Residual oxygen amount control method in ampoule bottle liquid medicine filling process

Abstract

The invention relates to a residual oxygen amount control method in an ampoule bottle liquid medicine filling process, which comprises the following steps of: 1, filling nitrogen into an empty ampoule bottle through a first nitrogen filling needle head with a bevel structure, and enabling the nitrogen to flow to the first nitrogen filling needle head through a nitrogen pipeline, a flow meter and a switch valve are sequentially arranged on the nitrogen pipeline along the flow direction of nitrogen; secondly, liquid medicine is injected into the empty ampoule bottle through a liquid injection needle; thirdly, nitrogen is injected into the ampoule bottle through a second nitrogen filling needle head, a flower opening structure is arranged at an air outlet of the second nitrogen filling needle head and comprises a plurality of air blocking petals arranged at intervals in the circumferential direction, and air flow channels are formed between every two adjacent air blocking petals in the circumferential direction and between the bottoms of all sets of air petals; fourthly, the second nitrogen charging needle is pulled out, and the ampoule bottle is sealed. By means of the residual oxygen amount control method in the ampoule bottle liquid medicine filling process, the residual oxygen amount in the ampoule bottle can be effectively reduced in the liquid medicine filling process.

Description

Technical Field

[0001] The invention relates to the technical field of tablet production, and in particular to a method for controlling residual oxygen content during ampoule bottle liquid filling. Background Art

[0002] During the process of filling the ampoule with drug solution, the control of residual oxygen level has an important impact on the quality and stability of the drug.

[0003] The traditional ampoule liquid filling process is as follows: the first step is to inject nitrogen into the empty ampoule through a nitrogen filling needle with an oblique mouth structure, which is called primary nitrogen filling, to expel the oxygen in the empty bottle; the second step is to inject liquid medicine into the empty ampoule through a liquid injection needle; the third step is to inject nitrogen into the upper side of the liquid medicine in the ampoule through a nitrogen filling needle with an oblique mouth structure, which is called secondary nitrogen filling, to reduce the oxygen mixed into the ampoule during the liquid medicine injection process; the fourth step is to pull out the nitrogen filling needle and seal the upper end of the ampoule.

[0004] It has been found in the prior art that the residual oxygen control effect in the sealed ampoule is not particularly ideal when the ampoule is filled with liquid medicine through the existing process. The residual oxygen concentration is still around 2%, which is not particularly conducive to the long-term stable storage of medicines. Through multiple experiments and theoretical analysis, we found that the shape of the needles for primary and secondary nitrogen filling, the height of the needles inserted into the bottle, the filling speed of the liquid medicine, the sealing position of the ampoule, and the nitrogen flow path are all the main factors affecting the residual oxygen level. Summary of the invention

[0005] The object of the present invention is to provide a method for controlling the residual oxygen content in the ampoule medicine solution perfusion process, which can effectively reduce the residual oxygen content in the ampoule bottle during the medicine solution perfusion process.

[0006] In order to solve the above technical problems, the technical solution of a method for controlling residual oxygen content during ampoule liquid infusion in the present invention is as follows:

[0007] A method for controlling residual oxygen content during ampoule liquid filling process, the method comprising the following steps: a first step, charging nitrogen into an empty ampoule via a first nitrogen filling needle with an oblique mouth structure to realize primary nitrogen filling, the nitrogen flows to the first nitrogen filling needle via a nitrogen pipeline, a flow meter and a switch valve are sequentially arranged on the nitrogen pipeline along the flow direction of the nitrogen; a second step, injecting liquid medicine into the empty ampoule via a liquid injection needle; a third step, charging nitrogen into the ampoule via a second nitrogen filling needle to realize secondary nitrogen filling, the gas outlet of the second nitrogen filling needle is provided with a flower mouth structure, the flower mouth structure comprises a plurality of air blocking flaps arranged at intervals along the circumferential direction, and air flow channels are provided between two adjacent air blocking flaps in the circumferential direction and between the bottoms of each group of air flaps; a fourth step, pulling out the second nitrogen filling needle to seal the ampoule.

