CN101134014A - Calcium sulphate bead string implantation type medicine partial releasing system with top coat and method of producing the same - Google Patents
Calcium sulphate bead string implantation type medicine partial releasing system with top coat and method of producing the same Download PDFInfo
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- CN101134014A CN101134014A CNA200710059721XA CN200710059721A CN101134014A CN 101134014 A CN101134014 A CN 101134014A CN A200710059721X A CNA200710059721X A CN A200710059721XA CN 200710059721 A CN200710059721 A CN 200710059721A CN 101134014 A CN101134014 A CN 101134014A
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Abstract
The present invention relates to a calcium sulfate beaded implanted type locally-released medicine system and its preparation method. Said system is composed of three portions of medicine-carried bead bodies, stringing thread and bead body surface coating material, in which the bead bodies are formed from calcium sulfate and medicine according to the weight mixing ratio of 100:1-5. Besides, said invention also provides the concrete operation steps of its preparation method.
Description
Technical field
The invention belongs to the biological medicine technology field, particularly a kind of calcium sulphate bead string implantation type local medicine releasing system and preparation method that has face coat.
Background technology
The local delivery systme of medicine has characteristics such as toxicity is little, drug effect is long.It is many based on polymer to implant carrier material at present both at home and abroad, for example polylactic acid and copolymer thereof, poly-second lactone, polyvinyl alcohol and various natural macromoleculars etc., also available biologic inorganic material such as calcium phosphate etc., the medicine of load has anticarcinogen, antibiotic and pharmaceutical grade protein etc.The embedded material that for example poly-anhydride load card nitrogen is situated between by the FDA examination, is used for the treatment of cerebral glioma in the U.S..The anticarcinogen of inorganic material load can be used for the postoperative packing material of osteocarcinoma, plays the dual-use function of bone reparation and local drug release simultaneously.Antibiotic beading with methyl methacrylate (PMMA) load have been used for myelitic treatment abroad, beading form is inserted bone when damaged, frictionally damage to tissue is more other forms of little, so it is more satisfactory adopting beading form, but PMMA can not degrade in vivo, therefore needs second operation to take out.Adopting calcium phosphate is that its degradation speed of carrier is slower, is that the carrier degradation speed improves though adopt calcium sulfate, and the instability of drug release rate usually produces prominent problem such as release.
Summary of the invention
In order to solve the deficiencies in the prior art, the present invention proposes a kind of new face coat calcium sulphate bead string implantation type local medicine releasing system and preparation method.Concrete technology is as follows:
The calcium sulphate bead string implantation type local medicine releasing system of face coat of the present invention, this system is made up of three parts: medicine carrying pearl body, get lines crossed, pearl surface coating material.
Wherein beading are made up of calcium sulfate and medicine, and set of dispense is such as following by weight:
100 parts in calcium sulfate,
1 ~ 5 part of medicine;
Getting lines crossed is being the degradable operation suture thread, and the specification of line limits as follows according to mould:
Diameter 0.1 ~ 0.4mm,
Length 10 ~ 30cm;
Coating material is a biocompatible polymer, and face coat thickness is decided by the concentration of polymer solution, is made into certain density solution during use and applies, and solution concentration is:
Polymer accounts for the percentage by weight 1% ~ 5% of solvent; Solvent is the solvent of the lower soluble polymeric thing of boiling point.
Described polymer is natural biological degradable polymer, synthetic degradable polymer.
Described getting lines crossed is being the absorbable suture of natural material absorbable suture and synthetic.
Described natural biological degradable polymer comprises polysaccharide macro-molecular such as chitosan, alginate, carrageenan, starch and derivant thereof, cellulose and derivant thereof, reaches protein macromolecule such as collagen, gelatin; The synthetic polymer biomaterial comprises polycaprolactone, poly butyric ester and copolymer thereof.Above-mentioned polymer can use separately, also can two or the composite use of two or more polymer.
Described natural material absorbable suture is a gutstring, the collagen line.
Described medicine is anti-inflammatory drug, anticancer class medicine, bone morphogenetic protein somatomedin, and this implant can be used for osteomyelitis or osteocarcinoma postoperative topical, also can be used as the bone renovating material in the bone defect healing.
