CN101332311B - Drug-loaded mesh grid with slow-release function, production method and use thereof - Google Patents

Drug-loaded mesh grid with slow-release function, production method and use thereof Download PDF

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CN101332311B
CN101332311B CN 200710123507 CN200710123507A CN101332311B CN 101332311 B CN101332311 B CN 101332311B CN 200710123507 CN200710123507 CN 200710123507 CN 200710123507 A CN200710123507 A CN 200710123507A CN 101332311 B CN101332311 B CN 101332311B
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drug
mesh
matrix
woven
braid
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CN 200710123507
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Chinese (zh)
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CN101332311A (en )
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乔红英
任福来
孙杰
孟凯
荆江
郭伟
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北京天助畅运医疗技术股份有限公司
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Abstract

The invention provides a drug-loading weave net which has the drug release function, the manufacturing method and the usage thereof. The drug-loading woven net comprises a weave net, a matrix and the drugs loaded, and can be used as a soft tissue repair material, a cardiac pacemaker or the antibacterial bag of a defibrillator, and so on.

Description

具有药物缓释功能的载药编织网、其制造方法及其用途 Drug Delivery The drug woven mesh, a manufacturing method and use thereof

技术领域 FIELD

[0001] 本发明涉及一种具有药物缓释功能的载药编织网、其制造方法及其用途。 [0001] The present invention relates to a drug having a braid Drug Delivery, their manufacture and their use. 背景技术 Background technique

[0002] 编织网,特别是聚丙烯编织网,是目前广泛应用的一种医用材料,尤其是作为修补材料,其与生物体组织的相容性好,无排斥反应,术后并发症少,复发率低,临床效果优异。 [0002] braid, especially polypropylene woven mesh, is a medical materials are currently widely used, especially as repair material, with the living tissue compatibility, no rejection, fewer complications, recurrence rate, an excellent clinical effect. 但是,近年来,医生和患者逐渐发现,聚丙烯编织网在应用中也存在一些问题。 However, in recent years, doctors and patients are finding that polypropylene woven mesh, there are some problems in the application. 例如,植入聚丙烯编织网后发生术后感染,或伴随疼痛等。 For example, postoperative infection after implantation of polypropylene woven mesh, or accompanied by pain.

发明内容 SUMMARY

[0003] 本发明是鉴于上述现有技术的问题而完成的,其目的是提供: [0003] The present invention was made in view of the problems of the prior art and has as its object to provide:

[0004] (1) 一种具有药物缓释功能的载药编织网,其包括编织网、基质和所载的药物。 [0004] (1) having a drug Drug Delivery woven mesh, braided mesh comprising a drug, contained in the matrix and.

[0005] (2)上述(1)所述的载药编织网,其中所述编织网是聚丙烯编织网。 [0005] (2) above (1), wherein the drug carrier braid, wherein the braid is a woven polypropylene mesh.

[0006] (3)上述(1)或(¾所述的载药编织网,其中所述编织网是经过表面处理和/或改性的编织网。 [0006] (3) (1) or (¾ of the above drug braid, wherein the braid is subjected to surface treatment and / or modification of a woven mesh.

[0007] (4)上述C3)所述的载药编织网,其中所述表面处理或改性是通过化学方法和/或等离子体方法进行的。 [0007] (4) The C3) of the drug woven mesh, or wherein the surface modification treatment is performed by chemical and / or plasma methods.

[0008] (5)上述⑴〜(4)中任意一项所述的载药编织网,其中所载的药物为镇痛消炎类药物、麻醉类药物或抗生素类药物。 [0008] (5) ⑴~ (4) according to any one of woven mesh drug, wherein the drug is contained in the anti-inflammatory analgesic drugs, narcotic drugs or antibiotics.

[0009] (6)上述(1)〜(5)中任意一项所述的载药编织网,其中所述药物为利福平、布洛芬或布比卡因。 [0009] (6) (1) to (5) according to any one braid drug, wherein the drug is rifampicin, ibuprofen or bupivacaine.

