JP2006061421A - Medicine containing unit - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medicine containing unit containing a particulate medicine. <P>SOLUTION: This medicine containing unit 100 is mounted on a syringe 200. The unit 100 has a filter 120 that blocks a flow passage from an inlet 111 to an outlet 112. Particulate medicine is attached on the filter 120. When an injection needle 230 is inserted into a liquid vehicle 300 within a vial or an ampule and a piston 220 is pulled, the liquid vehicle 300 is sucked into a body 210 of the syringe via the injection needle 230 and the medicine containing unit 100. By doing so, the medicine attached on the filter 120 is dissolved in the liquid vehicle 300, and the medicine solution 301 is introduced into the body 210 of the syringe. Because the medicine is attached to the filter 120 arranged in the flow passage of the liquid vehicle 300, the medicine is dissolved quickly and credibly. The particulate medicine is produced by discharging a medicine solution from a material nozzle and crushing using an air current. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a manufacturing apparatus and manufacturing method for a medicine container unit containing a fine drug, and further to a medicine container unit itself and a syringe containing a medicine.

  2. Description of the Related Art There is known a syringe in which a medicine for a syringe and its solvent are previously separated and accommodated in the syringe.

  This type of syringe has the advantage of being hygienic and ready to be used immediately in an emergency because it can be used as it is by dissolving the syringe drug inside the syringe during use (for example, Patent Document 1, (See Patent Document 2).

  However, the drug contained in the conventional syringe of this type is often a freeze-dried preparation. For this reason, a large-scale freeze-drying facility is required, and it is very difficult to freeze and dry a drug composed of fine particles by supplying it to a predetermined space in a syringe in a very small amount. For this reason, this type of syringe has a problem of high manufacturing cost.

In addition, in a freeze-dried preparation, it is difficult to control the particle diameter of the drug uniformly, and therefore, the ease of dissolution of the drug may vary depending on the syringe.
JP 2001-17545 A JP2003-164509A

  The problem to be solved by the present invention is that a large-scale drug production facility such as a freeze-drying facility is not required, and the drug is efficiently produced while controlling the particle diameter to a desired value and uniformly. A manufacturing apparatus and a manufacturing method capable of reliably storing a certain amount in a medicine container unit even in a very small amount, and further, a medicine container unit manufactured by this manufacturing method, and this medicine container The object is to provide a syringe with a unit.

  In order to solve the above problems, a manufacturing apparatus according to the present invention includes a housing having an inlet connected to an injection liquid nozzle of a syringe and an outlet connected to a base of an injection needle, and a flow from the inlet to the outlet. An apparatus for manufacturing a medicine storage unit by attaching a medicine to the medicine carrier of a unit having a breathable medicine carrier provided in the housing so as to block a path, and having a fluidity A fine particle generation system for controlling the particle diameter of the fine particles by controlling the discharge amount of the drug solution from the raw material nozzle, while generating the fine particles of the drug solution by crushing with an air flow while discharging the solution from the raw material nozzle, A fine particle conveyance system for introducing the fine particles generated by the drug fine particle generator onto a carrier air flow and introducing the fine particles into the unit to adhere to the drug carrier; I was painting.

  According to this manufacturing apparatus, a drug solution having fluidity is crushed by an air flow while being discharged from a raw material nozzle to generate fine particles of the drug solution, and by controlling the discharge amount of the drug solution from the raw material nozzle, Can be efficiently generated while controlling the particle diameter to a desired value and uniformly, and by introducing the generated fine drug particles into the unit and adhering them to the drug carrier, Can be reliably accommodated in the unit by a certain amount. The amount of drug accommodated in the unit can be accurately controlled by adjusting the particle size and transport amount of the drug, the supply time, the size and pore size of the drug carrier, the flow rate of the transport gas, temperature and humidity, and the like.

  In the production apparatus of the present invention, it is desirable that the fine particle transport system has a plurality of branched channels so as to simultaneously introduce the fine particles generated in the fine particle generation system into the plurality of units. Moreover, it is desirable that the fine particle transport system is configured to return the fine particles that have passed through the unit to the drug fine particle generator.

  In the manufacturing method of the present invention, a housing having an inlet connected to an injection liquid nozzle of a syringe and an outlet connected to a base of an injection needle, and a flow path from the inlet to the outlet are blocked. A method for producing a medicine containing unit by adhering a medicine to the medicine carrier of a unit having a breathable medicine carrier provided in the housing, and discharging a fluid medicine solution from a raw material nozzle A fine particle generation step for generating fine particles of a drug solution by being crushed by an air flow, a particle size control step for controlling the particle size of the fine particles by controlling a discharge amount of the drug solution from the raw material nozzle, and the fine particles A fine particle conveying step in which the fine particles generated in the generating step are introduced into the unit by being carried on a conveying air flow and adhered to the drug carrier. Having.

