WO2019157833A1 - 一种新型智能透皮和口腔给药设备及方法 - Google Patents

一种新型智能透皮和口腔给药设备及方法 Download PDF

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Publication number
WO2019157833A1
WO2019157833A1 PCT/CN2018/111187 CN2018111187W WO2019157833A1 WO 2019157833 A1 WO2019157833 A1 WO 2019157833A1 CN 2018111187 W CN2018111187 W CN 2018111187W WO 2019157833 A1 WO2019157833 A1 WO 2019157833A1
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pool
patch
receiving
transdermal
drug
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PCT/CN2018/111187
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English (en)
French (fr)
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胡隆胜
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常州华佳医疗器械有限公司
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Publication of WO2019157833A1 publication Critical patent/WO2019157833A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N13/00—Investigating surface or boundary effects, e.g. wetting power; Investigating diffusion effects; Analysing materials by determining surface, boundary, or diffusion effects
    • G01N13/04—Investigating osmotic effects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0009—Galenical forms characterised by the drug release technique; Application systems commanded by energy involving or responsive to electricity, magnetism or acoustic waves; Galenical aspects of sonophoresis, iontophoresis, electroporation or electroosmosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions

Definitions

  • the present invention relates to the field of transdermal and oral administration, and more particularly to a transdermal and oral administration test device.
  • the drug substance is usually prepared into a medicament of various dosage forms, and the manner or route of administration varies depending on the dosage form, and oral administration, injection administration, nasal administration, and transdermal administration are common.
  • oral administration, injection administration, nasal administration, and transdermal administration are common.
  • the United States first proposed a therapeutic regimen for transdermal controlled release administration and also prepared a scopolamine patch.
  • the transdermal drug delivery system has also begun to develop rapidly and has achieved a certain degree of perfection. The more research is devoted to drug selection and testing for transdermal drug delivery.
  • a drug transdermal delivery system refers to a formulation that is administered on the surface of the skin to allow the drug to pass through various layers of the skin at a constant rate (or near a constant rate) into the systemic circulation to produce a systemic or topical therapeutic effect.
  • the transdermal drug delivery system can avoid problems caused by many other routes of administration, such as avoiding the first pass effect of the liver and inactivation of the gastrointestinal tract so as not to reduce the utilization of the drug; maintaining a constant blood concentration or pharmacology Effect; can also improve the bioavailability of drugs such as proteins or peptides; and can also reduce adverse drug reactions, without causing side effects caused by injection, and patients can also use drugs on their own, more humane, can greatly increase patients Compliance.
  • the ion drug introduction technology has been in existence for a long time, and its core technology is to actively transport ionized drug molecules with low-intensity current, and exert therapeutic effects through the skin into the human body.
  • the electrode current of the device can drive the ionized drug through the skin.
  • the principle of repelling the same kind of electric charge and the electroosmotic pressure generated by a large amount of liquid flow drive the ionized drug to transport through the skin. This process is a process.
  • the active transport process in addition to the flow of current may also increase the osmotic pressure of the skin to facilitate the transport of the drug, so that the cations in the drug are introduced into the body from the anode and the anion from the cathode to achieve the purpose of treating the disease.
  • This method has the characteristics of direct drug delivery, long-lasting efficacy, no pain, and easy acceptance by patients.
  • the drug ions penetrate from the acupoints, and the system can be fully exerted by the excitatory drinking and circulation of the meridians.
  • the above changes are reversible and do not cause skin damage.
  • Iontophoresis is a new generation of medical instruments based on bioelectrical pharmacology theory, bionics theory, hot compress medicine, magnetic field science, Chinese classical Chinese medicine and modern microcomputer technology, combined with years of clinical practice and a large number of user feedback.
  • the instrument has intermediate frequency, low frequency, drug introduction and treatment functions, and is suitable for use in rehabilitation medical institutions and family treatment at all levels.
  • the Chinese medicine importer can introduce Mivisy biological factor liquid series, GMI biological freeze-dried powder series, Sicimy biological spray series, Marfi biological mask liquid series, Archa biological cleansing series and Vivimy eye care biological essence.
  • the introduction device is designed for the new microcomputer chip and has multiple safety protection functions.
  • the special asymmetric intermediate frequency current introduces the drug ions deeper and more effectively into the lesion site, and can be used for home health care treatment by far infrared heat application and promoting blood circulation.