[0010] (7)上述(1)〜(6)中任意一项所述的载药编织网,其中所述基质为生物降解型聚合物或非生物降解型聚合物。 [0010] (7) (1) to (6) according to any one of the above-described drug braided mesh, wherein the polymeric matrix is ​​biodegradable or non-biodegradable polymers.

[0011] (8)上述(1)〜(7)中任意一项所述的载药编织网,其中所述基质为聚乳酸、壳聚糖或者它们的混合物。 In [0011] (8) above (1) to (7) according to any one of the drug braid, wherein the matrix is ​​a polylactic acid, chitosan or mixtures thereof.

[0012] (9)上述(1)〜(8)中任意一项所述的载药编织网的制造方法,该方法包括:将基质和药物分别溶解于溶剂中,将所得溶液混合后经滤膜挤出除菌,或者直接将基质和药物一起溶解于溶剂中,然后将所得溶液经滤膜挤出除菌,将聚丙烯编织网浸入上述除菌后的溶液中,取出,待基质成膜后干燥去除残留溶剂。 [0012] (9) (1) A method for producing drug-loaded woven mesh to (8) according to any preceding claim, the method comprising: the matrix and the drug are dissolved in a solvent, the resultant mixed solution was filtered sterilized film extrusion, or directly dissolved in a solvent together with the matrix and the drug, extruding the resulting solution was then sterilized through a filter membrane, a polypropylene woven mesh was immersed in the solution after the sterilization, taken to be the film-forming matrix after drying to remove residual solvent.

[0013] (10)上述(9)所述的载药编织网的制造方法,其进一步包括在使基质和药物结合到编织网之前对编织网进行表面处理和/或改性。 [0013] (10) (9) The method for producing the drug woven mesh, braided mesh which further comprises surface treated and / or modified prior to binding to the matrix and the drug braid.

[0014] (11)上述(10)所述的载药编织网的制造方法,其中所述表面处理或改性是通过化学方法和/或等离子体方法进行的。 A method for producing [0014] (11) (10) of the drug woven mesh, or wherein the surface modification treatment is performed by chemical and / or plasma methods.

[0015] (11)上述(9)〜(11)中任意一项所述的载药编织网的制造方法,其中所述溶剂是选自丙酮、乙酸乙酯、乙酸丁酯、甲乙酮、甲酸乙酯、乙酸异丁酯、乙酸甲酯、乙酸丙酯、氯仿、 二氯甲烷、N-甲基吡咯烷酮、1,4_ 二氧六环和二甲基亚砜中的一种或多种物质。 [0015] (11) (9) The production method of the woven mesh drug to (11) according to any preceding claim, wherein the solvent is selected from acetone, ethyl acetate, butyl acetate, methyl ethyl ketone, ethyl formate acetate, isobutyl acetate, methyl acetate, propyl acetate, chloroform, methylene chloride, N- methylpyrrolidone, dimethylsulfoxide and dioxane 1,4_ of one or more substances.

3[0016] (12)上述⑴〜⑶中任意一项所述的载药编织网用于制造软组织修补材料的用途。 3 [0016] (12) The ⑴~⑶ in any one of the drug for the manufacture of a woven mesh of soft tissue repair material.

[0017] (13)上述(12)所述的用途,其中所述软组织修补材料是疝修补材料或盆底修补材料。 The use according to (12) above [0017] (13), wherein said material is a soft tissue repair material hernia repair or pelvic floor repair materials.

[0018] (14)上述⑴〜⑶中任意一项所述的载药编织网用于制造心脏起博器或除颤器抑菌袋的用途。 [0018] (14) according to any one of ⑴~⑶ drug for the manufacture of a woven mesh pacemaker or defibrillator bacteriostatic bag.