  According to this manufacturing method, the drug solution having fluidity is crushed by an air flow while being discharged from the raw material nozzle to generate fine particles of the drug solution, and the amount of the drug solution discharged from the raw material nozzle is controlled, thereby Can be efficiently generated while controlling the particle diameter to a desired value and uniformly, and by introducing the generated fine drug particles into the unit and adhering them to the drug carrier, In addition, it can be surely stored in the medicine storage unit by a certain amount. The amount of drug contained in the unit can be accurately controlled by adjusting the particle size and transport amount of the drug, the supply time, the size and pore size of the drug carrier, the flow rate of the transport gas, temperature and humidity, and the like.

  In the manufacturing method of the present invention, it is desirable that in the fine particle transporting step, the fine particles generated in the fine particle generating step are simultaneously introduced into the plurality of units through a plurality of branched channels.

  The medicine storage unit of the present invention is configured to block a housing having an inlet connected to the injection liquid nozzle of the syringe and an outlet connected to the base of the injection needle, and a flow path from the inlet to the outlet. A gas-permeable drug carrier provided in the housing, a drug attached to the drug carrier, and a cap that seals the inlet and the outlet.

  The drug storage unit is attached to the syringe by removing the cap and connecting the inlet to the injection solution nozzle of the syringe. An injection needle is attached to the outlet. When the tip of the injection needle is inserted into the solvent liquid in the vial or ampoule and the piston of the syringe is pulled, the solvent liquid is sucked and introduced into the syringe through the injection needle and the drug storage unit. At that time, since the drug adhering to the drug carrier is dissolved in the solvent solution, the drug solution (injection solution) is introduced into the syringe. If there is a concern that the drug remains undissolved by a single suction operation into the syringe, the drug can be completely dissolved by agitating the solution by moving the piston of the syringe back and forth several times.

  In the medicine storage unit of the present invention, the medicine is crushed by an air flow while discharging a fluid medicine solution from the raw material nozzle, and the fine particles are controlled by controlling the discharge amount of the pharmaceutical solution from the raw material nozzle. It is desirable to be fine particles of a drug solution generated while controlling the diameter or a dried product thereof.

  The drug carrier is preferably a filter for removing foreign substances in the solution flowing from the inlet to the outlet. The filter preferably has a pore size of 0.2 μm to 0.22 μm.

  The syringe of the present invention is a syringe provided with a drug storage unit between the syringe body and the injection needle. The drug storage unit includes an inlet connected to an injection solution nozzle of the syringe body, and an injection needle. A housing having an outlet connected to a base, a breathable drug carrier provided in the housing so as to block a flow path from the inlet to the outlet, and a drug attached to the drug carrier It is a thing to have.

  This syringe is hygienic and can be used immediately in an emergency because it can be used as it is by dissolving the drug inside the syringe at the time of use. That is, when the tip of the injection needle of this syringe is inserted into the solvent liquid in the vial or ampoule and the piston is pulled, the solvent liquid is sucked and introduced into the syringe through the injection needle and the drug storage unit. At that time, since the drug adhering to the drug carrier is dissolved in the solvent liquid, the drug solution is introduced into the syringe. If there is a concern that the drug remains undissolved by a single suction operation into the syringe, the drug can be completely dissolved by agitating the solution by moving the piston of the syringe back and forth several times.

  In the syringe of the present invention, the drug is crushed by an air flow while discharging a fluid drug solution from the raw material nozzle, and the particle size of the fine particles is controlled by controlling the discharge amount of the drug solution from the raw material nozzle. It is desirable to be fine particles of a drug solution generated while being controlled or a dried product thereof.

  The drug carrier is preferably a filter for removing foreign substances in the solution flowing from the inlet to the outlet. The filter preferably has a pore size of 0.2 μm to 0.22 μm.

  According to the manufacturing apparatus and the manufacturing method of the present invention, it is possible to manufacture a drug storage unit that stores a drug without requiring a large-scale drug manufacturing facility such as a freeze-drying facility. Even if the amount of the medicine to be accommodated in the medicine accommodating unit is extremely small, a certain amount of the medicine can be surely accommodated. Since the average particle diameter of the medicine stored in the medicine storage unit is a desired value and extremely uniform, there is no variation in the ease of dissolution of the medicine.

  In the medicine storage unit of the present invention, the medicine is attached to the medicine carrier in the inside thereof, and this is connected to the syringe, and after the injection needle is attached, the solvent is sucked from the injection needle to dissolve the medicine. Can be used immediately. Since the cap closing the inlet and outlet of the medicine storage unit is removed immediately before use, the inside of the unit is kept clean until use even when stored for a long time. Since the drug is held on the drug carrier disposed in the flow path of the solvent liquid, the drug can be reliably dissolved in the solvent liquid.

  The syringe of the present invention has a drug attached to its internal drug carrier, so that it can be used as it is by dissolving the drug inside the syringe at the time of use, so it is hygienic and can be used immediately in an emergency. Since the drug is held on the drug carrier disposed in the flow path of the solvent liquid, the drug can be reliably dissolved in the solvent liquid.

  Embodiments of the present invention will be described below with reference to the drawings.