  • the introduction instrument is large in size and difficult to move, and the use is inconvenient.
  • iontophoretic transdermal drug delivery mainly ion-implanted patch products, such as Zecuity, the most commonly used drug for migraine, which can be used for the treatment of hospitalization.
  • Ionsys for acute moderate to severe postoperative pain in adults LidoSite Topical System for local analgesia
  • IOMED Phoresor Ionphretic drug delivery system for delivering water-soluble drugs ACTIVA patch products.
  • These products are supplied with current from the battery carried by the product for transdermal administration.
  • These products are all disposable and the current and dosage are fixed and not adjustable.
  • a novel intelligent transdermal and oral drug delivery device comprising: a transdermal diffuser, the transdermal diffuser comprising: a receiving pool having two receiving cell ports on the receiving pool, the receiving pool further comprising a sampling port; a supply pool, each of the supply pools has a supply pool port, and the two supply pool ports are respectively opposite to the two receiving pool ports, and each of the supply pool ports and the receiving pool port is further provided a simulated skin; further comprising: a positive electrode patch and a negative electrode patch, wherein the positive electrode patch and the negative electrode patch are respectively attached to the two simulated skins; and the intelligent current controller, the smart current controller passes through the positive electrode circuit Connected to the positive electrode patch, the intelligent current controller is connected to the negative electrode patch through a negative electrode circuit.
  • the above-mentioned novel intelligent transdermal and oral drug delivery device further includes: a current real-time detector, wherein the positive electrode circuit or the negative electrode circuit is provided with a current real-time detector.
  • transdermal diffuser further comprises a stirrer and a magnetic stirrer, the stirrer is disposed in the receiving tank, and the magnetic stirrer is for the stirring child.
  • the positive electrode patch is a drug-containing patch and the negative electrode patch is a drug-free patch, or the positive electrode patch is a drug-free patch at the same time.
  • the negative electrode patch is a drug-containing patch.
  • the above-mentioned novel intelligent transdermal and oral drug delivery device wherein the drug-containing patch has a plurality of drug solutions in the suction pad, and the drug-free patch has the same amount of the drug solution as the drug solution water.
  • the simulated skin is a pig oral mucosa from which adipose tissue is removed or pig skin from which a subcutaneous tissue is removed.
  • the above-mentioned novel intelligent transdermal and oral drug delivery device wherein the receiving pool is a closed box structure, and both of the receiving pool openings are opened at the upper end of the receiving pool.
  • the above-mentioned novel intelligent transdermal and oral drug delivery device includes two sampling ports, and the two sampling ports are respectively opened on both sides of the receiving pool.
  • a novel method for using a smart transdermal and oral drug delivery device comprising any of the novel intelligent transdermal and oral drug delivery devices described above, the method of use comprising:
  • Step S1 placing the simulated skin between each of the supply pool and one of the receiving pools, the inner side of the simulated skin facing the receiving pool;
  • Step S2 The positive electrode patch and the negative electrode patch are respectively placed in the two supply pools, and respectively attached to the two simulated skins;
  • Step S3 filling the receiving pool with phosphate buffered saline to simulate blood circulation; and maintaining the temperature in the receiving pool at 37 ° C for simulating human body temperature; simultaneously setting current and energization time, and energizing the drug;
  • Step S4 selecting a plurality of time points respectively, sampling from the receiving pool at a plurality of the time points, performing drug analysis and recording by a high pressure liquid phase analyzer;
  • Step S5 After the end of the administration, the simulated skin was immersed in water for several days, and the residual drug content was analyzed by a high pressure liquid phase analyzer and recorded.
  • the invention has the positive effects compared with the prior art by adopting the above technology: (1)
  • the present invention avoids causing the proximity of the positive electrode patch and the negative electrode patch due to the provision of two independent supply cells. Short circuit problem, while the current loop can be formed normally.
  • the present invention avoids the influence of the drug permeation rate and the flow velocity of the solution on the uneven concentration of the osmotic concentration in the receiving pool by simultaneously sampling both sides.
  • Figure 1 is a schematic illustration of a novel intelligent transdermal and oral drug delivery device of the present invention.
  • FIG. 2 is a schematic illustration of a transdermal diffuser of the novel intelligent transdermal and oral drug delivery device of the present invention.
