WO2021017791A1 - 胃肠道取样释药胶囊 - Google Patents

胃肠道取样释药胶囊 Download PDF

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Publication number
WO2021017791A1
WO2021017791A1 PCT/CN2020/101250 CN2020101250W WO2021017791A1 WO 2021017791 A1 WO2021017791 A1 WO 2021017791A1 CN 2020101250 W CN2020101250 W CN 2020101250W WO 2021017791 A1 WO2021017791 A1 WO 2021017791A1
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WIPO (PCT)
Prior art keywords
drug release
sampling
gastrointestinal
storage tank
sample collection
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PCT/CN2020/101250
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English (en)
French (fr)
Inventor
张景亮
李晓婷
常宝珠
岳丽晓
决利利
张轲
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温州芳植生物科技有限公司
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Priority claimed from CN201910687532.XA external-priority patent/CN110354375A/zh
Priority claimed from CN201910681840.1A external-priority patent/CN110301943A/zh
Application filed by 温州芳植生物科技有限公司 filed Critical 温州芳植生物科技有限公司
Publication of WO2021017791A1 publication Critical patent/WO2021017791A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

  • the invention belongs to the technical field of medical appliances, and specifically relates to a gastrointestinal sampling and drug release capsule.
  • Stomach and intestines are important organs for food digestion and absorption, which are of great significance to human health. Stomach and intestinal diseases occur from time to time in daily life, and some chronic diseases have a long treatment cycle, requiring long-term medications, and may even transform into serious diseases such as cancer. In addition, the presence of microorganisms in the stomach and intestines also has an important impact on the health of the stomach and intestines.
  • the current common detection methods such as ultrasound, X-ray barium meal examination, endoscopy and CT, etc.
  • the present invention provides a gastrointestinal sampling drug release capsule capable of sampling the gastrointestinal tract.
  • a gastrointestinal sampling and drug release capsule having a shell, a sampling tube, at least one inner core set in the shell, and an annular area surrounded by adjacent layers.
  • the ring-shaped area is divided up and down by partitions arranged between the layers.
  • the ring-shaped area above the partition is the drug release area, and the ring-shaped area below the partition is the sample collection area;
  • the outer layer of the adjacent layer is At least two drug release holes are provided at a position corresponding to the drug release area, wherein at least one of the drug release holes is connected to one end of the sampling tube, and the other end of the sampling tube is connected to the sample collection area.
  • the release hole is provided with a sealing film, the sealing film is made of materials that can be digested in a specific environment, and the shell and inner core are made of medical materials that cannot be digested in the human body.
  • a gel-forming agent is arranged in the sample collection area, and the gel-forming agent becomes a gel-like substance after contacting with a liquid.
  • a gel-forming agent for example, gellan gum, xanthan gum, konjac gum and other substances. Among them, gellan gum is preferred. Gellan gum is easier to gel in the presence of divalent positive ions such as calcium ions or magnesium ions. It is possible to consider setting gellan gum and soluble divalent metal salt compounds in the sample area .
  • an effervescent agent is arranged in the medicine release zone or medicine, citric acid and sodium bicarbonate are arranged at intervals. Citric acid and sodium bicarbonate will produce bubbles when they are in contact with water, which can be similar to effervescent tablets, accelerating the gushing of drugs in the drug release area to achieve better drug release effects.
  • the sampling tube is a flexible capillary tube, and a water absorbing material is provided on the surface of the sample collection area.
  • a plurality of sealed sample collection cavities are separately arranged in the sample collection area, and the sample collection cavities are respectively connected to different sampling tubes, and the sealing membranes provided at the drug release holes corresponding to the different sample collection cavities can The capsules are digested at different time points after entering the human body.
  • the thickness of the sealing film provided at the drug release hole corresponding to different sample collection cavities is different.
  • the capsule has a first inner core and a second inner core, the second inner core is arranged in the first inner core, the outer shell is provided with a gastric releasing hole, and the gastric releasing hole is provided There is a gastric coating film; the first inner core is provided with an intestinal drug release hole, and the intestinal drug release hole is provided with an enteric coating film.
  • the gastric drug releasing hole and the intestinal drug releasing hole are arranged correspondingly, and the gastric drug releasing hole is larger than the enteric drug releasing hole.
  • the main raw material of the gastric soluble coating film is selected from any one or a combination of hydroxypropyl methylcellulose, PEG or gastric soluble acrylic resin IV.
  • the main raw material of the enteric coating film is selected from acrylic resin No. I, No. II, No. III, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, polyethylene Any one or a combination of alcohol phthalate, cellulose acetate trimellitate, acrylic resin Eus100, Eu1100 and shellac.
  • suitable materials can be used to make the sealing film according to the characteristics of each material and the specific environment where sampling is required.
  • a gastrointestinal drug release sampling device comprising a drug release sampling device set in the body and a magnetic control device set outside the body.
  • the drug release sampling device has a shell, an inner core, and a storage provided between the shell and the inner core.
  • the medicine tank, the area between the medicine storage tank and the outer shell forms a medicine storage cavity, the area between the medicine storage tank and the inner core forms a sample collection cavity, and the medicine storage tank is connected to the medicine storage tank through an elastic connecting piece.
  • the inner shell is connected, a first magnetic material is arranged on the medicine storage tank, a second magnetic material is arranged on the inner core, and the first magnetic material and the second magnetic material attract each other;
  • the magnetic control device Comprising a Hall-effect sensor probe and a third magnetic material;
  • the medicine storage tank is in the shape of a groove with an upper opening, and a sealing film for sealing the medicine storage cavity is provided on the housing corresponding to the position of the medicine storage tank,
  • the sealing film is made of materials that are soluble in the human body.