[0019] 本申请中所用的术语“编织网”是指包含大量小孔的网状编织物,其中编织包括单丝针织、复丝针织、单丝机织、复丝机织等。 [0019] As used herein, the term "braid" refers to a web of knitted fabric comprising a large number of pores, which comprises a woven knitted monofilament, knitted multifilament, woven monofilament, multifilament woven like. 丝直径可以为0. 1〜0. 2mm,厚度可以为0. 4〜 0. 8mm,优选为0. 5〜0. 7mm。 Wire diameter may be 0. 1~0. 2mm, the thickness may be 0. 4~ 0. 8mm, preferably 0. 5~0. 7mm. 例如,可以使用美国专利号5,356,432中公开的几种网状编织物,例如聚丙烯单丝网状编织物,例如可从CR Bard Inc.购得的Marlex® ;此外,也可以使用Prolene®、Dacron®、Teflon®、Merselene®、善释®等, For example, U.S. Patent No. 5,356,432 discloses several knit mesh, for example polypropylene filament mesh braid, e.g. available from CR Bard Inc. Marlex®; in addition, may also be used Prolene®, Dacron®, Teflon®, Merselene®, good release ®, etc.,

[0020] 构成本发明中的编织网的材料包括但不限于聚酯、聚四氟乙烯、聚乙烯、聚丙烯等高分子材料,其中优选目前应用最广泛的聚丙烯。 [0020] The material in the present invention include, but are not limited braided mesh polyester, polytetrafluoroethylene, polyethylene, polypropylene and other polymer materials, the most widely preferred polypropylene.

[0021] 在本发明的载药编织网中,基质可以将药物结合到编织网上,药物随着基质的降解而逐步持续释放或通过扩散作用持续释放。 [0021] In the drug of the present invention, woven mesh, the matrix may be woven web bonded to the drug, degradation of the matrix with the drug gradually sustained release or sustained release by diffusion. 基质包括生物降解型基质和非生物降解型基质,非生物降解型基质(例如醋酸乙烯)是良好的药物载体,药物可以以弥散的方式逐步释出,但最终回会留下载体异物。 Matrix comprises a biodegradable and non-biodegradable matrix type matrix, a non-biodegradable matrix (e.g. vinyl acetate) is a good drug carrier, the drug may be released gradually diffuse manner, but eventually return to leave foreign material carrier. 生物降解型基质有许多优点:体内基质从周边到中心以稳定的速度降解,所以药物释放稳定;可以防止药物被水解破坏,保持原有活性;药物释放持续时间长;最终体内不会留下异物。 Biodegradable matrix has many advantages: a matrix in vivo degradation at a steady rate from the periphery to the center, so that stable drug release; the drug can be prevented from being damaged hydrolyzed, maintaining the original activity; long duration of drug release; final body without leaving foreign material . 因此本发明的基质优选生物降解型基质。 Thus the matrix preferably biologically degradable matrices of the present invention.

[0022] 可利用涂层技术将基质结合到编织网材料上。 [0022] The coating techniques may be utilized to bind the matrix to the woven mesh material.

[0023] 本发明的基质包括但不限于下列物质:乙烯-醋酸乙烯共聚物(EVA)、硅橡胶、 聚氨酯(PU)等非生物降解型高分子;聚乳酸、壳聚糖、聚酸酐、聚氨基酸、聚磷腈、胶原、 透明质酸、海藻酸钠等生物降解型高分子;以及其它新型的高分子材料,例如聚酰胺-胺(PAMAM)、Polyol等新型树状(dendrimer)、超支化(hyperbranched)高分子。 [0023] The matrix of the present invention include, but are not limited to the following materials: ethylene - vinyl acetate copolymer (EVA), silicone rubber, polyurethane (PU) and other non-biodegradable polymer; polylactic acid, chitosan, polyanhydrides, poly amino acid, polyphosphazenes, collagen, hyaluronic acid, sodium alginate and other biodegradable polymer; and other new polymer material, such as polyamide - amine (PAMAM), Polyol other new tree (a dendrimer), hyperbranched (hyperbranched) polymers. 这些物质可以单独使用,或者也可以根据需要将2种以上组合使用。 These may be used alone or may be used as required in combination of two or more.

