CN115282412B - Drug delivery device for entering blood circulation through nasal cavity and application method thereof - Google Patents
Drug delivery device for entering blood circulation through nasal cavity and application method thereof Download PDFInfo
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- CN115282412B CN115282412B CN202210063981.9A CN202210063981A CN115282412B CN 115282412 B CN115282412 B CN 115282412B CN 202210063981 A CN202210063981 A CN 202210063981A CN 115282412 B CN115282412 B CN 115282412B
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- 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
- A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
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- 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
-
- 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
- A61M2210/00—Anatomical parts of the body
- A61M2210/06—Head
- A61M2210/0618—Nose
Abstract
The administration device for transnasal blood circulation of the present invention comprises: the nasal plug special for the nasal cavity, the catheter system special for the nasal cavity, the one-way switch, the two-way switch, the reversing valve, the expiration response switch and the aerosol container are connected into a whole by applying an integrated wearing type design, and the components are combined in a modularized manner and can be detached and replaced. The drug delivery device capable of entering the blood circulation through the nasal cavity overcomes the defects and the shortcomings of the traditional drug delivery device, and does not pass through the olfactory region of the nasal passage on the nasal cavity, so that the influence on the centering of the drug entering the brain is avoided, the applicable crowd is wide, the drug utilization rate is high, the drug is independently delivered by a patient, the dual advantages of quick acting and long-acting maintenance are achieved, and the purposes of safety, high efficiency and long-time nasal cavity delivery are achieved.
Description
Technical Field
The invention relates to a nasal administration device, in particular to a nasal administration device for entering blood circulation.
Background
The nasal cavity is divided into left and right sides by the nasal septum, including nasal vestibule, respiratory zone and olfactory zone, and respiratory zone is the biggest part in the nasal cavity, and its submucosal blood vessel is abundant, and venules, arterioles, capillaries, lymphatic vessel interweave into the net, can make the medicine absorb rapidly, and the medicine absorbs from this and gets into systemic blood circulation, can improve the bioavailability of medicine, avoids "first pass effect" of oral medicine. In addition, the medicine which is not easy to absorb and is easy to be destroyed by gastric acid in the gastrointestinal tract can be effectively absorbed by the nasal mucosa, thereby improving the treatment effect of the medicine.
The nasal administration is convenient, the dosage is small, and the medicine is widely applied to various therapeutic medicines. The nasal delivery system into the blood circulation has the following advantages:
1. the first pass effect of the medicine is avoided when the medicine is taken orally, and the bioavailability is high. The nasal mucosa is very weak in metabolism of drugs, and is particularly important for nasal administration of some drugs which cannot be orally administered.
2. Generally, only 1/10 or 1/5 of the dosage of the oral medicine is needed for nasal administration, so that the dosage of the medicine is reduced.
3. The nasal submucosa blood vessel is very abundant, arteries, veins and capillaries are interwoven into a net shape, and the liquid medicine can be rapidly absorbed and enters blood from the blood vessel.
4. Macromolecular drugs such as polypeptides and proteins are easy to destroy in the gastrointestinal tract, but are well absorbed in the nasal mucosa after being combined with an absorption promoter.
5. The rate and extent of absorption of nasal administration can sometimes be comparable to intravenous injection.
There are also problems with the administration system for transnasal access to the blood circulation, in particular the following disadvantages:
1. there is an olfactory region in the upper nasal passage, and generally some of the nasal administration formulation will pass through the olfactory region and enter the brain, thereby affecting centering.
2. The patient needs to be trained to grasp the administration procedure. Although the patient can self-apply the nasal administration preparation, there are few patients who need to be able to properly handle the nasal administration preparation.
3. The internal structure of the nasal cavity is complex, the medicine scattering area is small when the existing nasal cavity preparation is used for administration, and the space utilization rate is low.
4. For biomacromolecule drugs, the bioavailability of nasal administration is low (less than 1%), and absorption promoters or adhesion agents need to be added.
5. The absorption promoter, adhesive and other additives have serious influence on cilia activities, and nose cilia toxicity exists, so that long-term nasal administration is not suitable.
At present, when developing new dosage forms for nasal administration, emphasis is placed on preparing special drug carriers (gel, microsphere, liposome), preferably absorption promoters and adhesion agents with low toxicity to nasal cilia. However, since the olfactory region of the nasal meatus exists in the nasal cavity, a part of the drug entering the nasal cavity always passes through the olfactory region to enter the brain, and thus side effects are caused in the middle of the nasal cavity.