Described anti-inflammatory drug is gentamycin, cefalexin, norvancomycin; Anticancer class medicine is amycin, camptothecine or paclitaxel hydroxyapatite.
The preparation method of a kind of calcium sulphate based embedded type local medicine releasing system of the present invention adopts cast earlier, the method for back coating.
The preparation method that has the calcium sulphate bead string implantation type local medicine releasing system of face coat of the present invention:
(1) calcium sulfate is fully mixed with medicine, add distilled water then, the weight proportion of calcium sulfate and water is 8: 2～2: 8, mixed 3～10 minutes, and then mixture was injected the bead type mould, get lines crossed and put into mould in advance, treat to take out after the sample molding, the sample that makes is a beading;
(2) adopt the immersion method coating: beading are immersed in the polymer solution for preparing, taking-up places on the turntable then, makes its solvent evaporates, and is dry in vacuum drying oven, obtains the bead material of face coat.
Spray process is that the chain pearl is placed the rotating room, and the polymer solution for preparing is in advance evenly sprayed on beading surface, is placed on drying in the vacuum drying oven, obtains the bead material of face coat.
In addition, can repeat spin coating, thereby make the different calcium sulfate medicine carrying beading of coating layer thickness.Adopt coating technology to overcome the unstable and drug release rate instability that causes of calcium sulfate material degraded, prominent problem such as release, effect is to control local rate of release.
Mould can adopt silicone rubber to make.
The calcium sulphate bead string implantation type local medicine releasing system and the preparation method of face coat of the present invention, the drug release rate instability of having obeyed calcium sulfate material degraded instability and having caused, effect is than the calcium sulfate release material release cycle of coating did not grow for two to three weeks, and can control local rate of release, thereby effectively treat chronic osteomyelitis and osteocarcinoma etc.
The specific embodiment
Example 1 calcium sulfate/cefalexin/gutstring gathers second lactone system
Get 2g calcium sulfate, add 0.02g cefalexin and mix homogeneously, add the 0.5ml distilled water then, and fully stir, when treating the calcium sulfate initial set, be injected in the beading mould, it is 0.1mm that mould is put into diameter in advance, and length is the intestinal line of 10cm; Mould is at 40 ℃ of following vacuum dryings, and depanning after calcium sulfate fully condenses obtains the medicine carrying calcium sulphate bead string.
Get the 0.1g polylactic acid, be dissolved in the 7.0ml chloroform (10.0g), beading are placed the rotating room, the polylactic acid solution for preparing is in advance evenly sprayed on beading surface, be placed on drying in the vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with PLA.Polymer in the above-mentioned coating material can change poly butyric ester and copolymer thereof into.
Example 2 calcium sulfate/antibiotic/collagen line/chitosan system
Get 6.0g calcium sulfate, add the 0.3g gentamycin sulfate, add the 1.8ml distilled water then, fully stir, when treating the calcium sulfate initial set, mixture is injected the mould that silicone rubber makes, and (with diameter is 0.4mm, length is that the collagen line of 30cm places mould), depanning after calcium sulfate fully condenses at 60 ℃ of following vacuum dryings, obtains the medicine carrying calcium sulphate bead string.Natural biological degradable polymer, synthetic degradable polymer
Get the 0.5g chitosan, be dissolved in the acetum (10.0g) of 10.0ml 1M, beading are placed the rotating room, the chitosan solution for preparing is in advance evenly sprayed on string ball surface, be placed on drying in the vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with chitosan.Polymer in the above-mentioned coating material can change sodium alginate or polyvinyl alcohol into.Example 3 calcium sulfate/gentamycin sulfate/gutstring/chitosan (CS)/sodium alginate (Alg) system
Get 4.0g calcium sulfate, add 0.12g norvancomycin and mix homogeneously, add the 3.2ml distilled water then, and fully stir, when treating the calcium sulfate initial set, (with diameter is 0.3mm to be injected into mould, length is that the 20cm gutstring places mould in advance), depanning after calcium sulfate fully condenses at 50 ℃ of following vacuum dryings, obtains the medicine carrying calcium sulphate bead string.