1. 1. Drug Storage Unit 1.1 Configuration of Drug Storage Unit FIG. 1 is a perspective view showing an embodiment of the drug storage unit of the present invention. FIG. 2 is a side view of the medicine storage unit shown in FIG. FIG. 3 is a sectional view of the medicine storage unit shown in FIG. FIG. 4 is a side view illustrating a state in which the medicine storage unit shown in FIG. 1 is mounted on a syringe.

  The drug storage unit 100 includes a housing 110 having an inlet 111 connected to an injection solution nozzle 211 of a syringe body (cylinder) 210 and an outlet 112 connected to a base 230 a of an injection needle 230, and the inlet 111 to the outlet 112. A filter (drug carrier) 120 provided in the housing 110 to remove foreign substances in the injection solution that reaches the throat, and caps 131 and 132 made of synthetic resin that seal the inlet 111 and the outlet 112. FIG. 1 shows a state where the caps 131 and 132 are removed. The housing 110 is sterilized.

  The material of the housing 110 and the caps 131 and 132 is polypropylene, high density polyethylene, modified acrylic, vinyl chloride resin, or the like.

  For the filter 120, a polysulfone membrane, nylon membrane, polyethersulfone membrane, cellulose mixed ester membrane, borosilicate glass fiber, glass fiber filter paper, or the like is used. Although the disk-shaped filter 120 is shown in the illustrated example, the shape of the filter 120 is not limited to this.

  The hole diameter of the filter 120 is 0.2 μm or more. A filter 120 having an appropriate pore size is used depending on the application. For example, in the case of an injection solution or the like, those having a pore diameter of 0.2 μm to 0.45 μm are used. In the case of a drug having a large particle size, those having a pore size of 0.45 μm or more are also used.

  A drug is attached to the filter 120. Examples of such agents include human and veterinary vaccines, immunoglobulins, antibody peptides, and other biologics in general. This drug is a spherical fine particle drug, and its average particle system is 0.1 to several tens of μm, and is selected to a desired value according to the application. The standard deviation of the particle diameter is 0.085 or less. The manufacture of the drug and the process of attaching the drug to the filter 120 are performed using a manufacturing apparatus described later.

1.2 Action and Effect of Drug Storage Unit The drug storage unit 100 is attached to the syringe body 210 by connecting the inlet 111 to the injection solution nozzle 211 of the syringe body 210 after removing the caps 131 and 132. An injection needle 230 is attached to the outlet 112. As shown in FIG. 5, when the tip of the injection needle 230 is inserted into the solvent liquid 300 in the vial or ampoule and the piston 220 of the syringe 200 is pulled, the solvent liquid 300 is sucked, and the injection needle 230 and the drug storage unit 100 are drawn. Through the syringe body 210. At that time, since the medicine adhering to the filter 120 is dissolved in the solvent liquid 300, the medicine solution (injection liquid) 301 is introduced into the syringe main body 210. When there is a possibility that undissolved drug may be generated by only one suction operation, the drug can be completely dissolved by moving the piston 220 of the syringe back and forth several times and stirring the solvent liquid 300.

  Since the caps 131 and 132 blocking the inlet 111 and the outlet 112 of the medicine storage unit 100 are removed immediately before using the medicine storage unit 100, the inside of the medicine storage unit 100 is clean until use even when stored for a long period of time. To be kept. Moreover, since the chemical | medical agent is hold | maintained at the filter 120 arrange | positioned in the flow path of the solvent liquid 300, a chemical | medical agent can be dissolved rapidly and reliably. Furthermore, since the average particle diameter of the medicine adhering to the filter 120 is a desired value and extremely uniform, there is no variation in the ease of dissolution of the medicine. Even if foreign matter such as bacteria or dirt is contained in the syringe main body 210, foreign matter larger than the hole diameter of the filter 120 is trapped by the filter 120 at the time of injection, so that it is very hygienic. For example, if a filter 120 having a pore diameter of 0.2 μm is used, even minute foreign matters such as bacteria can be trapped almost completely.

2. 2. Syringe 2.1 Configuration of Syringe FIG. 6 is a side view showing an embodiment of the syringe of the present invention.

  The syringe 400 includes the drug storage unit 100 between the syringe body 210 and the injection needle 230. The structure of the medicine storage unit 100 is the same as that described above. The injection needle 230 is covered with a resin cap 231, and the entire injection needle 230 is sealed with the cap 231. The syringe 400 is stored in a state of being completely accommodated in a bag-like package (not shown) made of a highly airtight resin sheet after sterilization.

2.2 Action and Effect of Syringe After removing the cap 231 of the injection needle 230 from the package and removing the cap 231 of the injection needle 230, the syringe 400 sucks and stirs the solvent solution 300 into the syringe body 210 in the same manner as in FIG. Thus, the drug adhering to the filter 120 can be dissolved in the solvent liquid 300 and the drug solution (injection solution) 301 can be introduced into the syringe body 210. Since the medicine is dissolved in the syringe 400 and can be used as it is, it is hygienic and can be used immediately in an emergency.

