大学 | Auxiliary device and method for ultrasonic triggering of cement-based material self-repairing microcapsule |
| CN115737934B (en) * | 2022-12-07 | 2024-04-02 | 西安理工大学 | Preparation method of sandwich structure fiber gradient drug release bone cement bracket |
| CN117105211A (en) * | 2023-08-23 | 2023-11-24 | 中科汇生(北京)医药科技有限公司 | Preparation method of hollow carbonaceous nano pump and preparation method of drug carrier containing nano pump |
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