In summary, existing drug delivery systems that enter the blood circulation transnasally cannot avoid side effects on centering. At present, a safe and efficient nasal cavity special drug delivery device which does not pass through the olfactory region is not seen, so that the application and development of clinical nasal cavity drug treatment are greatly limited.
Disclosure of Invention
The invention aims to provide a safe and efficient nasal cavity special drug delivery device which does not pass through a sniffing zone, has wide application range of drugs, is suitable for various patients, has good compliance, has no stimulation and pain sense, and overcomes various defects of the traditional drug delivery device.
The drug delivery device for entering blood circulation through nasal cavity has the following advantages which are different from the existing drug administration device for entering blood through nasal cavity:
1. high safety and wide applicable crowd: the medicine does not need to be added with adhesives with cilia toxicity (cilia fall-off caused by cilia swing inhibition), mucous membrane absorption promoters with potential safety and other additives, has no influence on physiological microenvironment of nasal cavity and cilia movement, has no side effects such as stimulation and the like, has high safety and is suitable for a wide range of people.
2. Accurate positioning and high medicine utilization rate: as shown in figure 1, the nasal cavity upper nasal passage has a sniffing zone, and the drug administration device entering blood circulation through the nasal cavity of the invention utilizes a uniquely designed nasal plug special for the nasal cavity to plug the upper nasal passage, so that the aerosol can only be delivered into the middle nasal passage and the lower nasal passage. In addition, the drug administration device for entering the blood circulation through the nasal cavity does not need to prepare the drug into a special dosage form or apply a special carrier; the drug is only prepared into one of liquid, gas or solid (including aqueous solution, oil solution, suspension, emulsion, aerosol, ultra-fine mist, nanoparticle, liposome and micelle) which takes propellant, high-pressure gas or volatile solvent as driving force transmission, so that the positioning and high-efficiency delivery of the drug in and under the nasal passages can be safely and painlessly realized, the drug can not enter the trachea and the lung, and the utilization rate is high.
3. Has the double advantages of quick action and long-acting maintenance: the aerosol particles have small particle size, large contact area with the nasal cavity after entering the nasal cavity and descending the nasal passage, uniform distribution, maximum acceleration of drug absorption and high onset of action. Meanwhile, the administration device for entering the blood circulation through the nasal cavity can carry out continuous long-time administration, so that the administration device has the advantage of long-term maintenance.
4. The drug is administered in the process of cooperating with exhalation, and the retention and absorption effects of the drug at the nasal cavity part are ensured by using the exhalation resistance of the respiratory tract: as shown in figures 2-4, the invention adopts the unique designs of nasal plugs, nasal special catheter systems, one-way switches, two-way switches, reversing valves, expiration response switches, aerosol containers and the like, and ensures synchronous oral expiration and nasal administration. During inhalation of the user, the exhalation response switch is in a closed state, and no aerosol enters the nasal cavity of the user: when a user slowly exhales, an expiration response switch is started, aerosol in the aerosol container enters a special nasal cavity guide pipe system under the driving action of a propellant, high-pressure gas or volatile solvent, and enters a nasal cavity and a lower nasal passage from a special nasal plug on one side of the nasal cavity after passing through a reversing valve; when the middle nasal passage and the lower nasal passage on one side are filled with the aerosol, the redundant aerosol bypasses the nasopharynx part and enters the middle nasal passage and the lower nasal passage on the other side, finally overflows from the nasal plug special for the nasal cavity on the other side to the nasal cavity special catheter system, and enters the nasal plug special for the nasal cavity on one side again through the culvert, so that the full utilization of the aerosol is ensured. Therefore, the drug administration device entering blood circulation through the nasal cavity ensures the stay and absorption effect of the drug at the nasal cavity part, and remarkably improves the blood entering efficiency of the drug through the nasal cavity passage.
5. Patients independently administer the medicine, the compliance is good, and special requirements are not needed: the administration device for entering the blood circulation through the nasal cavity is simple and convenient to operate, and patients can independently administer the medicine without the participation of medical staff, so that the administration device is also suitable for children, old people, mental retardation, coma and other patients.
Drawings
Fig. 1 is a schematic structural design of the nasal cavity-dedicated catheter system of the present invention.
Fig. 2 is a schematic illustration of the structure of the nasal cavity-specific catheter system of the present invention in conjunction with other components.