  Since the package containing the syringe 400 and the cap 231 of the injection needle 230 are removed immediately before the syringe 400 is used, the syringe 400 is kept clean until it is used even when stored for a long period of time. Moreover, since the chemical | medical agent is hold | maintained at the filter 120 arrange | positioned in the flow path of the solvent liquid 300, a chemical | medical agent can be dissolved rapidly and reliably. Furthermore, since the average particle diameter of the medicine adhering to the filter 120 is a desired value and extremely uniform, there is no variation in the ease of dissolution of the medicine.

3. Manufacturing Device 3.1 Configuration of Manufacturing Device FIG. 7 is a configuration diagram of a manufacturing device according to the present invention. The manufacturing apparatus 1 includes a drug particle generator (particle generation system) 2 and a drug particle supply apparatus (particle delivery system) 3 that supplies the drug particles generated by the drug particle generator 2 into the drug storage unit 100. It is prepared for.

  FIG. 8 is a diagram showing the configuration of the drug fine particle generator 2. As shown in this figure, the drug particulate generator 2 includes a cylindrical particulate sorting container 10 having a lower end closed and a lid 10a at the upper end. The lid 10 a of the fine particle sorting container 10 is provided with a two-fluid nozzle (fine particle generating nozzle) 12 that crushes and refines a fluid drug solution with gas. The two-fluid nozzle 12 jets gas from the gas jet to the outer periphery of the drug solution jetted from the liquid jet (raw material nozzle) provided at the tip of the nozzle, and crushes and refines the drug solution with gas. To eject the fine particles of the drug solution.

  A rectifying cone (rectifying member) 14 for rectifying and guiding fine particles generated by the two-fluid nozzle 12 to the lower part of the fine particle sorting container 10 is provided in the fine particle sorting container 10. Here, the tip of the two-fluid nozzle 12 is disposed in the opening of the upper part of the rectifying cone 14. Further, a secondary gas supply pipe 18 extending from the secondary gas compressor 16 is disposed in the fine particle separation container 10, and the secondary gas from the secondary gas compressor 16 is opened at the lower portion of the rectifying cone 14. Supplied near the section. Further, in the fine particle sorting container 10, three fine particle sorting plates 20, 22, 24 are provided for suppressing the floating of the fine particles guided to the lower part of the fine particle sorting container 10 by the rectifying cone 14 and sorting the fine particles. ing.

  As shown in FIG. 9, the fine particle sorting plate 20 is a disk-shaped plate-like member having an opening 20a through which the rectifying cone 14 penetrates at the center, and is provided with a large number of through holes 20b. Further, as shown in FIG. 10, the fine particle sorting plate 22 is a disk-shaped plate-like member having an opening 22a through which the rectifying cone 14 penetrates at the center, and has a large number of through holes 22b. Yes. The through hole 22 b is formed larger than the size of the through hole 20 b of the fine particle sorting plate 20. Further, as shown in FIG. 11, the fine particle sorting plate 24 is a disk-shaped plate-like member provided with an opening 24a through which the rectifying cone 14 penetrates in the center, and is provided with a large number of through holes 24b. . The through hole 24 b is formed larger than the size of the through hole 22 b of the fine particle sorting plate 22.

  A liquid discharge port 10 b communicating with the liquid storage container 26 is provided at the bottom of the fine particle sorting container 10. The drug solution accumulated at the bottom of the fine particle sorting container 10 is discharged from the liquid discharge port 10 b and stored in the liquid storage container 26. The liquid storage container 26 is connected to the chemical solution recovery tube 4B of the drug fine particle supply device 3, so that the drug solution that has not been used in the drug fine particle supply device 3 is returned to the liquid storage container 26 through the drug solution recovery tube 4B. It has become.

  The lid 10 a of the fine particle sorting container 10 is provided with a discharge unit 28 for discharging ultra fine particles separated from the fine particles in the fine particle sorting container 10. Here, the discharge part 28 is comprised by the guide part 28b connected to the attaching part 28a attached to the cover part 10a of the particulate sorting container 10, and the attaching part 28a. A power supply device 40 is connected to the guide tube 28b for supplying electric charges to the ultrafine particles discharged from the discharge unit 28.

  The power supply device 40 supplies a desired DC high voltage to the guide tube 28b of the discharge unit 28, and supplies and charges the ultrafine particles discharged from the discharge unit 28. By charging the ultrafine particles and controlling the charge amount in this way, it is possible to prevent the discharged ultrafine particles from adhering to the inner wall of the apparatus or the particles from adhering again.

  A liquid supply pipe 30 for supplying the drug solution to the two-fluid nozzle 12 is provided between the liquid storage container 26 and the two-fluid nozzle 12. The liquid supply pipe 30 is provided with an electromagnetic valve 32 for adjusting the amount of liquid supplied to the two-fluid nozzle 12. The solution can be supplied to the two-fluid nozzle 12 from other than the liquid storage container 26 via the branch supply pipe 30a. A gas supply pipe 36 for supplying nozzle gas to the two-fluid nozzle 12 is provided between the nozzle supply compressor 34 and the two-fluid nozzle 12.