  • the sample collection cavity is in the shape of an inverted triangle, and a gel forming agent for fixing the collected sample in the sample collection cavity is placed in the sample collection cavity.
  • a guide groove for limiting the position of the medicine storage groove is extended inwardly on the inner surface of the housing, and the medicine storage groove is slidably connected in the guide groove.
  • the medicine storage tank has a shallow mouth shape.
  • the side surface of the medicine storage tank is connected with the bottom surface of the medicine storage tank through a torsion spring, the side surface of the medicine storage tank is provided with medicines, and the bottom surface of the medicine storage tank is provided with a sample to enter the collection.
  • the injection hole in the sample chamber is provided.
  • a plurality of groups of medicine storage devices are arranged circumferentially on the outer shell.
  • the sealing films corresponding to the multiple sets of drug storage devices are made of materials that can be dissolved under different physiological conditions.
  • the thicknesses of the sealing films corresponding to the multiple groups of medicine storage devices are different.
  • the sealing film is made of a gastric coating film/or an enteric coating film material.
  • the gastric coating film is independently selected from any one or a combination of hydroxypropyl methylcellulose, PEG or gastric acrylic resin IV; the main raw material of the enteric coating film is independently It is selected from acrylic resin No. I, No. II, No. III, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, polyvinyl phthalate, cellulose acetate trimellitate , Acrylic resin Eus100, Eu1100 and shellac any one or a combination of several.
  • the beneficial effects of the present invention are: the gastrointestinal tract sampling drug release capsule of the present invention can conveniently sample the gastrointestinal tract and release corresponding drugs. It is also possible to select different sealing membrane materials to realize the taking and/or releasing of medicines at different times (gastrointestinal sampling and releasing capsules at different positions in the gastrointestinal tract), so as to facilitate a more comprehensive understanding of the human gastrointestinal tract Physiological and biochemical status.
  • the gastrointestinal drug release sampling device can collect gastrointestinal samples for the detection of multiple physiological and biochemical indicators; and the gastrointestinal tract of the present invention
  • the arrangement of the first magnetic material, the second magnetic material and the third magnetic material of the drug release sampling device enables the gastrointestinal drug release sampling device of the present invention to realize most of the functions without a large number of electronic devices.
  • the gastrointestinal tract sampling and drug release capsule of the present invention has a compact and simple structure, convenient use and low manufacturing cost.
  • Figure 1 is a schematic diagram of the structure of the gastrointestinal sampling and drug release capsule of Example 1;
  • Example 2 is a schematic diagram of the structure of the gastrointestinal sampling and drug release capsule of Example 2;
  • Example 3 is a schematic diagram of the structure of the gastrointestinal sampling and drug release capsule of Example 3;
  • FIG. 4 is a schematic structural diagram of a gastrointestinal tract sampling and drug release sampling device of embodiment 4 of the present invention.
  • FIG. 5 is a schematic diagram of the structure of the gastrointestinal tract sampling and drug release sampling device of Embodiment 5 of the present invention.
  • FIG. 6 is a schematic structural diagram of a gastrointestinal tract sampling and drug release sampling device according to Embodiment 6 of the present invention.
  • Fig. 7 is a schematic diagram of the structure of the gastrointestinal tract sampling and drug release sampling device of embodiment 7 of the present invention.
  • a gastrointestinal sampling and drug release capsule As shown in Figure 1, a gastrointestinal sampling and drug release capsule.
  • the capsule has a shell 1, a sampling tube 2, at least one inner core 3 arranged in the shell 1, and an annular area surrounded by adjacent layers.
  • the partition 4 arranged between the layers is separated up and down.
  • the annular area above the partition is the drug release area 5, and the ring area below the partition 4 is the sample collection area 6.
  • the outer layer of the adjacent layer is connected to the drug release area 5.
  • At least two drug release holes 11 are provided at the corresponding positions, of which at least one drug release hole 11 is connected to one end of the sampling tube 2 and the other end of the sampling tube 2 is connected to the sample collection area 6; the drug release hole 11 is provided There is a sealing film (not shown in the figure), the sealing film is made of materials that can be digested in a specific environment, and the shell 1 and the inner core 3 are made of medical materials that cannot be digested in the human body.
  • the working principle of the gastrointestinal sampling drug release capsule of the present invention when it is necessary to administer and/or sample the gastrointestinal tract, the gastrointestinal sampling drug release capsule can be taken orally.
  • the material of the sealing film can be selected according to the actual situation. For example, when it is necessary to release the drugs in the drug release zone in the stomach, materials that can only be digested in the stomach can be used to make a sealing film, such as common gastric coating materials. After the sealing film is digested in a specific environment, the liquid or sample in the environment where the gastrointestinal sampling capsule is located will enter the sampling tube 2, and the medicine stored in the medicine release area 5 can also directly enter the environment to realize the medicine in the environment. Release in a specific environment to achieve the purpose of curing diseases. The sample entering the sampling tube 2 will further enter the sample collection area 6 along the sampling tube 2 to complete the sample collection;
  • a gelling agent can be set in the sample collection area 6.
  • the gelling agent will become a gel-like substance after contact with the liquid.
  • a one-way liquid inlet valve can also be set on the sampling pipe 2 for better effect.
  • an effervescent agent or an interval of drugs, citric acid and sodium bicarbonate can be arranged in the drug release area 5, so that after the drugs come into contact with the environment, When the medicine disintegrates, a small amount of gas will be generated (on the premise of not affecting the efficacy and health of the medicine), which promotes the medicine to gush out of the medicine release area 5 and more fully contact the environment.
  • the sampling tube 2 can be a flexible capillary tube, and the surface of the sample collection area 6 is provided with a water-absorbing material. Using the principle of capillary siphon, the sample can enter the sample collection area 6 more smoothly to realize the sample collection.