Fig. 3 is a schematic diagram of the application position and structural design of the nasal plug special for nasal cavity of the present invention.
Fig. 4 is a schematic diagram of the application of the transnasal blood circulation access drug delivery device of the present invention.
Fig. 5 is an aerosol delivery profile of the nasal cavity-specific catheter system of the present invention upon exhalation.
Detailed Description
Hereinafter, specific embodiments of the present invention will be described in detail. It should be noted that the technical features or combinations of technical features described in the following embodiments should not be regarded as being isolated, and they may be combined with each other to achieve a better technical effect.
As shown in fig. 1 to 5, the transnasal administration device for entering the blood circulation according to the present invention comprises: nasal prongs 10, nasal prongs catheter system 20, one-way switch 30, two-way switch 40, reversing valve 50, exhalation responsive switch 60 and aerosol container 70; the drug delivery device capable of entering the blood circulation through the nasal cavity is characterized in that the drug delivery device is integrally connected with all components through an integrated wearable design, and all components are combined in a modularized mode and can be detached and replaced.
The nasal cavity special nasal plug 10 is prepared from soft materials with good biocompatibility and good elasticity and air tightness, has a cylindrical, gourd-shaped, conical or external structure adapting to nasal anatomy structure, the nasal cavity special nasal plug 10 is divided into a head part, a waist part and a bottom part, the nasal cavity special nasal plug 10 comprises a channel 11, the channel 11 is only opened at the bottom part of the nasal cavity special nasal plug 10, and the waist part of the nasal cavity special nasal plug 10 is distributed with a plurality of holes 12 communicated with the channel 11.
The surface of the nasal plug 10 special for the nasal cavity is provided with annular bulges, and the bulges are any one of round, semicircular, elliptic, prismatic, triangular, trapezoidal or wavy and are used for fixing the position of the nasal plug 10 special for the nasal cavity in the nasal cavity and simultaneously plugging the outer nostril and the entrance of the upper nasal passage.
The nasal cavity special catheter system 20 is composed of a communicating pipe 21 and a duct 22, wherein the communicating pipe 21 is of a Y-shaped structure, the duct 22 is of a U-shaped structure and is arranged in the communicating pipe, the inlet of the duct 22 is wide, the outlet of the duct is narrow, and the duct 22 is used for conveying the reflowed aerosol to enter the nasal cavity again.
The unidirectional switch 30 is positioned at the outlet of the duct 22 of the nasal cavity dedicated catheter system 20 for opening and closing the outlet of the duct 22. The two-way switch is positioned at the bottom of the U-shaped structure of the nasal cavity special catheter system 20 and is used for regulating and controlling the asynchronous opening and closing of the inlets of the communication pipe 21 and the culvert 22 behind the reversing valve 50.
The reversing valve 50 is located at the crossing part of the Y-shaped structure of the nasal cavity special catheter system 20, and is used for ensuring that the reversing valve 50 changes the direction of the passage once every breath.
An expiration response switch 60 is positioned at the lower portion of the reversing valve 50 for ensuring that the expiration response switch 60 is opened during expiration, and the expiration response switch 60 is electronically controlled or autonomously controlled by the user.
An aerosol container 70 is positioned at the bottom of the Y-shaped structure of nasal cavity specific catheter system 20 for storing aerosol. Aerosol refers to a liquid, gas or solid with propellant, high pressure gas or volatile solvent as the driving force for transmission, including: one or more of aqueous solution, oil solution, suspension, emulsion, aerosol, ultra-fine mist, nanoparticle, liposome and micelle
A method of using a transnasal blood circulation access drug delivery device comprising the steps of:
(1) The nasal plug 10 special for the nasal cavity is plugged into the nasal cavities at two sides of a user, and the nasal cavity is completely plugged after the position is adjusted until the channel 11 of the nasal plug 10 special for the nasal cavity is closed;
(2) The user keeps a static state and inhales normally, and the exhalation response switch 60 is in a closed state during inhalation, so that no aerosol enters the nasal cavity of the user;
(4) The user exhales slowly, and when exhaling, the exhales the response switch 60 is started, the aerosol in the aerosol container 70 enters the special nasal cavity duct system 20 under the driving action of the propellant, the high-pressure gas or the volatile solvent, and enters the nasal cavity and the lower nasal passage from the special nasal plug 20 on one side of the nasal cavity through the reversing valve 50; when the middle nasal passage and the lower nasal passage on one side are filled with the aerosol, the redundant aerosol bypasses the nasopharynx part and enters the middle nasal passage and the lower nasal passage on the other side, finally flows back to the nasal cavity special catheter system 20 from the channel 11 of the nasal plug 10 on the other side, and enters the nasal plug 10 on the other side again through the duct 22, so that the full utilization of the aerosol is ensured.