  The pressure of the secondary gas supplied into the fine particle separation container 10 by the above-described secondary gas compressor 16, the pressure of the nozzle gas supplied to the secondary fluid nozzle 12 by the nozzle supply compressor 34, and the solenoid valve 32. The amount of the drug solution supplied to the two-fluid nozzle 12 is controlled by the control device 42. Further, the control device 42 controls the amount of charge supplied to the guide tube 28b of the discharge unit 28 by the power supply device 40.

  Further, the control device 42 is connected to a particle size detection unit S1 for detecting the particle size distribution of the fine particles discharged from the discharge unit 28 and a particle amount detection unit S2 for detecting the particle amount of the fine particles. Detection values are input from S1 and the particle amount detection unit S2. The particle size detection unit S1 and the particle amount detection unit S2 detect the particle size distribution of fine particles taken out from a fine particle extraction port (not shown) provided in the guide tube 28b and the amount of ultra fine particles. .

  Further, the control device 42 includes a particle diameter setting unit 44a for setting the particle diameter of the fine particles discharged from the discharge unit 28, a particle amount setting unit 44b for setting the particle amount of the fine particles, and a charge amount (supply charge amount) of the fine particles. A charge amount setting unit 44c to be set is connected.

  FIG. 12 is a conceptual diagram showing the configuration of the drug fine particle supply device 3. The drug fine particle supply device 3 includes a drug supply pipe 4A and a drug recovery pipe 4B.

  The upstream end of the drug supply pipe 4A is connected to the guide pipe 28b of the drug fine particle generator 2. The downstream side of the medicine supply pipe 4A is branched into a plurality, and the inlet 111 of the medicine storage unit 100 is detachably connected to the downstream end of each branch flow path 4Aa. A transport pump 5 is provided at an intermediate portion of the medicine supply pipe 4A. A supply source (not shown) of dry nitrogen (N), which is a carrier gas, is connected to the carrier pump 5. The conveyance pump 5 conveys the fine particles by forcibly sending the air containing the fine particles sent from the drug fine particle generator 2 to the downstream side of the drug supply pipe 4A together with the dry nitrogen.

  The upstream side of the drug recovery tube 4B is branched into a plurality (the same number as the number of branches of the drug supply tube 4A), and the outlet 112 of the drug storage unit 100 is detachably connected to the upstream end of each branch channel 4Ba. It is like that. The downstream end of the medicine recovery tube 4B is connected to the liquid storage container 26.

3.2 Functions and effects of manufacturing equipment (method for manufacturing drug storage unit)
When the manufacturing apparatus 1 is operated, the medicine storage unit 100 for which the medicine has not been collected is mounted between the branch flow paths 4Aa and 4Ba of the medicine fine particle supply apparatus 3. Supply and recovery of the medicine storage unit 100 to and from the manufacturing apparatus 1 are automatically performed by a medicine storage unit supply / recovery device (not shown).

  The operator of the manufacturing apparatus 1 sets the particle diameter and the particle amount of the fine particles discharged from the discharge unit 28 by operating the particle diameter setting unit 44a and the particle amount setting unit 44b. The set value of the particle diameter of the fine particles is set according to the average particle diameter of the drug fine particles to be manufactured. Further, the operator sets the charge amount of the fine particles discharged from the discharge unit 28 by operating the charge amount setting unit 44c. The charge amount is appropriately set so that fine particles do not adhere to unnecessary portions such as the guide tube 28b and the drug supply tube 4A of the discharge unit 28, and preferably the generated fine particles do not recombine. In order to prevent recombination of the fine particles, it is preferable to make the fine particles electrically neutral.

  After the mounting of the drug storage unit 100 and the setting of the particle diameter, the particle amount, and the charge amount of the fine particles are completed, the drug fine particle generator 2 is operated to generate ultra fine particles of the drug solution.

  In the drug particulate generator 2, when air (nozzle gas) is supplied from the nozzle supply compressor 34 to the two-fluid nozzle 12 via the gas supply pipe 36, this air is the gas at the tip of the two-fluid nozzle 12. The chemical solution in the liquid storage container 26 is sucked up by the jet outlet and supplied to the two-fluid nozzle 12 through the liquid supply pipe 30.

  In the two-fluid nozzle 12, the solution ejected from the liquid ejection port is crushed and refined by the air ejected from the gas ejection port, and the fine particles of the drug solution are ejected. The fine particles of the drug solution ejected from the two-fluid nozzle 12 are guided to the lower part of the fine particle sorting container 10 through the rectifying cone 14. On the other hand, air (secondary gas) from the secondary gas compressor 16 is supplied to the vicinity of the opening at the lower portion of the rectifying cone 14 via the secondary gas supply pipe 18.