  • the gastrointestinal sampling and drug release capsule has a first inner core 31 (located in the outer shell) and a second inner core 32, and the second inner core 32 is arranged on the first inner core 31.
  • the shell 1 is provided with a gastric drug release hole 111, and the stomach drug release hole 111 is provided with a gastric dissolving coating film;
  • the first inner core 31 is provided with an intestinal drug release hole 112, which 112 places are provided with enteric coating film.
  • the medicine release area 5 between the shell 1 and the first inner core 31 can be placed for treating gastric diseases, and the medicine release area 5 between the first inner core 31 and the second inner core 32 can be placed for treating intestinal diseases. Medicines.
  • a sampling tube 2 is arranged at the drug release hole, and the sample can enter the sample collection area 6 between the housing 1 and the first inner core 31 through the sampling tube 2 to realize the collection of gastric samples.
  • a sampling tube 2 is provided at the intestinal drug release hole 112, the sample can enter the first inner core through the sampling tube 2
  • the sample collection area 6 between 31 and the second inner core 32 realizes the collection of intestinal samples.
  • the gastric drug release hole 111 and the intestinal drug release hole 112 can be set correspondingly, and the stomach drug release hole 111 is larger than the intestinal drug release hole 112, that is, the intestine
  • the drug release hole 112 is arranged within the opening range of the gastric drug release hole 111, so that the drug stored in the drug release area 5 between the first inner core 31 and the second inner core 32 can more quickly and fully realize the contact with the intestinal environment .
  • the sample collection area 6 can be divided into a structure with multiple sealed sample collection cavities 61, and the sample collection cavities 61 and Different sampling tubes 2 are connected, and the sealing membranes at different sampling tubes 2 are controlled to be digested at different time points (different positions in the body), so as to realize sampling at different positions of the human stomach and intestine.
  • the control of the digestion time of the sealing film can be achieved by setting the sealing film of different thicknesses (when the materials of multiple sealing films are the same, the greater the thickness of the sealing film, the less easy it is to be digested. The later the time). It can also be realized by using sealing films of different materials according to actual needs.
  • acrylic resin No. II dissolves above pH 6
  • acrylic resin No. III dissolves above pH 7.
  • acrylic resin No. II or acrylic resin No. III can be used as the sealing film.
  • a variety of composite materials can also be used to prepare the sealing film to achieve the purpose of adjusting the sealing film to be digested at different time points.
  • a gastrointestinal drug release sampling device including a drug release sampling device set in the body and a magnetic control device set outside the body, the drug release sampling device has a shell 1, an inner core 2 and a shell 1 and The medicine storage tank 3 between the inner core 2 and the area between the medicine storage tank 3 and the shell 1 form a medicine storage cavity 4, the area between the medicine storage tank 3 and the inner core 2 forms a sample collection cavity 5, and the medicine storage tank 3 is elastic
  • the connecting piece 6 is connected to the inner shell 2, the medicine storage tank 3 is provided with a first magnetic material 31, and the core 2 is provided with a second magnetic material 21.
  • the first magnetic material 31 and the second magnetic material 21 attract each other; a magnetic control device It includes a Hall effect sensor probe and a third magnetic material; the medicine storage tank 3 is in the shape of a groove with an upper opening, and a sealing film 32 for sealing the medicine storage cavity 4 is provided on the housing 1 at a position corresponding to the opening of the medicine storage tank 3,
  • the sealing film 32 is made of a material that is soluble in the human body.
  • the drug release sampling device when it is necessary to sample and/or administer the gastrointestinal tract, the drug release sampling device (micro device) of the present invention can be taken orally, so as to facilitate oral administration and not to the gastrointestinal tract.
  • the sealing film 32 can be digested and dissolved in a specific physiological environment (for example, if it is necessary to sample and/or administer the medicine in the human stomach, the sealing film 32 should only be Materials with good biocompatibility that are digested and dissolved under acidic conditions in the stomach, such as commonly used gastric-soluble coating materials, etc., can release the medicines in the medicine storage tank 3 in the stomach.
  • the Hall-effect sensor probe (multiple settings can be provided) in the magnetron device can be used outside the body to determine the approximate position of the drug release sampling device in the body by detecting the magnetic field strength, and then the third magnetic material (magnetic force can be used) Strong permanent magnet material) is placed on the body surface close to the position of the drug release device in the body, the third magnetic material attracts the first magnetic material 21 arranged on the drug storage tank 3, when the third magnetic material is opposite to the first magnetic material
  • the elastic connecting member 6 will drive the medicine storage tank 3 to move in the direction outside the housing 1, and the medicine storage tank 3 After moving to the outside of the housing 1, the gap between the medicine storage tank 3 and the housing 1 is the channel through which the sample enters the sample collection cavity 5 to achieve sample collection.
  • a gelling agent can be set in the sample collection cavity 5. After the sample enters the sample collection cavity 5, it will be solidified by the gel forming agent.
  • the gel-like substance can play a role in fixing the sample to a certain extent.
  • the position of the drug release sampling device in the body can be roughly determined, so as to realize the tracking of the movement trajectory of the drug release sampling device in the body;
  • the third magnet is placed downstream of the drug release sampling device in the body. Under the action of the magnetic attraction of the third magnet, it can also accelerate the movement of the drug release sampling device in the body in the gastrointestinal tract and promote intestinal peristalsis.
  • the sample collection cavity 5 can be set up in the shape of a large upper and a small shape (especially an inverted cone shape).
  • a gel forming agent for fixing the collected sample in the sample collection cavity 5 is placed inside.
  • the gel forming agent can be konjac gum, xanthan gum, gellan gum, agar, carboxymethyl cellulose, guar Gum, sodium alginate, locust bean gum, etc., or a combination thereof.