[0008] Furthermore, the second nitrogen filling needle includes a second needle tube, the upper end of each air-blocking flap is hingedly connected to the bottom of the second needle tube, the outer periphery of each air-blocking flap is connected with an elastic ring for forcing the lower ends of each air-blocking flap to move closer to each other, the outer periphery of the second needle tube is guided and moved along the up and down directions with a driving sleeve, the driving sleeve is driven by a driving sleeve driving mechanism, and the lower end of the driving sleeve is provided with an air-blocking flap pull rope respectively connected to the outer periphery bottom of each air-blocking flap.

[0009] Furthermore, an elastic ring positioning groove is provided on the outer periphery of each air blocking flap along the circumferential direction, and the elastic ring is located in the corresponding elastic ring positioning groove.

[0010] Furthermore, the elastic ring is bonded to the groove wall of the elastic ring positioning groove.

[0011] Furthermore, the driving mechanism of the driving sleeve includes a left driving roller and a right driving roller located on the left and right sides of the driving sleeve, the left driving roller is driven by a left motor, and the right driving roller is driven by a right motor. The outer peripheries of the left driving roller and the right driving roller have arc grooves that are adapted to the outer periphery of the driving sleeve, and the driving mechanism of the driving sleeve also includes a power component for driving the left driving roller and the right driving roller to move relative to each other to achieve contact between the arc groove and the outer periphery of the driving sleeve.

[0012] Furthermore, the ampoule has a capacity of 1 ml, the first nitrogen filling needle and the second nitrogen filling needle are 0.7 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 7 L / min, the injection speed of the injection needle into the ampoule is 550 needles / minute, and in the fourth step, the sealing position is 4.5 cm away from the bottom of the ampoule.

[0013] Furthermore, the ampoule has a capacity of 2 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 8 L / min, the injection speed of the injection needle into the ampoule is 500 needles / minute, and in the fourth step, the sealing position is 5.5 cm away from the bottom of the ampoule.

[0014] Furthermore, the ampoule has a capacity of 5 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 10 L / min, the injection speed of the injection needle into the ampoule is 350 needles / minute, and in the fourth step, the sealing position is 7 cm away from the bottom of the ampoule.

[0015] Furthermore, the ampoule has a capacity of 10 ml, the first nitrogen filling needle and the second nitrogen filling needle are 3.5 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 13 L / min, the injection speed of the injection needle into the ampoule is 300 needles / minute, and in the fourth step, the sealing position is 8 cm away from the bottom of the ampoule.

[0016] Furthermore, the ampoule has a capacity of 20 ml, the first nitrogen filling needle and the second nitrogen filling needle are 4 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 15 L / min, the injection speed of the injection needle into the ampoule is 200 needles / minute, and in the fourth step, the sealing position is 11 cm away from the bottom of the ampoule.

[0017] The beneficial effects of the present invention are as follows: in the present invention, during the primary nitrogen filling, there is no liquid medicine in the ampoule bottle, so a first nitrogen filling needle with an oblique mouth structure is used, and the oblique mouth structure has a large gas outlet area, which can realize rapid nitrogen filling in the ampoule bottle, so that the original oxygen in the ampoule bottle is quickly and completely squeezed out, and at the same time, the nitrogen first passes through the flow meter and then through the switch valve, and when the nitrogen filling value reaches the closing switch valve, the ampoule bottle can obtain an accurate nitrogen filling amount; during the secondary nitrogen filling, since the ampoule bottle already has liquid medicine, a nitrogen filling needle with an oblique mouth structure is also used, which is easy to cause liquid level fluctuations during the nitrogen filling process and cause changes in the oxygen content in the ampoule bottle, so a second nitrogen filling needle with a flower mouth structure is used, and the nitrogen diffusion is more uniform, thereby ensuring that the oxygen mixed in the ampoule bottle is fully squeezed out, and finally effectively controlling the residual oxygen content in the ampoule bottle. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] By reading the following detailed description with reference to the accompanying drawings, the above and other objects, features and advantages of the exemplary embodiments of the present disclosure will become readily understood. In the accompanying drawings, several embodiments of the present disclosure are shown in an exemplary and non-limiting manner, and the same or corresponding reference numerals represent the same or corresponding parts, wherein:

[0019] Figure 1 It is a flow chart of the liquid medicine filling of the ampoule bottle in the present invention;

[0020] Figure 2 yes Figure 1 middle Figure 1 A schematic diagram of the cooperation between the second nitrogen filling needle and the driving mechanism of the driving sleeve;

[0021] Figure 3 yes Figure 2 A top view of

[0022] Figure 4 yes Figure 2 A schematic diagram of the structure of the middle drive sleeve driving mechanism;

[0023] Figure 5 yes Figure 2 A in the enlarged view;

[0024] Figure 6 yes Figure 5Schematic diagram of the state after the middle driving sleeve moves upward and the lower ends of each air-blocking flap move backward and open; 1. conveying mechanism; 2. oblique mouth structure; 3. ampoule bottle; 4. first nitrogen-filling needle; 5. medicine solution; 6. injection needle; 7. second nitrogen-filling needle; 8. driving sleeve; 9. right motor; 10. left driving roller; 11. driving mechanism of the driving sleeve; 12. flower mouth structure; 13. second needle tube; 14. first driving cylinder; 15. second driving cylinder; 16. first articulated arm; 17. second articulated arm; 18. right driving roller; 19. left motor; 20. air-blocking flap pull rope; 21. air-blocking flap; 22. air flow channel; 23. elastic ring; 24. hinge structure. DETAILED DESCRIPTION

[0025] In order to facilitate the understanding of the present invention, the present invention is described in more detail below in conjunction with the accompanying drawings and specific embodiments. Preferred embodiments of the present invention are provided in the accompanying drawings. However, the present invention can be implemented in many different forms and is not limited to the embodiments described in this specification. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present invention more thorough and comprehensive.

[0026] It should be noted that, unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0027] The embodiment of the method for controlling the residual oxygen content during the ampoule liquid infusion process of the present invention is as follows: Figures 1 to 6 As shown:

[0028] The method comprises the following steps: first, nitrogen is charged into an empty ampoule 3 through a first nitrogen charging needle 4 of an oblique mouth structure 2 to realize primary nitrogen charging, and the nitrogen flows to the first nitrogen charging needle through a first nitrogen pipeline, and a first flow meter and a first switch valve are sequentially arranged on the nitrogen pipeline along the flow direction of the nitrogen; second, a medicinal solution 5 is injected into the empty ampoule 3 through a liquid injection needle 6; third, nitrogen is charged into the ampoule through a second nitrogen charging needle 7 to realize secondary nitrogen charging, and the nitrogen flows to the second nitrogen charging needle through a second nitrogen pipeline, and a second flow meter and a second switch valve are sequentially arranged on the second nitrogen channel along the flow direction of the nitrogen, and a flower mouth structure 12 is arranged at the gas outlet of the second nitrogen charging needle, and the flower mouth structure 12 comprises a plurality of air blocking flaps 21 arranged at intervals along the circumferential direction, and an air flow channel 22 is provided between two adjacent air blocking flaps in the circumferential direction and between the bottoms of each group of air flaps; fourth, the second nitrogen charging needle is pulled out to seal the ampoule.

[0029] The first nitrogen filling needle 4 with an oblique mouth structure belongs to the prior art and will not be described in detail here.

[0030] The second nitrogen filling needle 7 includes a second needle tube 13, the upper end of each air-blocking flap is hingedly connected to the bottom of the second needle tube through a hinge structure 24, the hinge structure in this embodiment is a hinge, the outer periphery of each air-blocking flap is connected with an elastic ring 23 for forcing the lower ends of each air-blocking flap to move closer to each other, the outer periphery of the second needle tube is guided and moved along the up and down directions with a driving sleeve 8, the driving sleeve 8 is driven by the driving sleeve driving mechanism 11, and the lower end of the driving sleeve 8 is provided with an air-blocking flap pull rope 20 connected to the bottom of the outer periphery of each air-blocking flap. In this embodiment, there are four air-blocking flaps, so there are also four air-blocking flap pull ropes 20, each air-blocking flap pull rope is connected to each air-blocking flap respectively, the air-blocking flap pull rope is located on the outside of the corresponding air-blocking flap, the upper end of the air-blocking flap pull rope is connected to the bottom of the driving sleeve 8, and the lower end of the air-blocking flap pull rope 20 is connected to the outer side of the lower end of the corresponding air-blocking flap 21.