  The fine particles of the drug solution guided to the lower part of the fine particle sorting container 10 are suppressed by the fine particle sorting plates 20, 22, and 24 from being rapidly raised by the upward flow caused by the air and the secondary gas ejected from the two-fluid nozzle 12. Through the through holes 20b, 22b, and 24b provided in the particle sorting plates 20, 22, and 24, the inside of the particle sorting container 10 is gradually raised. That is, first, the fine particles that have passed through the fine particle sorting plate 24 are suppressed from rising by the fine particle sorting plate 22, and fine particles having a predetermined particle size distribution stay between the fine particle sorting plate 24 and the fine particle sorting plate 22. Here, the fine particles having a large particle diameter fall to the bottom of the fine particle sorting container 10 by their own weight. Further, the fine particles that have passed through the fine particle sorting plate 22 are prevented from rising by the fine particle sorting plate 20, and fine particles having a predetermined particle size distribution stay between the fine particle sorting plate 22 and the fine particle sorting plate 20. Here, fine particles having a large particle diameter fall to the bottom of the fine particle sorting container 10 by gravity. The particle size of the fine particles staying between the fine particle sorting plate 22 and the fine particle sorting plate 20 is smaller than the particle size of the fine particles staying between the fine particle sorting plate 24 and the fine particle sorting plate 22.

  As the fine particles float in the fine particle sorting container 10 in this way, the fine particles having a large particle size fall to the bottom of the fine particle sorting container 10, and only fine particles having a particle size of a predetermined value or less are discharged from the fine particle sorting container 10. It is discharged from the part 28. Here, the fine particles discharged from the discharge unit 28 have a charge corresponding to the charge amount set by the charge amount setting unit 44c. That is, the control device 42 outputs a control signal to the power supply device 40 based on the value set by the charge amount setting unit 44c, and the amount of charge supplied to the guide tube 28b of the discharge unit 28 by the power supply device 40. Take control. The drug solution accumulated at the bottom of the fine particle sorting container 10 is discharged from the liquid discharge port 10b, stored in the liquid storage container 26, and reused.

  The particle size distribution of the fine particles discharged from the discharge unit 28 is detected by the particle size detection unit S1, and the particle amount of the fine particles is detected by the particle amount detection unit S2. The detection values detected by the particle diameter detection unit S1 and the particle amount detection unit S2 are input to the control device 42. In the control device 42, the particle size of the fine particles discharged from the discharge unit 28 is set to the value set by the particle size setting unit 44a, and the particle amount of the fine particles is set to the value set by the particle amount setting unit 44b. The control signal is output to the compressor 16 for the secondary gas, the solenoid valve 32 and the nozzle supply compressor 34 so that the pressure of the air supplied to the two-fluid nozzle 12 and the solution supplied to the two-fluid nozzle 12 are obtained. And the pressure of the secondary gas supplied into the fine particle separation container 10 is controlled.

  That is, the control device 42 controls the nozzle supply compressor 34 when the particle size of the fine particles detected by the particle size detection unit S1 is larger than the size set by the particle size setting unit 44a. The pressure of the air supplied to the fluid nozzle 12 is increased. Further, the secondary gas compressor 16 is controlled to increase the pressure of the air supplied into the fine particle separation container 10. Thereby, the particle diameter of the fine particles discharged from the discharge unit 28 is reduced.

  On the other hand, when the particle size of the fine particles detected by the particle size detection unit S1 is smaller than the size set by the particle size setting unit 44a, the nozzle supply compressor 34 is controlled to be supplied to the two-fluid nozzle 12. Reduce the air pressure. Further, the pressure of the air supplied into the fine particle separation container 10 is lowered by controlling the secondary gas compressor 16. Thereby, the particle diameter of the fine particles discharged from the discharge unit 28 is increased.

  The particle diameter of the fine particles discharged from the discharge unit 28 is controlled not only by controlling the pressure of the air supplied to the two-fluid nozzle 12 but also by controlling the pressure of the air supplied into the fine particle sorting container 10. Is possible. By controlling both the pressure of the air supplied to the two-fluid nozzle 12 and the pressure of the air supplied into the fine particle sorting container 10, the particle diameter of the fine particles can be controlled with higher accuracy.

  When the amount of fine particles detected by the particle amount detection unit S2 is smaller than the amount set by the particle amount setting unit 44b, a control signal is output to the electromagnetic valve 32 and supplied to the two-fluid nozzle 12. Increase the amount of solution being made. As a result, the amount of fine particles discharged from the discharge unit 28 increases. On the other hand, when the amount of fine particles detected by the particle amount detection unit S2 is larger than the amount set by the particle amount setting unit 44b, a control signal is output to the electromagnetic valve 32 and supplied to the two-fluid nozzle 12. Reduce the amount of solution being made. As a result, the amount of fine particles discharged from the discharge unit 28 is reduced.

  In this drug fine particle generator 2, the particle size of the fine particles detected by the particle size detection unit S1 is set by the particle size setting unit 44a to become the particle size, and the particle amount detected by the particle amount detection unit S2 is set as the particle size setting. The above-described control is repeated until the amount of particles set by the unit 44b is reached.