  • FIG. 1 is a schematic view of a novel intelligent transdermal and oral drug delivery device of the present invention
  • FIG. 2 is a schematic view of a transdermal diffuser of the novel intelligent transdermal and oral drug delivery device of the present invention, as shown in FIG. 1 and FIG.
  • a novel intelligent transdermal and oral drug delivery device of a preferred embodiment is shown comprising: a transdermal diffuser comprising: an access cell 1 having two receiving cell ports 11 on the receiving cell 1 and receiving a cell
  • a sampling port 12 is also provided on the 1st.
  • the transdermal diffuser further includes: a supply tank 2, each of the supply tanks 2 has a supply tank port 21, and the two supply tank ports 21 are opposite to the two receiving pool ports 11, respectively, and each A dummy skin 3 is also provided between a supply tank opening 21 and the receiving tank opening 11.
  • the novel intelligent transdermal and oral drug delivery device further includes: a positive electrode patch 4 and a negative electrode patch 5, and the positive electrode patch 4 and the negative electrode patch 5 are respectively attached to the two dummy skins 3 .
  • the novel intelligent transdermal and oral drug delivery device further comprises: an intelligent current controller 6, and the intelligent current controller 6 is connected to the positive electrode patch 4 through a positive electrode circuit, and the intelligent current controller 6 It is connected to the negative electrode patch 5 through a negative electrode circuit. Only the current controller 6 can be adjusted by manual or Bluetooth or Wifi or remote GPRS control.
  • the novel intelligent transdermal and oral drug delivery device further comprises: a current real-time detector 7, and a current real-time detector 7 is provided in the positive circuit or the negative circuit.
  • the current real-time detector 7 is used to detect the current stability at the time of administration in real time.
  • the current real-time detector 7 can detect the maximum current and the average current for the set time every set time (for example, every 1 second, every 3 seconds, etc.), and feed back the tabulation.
  • the transdermal diffuser further includes a stirrer 81 and a magnetic stirrer 82, the stirrer 81 is disposed in the receiving tank 1, and the magnetic stirrer 82 is facing the stirrer 81.
  • the positive electrode patch 4 is a drug-containing patch
  • the negative electrode patch 5 is a drug-free patch
  • the positive electrode patch 4 is a drug-free patch
  • the negative electrode patch 5 is a drug-containing patch.
  • the drug-containing patch has a plurality of drug solutions in the pad, and the pad containing no drug patch has the same amount of water as the drug solution.
  • the drug solution in the drug-containing patch is any drug component which can be positively or negatively charged or ionized in the aqueous solution.
  • the receiving tank 1 is topped with phosphate buffered saline and the temperature in the receiving tank 1 is maintained at 37 °C.
  • the simulated skin 3 is a pig oral mucosa with adipose tissue removed or pig skin with a subcutaneous tissue removed.
  • the receiving cell 1 is a closed box structure, and both receiving cell ports 11 are open at the upper end of the receiving cell.
  • two sampling ports 12 are included, and two sampling ports 12 are respectively opened on both sides of the receiving pool 1.
  • the first method of use of the present invention is a first method of use of the present invention.
  • Step S1 placing the simulated skin 3 between each supply pool 2 and a receiving pool 1, the inner side of the simulated skin 3 facing the receiving pool 1;
  • Step S2 placing the positive electrode patch 4 and the negative electrode patch 5 in the two supply cells 2, respectively, and respectively attached to the two simulated skins 3;
  • Step S3 filling the receiving tank 1 with phosphate buffered saline to simulate blood circulation; and maintaining the temperature in the receiving tank 1 at 37 ° C for simulating human body temperature; and setting current (a current such as 100 can be set, 200, 300, 400, 500 ⁇ A, etc.) and the energization time, adjust the stirring speed to ensure that the drug in the receiving tank 1 is even and energized;
  • a current such as 100 can be set, 200, 300, 400, 500 ⁇ A, etc.
  • Step S4 selecting a plurality of time points respectively, sampling from the receiving pool 1 at a plurality of time points, performing drug analysis and recording by a high pressure liquid phase analyzer;
  • Step S5 After the end of the administration, the simulated skin 3 was immersed in water for several days, and the residual drug content was analyzed by a high pressure liquid phase analyzer and recorded.