Get the 0.3g chitosan, be dissolved in the acetum (10.0g) of 10.0ml 1M, beading are placed the rotating room, the chitosan solution for preparing is in advance evenly sprayed on string ball surface, be placed in the vacuum drying oven dry.
Get 0.2 sodium alginate, be dissolved in the 10ml distilled water (10.0g), beading that are coated with chitosan are placed the rotating room, the sodium alginate soln for preparing is in advance evenly sprayed on string ball surface, be placed on drying in the vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with chitosan and sodium alginate.Above-mentioned chitosan can change polyvinyl alcohol into.
Example 4 calcium sulfate/amycin/collagen line/carrageenan-sodium alginate system
Get 4.0g calcium sulfate, the amycin and the mix homogeneously that add 0.08g, add 2.8ml part distilled water then, and fully stir, when treating the calcium sulfate initial set, (with diameter is 0.3mm to be injected into mould, length is that the collagen line of 20cm places mould in advance), depanning after calcium sulfate fully condenses at 40 ℃ of following vacuum dryings, obtains the medicine carrying calcium sulphate bead string.
Get 0.1g carrageenan and 0.1g sodium alginate, be dissolved in the 10ml distilled water (10.0g), beading are placed the rotating room, the polymer latex solution for preparing is in advance evenly sprayed on string ball surface, be placed on drying in the vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with carrageenan.Cancer therapy drug can change camptothecine or paclitaxel into.
Example 5 calcium sulfate/camptothecine/collagen line/poly butyric ester
Get 2.0g calcium sulfate, add 0.05g camptothecine and mix homogeneously, add the 1.2ml distilled water then, fully stir, when treating the calcium sulfate initial set, (with diameter is 0.1mm to be injected into mould, length is that the collagen line of 10cm places mould in advance), depanning after calcium sulfate fully condenses at 60 ℃ of following vacuum dryings, obtains the medicine carrying calcium sulphate bead string.
Get the 0.4g poly butyric ester, be dissolved in the 7.0ml chloroform (10.0g), beading are immersed in the poly butyric ester solution for preparing in advance, taking-up places on the turntable, treat solvent evaporates, be placed on drying in the vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with poly butyric ester.Can repeat aforesaid operations, by the control coating number, thereby control coating thickness reaches the effect of control drug release speed.
Example 6 calcium sulfate/bone morphogenetic protein/gutstring/carboxymethyl cellulose (CMC)-gelatin system
Get the 0.12g bone morphogenetic protein, with 4.0g calcium sulfate mix homogeneously, add the 4ml distilled water, and fully stir, when treating the calcium sulfate initial set, (with diameter is 0.2mm to inject mould, length is that 20cm gutstring line places mould in advance), depanning after calcium sulfate fully condenses at 50 ℃ of following vacuum dryings, obtains the medicine carrying calcium sulphate bead string.
Getting 0.15gCMC and gelatin (weight ratio 1: 1) is dissolved in the 10ml normal saline (10.0g), make solution, beading are immersed in the polymer solution for preparing in advance, taking-up places on the turntable, treat solvent evaporates, dry in vacuum drying oven, make the calcium sulphate bead string release material that the surface is coated with CMC and gelatin.CMC in the above-mentioned coating material can change hydroxypropyl cellulose into.
The beading release material that present embodiment makes can be inserted the osteomyelitis affected area, can reach the effect of repairing bone defect and continual and steady local delivery of drug.This release bead material is compared with the beading of coating not, and pharmaceutical release time prolongs 5～20 days, and rate of release is more stable, near zero-order release.Calcium sulfate material has biological degradability simultaneously, can degrade in vivo, thereby avoid the second operation taking-up.
The present invention is not limited to the technology described in the example; its description is illustrative; and it is nonrestrictive; authority of the present invention is limited by claim; based on present technique field personnel according to the present invention can change, technology related to the present invention that method such as reorganization obtains, all in protection scope of the present invention.
Claims (10)
1. a calcium sulphate bead string implantation type local medicine releasing system that has face coat is comprising medicine carrying pearl body, is getting lines crossed and coating; It is characterized in that the pearl body is made up of calcium sulfate and medicine, as follows by weight ratio:
100 parts in calcium sulfate,
1～5 part of medicine.