  The drug fine particles generated by the super drug fine particle generator 2 are supplied to the drug fine particle supply device 3 through the guide tube 28b. The fine particles supplied to the drug fine particle supply device 3 are conveyed through the drug supply pipe 4A. Meanwhile, the fine particles are dried by a carrier gas (dry nitrogen). Then, the dried drug fine particles are simultaneously introduced into the plurality of drug storage units 100 through the branch flow path 4Aa together with the carrier gas.

  The carrier gas introduced into the medicine storage unit 100 passes through the filter 120 and flows to the medicine recovery tube 4B as it is, but the medicine particles in the carrier gas are trapped by the filter 120. The drug fine particles not trapped by the filter 120 (that is, the fine particles that have passed without being attached to the filter 120) are returned to the liquid storage container 26 of the drug fine particle generator 2 through the drug recovery tube 4B.

  After the process of introducing the drug fine particles into the drug storage unit 100 is performed for a predetermined time, the manufacturing apparatus 1 stops driving. The medicine storage unit 100 attached to the manufacturing apparatus 1 is collected by a medicine storage unit supply / collection device (not shown) and sent to a post-processing step. In the post-processing step, mounting of caps 131 and 132 to the medicine storage unit 100, inspection, packaging, and the like are performed.

  As described above, the manufacturing apparatus 1 pulverizes the drug solution by the air current by jetting the gas from the gas jet port of the two-fluid nozzle 12 while jetting the drug solution from the liquid jet port of the two-fluid nozzle 12. Particle generation step for generating fine particles of a drug solution, and selection using particles selection plates 24, 22, and 20 for preferentially extracting particles having a small particle diameter from the particles generated in this particle generation step A step for drying the fine particles taken out in the sorting step while being conveyed by a carrier gas in the drug supply pipe 4A of the drug fine particle supply device 3, and when the drying step is executed, the fine particles are charged. Through a charge supply step to be supplied and a particle size control step for controlling the discharge amount of the drug solution from the nozzle 12. Generating a dry drug particles.

  Therefore, according to this manufacturing apparatus 1, the diameters of the through holes 20b, 22b, 24b of the fine particle sorting plates 20, 22, 24, and the distance between the plates are appropriately selected, and the discharge amount of the drug solution from the nozzle 12 and By appropriately controlling the jet amount of the airflow, it is possible to generate a fine particle group of a drug solution having a uniform particle size with an average particle size of a predetermined value or less. Therefore, the fine powder composed of fine particle groups that are finally dried and manufactured can have an average particle size of a predetermined value or less and a uniform particle size.

  In addition, when the fine particle group of the drug solution is dried while being conveyed by the carrier gas, the charge state of the fine particle is controlled by supplying a charge to the fine particle, thereby suppressing the adhesion of the fine particle to each other or the inner wall of the apparatus. Thus, drug fine particles having a uniform particle diameter and shape can be efficiently produced. In other words, it is possible to prevent the fine particles from being damaged during the drying process and to produce drug fine particles having a uniform shape.

  In the manufacturing apparatus 1, the generated drug fine particles are placed on the carrier gas and introduced into the drug storage unit 100, and trapped by the filter 120 in the unit 100, so that the drug fine particles are stored in the unit 100. As a result, even if a very small amount of the medicine is used, it can be surely stored in the unit 100 by a fixed amount. The amount of the medicine accommodated in the unit 100 can be accurately controlled by adjusting the particle diameter and transport amount of the medicine, the supply time, the size and pore diameter of the medicine carrier, the flow rate of the carrier gas, temperature and humidity, and the like.

  Moreover, according to this manufacturing apparatus 1, since a chemical | medical agent can be simultaneously supplied in the some chemical | medical agent storage unit 100, the chemical | medical agent storage unit 100 which accommodated the chemical | medical agent can be manufactured very efficiently.

  In addition, the chemical | medical agent accommodation unit and syringe of this invention are not limited to the form example mentioned above. For example, as shown in FIG. 13, the medicine storage unit 100 may be configured integrally with the nozzle 211 of the syringe main body 210. That is, the filter 120 holding the fine drug particles is disposed in the nozzle 211 of the syringe body 210.

  Further, the drug carrier need not be a filter, and may be a net, fiber, chip, sheet or the like that does not have a filter function.

  Further, the manufacturing apparatus of the present invention is not limited to the above-described embodiment. For example, in the above embodiment, the fine particle group of the drug solution is transported by dry nitrogen, but it is also possible to use simple dry air as the transport gas.

  INDUSTRIAL APPLICABILITY The present invention can be widely used as a manufacturing technique for drug storage units that contain various drugs for general biologics such as human and animal vaccines, immunoglobulins, and antibody peptides.