  • Step S1 selecting pig skin with a thickness of 300-500 ⁇ m and an area of 4.0 cm 2 , placed between each supply tank 2 and a receiving tank 1 , the inner side of the pig membrane body facing the receiving pool 1;
  • Step S2 placing the connected drug-containing patch in the supply pool 2 and attaching it to the epidermis of the pig skin membrane body;
  • Step S3.1 Filling the receiving tank 1 with phosphate buffered saline to simulate blood circulation; and maintaining the temperature in the receiving tank 1 at 37 ° C for simulating human body temperature;
  • Step S3.2 Set the current to 300 ⁇ A, set the energization time to 3 hours, energize the drug, and start the current real-time detector 7 at the same time.
  • Step S3 After the administration of the current is started, the samples are taken from the receiving pool 1 at the time points of 1, 2, and 3 hours after the administration (sampling at the two sampling ports 12 simultaneously, the sampling amount is 1 ml), and analyzed by high pressure liquid phase.
  • the instrument performs drug analysis and records.
  • the transdermal administration (experimental drug is lidocaine hydrochloride) simulation experiment can be carried out according to the above second method of use, and the obtained results are shown in Tables 1 to 4.
  • Step S1 selecting a pig oral mucosa and pig skin having a thickness of 300-500 ⁇ m and an area of 4.0 cm 2 , and placing the pig skin between a supply tank 2 and a receiving tank 1 , the inner side of the pig skin membrane facing the receiving pool 1 , the pig The oral mucosa is placed between the other supply pool 2 and the other receiving pool 1, the inner side of the mucous membrane is facing the receiving pool 1;
  • Step S2 placing the connected drug-free patch in a supply tank 2 and attaching it to the epidermis of the pig skin film body, placing the connected drug-containing patch in another supply pool 2 and sticking it to the pig mouth On the epidermis of the mucosa;