  • a combination of gellan gum and soluble salt compounds is preferred, such as sodium citrate, sodium chloride, magnesium chloride, calcium chloride, and the like.
  • a guide groove (open at both ends) for limiting the position of the medicine storage tank 3 can be provided on the inner surface of the housing 1, and the medicine storage tank 3 is slidably connected in the guide groove to facilitate the storage
  • the medicine groove 3 slides in the radial direction of the housing 1.
  • the medicine storage tank 3 can be arranged in a shallow mouth shape, when the attraction of the third magnetic material to the first magnetic material When the attraction force of the second magnetic material to the first magnetic material is greater, the medicine storage tank 3 will be ejected to the outer surface of the housing 1 under the action of the elastic connector 6 (under the premise that the sealing film 32 has been digested or decomposed),
  • the shallow mouth-shaped medicine storage tank 3 makes it easier for medicines to enter the body.
  • the gap between the bottom surface of the medicine storage tank 3 and the housing 1 can be used as a channel for the sample to enter the sample collection cavity 5 to realize sample collection.
  • the side surface of the medicine storage tank 3 is connected to the bottom surface of the medicine storage tank 3 through a torsion spring, the side surface of the medicine storage tank 3 is provided with medicine, and the bottom surface of the medicine storage tank 3 is provided with a sample Enter the sample injection hole in the sample chamber 5.
  • the torsion spring connected to the ground on the side of the medicine storage tank 3 is deformed, so that the side surface of the medicine storage tank 3 becomes a horizontal plane Or the inclination angle becomes smaller, so that the medicines stored in the medicine storage tank 3 can be in contact with the human body more conveniently.
  • the sample injection hole on the bottom surface of the drug storage tank 3 allows the sample to enter the sample collection cavity 5 through the sample injection hole after the sealing film 32 is dissolved, so that the drug release and sampling can be performed simultaneously.
  • the sample collection cavity 5 can be set in an inverted conical shape to better realize the preservation of the sample in the sample collection cavity 5.
  • multiple sets of medicine storage tanks 3 can be provided on the outer shell 1 at intervals in the circumferential direction, so that multiple samples can be collected.