The perspective view which shows the example of 1 form of the chemical | medical agent accommodation unit of this invention Side view of the medicine storage unit shown in FIG. Sectional drawing of the chemical | medical agent accommodation unit shown in FIG. The side view which illustrates the state which mounted | wore the syringe with the chemical | medical agent accommodation unit shown in FIG. The side view which shows the state at the time of use of the chemical | medical agent accommodation unit and syringe of this invention The perspective view which shows one example of a syringe of this invention The block diagram which shows the structural example of the manufacturing apparatus of this invention Schematic block diagram showing a configuration example of the drug fine particle generator in FIG. FIG. 8 is a plan view showing a configuration example of the particle sorting plate in FIG. FIG. 8 is a plan view showing a configuration example of the particle sorting plate in FIG. FIG. 8 is a plan view showing a configuration example of the particle sorting plate in FIG. Schematic block diagram showing a configuration example of the drug fine particle supply device in FIG. The principal part side view which shows another form example of the chemical | medical agent accommodation unit and syringe of this invention

Explanation of symbols

1 Production Equipment 2 Drug Fine Particle Generator (Fine Particle Generation System)
3. Drug fine particle supply device (fine particle conveyance system)
4A Drug supply pipe 4Aa Branch flow path 4B Drug recovery pipe 4Ba Branch flow path 12 Two-fluid nozzle 44a Particle diameter setting section 44b Particle amount setting section 44c Charge amount setting section 100 Drug storage unit 110 Housing 111 Inlet 112 Outlet 120 Filter (drug carrier) )
131, 132 Cap 210 Syringe body (cylinder)
211 Injection nozzle 230 Injection needle 230a Base 231 Cap 300 Solvent liquid 301 Drug solution 400 Syringe

Claims (13)

A housing having an inlet connected to an injection liquid nozzle of an injector and an outlet connected to a base of an injection needle, and a breathability provided in the housing so as to block a flow path from the inlet to the outlet An apparatus for producing a drug containing unit by attaching a drug to the drug carrier of a unit having a drug carrier comprising:
While discharging a drug solution having fluidity from a raw material nozzle, it is crushed by an air flow to generate fine particles of the drug solution, and the particle size of the fine particles is controlled by controlling the discharge amount of the drug solution from the raw material nozzle. A fine particle generation system;
An apparatus for manufacturing a medicine container unit, comprising: a fine particle transport system for introducing the fine particles generated by the drug fine particle generator onto a transport air current and introducing the fine particles into the unit to adhere to the drug carrier.   2. The manufacturing apparatus according to claim 1, wherein the fine particle conveying system has a flow path branched into a plurality of channels so as to simultaneously introduce the fine particles generated in the fine particle generation system into the plurality of units.   3. The manufacturing apparatus according to claim 1, wherein the fine particle transport system returns the fine particles that have passed through the unit to the fine particle generation system. A housing having an inlet connected to an injection liquid nozzle of an injector and an outlet connected to a base of an injection needle, and a breathability provided in the housing so as to block a flow path from the inlet to the outlet A drug containing unit containing a drug by attaching the drug to the drug carrier of the unit having a drug carrier comprising:
A fine particle generation step for generating a fine particle of the drug solution by crushing by a gas stream while discharging the drug solution having fluidity from the raw material nozzle;
A particle size control step for controlling the particle size of the fine particles by controlling the discharge amount of the drug solution from the raw material nozzle;
A fine particle conveying step of introducing the fine particles generated in the fine particle generating step onto a carrier air flow and introducing the fine particles into the unit to adhere to the drug carrier, Method.   5. The manufacturing method according to claim 4, wherein, in the fine particle conveying step, the fine particles generated in the fine particle generating step are simultaneously introduced into the plurality of units through a plurality of branched channels. A housing having an inlet connected to the injection solution nozzle of the syringe and an outlet connected to the base of the injection needle;
An air-permeable drug carrier provided in the housing so as to block a flow path from the inlet to the outlet;
A drug attached to the drug carrier;
A drug storage unit containing a drug, comprising: a cap that seals the inlet and the outlet.   The drug was generated while controlling the particle diameter of the fine particles by controlling the discharge amount of the drug solution from the raw material nozzle while crushing it with an air flow while discharging the drug solution having fluidity from the raw material nozzle. 7. The medicine container unit according to claim 6, wherein the medicine container is a fine particle of a medicine solution or a dried product thereof.   The drug storage unit according to claim 7, wherein the drug carrier is a filter for removing foreign substances in the solution flowing from the inlet to the outlet.   9. The medicine container unit according to claim 8, wherein the pore diameter of the filter is 0.2 μm to 0.22 μm. A syringe provided with a medicine storage unit between the syringe body and the injection needle,
The medicine container unit is
A housing having an inlet connected to the injection nozzle of the syringe body and an outlet connected to the base of the injection needle;
An air-permeable drug carrier provided in the housing so as to block a flow path from the inlet to the outlet;
A syringe containing a drug, comprising: a drug attached to the drug carrier. The drug is
Fine particles of the drug solution generated while controlling the particle size of the fine particles by controlling the discharge amount of the drug solution from the raw material nozzle while crushing with a gas stream while discharging the fluid chemical solution from the raw material nozzle The syringe according to claim 10, which is a dried product thereof.   The syringe according to claim 11, wherein the drug carrier is a filter for removing foreign substances in the solution flowing from the inlet to the outlet.   The syringe of claim 12, wherein the filter has a pore size of 0.2 µm to 0.22 µm.

Images