CN105816952A - Novel electret microneedle transdermal drug delivery system - Google Patents
Novel electret microneedle transdermal drug delivery system Download PDFInfo
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- CN105816952A CN105816952A CN201610005552.0A CN201610005552A CN105816952A CN 105816952 A CN105816952 A CN 105816952A CN 201610005552 A CN201610005552 A CN 201610005552A CN 105816952 A CN105816952 A CN 105816952A
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0092—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
Description
技术领域technical field
本发明涉及医药技术领域，具体涉及一种给药系统。The invention relates to the technical field of medicine, in particular to a drug delivery system.
背景技术Background technique
透皮给药系统是指在皮肤表面给药，使药物以恒定速率或接近恒定速率通过皮肤进入体循环，产生全身或局部治疗作用的新剂型。其优点体现在：药物吸收不受消化道内PH、食物、转运时间等因素影响；避免肝脏受过效应；克服因吸收过快产生血液浓度过高而引起的不良反应；可持续控制给药速度、灵活给药等。The transdermal drug delivery system refers to a new dosage form that is administered on the surface of the skin so that the drug enters the systemic circulation through the skin at a constant rate or near a constant rate to produce systemic or local therapeutic effects. Its advantages are as follows: drug absorption is not affected by factors such as PH in the digestive tract, food, and transit time; avoids liver over-effect; overcomes adverse reactions caused by excessive blood concentration caused by excessive absorption; sustainable control of drug administration speed, flexible medication etc.
但是现有的透皮给药系统常存在对药物分子量及极性有所限制等缺陷，还存在送药剂量不容易控制、透气性差等问题。However, the existing transdermal drug delivery systems often have defects such as restrictions on the molecular weight and polarity of the drug, and there are also problems such as difficult control of the drug delivery dose and poor air permeability.
另外现有的透皮给药系统还存在渗透速度慢、药物利用不够充分等缺点。In addition, the existing transdermal drug delivery system also has disadvantages such as slow penetration rate and insufficient drug utilization.
发明内容Contents of the invention
本发明的目的在于，提供一种新型驻极体微针透皮给药系统，解决以上技术问题。The object of the present invention is to provide a novel electret microneedle transdermal drug delivery system to solve the above technical problems.
本发明所解决的技术问题可以采用以下技术方案来实现：The technical problem solved by the present invention can adopt following technical scheme to realize:
新型驻极体微针透皮给药系统，包括一隔离层，设置在所述隔离层内侧的含药压敏胶层，其特征在于，所述隔离层的外侧设有一采用驻极体材料制成的驻极体层，所述含药压敏胶层的内侧设有一控释膜层；The novel electret microneedle transdermal drug delivery system includes an isolation layer, and a drug-containing pressure-sensitive adhesive layer arranged on the inner side of the isolation layer. The formed electret layer, the inner side of the drug-containing pressure-sensitive adhesive layer is provided with a controlled-release film layer;
由外及内依次排布有所述驻极体层、所述隔离层、所述含药压敏胶层和所述控释膜层，形成一贮库型贴剂；The electret layer, the isolation layer, the drug-containing pressure-sensitive adhesive layer and the controlled-release film layer are sequentially arranged from the outside to the inside to form a storage-type patch;
所述贮库型贴剂内侧设有一微针阵列层，所述微针阵列层包括复数个微针形成的微针阵列；A microneedle array layer is provided inside the reservoir-type patch, and the microneedle array layer includes a microneedle array formed by a plurality of microneedles;
所述微针的直径为20微米～50微米，相邻所述微针的间距为1mm～1.5mm。The diameter of the microneedles is 20 microns to 50 microns, and the distance between adjacent microneedles is 1 mm to 1.5 mm.
本发明减弱皮肤屏障，使皮肤角质层结构改变，加速药物渗透。本发明通过优化微针的结构于排布，便于渗透入皮肤，本发明使用时，先用微针作用皮肤，药物通过微针的针孔快速渗透入皮肤，驻极体层加速药物的渗透，达到治疗效果。经实验证明，上述微针大小与排布状态下，给药效果最佳。The invention weakens the skin barrier, changes the structure of the cuticle of the skin, and accelerates drug penetration. The present invention facilitates penetration into the skin by optimizing the structure and arrangement of the microneedles. When the present invention is used, first use the microneedles to act on the skin, and the medicine penetrates into the skin quickly through the pinholes of the microneedles, and the electret layer accelerates the penetration of the medicine. achieve therapeutic effect. Experiments have proved that the drug delivery effect is the best under the above-mentioned size and arrangement state of the microneedles.