  • Step S3.1 Filling the receiving tank 1 with phosphate buffered saline to simulate blood circulation; and maintaining the temperature in the receiving tank 1 at 37 ° C for simulating human body temperature;
  • Step S3.2 Set the current to 300 ⁇ A, set the energization time to 3 hours, energize the drug, and start the current real-time detector 7 at the same time.
  • Step S3 After the administration of the energization is started, the samples are taken from the receiving pool 1 at the time points of 0, 0.5, 1, 2, and 3 h after the administration (the sampling is simultaneously performed at the two sampling ports 12, and the sampling amount is 1 ml).
  • the high pressure liquid phase analyzer was used for drug analysis and recording.
  • Step S4 After the administration, the oral cavity mucosa of the pig is soaked in 10 ml of water for 3-4 days, sampled, and analyzed by a high-pressure liquid phase analyzer to detect the content of the drug remaining in the oral mucosa of the pig.
  • the oral mucosal administration (experimental drug is lidocaine hydrochloride) simulation experiment can be carried out according to the above third method of use, and the obtained results are shown in Table 5.

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Abstract

一种新型智能透皮和口腔给药设备及方法，包括透皮扩散仪，透皮扩散仪包括：接受池（1），接受池上具有两接受池口（11），接受池上还设有取样口（12）；供给池（2），每一供给池均具有一供给池口（21），两供给池口分别与两接受池口相正对，并且每一供给池口和接受池口之间还设有模拟皮（3）；还包括：正极贴片（4）和负极贴片（5），正极贴片和负极贴片分别贴在两模拟皮上；智能电流控制器（6），智能电流控制器通过正极电路与正极贴片相连接，智能电流控制器通过负极电路与负极贴片相连接。由于设有两个独立的供给池，避免了造成正极贴片和负极贴片距离近导致短路问题，同时能够正常形成电流回路。

Description

一种新型智能透皮和口腔给药设备及方法 技术领域
本发明涉及透皮和口腔给药的技术领域，尤其涉及一种透皮和口腔给药测试设备。
背景技术
原料药通常会被制备成各种剂型的药剂，而由于剂型的不同，给药的方式或途径也有所不同，常见的有口服给药、注射给药、鼻腔给药以及经皮给药等。20世纪70年代中期美国有人首先提出了可用于透皮控释给药的治疗方案并且还制备成了东莨菪碱贴片，透皮给药***也开始不断的迅速发展并得到了一定的完善程度，越来越多的研究致力于透皮给药的药物选择及试验上。药物透皮给药***是指在皮肤表面给药，使药物以恒定的速度(或接近恒定速度)通过皮肤各层，进入体循环，产生全身或局部治疗作用的一种制剂剂型。尤其是对于大分子的蛋白、多肽类药物以及疫苗等，这些药物不能通过口服，只能采用注射的方法进行给药，但长期的注射容易引起脂肪萎缩、硬结等不良反应，而且病人的顺应性较低，给药时需由专业人员进行，造成了很多不便。而透皮给药***给药时可以避免很多其他给药途径所引起的问题，如可避免肝脏首过效应以及胃肠道灭活以免降低药物的利用率；能够维持恒定的血药浓度或药理效应；亦可以提高如蛋白或多肽类药物的生物利用度；并且还可以降低药物不良反应，不会引起注射所带来的副作用，另外患者也可以自主用药，更人性化，可极大地增加病人的依从性。