  • the sealing films 32 corresponding to multiple groups of medicine storage tanks 3 are made of materials that can be dissolved under different physiological conditions, or the thickness of the sealing films 32 corresponding to multiple groups of medicine storage devices are different. , So that different medicines contained in different medicine storage tanks 3 can respectively enter the human body at different time points after the medicine release sampling device enters the human body.
  • the sealing film 32 can be made of a gastric coating film/or an enteric coating film material.
  • the sealing film 32 can be a gastric-soluble coating film, and the main raw material of the gastric-soluble coating film can be independently selected from hydroxypropyl methylcellulose, PEG or gastric-soluble acrylic acid.
  • the sealing film 32 can be an enteric coating film, and the main raw material of the enteric coating film is independently selected from acrylic acid Resin I, II, III, cellulose acetate phthalate, hydroxypropyl methylcellulose phthalate, polyvinyl phthalate, cellulose acetate trimellitate, acrylic resin Eus100 , Eu1100 and shellac, etc. Any one or a combination of several.

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Abstract

一种胃肠道取样释药胶囊，具有外壳（1）、取样管（2）、设置在外壳（1）内的至少一层内核（3）及相邻层所围成的环形区域，环形区域被设置在层间的隔板（4）上下分隔，隔板（4）上方的环形区域为药品释放区（5），隔板（4）下方的环形区域为集样区（6）；相邻层中的较外层上与药品释放区（5）相对应的位置处设有至少2个释药孔（11），其中至少1个释药孔（11）与取样管（2）的一端相连，取样管（2）的另一端与集样区（6）相连。另一种胃肠道释药取样装置还包括设置在体内的释药取样装置和设置在体外的磁控装置，密封膜（32）采用在人体中可溶解的材料制成。胃肠道取样释药胶囊具有使用方便、成本低等多种优点。

Description

胃肠道取样释药胶囊 【技术领域】
本发明属于医疗用具技术领域，具体涉及一种胃肠道取样释药胶囊。
【背景技术】
胃、肠道是食物消化和吸收的重要器官，对人体健康有重要意义。胃、肠道疾病在日常生活中时有发生，且某些慢性病治疗周期长，需要长时间服用药品，甚至有可能会转化成癌症等严重疾病。此外，胃、肠道中微生物的存在也对胃、肠道的健康有重要影响，目前常见的检测手段如超声、X线钡餐检查、内镜检查及CT等，需要借助专业设备，且只能用于病情的诊断，不能方便的实现对胃、肠道取样等操作，使得不能直观的了解胃、肠道环境，以便更准确的查找病因和采取适当的治疗方法。
此外，现有技术中虽然有用于检测胃肠道疾病的微型诊断设备，但需要在诊断设备上负载大量电子器件，制作成本高，且不能对胃肠道内生长的微生物进行检测，不利于病因的查明。
【发明内容】
为了解决上述技术问题，本发明提供一种可对胃肠道进行取样的胃肠道取样释药胶囊。
本发明是通过以下技术方案实现的：一种胃肠道取样释药胶囊，所述胶囊具有外壳、取样管、设置在外壳内的至少一层内核及相邻层所围成的环形区域，所述环形区域被设置在层间的隔板上下分隔，隔板上方的环形区域为药品释放区，所述隔板下方的环形区域为集样区；所述相邻层中的较外层上与所述药品释放区相对应的位置处设有至少2个释药孔，其中至少1个所述释药孔与所述取样管的一端相连，所述取样管的另一端与所述集样区相连；所述释药孔处设有密封膜，所述密封膜采用可在特定环境中被消化的材料制成，所述外壳和内核采用在人体内不能被消化的医用材料制成。
优选的，所述集样区内设有成胶剂，所述成胶剂与液体接触后会变成凝胶状物质。例如结冷胶、黄原胶、魔芋胶等物质。其中，优选结冷胶，结冷胶在钙离子或镁离子等二价正离子存在的情况下，更容易成胶，可考虑在集样区内设置结冷胶和可溶性二价金属盐类化合物。
优选的，所述药品释放区内设有泡腾剂或间隔设置有药品、柠檬酸和碳酸氢钠。柠檬酸和碳酸氢钠在遇水后会产生气泡，进而可起类似于泡腾片，加速药品释放区内药品的涌出，以达到更好的释药效果。
优选的，所述所述取样管为柔性毛细管，所述集样区表面设有吸水材料。
优选的，所述集样区内分隔设置有多个密封集样腔，所述集样腔分别与不同的取样管相连，不同集样腔所对应的释药孔处设置的密封膜可在所述胶囊进入人体后的不同时间点被消化。
优选的，不同集样腔所对应的释药孔处设置的密封膜的厚度不同。
优选的，所述胶囊具有第一内核和第二内核，所述第二内核设置在所述第一内核内，所述外壳上设有胃部释药孔，所述胃部释药孔处设有胃溶包衣膜；所述第一内核上设有肠部释药孔，所述肠部释药孔处设有肠溶包衣膜。
优选的，所述胃部释药孔和所述肠部释药孔对应设置，且所述胃部释药孔大于所述肠溶释药孔。
优选的，所述胃溶包衣膜的主要原料选自羟丙基甲级纤维素、PEG或胃溶性丙烯酸树脂IV中的任意一种或几种组合。