所述微针阵列设有的微针包括可降解的第一微针，不可降解的第二微针，所述第一微针与所述第二微针相邻交替排布于所述微针阵列层；The microneedles provided in the microneedle array include degradable first microneedles and non-degradable second microneedles, and the first microneedles and the second microneedles are alternately arranged adjacent to the microneedles array layer;
所述第一微针内包括药物。Drugs are included in the first microneedles.
本发明通过优化传统微针阵列层采用单一材质的结构，通过可降解的第一微针与第二微针的结合，实现了第一微针对含药压敏胶层内的药物进行输送的同时，实现了给药的效果。In the present invention, by optimizing the single material structure of the traditional microneedle array layer and combining the degradable first microneedle with the second microneedle, the first microneedle can simultaneously deliver the drug in the drug-containing pressure-sensitive adhesive layer. , to achieve the effect of drug administration.
所述第一微针内的药物与所述含药压敏胶层内的药物一致。The medicine in the first microneedle is consistent with the medicine in the medicine-containing pressure-sensitive adhesive layer.
防止药物不一致造成的药性冲突。Prevent drug conflicts caused by drug inconsistencies.
所述微针的长度为500微米～1800微米。The length of the microneedles ranges from 500 microns to 1800 microns.
便于保证给药效果。It is convenient to ensure the effect of drug administration.
所述驻极体层外侧设有一微型马达，所述微型马达通过传动部件连接一偏心轮，所述偏心轮抵住所述驻极体层。A micromotor is provided outside the electret layer, and the micromotor is connected to an eccentric wheel through a transmission part, and the eccentric wheel is against the electret layer.
适合家用的同时，提高给药效果。It is suitable for home use and improves the drug delivery effect.
所述驻极体层外侧贴有一超声波发生层，超声波发生层连接有一超声波发生电路；An ultrasonic generating layer is pasted on the outside of the electret layer, and the ultrasonic generating layer is connected with an ultrasonic generating circuit;
所述超声波发生层包括与微针个数一致的压电陶瓷片，所述压电陶瓷片的排布与所述微针的排布一致，所述压电陶瓷片与所述微针的中心轴线处于同一直线上。The ultrasonic generating layer includes piezoelectric ceramic sheets consistent with the number of microneedles, the arrangement of the piezoelectric ceramic sheets is consistent with that of the microneedles, and the arrangement of the piezoelectric ceramic sheets is consistent with that of the microneedles. The central axes are on the same straight line.
超声波发生层发出的超声波作用于所述含药压敏胶层与驻极体层，可以提高药物活性、提高皮肤内水分活性促进药物吸收。The ultrasonic waves emitted by the ultrasonic generating layer act on the drug-containing pressure-sensitive adhesive layer and the electret layer, which can improve drug activity, increase water activity in the skin, and promote drug absorption.
所述含药压敏胶层内还设有均匀分散在所述基质中的增粘剂、透皮促进剂和抗氧剂。以便更好的一起协同促渗。The drug-containing pressure-sensitive adhesive layer is also provided with a tackifier, a skin penetration accelerator and an antioxidant uniformly dispersed in the matrix. In order to better work together to promote penetration.
所述驻极体层外侧还贴有一金属电极层，所述金属电极层连接一调整金属电极层电极极性的极性反转装置，所述极性反转装置连接一微型处理器系统，所述微型处理器系统连接一时钟模块。A metal electrode layer is also pasted on the outside of the electret layer, and the metal electrode layer is connected to a polarity reversing device for adjusting the polarity of the metal electrode layer, and the polarity reversing device is connected to a microprocessor system, so The microprocessor system is connected with a clock module.
本发明采用驻极体作为物理调控因子，可作为离子驱动源对皮肤提供静电场和微电流，调控皮肤的驻极态、电结构和增强离子型药物透皮吸收。通过金属电极层实现对驻极体内静电场与微电流的控制。The invention adopts the electret as a physical regulating factor, which can be used as an ion driving source to provide an electrostatic field and a microcurrent to the skin, regulate the electret state and electrical structure of the skin, and enhance the transdermal absorption of ionic drugs. The control of the electrostatic field and microcurrent in the electret is realized through the metal electrode layer.