[0024] 作为本发明基质所列举的上述物质中,聚乳酸(PLA)是目前广泛应用的高分子材料,具有很好的生物相容性,已经被FDA批准。 [0024] Examples of the matrix material in the present invention include, polylactic acid (PLA) polymer material is now widely used, has good biocompatibility, has been approved by the FDA. 壳聚糖(chitosan)可抑制细菌、霉菌生长, 限制成纤维细胞的活性。 Chitosan (Chitosan) inhibit bacteria, mold growth, to limit the activity of fibroblasts. 由于极性基团的存在,壳聚糖对水有很高的亲和力和持水性,能溶解于弱酸中,是很方便的成膜材料。 Due to the presence of polar groups, chitosan has a high affinity for water and water holding capacity, can be dissolved in weak acid, the film-forming material is very convenient. 壳聚糖具有良好的生物相容性和生物降解性,降解产物一般对人体无毒副作用,在体内不积蓄,无免疫原性。 Chitosan has biocompatible and biodegradable, the degradation products are generally toxic side effects on the human body, is not accumulated in the body, is non-immunogenic.

[0025] 用于本发明载药编织网的药物成分可以是一种药物,也可以是两种或多种药物的混合物。 [0025] The pharmaceutical compositions used in the present invention may be woven mesh drug is a drug, may be a mixture of two or more drugs. 该药物包括但不限于:镇痛消炎类药物、麻醉类药物和抗生素类药物。 The drugs include, but are not limited to: anti-inflammatory analgesic drugs, narcotic drugs and antibiotics. 其中镇痛类药物可列举例如布洛芬(ibuprofen),麻醉类药物可列举例如布比卡因(bupivacaine),抗生素类药物可列举例如利福平(rifampicin)。 Which include analgesic drugs such as ibuprofen (ibuprofen), narcotic drugs include, for example, bupivacaine (bupivacaine), for example, include antibiotics rifampicin (rifampicin).

[0026] 本发明具有缓释功能的载药编织网可以通过外科手术或内镜等方式植入到需要的位置,从而在该位置以一定的释放时间(例如从小时到几天)和释放量释放其所载的药物。 [0026] The present invention is a woven mesh having a drug release function may be implanted by surgery or endoscopy manner to the desired position, whereby the position of the release time constant (e.g., hours to days) and the release the release of the drug contained in it.

[0027] 本发明具有缓释功能的载药编织网所载的药物量因药物的种类而异,本领域技术人员可以根据该载药编织网的用途和所载药物的已知常规用量等合理确定。 [0027] The amount of drug contained in the sustained release drug having a woven mesh of the present invention function varies depending on the type of drug, one skilled in the art can use and medicament contained in the braided mesh known drug and the like in conventional amounts in accordance with reasonable determine. 例如,利福平、布洛芬和布比卡因的载药量一般优选为1〜20mg/平方厘米编织网。 For example, rifampicin, ibuprofen and bupivacaine drug loading is generally preferred 1~20mg / cm braid.

[0028] 另外,对本发明载药编织网中的基质用量没有特别限定,优选为0. 1〜2g/平方厘米编织网。 [0028] Further, the present invention is not particularly limited drug braided mesh matrix in an amount, preferably 0. 1~2g / cm braid.

[0029] 本发明的载药编织网可以按照以下方法制造:将基质和药物分别溶解于溶剂中, 将所得溶液混合后经滤膜挤出除菌,或者直接将基质和药物一起溶解于溶剂中,然后将所得溶液经滤膜挤出除菌,将编织网浸入上述除菌后的溶液中,取出,成膜后取出干燥去除残留溶剂,包装。 [0029] The drug of the present invention may be a woven mesh manufactured according to the following method: the matrix and the drug are dissolved in a solvent, mixing the resultant solution was sterilized by membrane extrusion, or directly dissolved in a solvent together with the matrix and the drug , and the resulting solution was filter sterilized extruded, braided mesh was immersed in the solution after the sterilization, the removed after the film was dried to remove residual solvent was removed, packaging.

[0030] 在本发明的优选方案中,为了使基质与编织网更加牢固地结合,在上述制造方法中,进一步包括在使基质和药物结合到编织网之前预先通过化学和/或等离子体方法等对编织网进行表面处理和/或改性。 [0030] In a preferred embodiment of the present invention, in order to make the substrate more firmly bound braided mesh, in the above manufacturing method, further comprising, prior to the matrix and the drug previously bound to the braided mesh by chemical and / or plasma methods braided mesh of surface treatment and / or modified.