(5) The user circulates the steps (3) and (4) to finish the delivery of the aerosol to the nasal cavity.
Example 1 test grouping of drug delivery devices into the blood circulation via the nasal cavity
The drug delivery device for transnasal access to the blood circulation of the present invention comprises: the drug delivery device is applied to the following test by connecting all components into a whole through an integrated wearing type design.
Experimental animals: the saanen goats (saanen goats) have the nasal structures closest to the human beings, so that the saanen goats are taken as experimental animal subjects, the male and female are not limited, and 3 saanen goats are taken as the following groups: 1 in 3-4 years old, 1 in 7-8 years old, and 1 in 11-13 years old, representing young, adult, and aged sabot goats, respectively.
Experimental drugs: oil-soluble quantum dots and water-soluble quantum dots with the same molar concentration and fluorescence intensity are used as drug objects, water-soluble CdSe/ZnS quantum dots are used for preparing quantum dot aqueous solution and quantum dot-starch ultrafine powder mist (starch adsorption quantum dots, particle size of 400-600 nm), and oil-soluble quantum dots are used for preparing quantum dot oil solution (petroleum ether), quantum dot O/W emulsion, quantum dot-gelatin nanoparticles (particle size of 100-200 nm) and quantum dot liposome.
The method is characterized in that the method is divided into an experimental group and a control group according to the design of table 1, the positions and volumes of the middle nasal passages and the lower nasal passages of animals are detected through images, and nasal plugs with proper sizes and special nasal cavities are selected to be plugged into the nostrils of the animals. The body of the animal is in a negative 30-degree body position (the head is slightly lower) after anesthesia, an oxygen tube is inserted into the mouth, and the animal is dosed by referring to an application method of a dosing device which enters the blood circulation through the nasal cavity, and after the dosing is finished, the animal is kept in the body position for 13min and wakes up. Experimental groups were dosed using the nasal administration device of the present invention into the blood circulation according to the table 1 design (the exhalation response switch was electronically controlled) and control groups were dosed simultaneously with reference to the experimental groups according to the table 1 design.
TABLE 1 test packets for drug delivery devices that enter the blood circulation transnasally
Note that: and/represents that the feature or structure is not present; * Indicating that the settings or parameters varied significantly from the experimental set.
Example 2 test results for each set
After administration according to the design of table 1, nasal cavities of experimental animals were dissected, the retention degree of each group of drugs in nasal cavities was evaluated, blood was separated, and the concentration of quantum dots in blood was detected, and the like.
Retention of drug in nasal cavity, lower nasal passage: and comparing the fluorescence intensity of the nasal cavity with that of the upper nasal passage of the nasal cavity, and evaluating the relative retention degree of the medicine in the nasal cavity and the lower nasal passage.
Detection of quantum dot concentration in blood: the concentration of the quantum dots in the blood of each group of animals is detected by combining blood drawing with a fluorescence detection method, and the blood inlet effect of the quantum dots after 3min, 6min and 12min of administration is compared.
The test results of each group are shown in table 2, the effect of each index in the table is expressed by a percentage (the higher the numerical value is, the better the evaluation result is), each index is synthesized, the overall evaluation of the safety and the effectiveness is given, and the higher the overall evaluation numerical value is, the better the comprehensive effect is.
TABLE 2 test results of drug delivery device for nasal access to the blood circulation
The results in table 2 show that the overall evaluation of the safety and effectiveness of the administration device for transnasal blood circulation of the experimental group is significantly higher than that of the control group, and the administration device has the advantages of high retention degree of the drug in the nasal cavity and the lower nasal passages, high blood-entering efficiency of the 3min, 6min and 12min quantum dots, good safety and the like, wherein the evaluation of the experimental groups 4 and 5 is the best.