所述含药压敏胶层内还分布有永磁体粉末颗粒。永磁体粉末颗粒可以采用汝铁硼永磁体粉末颗粒。通过磁场可以促进分子活性，特别可以促进人体内水分子的活性。Permanent magnet powder particles are also distributed in the drug-containing pressure-sensitive adhesive layer. The permanent magnet powder particles can adopt RuFeB permanent magnet powder particles. Molecular activity can be promoted through magnetic fields, especially the activity of water molecules in the human body.
所述含药压敏胶层包括含有5-氟尿嘧啶、生长因子、GLP-1或者DPP-4抑制剂任意一种药物的基质。The drug-containing pressure-sensitive adhesive layer includes a matrix containing any drug of 5-fluorouracil, growth factor, GLP-1 or DPP-4 inhibitor.
或者，所述含药压敏胶层包括含有5-氟尿嘧啶这种药物的基质，所述基质还含有生长因子、GLP-1或者DPP-4抑制剂任意一种药物。Alternatively, the drug-containing pressure-sensitive adhesive layer includes a matrix containing the drug 5-fluorouracil, and the matrix also contains any drug of growth factor, GLP-1 or DPP-4 inhibitor.
作为一种优选方案，所述含药压敏胶层包括含有5-氟尿嘧啶、生长因子、GLP-1药物的基质。As a preferred solution, the drug-containing pressure-sensitive adhesive layer includes a matrix containing 5-fluorouracil, growth factors, and GLP-1 drugs.
所述含药压敏胶层内还设有硬脂醇甘草亭酸酯，硬脂醇甘草亭酸酯与GLP-1质量比为1：10。硬脂醇甘草亭酸酯保湿和消炎功能强，还具有抗菌、消炎、抗氧化、抗衰老、美白亮肤、祛斑的功效。Stearyl glycyrrhetinate is also provided in the drug-containing pressure-sensitive adhesive layer, and the mass ratio of stearyl glycyrrhetinate to GLP-1 is 1:10. Stearyl Glycyrrhetinate has strong moisturizing and anti-inflammatory functions, and also has antibacterial, anti-inflammatory, anti-oxidation, anti-aging, whitening and brightening, and freckle-removing effects.
所述硬脂醇甘草亭酸酯位于所述基质外侧。The stearyl glycyrrhetinate is located outside the matrix.
所述硬脂醇甘草亭酸酯外包有一脂质体，脂质体内设有20％～50％的十四酸异丙酯和40％～60％的硬脂醇甘草亭酸酯。The stearyl glycyrrhetinate is surrounded by a liposome, and the liposome is provided with 20%-50% isopropyl myristate and 40%-60% stearyl glycyrrhetinate.
实现祛疤滋润皮肤的效果。Achieve the effect of removing scars and moisturizing the skin.
所述含药压敏胶层含有的药物还包括可溶性膳食纤维，可溶性膳食纤维与GLP-1的质量比为3:7。The drug contained in the drug-containing pressure-sensitive adhesive layer also includes soluble dietary fiber, and the mass ratio of soluble dietary fiber to GLP-1 is 3:7.
本发明便于治疗糖尿病，不会造成胃肠道的不耐受，且不会影响其他营养素的吸收。The invention is convenient for treating diabetes, does not cause gastrointestinal intolerance, and does not affect the absorption of other nutrients.
所述含药压敏胶层含有的药物还包括可溶性膳食纤维、维生素b1，可溶性膳食纤维、维生素b1与GLP-1三者质量比为2：2:6。The drug contained in the drug-containing pressure-sensitive adhesive layer also includes soluble dietary fiber, vitamin b1, and the mass ratio of the soluble dietary fiber, vitamin b1 and GLP-1 is 2:2:6.
本发明便于治疗糖尿病，不会造成胃肠道的不耐受，且不会影响其他营养素的吸收。同时糖尿病患者体内维生素b1水平明显低于正常人，因此糖尿病患者适当补充维生素b1是有益的。The invention is convenient for treating diabetes, does not cause gastrointestinal intolerance, and does not affect the absorption of other nutrients. At the same time, the level of vitamin B1 in diabetic patients is significantly lower than that of normal people, so it is beneficial for diabetic patients to supplement vitamin B1 appropriately.