[0031] 在本发明的另一优选方案中,上述编织网浸入溶液中的时间为1〜15分钟左右。 [0031] In a further preferred embodiment of the present invention, the aforementioned braided mesh dipping time in the solution is about 1~15 minutes.

[0032] 对用于制造本发明具有缓释功能的载药编织网的溶剂没有特别限制,可以列举丙酮、乙酸乙酯、乙酸丁酯、甲乙酮、甲酸乙酯、乙酸异丁酯、乙酸甲酯、乙酸丙酯、氯仿、二氯甲烷、N-甲基吡咯烷酮、1,4_ 二氧六环和二甲基亚砜等。 [0032] The solvent having a woven mesh drug release function for producing the present invention is not particularly limited, and include acetone, ethyl acetate, butyl acetate, methyl ethyl ketone, ethyl acetate, isobutyl acetate, methyl acetate , propyl acetate, chloroform, methylene chloride, N- methylpyrrolidone, dimethylsulfoxide and dioxane 1,4_ like. 这些溶剂可以单独使用,或者根据需要将两种以上组合使用。 These solvents may be used alone or in combination of two or more as needed.

[0033] 本发明具有缓释功能的载药编织网可以在患部持续释放镇痛消炎类药物、麻醉类药物、抗生素类药物等,从而可以减轻术后疼痛,或降低感染风险。 [0033] The present invention is a woven mesh having a drug release sustained release function may be anti-inflammatory analgesic drugs, anesthetic drugs, antibiotics, etc. in the affected area, which can reduce postoperative pain, or reduce the risk of infection.

附图说明 BRIEF DESCRIPTION

[0034] 图1是本发明实施例1的载药聚丙烯编织网的利福平时间-累计释放率曲线。 [0034] FIG. 1 is a time rifampicin medicated polypropylene woven mesh of the embodiment of the present invention Example 1 - cumulative release rate profile.

[0035] 图2是本发明实施例3的载药聚丙烯编织网的布洛芬时间-累计释放率曲线。 [0035] The embodiment of FIG. 2 time is ibuprofen drug polypropylene woven mesh of the embodiment of the present invention is 3 - cumulative release rate profile.

[0036] 图3是本发明实施例5的载药聚丙烯编织网的布比卡因时间-累计释放率曲线。 [0036] FIG. 3 is a time bupivacaine medicated polypropylene woven mesh of the present invention Example 5 - Cumulative release rate profile.

具体实施方式 detailed description

[0037] 下面通过实施例详细说明本发明,但本发明的范围不限于这些实施例。 [0037] The present invention will be described in detail by way of examples, but the scope of the present invention is not limited to these embodiments. 在不偏离本发明的精神和范围的情况下,本领域普通技术人员可以在形式和细节上对本发明作出各种改变和改进,这些改进和改变均被认为落入了本发明的范围。 Without departing from the spirit and scope of the present invention, those of ordinary skill in the art that various changes and modifications may be made to the present invention in form and detail, such modifications and variations are considered to be within the scope of the invention.

[0038] 实施例1 [0038] Example 1

[0039] 将Ig聚乳酸(Mw = 100,000)、10mg利福平溶于50ml乙酸乙酯中,将所得溶液经0. 2 μ m滤膜挤出除菌,将洗涤干燥后的1 X Icm聚丙烯编织网浸入上述溶液中大约5分钟后取出,待乙酸乙酯挥发成膜后置入真空干燥箱(4(TC,76mmHg,48h)去除残留乙酸乙酯,干燥保存备用。 [0039] The Ig polylactic acid (Mw = 100,000), 10mg rifampicin was dissolved in 50ml of ethyl acetate, the resulting solution was 0. 2 μ m filter sterilized extrusion, 1 X after the washing and drying Icm polypropylene woven mesh immersed in the above solution for about 5 minutes after removing the volatiles until forming into a vacuum oven with ethyl acetate (4 (TC, 76mmHg, 48h) to remove residual ethyl acetate, and dried for use.