优选的，所述肠溶包衣膜的主要原料选自丙烯酸树脂I号、II号、III号、邻苯二甲酸醋酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、聚乙烯醇酞酸酯、醋酸纤维素苯三酸酯、丙烯酸树脂Eus100、Eu1100和虫胶中的任意一种或几种的组合。实际选择时，可根据各材料的特点及所需取样的具体环境来选用合适的材料制作密封膜。
一种胃肠道释药取样装置，包括设置在体内的释药取样装置和设置在体外的磁控装置，所述释药取样装置具有外壳、内核和设置在所述外壳和内核之间的储药槽，所述储药槽与所述外壳之间的区域形成储药腔，所述储药槽与所述内核之间的区域形成集样腔，所述储药槽通过弹性连接件与所述内壳相连，所述储药槽上设有第一磁性材料，所述内核上设有第二磁性材料，所述第一磁性材料与所述第二磁性材料相互吸引；所述磁控装置包括霍尔效应传感器探头和第三磁性材料；所述储药槽呈上方开口的凹槽状，所述外壳上对应所述储药槽位置处设有用于密封所述储药腔的密封膜，所处密封膜在采用在人体中可溶解的材料制成。
优选的，所述集样腔呈倒三角状，所述集样腔内放置有用于将采集到的样品固定于所述集样腔内的成胶剂。
优选的，所述外壳内表面向内延伸设有用于对所述储药槽进行限位的导向槽，所述储药槽滑动连接于所述导向槽内。
优选的，所述储药槽呈浅口状。
优选的，所述储药槽的侧面通过扭簧与所述储药槽的底面相连，所述储药槽的侧面设有药品，所述储药槽的底面设有可使样品进入所述集样腔内的进样孔。
优选的，所述外壳上周向间隔设有多组储药装置。
优选的，多组储药装置所对应的密封膜采用可在不同生理条件下溶解的材料制成。
优选的，多组储药装置所对应的密封膜的厚度不同。
优选的，所述密封膜采用胃溶包衣膜/或肠溶包衣膜材料制成。
优选的，所述胃溶包衣膜独立地选自羟丙基甲级纤维素、PEG或胃溶性丙烯酸树脂IV中的任意一种或几种组合；所述肠溶包衣膜的主要原料独立地选自丙烯酸树脂I号、II号、III号、邻苯二甲酸醋酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、聚乙烯醇酞酸酯、醋酸纤维素苯三酸酯、丙烯酸树脂Eus100、Eu1100和虫胶中的任意一种或几种的组合。
本发明的有益效果是：本发明的胃肠道取样释药胶囊可方便的对胃肠道进行取样和释放相应的药品。还可通过选用不同的密封膜的材料，实现在不同时间(胃肠道取样释药胶囊在胃肠道的不同位置处)的取药和/或释药，便于更全面的了解人体胃肠道的生理、生化状态。此外，在本发明所揭示的一些实施例中，所述胃肠道释药取样装置可实现对胃肠道样品的采集，用于多项生理、生化指标的检测；并且本发明的胃肠道释药取样装置所述第一磁性材料、第二磁性材料和第三磁性材料的设置使得本发明的胃肠道释药取样装置无需大量电子器件即可实现大部分功能。本发明的胃肠道取样释药胶囊结构紧凑、简单，使用方便，制造成本低。
【附图说明】
图1为实施例1的胃肠道取样释药胶囊的结构示意图；
图2为实施例2的胃肠道取样释药胶囊的结构示意图；
图3为实施例3的胃肠道取样释药胶囊的结构示意图；
图4为本发明的实施例4的胃肠道取样释药取样装置的结构示意图；
图5为本发明的实施例5的胃肠道取样释药取样装置的结构示意图；
图6为本发明的实施例6的胃肠道取样释药取样装置的结构示意图；
图7为本发明的实施例7的胃肠道取样释药取样装置的结构示意图。
【具体实施方式】
下面结合附图与具体实施方式对本发明作进一步的详细描述：
实施例1
如图1所示，一种胃肠道取样释药胶囊，胶囊具有外壳1、取样管2、设置在外壳1内的至少一层内核3及相邻层所围成的环形区域，环形区域被设置在层间的隔板4上下分隔，隔板上方的环形区域为药品释放区5，隔板4下方的环形区域为集样区6；相 邻层中的较外层上与药品释放区5相对应的位置处设有至少2个释药孔11，其中至少1个释药孔11与取样管2的一端相连，取样管2的另一端与集样区6相连；释药孔11处设有密封膜(图中未示出)，密封膜采用可在特定环境中被消化的材料制成，外壳1和内核3采用在人体内不能被消化的医用材料制成。
本发明的胃肠道取样释药胶囊的工作原理：当需要对胃肠道施药和/或取样时，可口服该胃肠道取样释药胶囊。可根据实际情况对密封膜的材料进行选择。例如，当需要使药品释放区内的药品在胃部释放时，可选用仅在胃部可被消化的材料制作密封膜，如常见的胃溶包衣材料等。当密封膜在特定环境中被消化后，胃肠道取样胶囊所处的环境中的液体或样品会进入取样管2，药品释放区5中存储的药品也可直接进入所处环境，实现药品在特定环境的释放，达到治疗疾病的目的。进入取样管2中的样品会进一步沿取样管2进入集样区6，完成样品的采集；
为了使集样区6样品采集的效果更好，在上述技术方案的基础上，可在集样区6内设置成胶剂，成胶剂与液体接触后会变成凝胶状物质，一定程度上实现样品的固定，避免样品在人体内的损失。还可在取样管2上设置单向进液阀，效果更好。
为了更好的实现药品释放区5内药品释放的效果，可在药品释放区5内设置泡腾剂或间隔设置有药品、柠檬酸和碳酸氢钠，以使药品与所处的环境接触后，药品崩解时会产生少量的气体(以不影响药效和身体健康为前提)，促进药品涌出药品释放区5，与所处的环境更充分的接触。
为了更好的实现取样，在上述任意一项技术方案的基础上，可将取样管2为柔性毛细管，所述集样区6表面设有吸水材料。利用毛细管虹吸的作用原理，可使样品更顺利的进入集样区6，实现样品的采集。
实施例2
如图2所示，在实施例1的基础上，具体的，胃肠道取样释药胶囊具有第一内核31(位于外壳内)和第二内核32，第二内核32设置在第一内核31内，外壳1上设有胃部释药孔111，胃部释药孔111处设有胃溶包衣膜；第一内核31上设有肠部释药孔112，所述肠部释药孔112处设有肠溶包衣膜。可在外壳1和第一内核31之间的药品释放区5放置用于治疗胃部疾病的药品，在第一内核31和第二内核32之间的药品释放区5放置用于治疗肠部疾病的药品。当胃肠道取样释药胶囊进入胃部后，胃部释药孔111处的密封膜——胃溶包衣膜被溶解，治疗胃部疾病的药品即可在人体胃部释放，若胃部释药孔处设置有取样管2，样品即可通过取样管2进入外壳1和第一内核31之间的集样区6，实现胃部样品的采集。同理，当取样释药胶囊进入肠部后，设置在第一内核31上的肠部释药孔112处的密封膜——肠溶包衣膜被溶解，使得设置在第一内核 31和第二内核32之间的药品释放区5的用于治疗肠部疾病的药品在人体肠部释放，若肠部释药孔112处设置有取样管2，样品即可通过取样管2进入第一内核31和第二内核32之间的集样区6，实现肠部样品的采集。