所述药物设有一由脂质体构成的外包层。脂质体可以是单不饱和脂肪酸。可降低对胰岛素的抵抗，提高给药效果。The drug is provided with an outer coating consisting of liposomes. Liposomes can be monounsaturated fatty acids. It can reduce the resistance to insulin and improve the drug delivery effect.
所述基质采用不含水的基质，所述基质包括非极性聚合物和增塑剂。不含水分的基质能提高药物的稳定性，贴剂柔顺性好，粘附性适宜。The base adopts a base without water, and the base includes a non-polar polymer and a plasticizer. The moisture-free matrix can improve the stability of the drug, and the patch has good flexibility and suitable adhesion.
所述含药压敏胶层内还设有均匀分散在所述基质中的增粘剂、透皮促进剂和抗氧剂。以便更好的一起协同促渗。The drug-containing pressure-sensitive adhesive layer is also provided with a tackifier, a skin penetration accelerator and an antioxidant uniformly dispersed in the matrix. In order to better work together to promote penetration.
所述第一微针包括双层结构，分别为内层与外层，所述外层是由生物可降解聚合物构成，所述内层包括GLP-1、DPP-4抑制剂这两种药物中的至少一种。所述生物可降解聚合物是聚乳酸乙醇酸共聚物。The first microneedle includes a double-layer structure, which is an inner layer and an outer layer, the outer layer is composed of a biodegradable polymer, and the inner layer includes two drugs, GLP-1 and DPP-4 inhibitors. at least one of the The biodegradable polymer is poly(lactic-co-glycolic acid).
所述生物可降解聚合物为 The biodegradable polymer is
其中，-PEA-是-PEUR是n是50至150的范围，m是0.1至0.9的范围；p是0.9至0.1的范围。R1选自C6亚烷基或C7亚烯基；R2是氢或C6烷基；R3选自氢、(C2-C6)烷基、(C2-C6)烯基和(C2-C6)炔基；和R4选自(C2-C6)亚烷基、(C2-C6)亚烯基或烷氧基。where -PEA- is -PEUR is n is in the range of 50 to 150, m is in the range of 0.1 to 0.9; p is in the range of 0.9 to 0.1. R1 is selected from C 6 alkylene or C 7 alkenylene; R2 is hydrogen or C 6 alkyl; R3 is selected from hydrogen, (C 2 -C 6 ) alkyl, (C 2 -C 6 ) alkenyl and ( C 2 -C 6 )alkynyl; and R4 is selected from (C 2 -C 6 )alkylene, (C 2 -C 6 )alkenylene or alkoxy.
便于实现降解的同时，实现对糖尿病的治疗。It is convenient to realize the degradation and at the same time realize the treatment of diabetes.
所述含药压敏胶层内还分布有永磁体粉末颗粒。永磁体粉末颗粒可以采用汝铁硼永磁体粉末颗粒。通过磁场可以促进分子活性，特别可以促进人体内水分子的活性。Permanent magnet powder particles are also distributed in the drug-containing pressure-sensitive adhesive layer. The permanent magnet powder particles can adopt RuFeB permanent magnet powder particles. Molecular activity can be promoted through magnetic fields, especially the activity of water molecules in the human body.
所述含药压敏胶层内还分布有托玛琳粉末颗粒。Tourmaline powder particles are also distributed in the drug-containing pressure-sensitive adhesive layer.
附图说明Description of drawings
图1为本发明的部分结构示意图。Fig. 1 is a partial structural schematic diagram of the present invention.
具体实施方式detailed description
为了使本发明实现的技术手段、创作特征、达成目的与功效易于明白了解，下面结合具体图示进一步阐述本发明。In order to make the technical means, creative features, goals and effects achieved by the present invention easy to understand, the present invention will be further described below in conjunction with specific diagrams.