[0040] 实施例2 [0040] Example 2

[0041] 将Ig聚乳酸(Mw = 100,000)、10mg利福平溶于50ml乙酸乙酯中,将所得溶液经0. 2 μ m滤膜挤出除菌,将洗涤干燥后的1 X Icm聚丙烯编织网置入低温等离子体装置中, 在氢气流速lL/min、氮气流速0. 5L/min、放电功率100W的条件下处理anin。 [0041] The Ig polylactic acid (Mw = 100,000), 10mg rifampicin was dissolved in 50ml of ethyl acetate, the resulting solution was 0. 2 μ m filter sterilized extrusion, 1 X after the washing and drying Icm polypropylene braid apparatus into low-temperature plasma treatment under a hydrogen flow rate of anin lL / min, nitrogen flow rate of 0. 5L / min, discharge power condition of 100W. 将处理过的聚丙烯编织网浸入上述溶液中大约5分钟后取出,待乙酸乙酯挥发成膜后置入真空干燥箱(400C,76mmHg, 48h)去除残留乙酸乙酯,干燥保存备用。 The treated woven polypropylene mesh was immersed in the solution for approximately 5 minutes after removing the volatiles until the deposition of ethyl acetate into a vacuum oven (400C, 76mmHg, 48h) to remove residual ethyl acetate, and dried for use.

[0042] 实施例3 [0042] Example 3

5[0043]将 Ig 聚乳酸(Mw = 200,000)、0. 2g 壳聚糖(脱乙酰度80%,Mw= 150,000)、IOmg 布洛芬溶于50ml丙酮中,将所得溶液经0. 2 μ m滤膜挤出除菌,将洗涤干燥后的1 X Icm聚丙烯编织网浸入上述溶液中大约5分钟后取出,待丙酮挥发成膜后置入真空干燥箱(40°C, 76mmHg,48h)去除残留丙酮,干燥保存备用。 5 [0043] The Ig polylactic acid (Mw = 200,000), 0. 2g of chitosan (degree of deacetylation 80%, Mw = 150,000), IOmg ibuprofen was dissolved in 50ml of acetone, and the resulting solution was membrane extrusion 0. 2 μ m sterilizing, drying the washed 1 X Icm woven polypropylene mesh was immersed in the solution for approximately 5 minutes after removing the volatiles until the acetone into deposition vacuum oven (40 ° C, 76mmHg, 48h) to remove the residual acetone, and dried for use.

[0044] 实施例4 [0044] Example 4

[0045] 将Ig聚乳酸(Mw = 50,000)、IOmg布洛芬溶于50ml氯仿中,将所得溶液经0. 2 μ m 滤膜挤出除菌,将洗涤干燥后的IX Icrn聚丙烯编织网置入低温等离子体装置中,在氢气流速lL/min、氮气流速0. 5L/min、放电功率100W的条件下处理2min。 [0045] The Ig polylactic acid (Mw = 50,000), IOmg ibuprofen was dissolved in 50ml of chloroform, the resultant solution was 0. 2 μ m filter sterilized extrusion, IX after washing and drying the polypropylene Icrn braid into low-temperature plasma apparatus, treated under hydrogen flow rate of 2min lL / min, min, discharging power condition of 100W nitrogen flow rate 0. 5L /. 将处理过的聚丙烯编织网浸入上述溶液中大约5分钟后取出,待氯仿挥发成膜后置入真空干燥箱(4(TC,76mmHg, 48h)去除残留氯仿,干燥保存备用。 The treated woven polypropylene mesh was immersed in the solution for approximately 5 minutes after removing the volatiles until the deposition of chloroform into a vacuum oven (4 (TC, 76mmHg, 48h) to remove residual chloroform, and dried for use.

[0046] 实施例5 [0046] Example 5

[0047] 将Ig壳聚糖(脱乙酰度50%,Mw = 100,000)、10mg布比卡因溶于50ml 2%的醋酸溶液中,将所得溶液经0. 2 μ m滤膜挤出除菌,将洗涤干燥后的1 X Icm聚丙烯编织网浸入上述溶液中大约5分钟后取出,成膜后置入真空干燥箱(50°C,76mmHg,48h)干燥后保存备用。 [0047] The Ig chitosan (degree of deacetylation 50%, Mw = 100,000), 10mg of bupivacaine dissolved in 50ml 2% acetic acid solution, the resultant solution was 0. 2 μ m membrane extrusion sterilization, the polypropylene woven mesh 1 X Icm after washing and drying was immersed in the solution for about 5 minutes, taken out, placed in a vacuum drying oven after film formation (50 ° C, 76mmHg, 48h) stored for use after drying.