2. bead string implantation type local medicine releasing system as claimed in claim 1 is characterized in that described getting lines crossed being the degradable operation suture thread, and the specification of line limits as follows according to mould:
Diameter 0.1～0.4mm,
Length 10～30cm.
3. bead string implantation type local medicine releasing system as claimed in claim 1 is characterized in that described coating material is a biocompatible polymer, and polymer accounts for the percentage by weight 1%～5% of solvent; Polymer is natural biological degradable polymer, synthetic degradable polymer.
4. bead string implantation type local medicine releasing system as claimed in claim 3 is characterized in that described natural biological degradable polymer comprises polysaccharide macro-molecular and protein macromolecule.
5. bead string implantation type local medicine releasing system as claimed in claim 4 is characterized in that described polysaccharide macro-molecular comprises one or more mixing of chitosan, alginate, carrageenan, starch and derivant thereof, cellulose and derivant thereof.
6. bead string implantation type local medicine releasing system as claimed in claim 4 is characterized in that described protein macromolecule comprises one or both mixing of collagen or gelatin.
7. bead string implantation type local medicine releasing system as claimed in claim 3 is characterized in that described synthetic polymer biomaterial comprises one or more mixing of polycaprolactone, poly butyric ester and copolymer thereof.
8. bead string implantation type local medicine releasing system as claimed in claim 1 is characterized in that described medicine is anti-inflammatory drug, anticancer class medicine or bone morphogenetic protein somatomedin material.
9. the preparation method of the calcium sulphate bead string implantation type local medicine releasing system that has face coat of claim 1 is characterized in that:
(1) calcium sulfate is fully mixed with medicine, add distilled water then, the weight proportion of calcium sulfate and water is 8: 2～2: 8, mixed 3～10 minutes, and then mixture was injected the bead type mould, get lines crossed and put into mould in advance, treat to take out after the sample molding, the sample that makes is a beading;
(2) adopt the immersion method coating: beading are immersed in the polymer solution for preparing, taking-up places on the turntable then, makes its solvent evaporates, and is dry in vacuum drying oven, obtains the bead material of face coat.
10. the preparation method that has the calcium sulphate bead string implantation type local medicine releasing system of face coat as claimed in claim 9, it is characterized in that: step (2) adopts spray process, be that beading are placed the rotating room, the polymer solution for preparing is in advance evenly sprayed on beading surface, be placed on drying in the vacuum drying oven, obtain the bead material of face coat.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA200710059721XA CN101134014A (en) | 2007-09-19 | 2007-09-19 | Calcium sulphate bead string implantation type medicine partial releasing system with top coat and method of producing the same |
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| CNA200710059721XA CN101134014A (en) | 2007-09-19 | 2007-09-19 | Calcium sulphate bead string implantation type medicine partial releasing system with top coat and method of producing the same |
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| CN101134014A true CN101134014A (en) | 2008-03-05 |
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| CNA200710059721XA Pending CN101134014A (en) | 2007-09-19 | 2007-09-19 | Calcium sulphate bead string implantation type medicine partial releasing system with top coat and method of producing the same |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2489229A (en) * | 2011-03-21 | 2012-09-26 | Keighleycolo Ltd | Seton for fistula |
| WO2020001596A1 (en) * | 2018-06-29 | 2020-01-02 | 信福(北京)医药科技有限公司 | Method for preparing composite for enhancing immune response |
-
2007
- 2007-09-19 CN CNA200710059721XA patent/CN101134014A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2489229A (en) * | 2011-03-21 | 2012-09-26 | Keighleycolo Ltd | Seton for fistula |
| US9907885B2 (en) | 2011-03-21 | 2018-03-06 | Keighleycolo Ltd | Device |
| WO2020001596A1 (en) * | 2018-06-29 | 2020-01-02 | 信福(北京)医药科技有限公司 | Method for preparing composite for enhancing immune response |
| WO2020001587A1 (en) * | 2018-06-29 | 2020-01-02 | 信福(北京)医药科技有限公司 | Complex for enhancing immune response |
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