参照图1，新型驻极体微针透皮给药系统，包括一隔离层23，设置在隔离层23内侧的含药压敏胶层22，隔离层23的外侧设有一采用驻极体材料制成的驻极体层24，含药压敏胶层22的内侧设有一控释膜层21；由外及内依次排布有驻极体层24、隔离层23、含药压敏胶层22和控释膜层21，形成一贮库型贴剂；贮库型贴剂内侧设有一微针阵列层，微针阵列层包括复数个微针11形成的微针阵列；微针11的直径为20微米～50微米，相邻微针11的间距为1mm～1.5mm。本发明减弱皮肤屏障，使皮肤角质层结构改变，加速药物渗透。本发明通过优化微针11的结构于排布，便于渗透入皮肤，本发明使用时，先用微针11作用皮肤，药物通过微针11的针孔快速渗透入皮肤，驻极体层24加速药物的渗透，达到治疗效果。经实验证明，上述微针11大小与排布状态下，给药效果最佳。With reference to Fig. 1, the novel electret microneedle transdermal drug delivery system comprises an isolation layer 23, a drug-containing pressure-sensitive adhesive layer 22 arranged on the inner side of the isolation layer 23, and an electret material system is arranged on the outer side of the isolation layer 23. The formed electret layer 24, the inner side of the drug-containing pressure-sensitive adhesive layer 22 is provided with a controlled-release film layer 21; the electret layer 24, the isolation layer 23, and the drug-containing pressure-sensitive adhesive layer 22 are sequentially arranged from the outside to the inside. and release-controlling membrane layer 21 to form a reservoir type patch; the inside of the reservoir type patch is provided with a microneedle array layer, and the microneedle array layer includes a microneedle array formed by a plurality of microneedles 11; the diameter of the microneedle 11 is 20 microns to 50 microns, and the distance between adjacent microneedles 11 is 1 mm to 1.5 mm. The invention weakens the skin barrier, changes the structure of the cuticle of the skin, and accelerates drug penetration. The present invention facilitates penetration into the skin by optimizing the structure and arrangement of the microneedles 11. When the present invention is used, the microneedles 11 are first used to act on the skin, and the medicine quickly penetrates into the skin through the pinholes of the microneedles 11, and the electret layer 24 accelerates the process. Penetration of drugs to achieve therapeutic effect. It has been proved by experiments that the drug delivery effect is the best under the size and arrangement state of the above-mentioned microneedles 11 .
微针11阵列设有的微针11包括可降解的第一微针，不可降解的第二微针，第一微针与第二微针相邻交替排布于微针阵列层；第一微针内包括药物。本发明通过优化传统微针阵列层采用单一材质的结构，通过可降解的第一微针与第二微针的结合，实现了第一微针对含药压敏胶层22内的药物进行输送的同时，实现了给药的效果。The microneedles 11 provided in the microneedle 11 array include degradable first microneedles, non-degradable second microneedles, and the first microneedles and the second microneedles are alternately arranged in the microneedle array layer; the first microneedles The needle contains the drug. In the present invention, by optimizing the single-material structure of the traditional microneedle array layer and combining the degradable first microneedle with the second microneedle, the first microneedle can deliver the drug in the drug-containing pressure-sensitive adhesive layer 22. Simultaneously, the effect of administration is realized.
第一微针内的药物与含药压敏胶层22内的药物一致。防止药物不一致造成的药性冲突。The medicine in the first microneedle is consistent with the medicine in the medicine-containing pressure-sensitive adhesive layer 22 . Prevent drug conflicts caused by drug inconsistencies.
微针的长度为500微米～1800微米。便于保证给药效果。The length of the microneedles ranges from 500 microns to 1800 microns. It is convenient to ensure the effect of drug administration.
驻极体层外侧设有一微型马达，微型马达通过传动部件连接一偏心轮，偏心轮抵住驻极体层。适合家用的同时，提高给药效果。A micromotor is arranged outside the electret layer, and the micromotor is connected with an eccentric wheel through a transmission part, and the eccentric wheel is against the electret layer. It is suitable for home use and improves the drug delivery effect.