而离子药物导入技术由来已久，其核心技术就是采用低强度电流主动转运离子化的药物分子，经皮肤进人体循环发挥治疗作用。装置的电极电流之所以能驱使离子化的药物透过皮肤，是通过同种电荷相斥的原理以及大量液体流动产生的电渗透压驱使离子化的药物转运而透过皮肤的，这个过程是一个主动转运过程，此外电流的流动还可能提高皮肤的渗透压有助于药物的转运，使药物中的阳离子从阳极，阴离子从阴极导入体内，达到治疗疾病的目 的。这种方法具有药物直达病所、药效维持时间长、无痛、病人易于接受的特点。特别是药物离子从穴位透入，可借经络的兴奋性喝导性循环周流全身，能充分发挥疗效。上述改变过程都是可逆的，并不会造成皮肤损伤。
迄今为止已经有非常多的药物经离子导入给药***给药，取得了不同程度的成效。目前使用离子导入法给药的方式主要有两种：离子导入仪给药和离子导入贴片式给药。离子导入仪是根据生物电药导理论，仿生论，热敷医学，磁场学，中国古典中医医学及现代微电脑技术，结合多年临床实践和大量用户反馈意见的基础上研制开发的新一代医疗仪器。仪器具有中频、低频、药物导入治疗功能，适用于各级康复医疗机构及家庭治疗使用。如中药导入仪，可以导入的产品系列有Mivisy生物因子原液系列、GMI生物冻干粉系列、Sicimy生物喷雾剂系列、Marfi生物面膜液系列、Archa生物洁面品系列和Vivimy眼部护理生物精华。导入仪为新型微电脑芯片设计，具有多重安全保护功能，而特设的非对称中频电流将药物离子更深更有效的导入病灶部位，能够远红外热敷、促进血液循环，适用于家庭保健治疗。然而导入仪体积较大不易移动，使用也会有所不便。
而在美国也已有利用离子电渗析透皮给药法的产品上市，主要是离子导入贴片式产品，如可以经皮肤主动输送偏头痛最常用药物舒马曲坦的Zecuity，用于治疗住院成人急性中度至严重的术后疼痛的Ionsys，用于局部镇痛的LidoSite Topical System，用于传递水溶性药物的IOMED Phoresor Ionphretic药物传递***以及ACTIVA patch产品。这些产品是由产品所携带的电池提供电流，以达到透皮给药的目的，而这些产品均为一次性使用，所供电流及给药量皆是固定的，不可调的。
发明内容
有鉴于此，本发明的目的在于提供一种新型智能透皮和口腔给药设备。
为了实现上述目的，本发明采取的技术方案为：
一种新型智能透皮和口腔给药设备，其特征在于，包括：透皮扩散仪，所述透皮扩散仪包括：接受池，所述接受池上具有两接受池口，所述接受池上还设有取样口；供给池，每一所述供给池均具有一供给池口，两所述供给池口分别与两所述接受池口相正对，并且每一所述供给池口和所述接受池口 之间还设有模拟皮；还包括：正极贴片和负极贴片，所述正极贴片和所述负极贴片分别贴在两所述模拟皮上；智能电流控制器，所述智能电流控制器通过正极电路与所述正极贴片相连接，所述智能电流控制器通过负极电路与所述负极贴片相连接。
上述的新型智能透皮和口腔给药设备，其中，还包括：电流实时检测仪，所述正极电路或所述负极电路中设有电流实时检测器。
上述的新型智能透皮和口腔给药设备，其中，所述透皮扩散仪还包括搅拌子和磁力搅拌器，所述搅拌子设置在所述接受池内，所述磁力搅拌器正对于所述搅拌子。
上述的新型智能透皮和口腔给药设备，其中，所述正极贴片为含药贴片同时所述负极贴片为不含药贴片，或所述正极贴片为不含药贴片同时所述负极贴片为含药贴片。
上述的新型智能透皮和口腔给药设备，其中，所述含药贴片的吸垫内具有若干药溶液，所述不含药贴片的吸垫内具有与若干所述药溶液等量的水。
上述的新型智能透皮和口腔给药设备，其中，所述接受池内加满磷酸盐缓冲盐水，所述接受池内的温度保持在37℃。
上述的新型智能透皮和口腔给药设备，其中，所述模拟皮为去除了脂肪组织的猪口腔黏膜或去除了皮下组织的猪皮。
上述的新型智能透皮和口腔给药设备，其中，所述接受池为密闭的盒体结构，两所述接受池口均开设在所述接受池的上端。
上述的新型智能透皮和口腔给药设备，其中，包括两所述取样口，两所述取样口分别开设在所述接受池的两侧。
一种新型智能透皮和口腔给药设备的使用方法，其中，包括上述的任意一项新型智能透皮和口腔给药设备，所述使用方法包括：
步骤S1：将所述模拟皮置于每一所述供给池和一所述接受池之间，所述模拟皮的内侧朝向接受池；
步骤S2：将所述正极贴片和所述负极贴片分别置于两所述供给池内，并分别贴在两所述模拟皮上；
步骤S3：在所述接受池内加满磷酸盐缓冲盐水，用以模拟血液循环；并使接受池内的温度保持在37℃，用于模拟人体体温；同时设置电流和通电时 间，并通电给药；
步骤S4：分别选取若干时间点，并在若干所述时间点从所述接受池中取样，通过高压液相分析仪进行药物分析并记录；
步骤S5：给药结束后，将所述模拟皮放入水中浸泡若干天，并通过高压液相分析仪分析残留的药物含量并记录。
本发明由于采用了上述技术，使之与现有技术相比具有的积极效果是：(1)本发明由于设有两个独立的供给池，避免了造成正极贴片和负极贴片距离近导致短路问题，同时能够正常形成电流回路。
