CN102727944A - Anti-benign and malignant biliary stricture drug eluting stent and preparation method thereof - Google Patents
Anti-benign and malignant biliary stricture drug eluting stent and preparation method thereof Download PDFInfo
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- CN102727944A CN102727944A CN2012100289277A CN201210028927A CN102727944A CN 102727944 A CN102727944 A CN 102727944A CN 2012100289277 A CN2012100289277 A CN 2012100289277A CN 201210028927 A CN201210028927 A CN 201210028927A CN 102727944 A CN102727944 A CN 102727944A
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Abstract
The invention, belonging to the field of biomedicine and bio-polymer material, particularly relates to an anti-benign and malignant biliary stricture drug eluting stent and a preparation method thereof. The stent is prepared by coating a biodegradable polymer layer containing anti-malignant biliary stricture drug mitomycin or/and paclitaxel on the inner surface and outer surface of a bare bile duct stent. Clinical outcomes show that the anti-benign and malignant biliary stricture drug eluting stent of the invention has good radial supporting performance, can prevent benign and malignant biliary proliferation and stricture from occlusion and keep the bile duct smooth, has good biocompatibility, and generates almost no internal inflammation. Simultaneously, mitomycin or/and paclitaxel slowly released by the polymer layer can resist benign and malignant biliary proliferation and stricture, and prevent aggravation of biliary obstruction caused by bile duct proliferation and then stricture after stent implantation.
Description
Technical field
The invention belongs to biomedical sector and bioabsorbable polymer material field, be specifically related to a kind of coating stent of medicine and method for preparing of anti-bile duct benign and malignant stenosis.
Background technology
Modern medicine study finds, the pancreas gallbladder is that malignant tumor companion pancreatic duct blocks is clinical common disease, has very high sickness rate.The pancreas gallbladder is the concealment of malignant tumor onset, belongs to late period during discovery mostly, is associated with tangible pancreatic duct and blocks, and clinical manifestations such as cholestasis, obstructive pancreatitis occur, and about 60～70% patients have lost the chance of surgical radical treatment when making a definite diagnosis; Other has weak with age or concurrent other organ serious diseases of some patients also can only take non-operation palliative treatment; And the palliative treatment method mainly is to remove pancreatic duct to block, guarantee that drain is common at present, comprising: whole body or intravascular get involved chemotherapy, radiotherapy, surgery through abdomen gallbladder intestinal or Pancreaticoenterostomy or the like, but side effect is too big; Therefore, current clinical under the more employing scope pancreatic duct support insert drainage and treat.
But; Usually the pancreatic duct support that adopts in the clinical treatment has following defective: though above-mentioned support can improve drain; The development of uncontrollable tumor; Often occur once more narrowly because of the continuous hypertrophy of tumor, support is changed or inserted once more to many needs of patients times without number, finally causes the state of an illness to worsen rapidly; In addition, owing to put histio-irritative hypertrophy in frame position or the remarkable hypertrophy of tumor tissues, and closely be entrenched togather, increase the weight of narrowly, cause many supports when the pancreatic duct restenosis occurring, to be difficult to take out, influence patient treatment with support.
Have report to point out, mitomycin is to find in recent decades and Application Research antitumor, anti-scar drug thing more widely that it can effectively be suppressed to fibrocellular mitosis and propagation, stops the deposition of collagen and fibronectin; Therefore, can suppress fibroblast proliferation, the adjustment collagenic supersession reduces granulation tissue hyperplasia unusually, prevents the tissue adhesion, prevents that effectively pathologic scar from forming.The effect of said mitomycin gains public acceptance, and is widely used in the clinical treatment; Wherein, paclitaxel is the secondary metabolite of a kind of complicacy in the Chinese yew genus plants, also is only a kind of microtubule polymerization and stable medicine of polymerization microtubule of promoting of discovering at present; Isotopic tracing shows that paclitaxel only is attached on the polymeric microtubule, not with unpolymerized tubulin dimer reaction; Can in cell, accumulate a large amount of microtubules behind the cells contacting paclitaxel, the various functions of cell have been disturbed in the accumulation of above-mentioned microtubule, particularly make cell division stop at mitotic phase, have blocked the proper splitting of cell, prevent the increment of stenosis of bile duct and cell.
Prior art discloses biodegradable polymer such as polycaprolactone, polylactic acid, has gathered hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, be collagen protein, phosphocholine, gelatin or chitosan and derivant thereof etc.; Has the good tissue compatibility; In the environment of body fluid, degrade through ester linkage hydrolyzing; Intermediate product lactic acid is normal glycometabolic product in the body, and final metabolite is CO
2And H
2O discharges in the Yi Congti and can not assemble at vitals, therefore has excellent biodegradable absorbability.Above-mentioned material is nontoxic, nonirritant, non-immunogenicity and biocompatibility are good, can be used safely in the body, and be ideal material as medicament slow release/controlled release.