驻极体层24外侧贴有一超声波发生层，超声波发生层连接有一超声波发生电路；超声波发生层包括与微针个数一致的压电陶瓷片，压电陶瓷片的排布与微针的排布一致，压电陶瓷片与微针的中心轴线处于同一直线上。超声波发生层发出的超声波作用于含药压敏胶层22与驻极体层24，可以提高药物活性、提高皮肤内水分活性促进药物吸收。含药压敏胶层22内还设有均匀分散在基质中的增粘剂、透皮促进剂和抗氧剂。以便更好的一起协同促渗。An ultrasonic generating layer is pasted on the outside of the electret layer 24, and the ultrasonic generating layer is connected with an ultrasonic generating circuit; the ultrasonic generating layer includes piezoelectric ceramic sheets consistent with the number of microneedles, and the arrangement of the piezoelectric ceramic sheets is consistent with the arrangement of the microneedles. The distribution is consistent, and the central axis of the piezoelectric ceramic sheet and the microneedle is on the same straight line. The ultrasonic waves emitted by the ultrasonic generating layer act on the drug-containing pressure-sensitive adhesive layer 22 and the electret layer 24, which can improve drug activity, increase water activity in the skin, and promote drug absorption. The drug-containing pressure-sensitive adhesive layer 22 is also provided with a tackifier, a skin penetration accelerator and an antioxidant uniformly dispersed in the matrix. In order to better work together to promote penetration.
驻极体层24外侧还贴有一金属电极层，金属电极层连接一调整金属电极层电极极性的极性反转装置，极性反转装置连接一微型处理器系统，微型处理器系统连接一时钟模块。本发明采用驻极体作为物理调控因子，可作为离子驱动源对皮肤提供静电场和微电流，调控皮肤的驻极态、电结构和增强离子型药物透皮吸收。通过金属电极层实现对驻极体内静电场与微电流的控制。A metal electrode layer is also pasted on the outside of the electret layer 24, and the metal electrode layer is connected to a polarity inversion device for adjusting the polarity of the metal electrode layer, the polarity inversion device is connected to a microprocessor system, and the microprocessor system is connected to a clock module. The invention adopts the electret as a physical regulating factor, which can be used as an ion driving source to provide an electrostatic field and a microcurrent to the skin, regulate the electret state and electrical structure of the skin, and enhance the transdermal absorption of ionic drugs. The control of the electrostatic field and microcurrent in the electret is realized through the metal electrode layer.
含药压敏胶层22内还分布有永磁体粉末颗粒。永磁体粉末颗粒可以采用汝铁硼永磁体粉末颗粒。通过磁场可以促进分子活性，特别可以促进人体内水分子的活性。含药压敏胶层22包括含有5-氟尿嘧啶、生长因子、GLP-1或者DPP-4抑制剂任意一种药物的基质。含药压敏胶层22包括含有5-氟尿嘧啶、生长因子、GLP-1或者DPP-4抑制剂至少一种药物的基质。以提高治疗增生性瘢痕或糖尿病的疗效或为临床提供一种新的治疗增生性瘢痕或糖尿病的有效方法和制剂。含药压敏胶层内还设有硬脂醇甘草亭酸酯，硬脂醇甘草亭酸酯与GLP-1质量比为1：10。硬脂醇甘草亭酸酯保湿和消炎功能强，还具有抗菌、消炎、抗氧化、抗衰老、美白亮肤、祛斑的功效。含药压敏胶层含有的药物还包括可溶性膳食纤维，可溶性膳食纤维与GLP-1的质量比为3:7。本发明便于治疗糖尿病，不会造成胃肠道的不耐受，且不会影响其他营养素的吸收。含药压敏胶层含有的药物还包括可溶性膳食纤维、维生素b1，可溶性膳食纤维、维生素b1与GLP-1三者质量比为2：2:6。本发明便于治疗糖尿病，不会造成胃肠道的不耐受，且不会影响其他营养素的吸收。同时糖尿病患者体内维生素b1水平明显低于正常人，因此糖尿病患者适当补充维生素b1是有益的。There are also permanent magnet powder particles distributed in the drug-containing pressure-sensitive adhesive layer 22 . The permanent magnet powder particles can adopt RuFeB permanent magnet powder particles. Molecular activity can be promoted through magnetic fields, especially the activity of water molecules in the human body. The drug-containing pressure-sensitive adhesive layer 22 includes a matrix containing any drug of 5-fluorouracil, growth factor, GLP-1 or DPP-4 inhibitor. The drug-containing pressure-sensitive adhesive layer 22 includes a matrix containing at least one