(2)本发明通过设置两侧同时取样，避免了实验过程中药物渗透速度及溶液的流动速度对接受池内的渗药浓度不均的影响。
附图说明
图1是本发明的新型智能透皮和口腔给药设备的示意图。
图2是本发明的新型智能透皮和口腔给药设备的透皮扩散仪的示意图。
附图中：1、接受池；11、接受池口；12、取样口；2、供给池；21、供给池口；3、模拟皮；4、正极贴片；5、负极贴片；6、智能电流控制器；7、电流实时检测仪；81、搅拌子；82、磁力搅拌器。
具体实施方式
下面结合附图和具体实施例对本发明作进一步说明，但不作为本发明的限定。
图1是本发明的新型智能透皮和口腔给药设备的示意图，图2是本发明的新型智能透皮和口腔给药设备的透皮扩散仪的示意图，请参见图1、图2所示，示出了一种较佳实施例的新型智能透皮和口腔给药设备，包括：透皮扩散仪，透皮扩散仪包括：接受池1，接受池1上具有两接受池口11，接受池1上还设有取样口12。
此外，作为一种较佳的实施例，透皮扩散仪还包括：供给池2，每一供给池2均具有一供给池口21，两供给池口21分别与两接受池口11相正对，并且每一供给池口21和接受池口11之间还设有模拟皮3。
另外，作为一种较佳的实施例，新型智能透皮和口腔给药设备还包括： 正极贴片4和负极贴片5，正极贴片4和负极贴片5分别贴在两模拟皮3上。
进一步，作为一种较佳的实施例，新型智能透皮和口腔给药设备还包括：智能电流控制器6，智能电流控制器6通过正极电路与正极贴片4相连接，智能电流控制器6通过负极电路与负极贴片5相连接。只能电流控制器6可由手动或蓝牙或Wifi或远程GPRS控制调节电流大小。
更进一步，作为一种较佳的实施例，新型智能透皮和口腔给药设备还包括：电流实时检测仪7，正极电路或负极电路中设有电流实时检测器7。电流实时检测器7用于实时检测给药时的电流稳定性。电流实时检测器7能够每隔一设定时间(例如每隔1秒、每隔3秒等)检测该设定时间内的最大电流和平均电流，并反馈制表。
再进一步，作为一种较佳的实施例，透皮扩散仪还包括搅拌子81和磁力搅拌器82，搅拌子81设置在接受池1内，磁力搅拌器82正对于搅拌子81。
以上所述仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围。
本发明在上述基础上还具有如下实施方式：
本发明的进一步实施例中，请继续参见图1、图2所示，正极贴片4为含药贴片同时负极贴片5为不含药贴片，或正极贴片4为不含药贴片同时负极贴片5为含药贴片。
本发明的进一步实施例中，含药贴片的吸垫内具有若干药溶液，不含药贴片的吸垫内具有与若干药溶液等量的水。其中，含药贴片内的药溶液为任何在水溶液中可以带正电荷或负电荷或离子化的药物成分。
本发明的进一步实施例中，接受池1内加满磷酸盐缓冲盐水，接受池1内的温度保持在37℃。
本发明的进一步实施例中，模拟皮3为去除了脂肪组织的猪口腔黏膜或去除了皮下组织的猪皮。
本发明的进一步实施例中，接受池1为密闭的盒体结构，两接受池口11均开设在接受池的上端。
本发明的进一步实施例中，包括两取样口12，两取样口12分别开设在接受池1的两侧。
本发明的第一种使用方法：
步骤S1：将模拟皮3置于每一供给池2和一接受池1之间，模拟皮3的内侧朝向接受池1；
步骤S2：将正极贴片4和负极贴片5分别置于两供给池2内，并分别贴在两模拟皮3上；
步骤S3：在接受池1内加满磷酸盐缓冲盐水，用以模拟血液循环；并使接受池1内的温度保持在37℃，用于模拟人体体温；同时设置电流(可设置电流例如100、200、300、400、500μA等)和通电时间，调节搅拌子转速以保证接受池1中的药物均匀，并通电给药；
步骤S4：分别选取若干时间点，并在若干时间点从接受池1中取样，通过高压液相分析仪进行药物分析并记录；
步骤S5：给药结束后，将模拟皮3放入水中浸泡若干天，并通过高压液相分析仪分析残留的药物含量并记录。
本发明的第二种使用方法：
步骤S1：选用厚度300-500μm，面积为4.0cm 2的猪皮，置于每一供给池2和一接受池1之间，猪皮膜体的内侧朝向接受池1；
步骤S2：将连接好的含药贴片置于供给池2内并贴在猪皮膜体的表皮上；
步骤S3.1：在接受池1内加满磷酸盐缓冲盐水，用以模拟血液循环；并使接受池1内的温度保持在37℃，用于模拟人体体温；
步骤S3.2：设置电流为300μA，设置通电时间为3小时，通电给药，同时启动电流实时检测仪7。
步骤S3：通电开始给药后，分别在给药后1，2，3h的时间点从接受池1中取样品(在两个取样口12同时取样，取样量为1ml)，用高压液相分析仪进行药物分析，记录。
按照上述第二种使用方法可实施经皮给药(实验药物为盐酸利多卡因)模拟实验，获得的结果如表1至表4所示。
Figure PCTCN2018111187-appb-000001
Figure PCTCN2018111187-appb-000002