Therefore; Clinical practice presses for about treating the narrow carried stent that the pancreas gallbladder is a malignant tumor; This support can carry out chemotherapy to tumor in the part, prevent to put histio-irritative hypertrophy in frame position or the remarkable hypertrophy of tumor tissues, has both improved the systemic side effects that curative effect has also reduced radiotherapy; It has reduced the hypertrophy pathological reaction of local anomaly, avoids taking place behind the restenosis and increases the weight of to block.
Summary of the invention
The objective of the invention is to overcome defective of the prior art and deficiency, a kind of coating stent of medicine of anti-bile duct benign and malignant stenosis is provided; Said support can keep under the unobstructed situation of biliary tract, and anti-bile duct benign and malignant stenosis medicine can be avoided taking place behind the restenosis and increase the weight of obstruction of bile duct.
The coating stent of medicine of anti-bile duct benign and malignant stenosis of the present invention contains anti-bile duct malignant stricture Mitomycin C or/and the biodegradable polymer layer of paclitaxel is processed for scribbling at the inner surface of bile duct bare bracket and outer surface;
Particularly; The coating stent of medicine of anti-bile duct benign and malignant stenosis of the present invention; It is characterized in that the bile duct bare bracket inner surface of this coating stent of medicine and outer surface scribble and contain anti-bile duct malignant stricture Mitomycin C or/and the biodegradable polymer layer of paclitaxel;
Described anti-bile duct benign and malignant stenosis medicine is selected from mitomycin or/and paclitaxel;
The mass ratio of described mitomycin and paclitaxel is 0-10mol: 0-10mol;
Among the present invention, described bile duct bare bracket is selected from common plastics biliary tract prosthesis, titanium alloy braiding biliary tract prosthesis or titanium alloy engraving biliary tract prosthesis;
Among the present invention, described biodegradable polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, collagen protein, phosphocholine, gelatin or chitosan and derivant at least a.
Another object of the present invention provides the coating stent of medicine method for preparing of said anti-bile duct benign and malignant stenosis, it is characterized in that, may further comprise the steps:
(1) place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 15-20 minute the bile duct bare bracket, 65-80 ℃ of drying is 24 hours in vacuum drying oven;
(2) in 0-300mg: the ratio of 1ml; Biodegradable polymer is dissolved in dichloromethane or chloroform or oxolane or acetone or carbon tetrachloride or the dimethyl formamide; Processing solution, is that mitomycin and the paclitaxel of 0-10mol: 0-10mol is dispersed in the said biodegradable polymer solution with mass ratio, through soaking or spray treatment; Be arranged on the rack surface of said step (1) preparation, promptly process the coating stent of medicine of anti-bile duct benign and malignant stenosis;
(3) coating stent of medicine with the anti-bile duct benign and malignant stenosis that makes in the above-mentioned steps (2) places vacuum drying oven, 31-45 ℃ of drying, and with encapsulating behind the oxirane disinfection.
In the method for preparing according to the invention, the bile duct bare bracket is selected from common plastics biliary tract prosthesis, titanium alloy braiding biliary tract prosthesis, titanium alloy engraving biliary tract prosthesis;
In the method for preparing according to the invention, biodegradable polymer is polycaprolactone, polylactic acid, gather hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, collagen protein, phosphocholine, gelatin or chitosan and derivant at least a.
In the method for preparing according to the invention, anti-bile duct benign and malignant stenosis medicine is that mitomycin and paclitaxel are at least a.
The coating stent of medicine of anti-bile duct benign and malignant stenosis of the present invention compared with prior art has the following advantages:
(1) coating stent of medicine of this anti-bile duct benign and malignant stenosis is a raw material with the bile duct bare bracket, and the radial support better performances can prevent the narrow closure of bile duct proliferation, keeps biliary tract unobstructed;
(2) this bracket coating pharmaceutical carrier is a biodegradable polymer, and biocompatibility is better, and effect seldom has inflammation in the body;
(3) contain mitomycin that the polymer coating of medicine slowly discharges or/and paclitaxel can the good malignant proliferation of anti-bile duct and narrow, avoid taking place behind the restenosis and increase the weight of obstruction of bile duct.
The coating stent of medicine of anti-bile duct benign and malignant stenosis of the present invention can carry out chemotherapy to tumor in the part, prevent to put histio-irritative hypertrophy in frame position or the remarkable hypertrophy of tumor tissues, has both improved the systemic side effects that curative effect has also reduced radiotherapy; It has reduced the hypertrophy pathological reaction of local anomaly, avoids taking place behind the restenosis and increases the weight of to block.
For the ease of understanding, through specific embodiment the coating stent of medicine of anti-bile duct benign and malignant stenosis of the present invention is carried out detailed description below.What need particularly point out is, specific embodiment only is in order to explain that obviously those skilled in the art can explain according to this paper, and the present invention is carried out various corrections or change, and these corrections and changing also will be included within the scope.