实施例3
如图3所示，在实施例2的基础上，胃部释药孔111和肠部释药孔112可对应设置，并使胃部释药孔111大于肠部释药孔112，即将肠部释药孔112设置在胃部释药孔111的开口范围内，便于第一内核31和第二内核32之间的药品释放区5存放的药品可更快速、充分的实现与肠道环境的接触。
为了可以实现在体内不同位置处分别取样的目的，在上述任意一项技术方案的基础上，可将集样区6分隔设置为具有多个密封集样腔61的结构，集样腔61分别与不同的取样管2相连，控制不同的取样管2处的密封膜在不同时间点(体内的不同位置处)被消化，即可实现对人体胃、肠道不同位置处的取样。置于密封膜消化时间的控制，可通过设置不同厚度的密封膜来实现(在所采用的多个密封膜的材料相同的情况下，密封膜的厚度越大，越不容易被消化，采样的时间越晚)。也可根据实际需要采用不同材质的密封膜来实现。例如，常见的肠溶包膜材料丙烯酸树脂II号在pH6以上溶解，丙烯酸树脂III号在pH7以上溶解，根据体内环境pH不同，可通过分别采用丙烯酸树脂II号或丙烯酸树脂III号作为密封膜来实现不同时间的取样和/或释药，也可采用多种复合材料来制备密封膜，实现调整密封膜在不同时间点被消化的目的。
实施例4
请结合参阅图4，一种胃肠道释药取样装置，包括设置在体内的释药取样装置和设置在体外的磁控装置，释药取样装置具有外壳1、内核2和设置在外壳1和内核2之间的储药槽3，储药槽3与外壳1之间的区域形成储药腔4，储药槽3与内核2之间的区域形成集样腔5，储药槽3通过弹性连接件6与内壳2相连，储药槽3上设有第一磁性材料31，内核2上设有第二磁性材料21，第一磁性材料31与第二磁性材料21相互吸引；磁控装置包括霍尔效应传感器探头和第三磁性材料；所述储药槽3呈上方开口的凹槽状，外壳1上对应储药槽3开口位置处设有用于密封储药腔4的密封膜32，密封膜32采用在人体中可溶解的材料制成。
本发明的胃肠道释药取样装置的原理：当需要对胃肠道取样和/或施药时，可口服本发明的释药取样装置(微型装置，以便于口服和不会对胃肠道造成损失为宜)，当释药取样装置进入人体后，密封膜32可在特定生理环境中被消化溶解(例如，需要在人体胃部取样和/或施药，则密封膜32应当采用仅可在胃内的酸性条件下被消化溶解的生物相容性好的材料，例如，常用的胃溶型包衣材料等)，则设置在储药槽3内的药品 即可在胃部释放。若需要取样，则可在体外通过磁控装置中的霍尔效应传感器探头(可设置多个)，通过检测磁场强度确定体内释药取样装置的大致位置，再将第三磁性材料(可采用磁力较强的永磁体材料制作)置于体表上接近体内释药装置的位置处，第三磁性材料吸引设置在储药槽3上的第一磁性材料21，当第三磁性材料对第一磁性材料21的磁吸引力大于内核2上的第二磁性材料21对第一磁性材料31的磁吸引力时，弹性连接件6会带动储药槽3向外壳1外的方向运动，储药槽3运动至外壳1外后，储药槽3和外壳1之间的空隙即为样品进入集样腔5的通道，实现样品的采集。为了便于使集样腔5内采集到的样品保持在集样腔5内不会洒出，可在集样腔5内设置成胶剂，样品进入集样腔5后与成胶剂作用凝固生产凝胶状物质，一定程度上可起到固定样品的作用。
此外，通过霍尔效应传感器探头(根据需要可设置多个)所检测到的信息，可大致确定体内释药取样装置所处的位置，进而实现对体内释药取样装置的运动轨迹的追踪；若将第三磁铁放置于体内释药取样装置的下游，在第三磁铁的磁吸引力的作用下，还可起到加速体内释药取样装置在胃肠道内的运动、促进肠道蠕动的目的。
在上述技术方案的基础上，为了更好的实现防止集样腔5内样品的损失，可将集样腔5设置成上大下小状(尤以倒圆锥状为宜)，集样腔5内放置有用于将采集到的样品固定于所述集样腔5内的成胶剂，成胶剂可选用魔芋胶、黄原胶、结冷胶、琼脂、羧甲基纤维素、瓜尔豆胶、海藻酸钠、槐豆胶等，或其组合物。优选结冷胶与可溶性盐类化合物的组合物，例如柠檬酸钠、氯化钠、氯化镁、氯化钙等。
实施例5
在实施例1的基础上，可在外壳1的内表面设置用于对储药槽3进行限位的导向槽(两端开口)，储药槽3滑动连接于导向槽内，以便于实现储药槽3在外壳1的径向方向的滑动。
如图5所示，为了使储药槽3内盛放的药品可更好的释放于人体内，可将储药槽3设置成浅口状，当第三磁性材料对第一磁性材料的吸引力大于第二磁性材料对第一磁性材料的吸引力时，储药槽3在弹性连接件6的作用下会弹出至外壳1的外表面(在密封膜32已被消化或分解的前提下)，浅口状的储药槽3可使药品更容易进入体内。且储药槽3的底面与外壳1之间的空隙可作为样品进入集样腔5的通道，实现样品的采集。
作为上述技术方案的替代方案或优化方案，储药槽3的侧面通过扭簧与储药槽3的底面相连，储药槽3的侧面设有药品，储药槽3的底面设有可使样品进入集样腔5内的进样孔。当储药槽3在第三磁性材料的吸引力作用下，滑出导向槽后，储药槽3 的侧面与地面连接的扭簧发生形变，使储药槽3的侧面变成水平方向的平面或倾斜角度变小，以便于储药槽3内存储的药品可更方便的与人体接触。储药槽3底面上的进样孔则可使在密封膜32被溶解后，样品即可通过进样孔进入集样腔5，实现释药和取样的同步进行。
实施例6
如图6所示，在实施例1或2的基础上，可将集样腔5设置为倒置圆锥状，以更好的实现集样腔5内样品的保存。
实施例7
在实施例1-3任意一项的基础上，如图7所示，可在外壳1上周向间隔设有多组储药槽3，以便可实现多个样品的采集。
在上述任意一项技术方案的基础上，多组储药槽3所对应的密封膜32采用可在不同生理条件下溶解的材料制成或多组储药装置所对应的密封膜32的厚度不同，以便使不同储药槽3内盛放的不同药品可在在释药取样装置进入人体后的不同时间点，分别进入人体。例如，密封膜32可采用胃溶包衣膜/或肠溶包衣膜材料制成。当需要在胃部施药和/或取样时，密封膜32可采用胃溶包衣膜，胃溶包衣膜的主要原料可独立地选自羟丙基甲级纤维素、PEG或胃溶性丙烯酸树脂IV等中的任意一种或几种组合；当需要在肠道内施药和/或取样时，密封膜32可采用肠溶包衣膜，肠溶包衣膜的主要原料独立地选自丙烯酸树脂I号、II号、III号、邻苯二甲酸醋酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、聚乙烯醇酞酸酯、醋酸纤维素苯三酸酯、丙烯酸树脂Eus100、Eu1100和虫胶等中的任意一种或几种的组合。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。