[0048] 实施例6 [0048] Example 6

[0049] 将Ig多聚赖氨酸(Mw = 200,000)、5mg布比卡因溶于50ml去离子水中,将所得溶液经0. 2 μ m滤膜挤出除菌,将洗涤干燥后的1 X Icm的聚丙烯编织网置入低温等离子体装置中,在氢气流速lL/min、氮气流速0.5L/min、放电功率100W的条件下处理aiiin。 After [0049] The Ig polylysine (Mw = 200,000), 5mg bupivacaine dissolved in 50ml of deionized water and the resultant solution was 0. 2 μ m sterilizing filter out, washed and dried 1 X Icm is a polypropylene woven mesh device into low-temperature plasma treatment under a hydrogen flow rate of aiiin lL / min, nitrogen flow rate of 0.5L / min, discharge power condition of 100W. 将处理过的聚丙烯编织网浸入上述溶液中大约5分钟后取出,成膜后置入真空干燥箱(50°C, 76mmHg, 48h),干燥保存备用。 The treated woven polypropylene mesh was immersed in the solution for about 5 minutes, remove, after the film placed in a vacuum drying oven (50 ° C, 76mmHg, 48h), and dried for use.

[0050] 实施例7 [0050] Example 7

[0051] 用聚乙烯编织网代替聚丙烯编织网,其余按照与实施例1同样的方法得到载药聚乙烯编织网。 [0051] instead of the polypropylene with polyethylene braid woven mesh, to obtain drug remaining polyethylene woven mesh in the same manner as in Example 1.

[0052] 实施例8 [0052] Example 8

[0053] 用聚乙烯编织网代替聚丙烯编织网,其余按照与实施例2同样的方法得到载药聚乙烯编织网。 [0053] instead of the polypropylene with polyethylene braid woven mesh, and the rest according to the same manner as in Example 2 to obtain drug polyethylene braid.

[0054] 实施例9 [0054] Example 9

[0055] 用聚对苯二甲酸乙二醇酯编织网代替聚丙烯编织网,其余按照与实施例1同样的方法得到载药聚对苯二甲酸乙二醇酯编织网。 [0055] using polyethylene terephthalate polypropylene braid instead of wire mesh, the remaining polyethylene terephthalate obtained according to the braided mesh drug in the same manner as in Example 1.

[0056] 实施例10 [0056] Example 10

[0057] 用聚对苯二甲酸乙二醇酯编织网代替聚丙烯编织网,其余按照与实施例2同样的方法得到载药聚对苯二甲酸乙二醇酯编织网。 [0057] using polyethylene terephthalate polypropylene braid instead of wire mesh, the remaining polyethylene terephthalate braided mesh in accordance with the same drug obtained Example 2.

[0058] 实施例11 [0058] Example 11

[0059] 将上述实施例1中制造的聚丙烯编织网置入装有IOml 0. lmol/L(pH = 7. 4)的磷酸盐缓冲溶液(PBS)的小瓶中,37°C浸泡Mh;取出编织网并更换到新鲜的PBS溶液中继续浸泡,每24h换液一次。 [0059] The above-described Example 1 for producing a polypropylene woven mesh into a vial of phosphate buffer solution (PBS) equipped IOml 0. lmol / L (pH = 7. 4) of, 37 ° C soak Mh; braid removed and replaced with fresh PBS solution to continue soaking, medium was changed every 24h. 浸出液中的利福平浓度由高效液相色谱法(HPLC)测得,根据标准曲线方法计算利福平的累计释放率。 Rifampicin concentrations in leachate measured by a high performance liquid chromatography (HPLC), the cumulative release rate is calculated according to the standard curve method rifampicin.