The specific embodiment
Embodiment 1
The coating stent of medicine for preparing anti-bile duct benign and malignant stenosis through following steps:
(1) titanium alloy is engraved support and place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 15 minutes, 75 ℃ of dryings are 24 hours in vacuum drying oven;
(2) in 20mg: the ratio of 1ml; Polycaprolactone is dissolved in the acetone; Processing solution, is that mitomycin and the paclitaxel of 1mol: 1mol is dispersed in the said polycaprolactone solution, through spray treatment with mass ratio; Be arranged on the rack surface of said step (1) preparation, promptly process the coating stent of medicine of anti-bile duct benign and malignant stenosis;
(3) medication coat of biliary tract prosthesis preparation finishes and is placed in the vacuum drying oven, 35 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
Embodiment 2
The coating stent of medicine for preparing anti-bile duct benign and malignant stenosis,
(1) place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 18 minutes the titanium alloy braided support, 63 ℃ of dryings are 24 hours in vacuum drying oven;
(2) in 30mg: the ratio of 1ml; Polylactic acid is dissolved in the dichloromethane; Processing solution, is that mitomycin and the paclitaxel of 1mol: 2mol is dispersed in the said polylactic acid solution, through immersion treatment with mass ratio; Be arranged on the rack surface of said step (1) preparation, promptly process the coating stent of medicine of anti-bile duct benign and malignant stenosis;
(3) coating stent of medicine with the anti-bile duct benign and malignant stenosis that makes in the above-mentioned steps (2) places vacuum drying oven, 42 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
Embodiment 3
The coating stent of medicine for preparing anti-bile duct benign and malignant stenosis:
Titanium alloy is engraved support place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 18 minutes, 70 ℃ of dryings are 24 hours in vacuum drying oven; Ratio in 40mg: 1ml; To gather hexanol acid is dissolved in the chloroform; Processing solution, is that mitomycin and the paclitaxel of 2mol: 1mol is dispersed in said gathering in the hexanol acid solution, through spray treatment with mass ratio; Be arranged on described rack surface, promptly process the coating stent of medicine of anti-bile duct benign and malignant stenosis; The coating stent of medicine of above-mentioned anti-bile duct benign and malignant stenosis is placed vacuum drying oven, 40 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
Embodiment 4
At first, place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 20 minutes on the common plastics support, 80 ℃ of dryings are 24 hours in vacuum drying oven; Then; In the ratio of 50mg: 1ml, chitosan is dissolved in the carbon tetrachloride, process solution; With mass ratio is that mitomycin and the paclitaxel of 2mol: 3mol is dispersed in the said chitosan solution; Through immersion treatment, place described common plastics rack surface, process the coating stent of medicine of anti-bile duct benign and malignant stenosis; At last, the coating stent of medicine of above-mentioned anti-bile duct benign and malignant stenosis is placed vacuum drying oven, 45 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
Embodiment 5
Titanium alloy is engraved support place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 18 minutes, 70 ℃ of dryings are 24 hours in vacuum drying oven; In the ratio of 40mg: 1ml, will gather hexanol acid and be dissolved in the chloroform, process solution; With quality is that the mitomycin of 10mol is dispersed in said gathering in the hexanol acid solution; Through spray treatment, be arranged on described rack surface, promptly process the coating stent of medicine of anti-bile duct benign and malignant stenosis; The coating stent of medicine of above-mentioned anti-bile duct benign and malignant stenosis is placed vacuum drying oven, 40 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
Embodiment 6
At first, place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 20 minutes on the common plastics support, 80 ℃ of dryings are 24 hours in vacuum drying oven; Then; In the ratio of 50mg: 1ml, chitosan is dissolved in the carbon tetrachloride, process solution; With quality is that the paclitaxel of 10mol is dispersed in the said chitosan solution; Through immersion treatment, place described common plastics rack surface, process the coating stent of medicine of anti-bile duct benign and malignant stenosis; At last, the coating stent of medicine of above-mentioned anti-bile duct benign and malignant stenosis is placed vacuum drying oven, 45 ℃ of dryings, and with encapsulating behind the oxirane disinfection.
The coating stent of medicine of the anti-bile duct benign and malignant stenosis that the foregoing description is made is tried out; The result shows; The coating stent of medicine radial support better performances of anti-bile duct benign and malignant stenosis of the present invention can prevent the narrow closure of the good neoplasm of bile duct, keeps biliary tract unobstructed; And its biocompatibility is better, and effect does not almost have inflammation in the body; Simultaneously, contain mitomycin that the polymer coating of anti-bile duct benign and malignant stenosis medicine slowly discharges, avoid support to implant the back restenosis postemphasis obstruction of bile duct behind the bile duct proliferation takes place or/and paclitaxel is can the good neoplasm of anti-bile duct narrow.