drug of 5-fluorouracil, growth factor, GLP-1 or DPP-4 inhibitor. To improve the curative effect of treating hypertrophic scar or diabetes or to provide a new effective method and preparation for clinical treatment of hypertrophic scar or diabetes. Stearyl glycyrrhetinate is also arranged in the drug-containing pressure-sensitive adhesive layer, and the mass ratio of stearyl glycyrrhetinate to GLP-1 is 1:10. Stearyl Glycyrrhetinate has strong moisturizing and anti-inflammatory functions, and also has antibacterial, anti-inflammatory, anti-oxidation, anti-aging, whitening and brightening, and freckle-removing effects. The drug contained in the drug-containing pressure-sensitive adhesive layer also includes soluble dietary fiber, and the mass ratio of soluble dietary fiber to GLP-1 is 3:7. The invention is convenient for treating diabetes, does not cause gastrointestinal intolerance, and does not affect the absorption of other nutrients. The drug contained in the drug-containing pressure-sensitive adhesive layer also includes soluble dietary fiber, vitamin b1, and the mass ratio of the soluble dietary fiber, vitamin b1 and GLP-1 is 2:2:6. The invention is convenient for treating diabetes, does not cause gastrointestinal intolerance, and does not affect the absorption of other nutrients. At the same time, the level of vitamin B1 in diabetic patients is significantly lower than that of normal people, so it is beneficial for diabetic patients to supplement vitamin B1 appropriately.
药物设有一由脂质体构成的外包层。脂质体可以是单不饱和脂肪酸。可降低对胰岛素的抵抗，提高给药效果。The drug is provided with an outer envelope consisting of liposomes. Liposomes can be monounsaturated fatty acids. It can reduce the resistance to insulin and improve the drug delivery effect.
基质采用不含水的基质，基质包括非极性聚合物和增塑剂。不含水分的基质能提高药物的稳定性，贴剂柔顺性好，粘附性适宜。The matrix adopts a non-aqueous matrix, and the matrix includes non-polar polymers and plasticizers. The moisture-free matrix can improve the stability of the drug, and the patch has good flexibility and suitable adhesion.
含药压敏胶层22内还设有均匀分散在基质中的增粘剂、透皮促进剂和抗氧剂。以便更好的一起协同促渗。The drug-containing pressure-sensitive adhesive layer 22 is also provided with a tackifier, a skin penetration accelerator and an antioxidant uniformly dispersed in the matrix. In order to better work together to promote penetration.
第一微针包括双层结构，分别为内层与外层，外层是由生物可降解聚合物构成，内层包括GLP-1、DPP-4抑制剂这两种药物中的至少一种，生物可降解聚合物是聚乳酸乙醇酸共聚物。The first microneedle includes a double-layer structure, which is an inner layer and an outer layer respectively, the outer layer is composed of a biodegradable polymer, and the inner layer includes at least one of the two drugs of GLP-1 and DPP-4 inhibitors, The biodegradable polymer is poly(lactic-co-glycolic acid).
生物可降解聚合物为 Biodegradable polymers are
其中，-PEA-是-PEUR是n是50至150的范围，m是0.1至0.9的范围；p是0.9至0.1的范围。R1选自C6亚烷基或C7亚烯基；R2是氢或C6烷基；R3选自氢、(C2-C6)烷基、(C2-C6)烯基和(C2-C6)炔基；和R4选自(C2-C6)亚烷基、(C2-C6)亚烯基或烷氧基。where -PEA- is -PEUR is n is in the range of 50 to 150, m is in the range of 0.1 to 0.9; p is in the range of 0.9 to 0.1. R1 is selected from C 6 alkylene or C 7 alkenylene; R2 is hydrogen or C 6 alkyl; R3 is selected from hydrogen, (C 2 -C 6 ) alkyl, (C 2 -C 6 ) alkenyl and ( C 2 -C 6 )alkynyl; and R4 is selected from (C 2 -C 6 )alkylene, (C 2 -C 6 )alkenylene or alkoxy.