表1
Figure PCTCN2018111187-appb-000003
表2
Figure PCTCN2018111187-appb-000004
表3
Figure PCTCN2018111187-appb-000005
表4
本发明的第三种使用方法：
步骤S1：选用厚度300-500μm，面积为4.0cm2的猪口腔黏膜和猪皮，将猪皮置于一供给池2和一接受池1之间，猪皮膜体的内侧朝向接受池1，将猪口腔黏膜置于另一供给池2和另一接受池1之间，黏膜内侧朝向接受池1；
步骤S2：将连接好的不含药贴片置于一供给池2内并贴在猪皮膜体的表皮上，将连接好的含药贴片置于另一供给池2内并贴在猪口腔黏膜的表皮上；
步骤S3.1：在接受池1内加满磷酸盐缓冲盐水，用以模拟血液循环；并使接受池1内的温度保持在37℃，用于模拟人体体温；
步骤S3.2：设置电流为300μA，设置通电时间为3小时，通电给药，同时启动电流实时检测仪7。
步骤S3：通电开始给药后，分别在给药后0，0.5，1，2，3h的时间点从接受池1中取样品(在两个取样口12同时取样，取样量为1ml)，用高压液相分析仪进行药物分析，记录。
步骤S4：给药结束后将猪口腔黏膜放入10ml水中浸泡3-4天，取样，用高压液相分析仪进行分析检测残留在猪口腔黏膜内的药物含量。
按照上述第三种使用方法可实施口腔黏膜给药(实验药物为盐酸利多卡因)模拟实验，获得的结果如表5所示。
Figure PCTCN2018111187-appb-000006
表5
以上所述仅为本发明较佳的实施例，并非因此限制本发明的实施方式及保护范围，对于本领域技术人员而言，应当能够意识到凡运用本发明说明书及图示内容所作出的等同替换和显而易见的变化所得到的方案，均应当包含在本发明的保护范围内。

Claims (10)

  1. 一种新型智能透皮和口腔给药设备，其特征在于，包括：
    透皮扩散仪，所述透皮扩散仪包括：
    接受池，所述接受池上具有两接受池口，所述接受池上还设有取样口；
    供给池，每一所述供给池均具有一供给池口，两所述供给池口分别与两所述接受池口相正对，并且每一所述供给池口和所述接受池口之间还设有模拟皮；
    还包括：
    正极贴片和负极贴片，所述正极贴片和所述负极贴片分别贴在两所述模拟皮上；
    智能电流控制器，所述智能电流控制器通过正极电路与所述正极贴片相连接，所述智能电流控制器通过负极电路与所述负极贴片相连接。
  2. 根据权利要求1所述的新型智能透皮和口腔给药设备，其特征在于，还包括：
    电流实时检测仪，所述正极电路或所述负极电路中设有电流实时检测器。
  3. 根据权利要求2所述的新型智能透皮和口腔给药设备，其特征在于，所述透皮扩散仪还包括搅拌子和磁力搅拌器，所述搅拌子设置在所述接受池内，所述磁力搅拌器正对于所述搅拌子。
  4. 根据权利要求1或3所述的新型智能透皮和口腔给药设备，其特征在于，所述正极贴片为含药贴片同时所述负极贴片为不含药贴片，或所述正极贴片为不含药贴片同时所述负极贴片为含药贴片。
  5. 根据权利要求4所述的新型智能透皮和口腔给药设备，其特征在于，所述含药贴片的吸垫内具有若干药溶液，所述不含药贴片的吸垫内具有与若干所述药溶液等量的水。
  6. 根据权利要求1所述的新型智能透皮和口腔给药设备，其特征在于，所述接受池内加满磷酸盐缓冲盐水，所述接受池内的温度保持在37℃。
  7. 根据权利要求1所述的新型智能透皮和口腔给药设备，其特征在于，所述模拟皮为去除了脂肪组织的猪口腔黏膜或去除了皮下组织的猪皮。
  8. 根据权利要求1所述的新型智能透皮和口腔给药设备，其特征在于，所述 接受池为密闭的盒体结构，两所述接受池口均开设在所述接受池的上端。
  9. 根据权利要求8所述的新型智能透皮和口腔给药设备，其特征在于，包括两所述取样口，两所述取样口分别开设在所述接受池的两侧。
  10. 一种新型智能透皮和口腔给药设备的使用方法，其特征在于，包括权利要求1至9中所述的任意一项新型智能透皮和口腔给药设备，所述使用方法包括：
    步骤S1：将所述模拟皮置于每一所述供给池和一所述接受池之间，所述模拟皮的内侧朝向接受池；
    步骤S2：将所述正极贴片和所述负极贴片分别置于两所述供给池内，并分别贴在两所述模拟皮上；
    步骤S3：在所述接受池内加满磷酸盐缓冲盐水，用以模拟血液循环；并使接受池内的温度保持在37℃，用于模拟人体体温；同时设置电流和通电时间，并通电给药；
    步骤S4：分别选取若干时间点，并在若干所述时间点从所述接受池中取样，通过高压液相分析仪进行药物分析并记录；
    步骤S5：给药结束后，将所述模拟皮放入水中浸泡若干天，并通过高压液相分析仪分析残留的药物含量并记录。
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