Compared with the experimental group, the control group has poorer overall evaluation of safety and effectiveness, and the control group 2 adopts a hard plastic nasal plug and causes damage to nasal mucosa; the retention degree of the medicines in the control groups 3-8 in the nasal cavity and the lower nasal passages is low, so that the blood inlet efficiency of the quantum dots is low; the medicines in the control groups 9-11 cannot effectively enter the nasal cavity, so that no blood entering effect exists, the control groups 12-14 are the control groups of the existing nasal preparations, and the retention degree of the medicines in the nasal cavity and the lower nasal passages is low, so that the blood entering effect is poor.
The results in table 2 prove that any component and parameter in the technical protection scheme of the drug administration device entering the blood circulation through the nasal cavity are mutually synergistic and indispensable, and the lack of any component and parameter in the technical protection scheme of the invention can greatly influence the blood-entering effect of the drug. The drug delivery device entering blood circulation through the nasal cavity has the characteristics of safety, high efficiency and convenience in application, and has good application prospect.
The foregoing detailed description is directed to embodiments of the invention which are not intended to limit the scope of the invention, but rather to cover all modifications and variations within the scope of the invention. Further, various modifications, additions and substitutions in other forms and details may be made by those skilled in the art within the scope and spirit of the invention as disclosed in the accompanying claims. Of course, such modifications, additions and substitutions are intended to be included within the scope of the invention as set forth in the accompanying claims.
Claims (3)
1. A device for transnasal access to the blood circulation, said device comprising: a nasal plug special for nasal cavity, a nasal cavity special catheter system, a one-way switch, a two-way switch, a reversing valve, an expiration response switch and an aerosol container; the special catheter system for the nasal cavity consists of a communicating pipe and a duct, wherein the communicating pipe is of a Y-shaped structure, the duct is of a U-shaped structure and is arranged in the communicating pipe, the inlet of the duct is wide, the outlet of the duct is narrow, and the duct is used for conveying the reflowed aerosol to enter the nasal cavity again; the nasal cavity special catheter system connects the nasal cavity special nasal plug, the one-way switch, the two-way switch, the reversing valve, the expiration response switch and the aerosol container into a whole; the special nasal plug for the nasal cavity is prepared from soft materials with good biocompatibility and good elasticity and air tightness, has a cylindrical, gourd-shaped, conical or external structure which is suitable for the anatomical structure of the nasal cavity, the special nasal plug for the nasal cavity is divided into a head part, a waist part and a bottom part, the special nasal plug for the nasal cavity comprises a channel, the channel is only opened at the bottom part of the special nasal plug for the nasal cavity, and the waist part of the special nasal plug for the nasal cavity is distributed with holes communicated with the channels; the one-way switch is positioned at the duct outlet of the nasal cavity special catheter system and is used for opening and closing the duct outlet; the bidirectional switch is positioned at the bottom of the U-shaped structure of the nasal cavity special catheter system and is used for regulating and controlling asynchronous opening and closing of the rear communication pipe and the culvert inlet of the reversing valve; the reversing valve is positioned at the crossing part of the Y-shaped structure of the nasal cavity special catheter system and is used for ensuring that the reversing valve changes the direction of a passage once every breath; the expiration response switch is positioned at the lower part of the reversing valve and used for ensuring that the expiration response switch is opened during expiration, and the expiration response switch is electronically controlled or controlled by a user; the aerosol container is positioned at the bottom of the Y-shaped structure of the special nasal cavity catheter system and is used for storing aerosol; the aerosol refers to liquid, gas or solid taking a propellant, high-pressure gas or volatile solvent as a transmission driving force; the drug delivery device is characterized in that the drug delivery device is integrally connected with all components by an integrated wearable design, and all components are combined in a modularized mode and can be detached and replaced.
2. The device for transnasal delivery of blood circulation according to claim 1, wherein the surface of the nasal special-purpose nasal plug is provided with an annular bulge, and the bulge is any one of round, semicircular, elliptic, prismatic, triangular, trapezoidal or wavy, and is used for fixing the position of the nasal special-purpose nasal plug in the nasal cavity and simultaneously sealing the outer nostril and the entrance of the upper nasal passage.
3. The transnasal blood circulation administration device of claim 1, wherein the aerosol comprises: one or more of aqueous solution, oil solution, suspension, emulsion, aerosol, ultra-fine mist, nanoparticle, liposome and micelle.
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Cited By (1)
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| CN114470496A (en) * | 2022-01-14 | 2022-05-13 | 赵子逸 | Nasal olfactory region circulating administration device and application method thereof |
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| CN115282412A (en) | 2022-11-04 |
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