以上所述仅为本发明的较佳实施例，并不用以限制本发明，凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (20)

  1. 一种胃肠道取样释药胶囊，其特征在于，所述胶囊具有外壳、取样管、设置在外壳内的至少一层内核及相邻层所围成的环形区域，所述环形区域被设置在层间的隔板上下分隔，隔板上方的环形区域为药品释放区，所述隔板下方的环形区域为集样区；所述相邻层中的较外层上与所述药品释放区相对应的位置处设有至少2个释药孔，其中至少1个所述释药孔与所述取样管的一端相连，所述取样管的另一端与所述集样区相连；所述释药孔处设有密封膜，所述密封膜采用可在特定环境中被消化的材料制成，所述外壳和内核采用在人体内不能被消化的医用材料制成。
  2. 根据权利要求1所述的胃肠道取样释药胶囊，其特征在于，所述集样区内设有成胶剂，所述成胶剂与液体接触后会变成凝胶状物质。
  3. 根据权利要求1所述的胃肠道取样释药胶囊，其特征在于，所述药品释放区内设有泡腾剂或间隔设置有药品、柠檬酸和碳酸氢钠。
  4. 根据权利要求1所述的胃肠道取样释药胶囊，其特征在于，所述所述取样管为柔性毛细管，所述集样区表面设有吸水材料。
  5. 根据权利要求1所述的胃肠道取样释药胶囊，其特征在于，所述集样区内分隔设置有多个密封集样腔，所述集样腔分别与不同的取样管相连，不同集样腔所对应的释药孔处设置的密封膜可在所述胶囊进入人体后的不同时间点被消化。
  6. 根据权利要求5所述的胃肠道取样释药胶囊，其特征在于，不同集样腔所对应的释药孔处设置的密封膜的厚度不同。
  7. 根据权利要求1-6中任意一项所述的胃肠道取样释药胶囊，其特征在于，所述胶囊具有第一内核和第二内核，所述第二内核设置在所述第一内核内，所述外壳上设有胃部释药孔，所述胃部释药孔处设有胃溶包衣膜；所述第一内核上设有肠部释药孔，所述肠部释药孔处设有肠溶包衣膜。
  8. 根据权利要求7所述的胃肠道取样释药胶囊，其特征在于，所述胃部释药孔和所述肠部释药孔对应设置，且所述胃部释药孔大于所述肠溶释药孔。
  9. 根据权利要求7所述的胃肠道取样释药胶囊，其特征在于，所述胃溶包衣膜的主要原料选自羟丙基甲级纤维素、PEG或胃溶性丙烯酸树脂IV中的任意一种或几种组合。
  10. 根据权利要求7所述的胃肠道取样释药胶囊，其特征在于，所述肠溶包衣膜的主要原料选自丙烯酸树脂I号、II号、III号、邻苯二甲酸醋酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、聚乙烯醇酞酸酯、醋酸纤维素苯三酸酯、丙烯酸树脂Eus100、Eu1100和虫胶中的任意一种或几种的组合。
  11. 一种胃肠道释药取样装置，其特征在于，包括设置在体内的释药取样装置和设置在体外的磁控装置，所述释药取样装置具有外壳、内核和设置在所述外壳和内核之间的储药槽，所述储药槽与所述外壳之间的区域形成储药腔，所述储药槽与所述内核之间的区域形成集样腔，所述储药槽通过弹性连接件与所述内壳相连，所述储药槽上设有第一磁性材料，所述内核上设有第二磁性材料，所述第一磁性材料与所述第二磁性材料相互吸引；所述磁控装置包括霍尔效应传感器探头和第三磁性材料；所述储药槽呈上方开口的凹槽状，所述外壳上对应所述储药槽位置处设有用于密封所述储药腔的密封膜，所处密封膜在采用在人体中可溶解的材料制成。
  12. 根据权利要求11所述的胃肠道释药取样装置，其特征在于，所述集样腔呈倒三角状，所述集样腔内放置有用于将采集到的样品固定于所述集样腔内的成胶剂。
  13. 根据权利要求11所述的胃肠道释药取样装置，其特征在于，所述外壳内表面向内延伸设有用于对所述储药槽进行限位的导向槽，所述储药槽滑动连接于所述导向槽内。
  14. 根据权利要求13所述的胃肠道释药取样装置，所述储药槽呈浅口状。
  15. 根据权利要求13所述的胃肠道释药取样装置，其特征在于，所述储药槽的侧面通过扭簧与所述储药槽的底面相连，所述储药槽的侧面设有药品，所述储药槽的底面设有可使样品进入所述集样腔内的进样孔。
  16. 根据权利要求11-15中任意一项所述的胃肠道释药取样装置，其特征在于，所述外壳上周向间隔设有多组储药装置。
  17. 根据权利要求16所述的胃肠道释药取样装置，其特征在于，多组储药装置所对应的密封膜采用可在不同生理条件下溶解的材料制成。
  18. 根据权利要求16所述的胃肠道释药取样装置，其特征在于，多组储药装置所对应的密封膜的厚度不同。
  19. 根据权利要求17或18所述的胃肠道释药取样装置，其特征在于，所述密封膜采用胃溶包衣膜/或肠溶包衣膜材料制成。
  20. 根据权利要求19所述的胃肠道释药取样装置，其特征在于，所述胃溶包衣膜独立地选自羟丙基甲级纤维素、PEG或胃溶性丙烯酸树脂IV中的任意一种或几种组合；所述肠溶包衣膜的主要原料独立地选自丙烯酸树脂I号、II号、III号、邻苯二甲酸醋酸纤维素、羟丙基甲基纤维素邻苯二甲酸酯、聚乙烯醇酞酸酯、醋酸纤维素苯三酸酯、丙烯酸树脂Eus100、Eu1100和虫胶中的任意一种或几种的组合。
PCT/CN2020/101250 2019-07-26 2020-07-10 胃肠道取样释药胶囊 WO2021017791A1 (zh)

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EP0460327A1 (en) * 1990-07-06 1991-12-11 Miyarisan Kabushiki Kaisha Medical capsule and apparatus for activating the same
CN2757729Y (zh) * 2004-11-19 2006-02-15 华南理工大学 一种吸取式胃肠道取样微胶囊
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