[0060] 累计释放率(% )=累计释放量(mg)/所载药物总量(mg) X 100%[0061] 色谱条件:C18柱(4 μ m,150mmX3. 9mm),流动相为3 : 2的甲醇/乙酸钠(0. 02mol/L)混合溶液,流速1. Oml/min,柱温20°C,进样量10 μ 1,检测波长334nm。 [0060] The cumulative release rate (%) = cumulative release (mg) total / medicament contained (mg) X 100% [0061] Chromatographic conditions: C18 column (. 4 μ m, 150mmX3 9mm), mobile phase 3 : methanol / sodium acetate 2 (0. 02mol / L) mixed solution, flow rate 1. Oml / min, column temperature 20 ° C, the injection volume was 10 μ 1, detection wavelength 334nm.

[0062] 结果:如图1所示,体外释放实验显示第1天的利福平释放率为31. 4%,之后释放速度逐渐下降,药物释放7天后的利福平累计释放率为84. 2%。 [0062] Results: As shown, the in vitro release experiments showed that on day 1 1 rifampicin released was 31.4%, after the release rate decreased gradually, releasing the drug after 7 days of rifampicin cumulative release was 84. 2%.

[0063] 另外,按照与上述相同的方法分别对实施例3和5的载药聚丙烯编织网进行测定, 结果分别如图2和图3所示。 [0063] Further, according to the same method as the above-described embodiment respectively drug polypropylene braid 3 and embodiment 5 was measured, the results are shown in Figures 2 and 3.

Claims (1)

  1. 1. 一种制造具有药物缓释功能的载药编织网的方法,该方法包括:将基质和药物分别溶解于溶剂中,将所得溶液混合后经滤膜挤出除菌,或者直接将基质和药物一起溶解于溶剂中,然后将所得溶液经滤膜挤出除菌,将编织网浸入上述除菌后的溶液中1-15分钟,取出,待基质成膜后干燥去除残留溶剂;载药编织网中的基质用量为0. lg_2g/平方厘米编织网; 载药量为l_20mg/平方厘米编织网; 在使基质和药物结合到编织网之前通过化学方法和/或等离子体方法对编织网进行表面处理和/或改性;所载的药物为镇痛消炎类药物、麻醉类药物或抗生素类药物; 所述基质为生物降解型聚合物或非生物降解型聚合物; 编织网使用聚丙烯编织网或聚乙烯编织网; 该载药编织网用于制造心脏起博器抑菌袋或除颤器抑菌袋。 1. A method for drug woven mesh Drug Delivery manufacturing, the method comprising: the matrix and the drug are dissolved in a solvent, after mixing the resulting solution sterilized by membrane extrusion, or directly to the substrate and It was dissolved in a solvent together with the drug, extruding the resulting solution was then sterilized through a filter membrane, immersing the braided mesh filtering the solution after 1-15 minutes, remove the residual solvent is removed by drying until the film formation substrate; drug woven the amount of the matrix network is 0. lg_2g / cm braided mesh; drug loading l_20mg / cm braided mesh; mesh knitting surface chemically and / or plasma process and prior to the drug incorporated into the matrix braid treatment and / or modification; for anti-inflammatory analgesic drugs contained in drugs, narcotic drugs, or antibiotics; said polymer matrix is ​​biodegradable or non-biodegradable polymers; polypropylene woven mesh braid or polyethylene woven mesh; the drug for the manufacture of a woven mesh pacemaker or defibrillator bacteriostatic bacteriostatic bags bag.
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CN102217981B (en) * 2011-05-16 2013-06-12 北京天助畅运医疗技术股份有限公司 Multi-layer hernia repairing patch and preparation method thereof
CN102302800B (en) * 2011-09-14 2013-12-11 上海市第六人民医院 Chitosan biofilm polypropylene mesh and preparation method thereof
CN103028144B (en) * 2011-09-30 2014-10-29 王明刚 A non-tension hernia patch and preparation method
CN103463679B (en) * 2013-09-04 2015-11-18 江苏知原药业有限公司 Preparing a kind of single-wire cloth of polypropylene fiber after modification hernia mesh plug
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