Claims (10)
1. the coating stent of medicine of good, the malignant stricture of an anti-bile duct comprises the bile duct bare bracket, it is characterized in that, the bile duct bare bracket inner surface of this coating stent of medicine and outer surface scribble contain anti-bile duct very, the biodegradable polymer layer of malignant stricture medicine;
Described medicine is selected from mitomycin or/and paclitaxel, and its mass ratio is 0-10mol: 0-10mol.
2. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that the mass ratio of described mitomycin and paclitaxel is 1mol: 1mol.
3. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that the mass ratio of described mitomycin and paclitaxel is 1mol: 2mol.
4. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that the mass ratio of described mitomycin and paclitaxel is 2mol: 1mol.
5. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that the mass ratio of described mitomycin and paclitaxel is 2mol: 3mol.
6. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that described dissolved stone medicine is the mitomycin of 10mol.
7. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that described dissolved stone medicine is the paclitaxel of 10mol.
8. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture, it is characterized in that, described bile duct bare bracket is selected from plastics biliary tract prosthesis, titanium alloy braiding biliary tract prosthesis or titanium alloy engraving biliary tract prosthesis.
9. anti-bile duct according to claim 1 is good, the coating stent of medicine of malignant stricture; It is characterized in that described biodegradable polymer is selected from polycaprolactone, polylactic acid, gathers hexanol acid, polylactic acid-polyglycolic acid copolymer, polycaprolactone-copolymer of poly lactic acid, gather dioxane, collagen protein, phosphocholine, gelatin or chitosan and derivant thereof.
10. the method for preparing of the coating stent of medicine of good, the malignant stricture of the anti-bile duct of claim 1 is characterized in that it comprises step:
(1) place the ultrasonic concussion of acetone, ethanol and distilled water to clean respectively 15-20 minute the bile duct bare bracket, 65-80 ℃ of drying is 24 hours in vacuum drying oven;
(2) in 0～300mg: the ratio of 1ml; Biodegradable polymer is dissolved in dichloromethane or chloroform or oxolane or acetone or carbon tetrachloride or the dimethyl formamide; Process solution, with mass ratio be 0～10mol: 0～10mol mitomycin or/and paclitaxel be dispersed in the said biodegradable polymer solution, through soaking or spray treatment; Be arranged on the rack surface of said step (1) preparation, make coating stent of medicine;
(3) coating stent of medicine that step (2) is made places vacuum drying oven, and 31-45 ℃ of drying, and with encapsulating behind the oxirane disinfection makes that anti-bile duct is good, the coating stent of medicine of malignant stricture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100289277A CN102727944A (en) | 2011-11-14 | 2012-02-09 | Anti-benign and malignant biliary stricture drug eluting stent and preparation method thereof |
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| CN201110360164 | 2011-11-14 | ||
| CN201110360164.1 | 2011-11-14 | ||
| CN2012100289277A CN102727944A (en) | 2011-11-14 | 2012-02-09 | Anti-benign and malignant biliary stricture drug eluting stent and preparation method thereof |
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| CN102727944A true CN102727944A (en) | 2012-10-17 |
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Cited By (5)
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| WO2014169137A1 (en) * | 2013-04-10 | 2014-10-16 | Massachusetts Institute Of Technology | Local drug delivery devices and methods for treating cancer |
| WO2018094845A1 (en) * | 2016-11-24 | 2018-05-31 | 广东美的制冷设备有限公司 | Panel component and air conditioner |
| CN108888808A (en) * | 2018-08-23 | 2018-11-27 | 上海市第人民医院 | A kind of photosensitizer bracket can be used for photodynamic therapy treatment cholangiocarcinoma |
| CN114272446A (en) * | 2021-12-29 | 2022-04-05 | 湖南华耀百奥医疗科技有限公司 | Degradable drug-loaded bile pancreatic duct stent and preparation method thereof |
| CN115444990A (en) * | 2022-08-18 | 2022-12-09 | 复旦大学附属中山医院 | Degradable magnesium metal stent loaded with medicine through nano-porous and preparation method thereof |
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| CN108888808A (en) * | 2018-08-23 | 2018-11-27 | 上海市第人民医院 | A kind of photosensitizer bracket can be used for photodynamic therapy treatment cholangiocarcinoma |
| CN114272446A (en) * | 2021-12-29 | 2022-04-05 | 湖南华耀百奥医疗科技有限公司 | Degradable drug-loaded bile pancreatic duct stent and preparation method thereof |
| CN115444990A (en) * | 2022-08-18 | 2022-12-09 | 复旦大学附属中山医院 | Degradable magnesium metal stent loaded with medicine through nano-porous and preparation method thereof |
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Application publication date: 20121017 |