含药压敏胶层内还分布有永磁体粉末颗粒。永磁体粉末颗粒可以采用汝铁硼永磁体粉末颗粒。通过磁场可以促进分子活性，特别可以促进人体内水分子的活性。含药压敏胶层内还分布有托玛琳粉末颗粒。Permanent magnet powder particles are also distributed in the drug-containing pressure-sensitive adhesive layer. The permanent magnet powder particles can adopt RuFeB permanent magnet powder particles. Molecular activity can be promoted through magnetic fields, especially the activity of water molecules in the human body. Tourmaline powder particles are also distributed in the drug-containing pressure-sensitive adhesive layer.
以上显示和描述了本发明的基本原理和主要特征和本发明的优点。本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等效物界定。The basic principles and main features of the present invention and the advantages of the present invention have been shown and described above. Those skilled in the industry should understand that the present invention is not limited by the above-mentioned embodiments, and what described in the above-mentioned embodiments and the description only illustrates the principles of the present invention, and the present invention will also have other functions without departing from the spirit and scope of the present invention. Variations and improvements all fall within the scope of the claimed invention. The protection scope of the present invention is defined by the appended claims and their equivalents.
Claims (10)
- The microneedle cutaneous system of the most novel electret, including a sealing coat, it is arranged on the pastille pressure-sensitive adhesive layer inside described sealing coat, it is characterised in that, the outside of described sealing coat is provided with the electret layer that an employing electret is made, and the inner side of described pastille pressure-sensitive adhesive layer is provided with a release-controlled film layer；It is placed with described electret layer, described sealing coat, described pastille pressure-sensitive adhesive layer and described release-controlled film layer successively by outer and interior, forms a reservoir devices patch；Being provided with a microneedle array layer inside described reservoir devices patch, described microneedle array layer includes the microneedle array that a plurality of micropin is formed；A diameter of 20 microns～50 microns of described micropin, the spacing of adjacent described micropin is 1mm～1.5mm.
- The microneedle cutaneous system of novel electret the most according to claim 1, it is characterized in that, the micropin that described microneedle array is provided with includes degradable first micropin, nondegradable second micropin, and described first micropin is adjacent with described second micropin to be arranged alternately in described microneedle array layer.
- The microneedle cutaneous system of novel electret the most according to claim 1, it is characterised in that be provided with a micromotor outside described electret layer, described micromotor connects an eccentric by drive disk assembly, and described eccentric props up described electret layer.
- The microneedle cutaneous system of novel electret the most according to claim 1, it is characterised in that post a ultrasound wave genetic horizon outside described electret layer, ultrasound wave genetic horizon connects a ultrasonic output circuit；Described ultrasound wave genetic horizon includes the piezoelectric ceramic piece consistent with micropin number, and the arrangement of described piezoelectric ceramic piece is consistent with the arrangement of described micropin, and described piezoelectric ceramic piece is on same straight line with the central axis of described micropin.
- 5. according to the microneedle cutaneous system of novel electret described in claim 1 or 4, it is characterized in that, a metal electrode layer is also posted outside described electret layer, described metal electrode layer connects the polarity reversing device of an adjustment metal electrode layer polarity of electrode, described polarity reversing device connects a microprocessor system, and described microprocessor system connects a clock module.
- The microneedle cutaneous system of novel electret the most according to claim 1, it is characterised in that described pastille pressure-sensitive adhesive layer includes containing 5-fluorouracil, somatomedin, the substrate of GLP-1 or DPP-4 any one medicine of inhibitor.
- The microneedle cutaneous system of novel electret the most according to claim 6, it is characterised in that being additionally provided with stearyl alcohol glycyrrhetin acid esters in described pastille pressure-sensitive adhesive layer, stearyl alcohol glycyrrhetin acid esters and GLP-1 mass ratio are 1:10.
- 8. according to the microneedle cutaneous system of novel electret described in claim 6 or 7, it is characterised in that the medicine that described pastille pressure-sensitive adhesive layer contains also includes that water soluble dietary fiber, water soluble dietary fiber are 3:7 with the mass ratio of GLP-1.
- The microneedle cutaneous system of novel electret the most according to claim 6, it is characterised in that described medicine is provided with a surrounding layer being made up of liposome.
- The microneedle cutaneous system of novel electret the most according to claim 2, it is characterized in that, described first micropin includes double-decker, it is respectively internal layer and outer layer, described outer layer is to be made up of biodegradable polymer, and described internal layer includes at least one in 5-fluorouracil, somatomedin, GLP-1, DPP-4 inhibitor these four medicine.
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