[0031] When the driving sleeve 8 is positioned relatively low, under the tightening action of the elastic ring 23, the lower ends of the air-blocking flaps move closer to each other, and the air flow channel becomes narrower; when the driving sleeve moves upward, the driving sleeve pulls the lower end of the corresponding air-blocking flap through the air-blocking flap pull rope to swing toward and away, and the air flow channel becomes wider.

[0032] In this embodiment, an elastic ring positioning groove is circumferentially arranged on the outer circumference of each air blocking flap, and the elastic ring 23 is located in the corresponding elastic ring positioning groove, and the elastic ring 23 is bonded to the groove wall of the elastic ring positioning groove.

[0033] The driving mechanism of the driving sleeve includes a left driving roller 10 and a right driving roller 18 located on the left and right sides of the driving sleeve, the left driving roller 10 is driven by a left motor 19, and the right driving roller 18 is driven by a right motor 9. The outer peripheries of the left driving roller and the right driving roller have arc grooves adapted to the outer periphery of the driving sleeve, and the driving mechanism of the driving sleeve also includes a power component for driving the left driving roller and the right driving roller to move relative to each other so as to achieve contact between the arc groove and the outer periphery of the driving sleeve. In this embodiment, the left motor is located at the front side of the left driving roller, and the right motor is located at the rear side of the right driving roller. The left motor and the right motor are in diagonal positions, which helps to ensure the stability of the entire structure.

[0034] Both ends of the right driving roller are rotatably assembled on two second articulated arms 17 arranged front and back, and both ends of the left driving roller are rotatably assembled on two first articulated arms 16 arranged front and back. The first articulated arm 16 at the front is hingedly connected to the second articulated arm 17 at the front; the first articulated arm 16 at the rear is articulatedly connected to the second articulated arm 17 at the rear. The drive sleeve driving mechanism also includes a second drive cylinder 15 corresponding to each first articulated arm and a first drive cylinder 14 corresponding to each second articulated arm. When the piston rods of the first drive cylinder 14 and the second drive cylinder 15 are extended, the first articulated arm 16 and the second articulated arm 17 rotate, and the left drive roller 10 and the right drive roller 18 swing relative to each other, so that the left drive roller and the right drive roller can clamp the drive sleeve. The left motor 19 drives the left drive roller 10 to rotate, and the right motor 9 drives the right drive roller 18 to rotate. The left drive roller and the right drive roller cooperate with the drive sleeve in friction and rolling, so that the drive sleeve 8 can be moved up and down; when the piston rods of the first drive cylinder 14 and the second drive cylinder 15 are retracted, the left drive roller and the right drive roller swing back to each other, so that the clamping effect on the drive sleeve can be released. The first drive cylinder and the second drive cylinder are installed on corresponding fixed brackets (not shown in the figure), and the hinge shafts of the first articulated arm and the second articulated arm are also arranged on the corresponding fixed brackets.

[0035] When the ampoule has a capacity of 1 ml, the height between the first nitrogen filling needle and the second nitrogen filling needle and the bottom of the ampoule is 0.7 cm, the nitrogen flow rate in the first and second nitrogen filling is 7 L / min, and the injection speed of the injection needle into the ampoule is 550 needles / minute. In the fourth step, the sealing position is 4.5 cm above the bottom of the ampoule.

[0036] When the ampoule has a capacity of 2 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first and second nitrogen filling is 8 L / min, the injection speed of the injection needle into the ampoule is 500 needles / minute, and in the fourth step, the sealing position is 5.5 cm away from the bottom of the ampoule.

[0037] When the ampoule has a capacity of 5 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first and second nitrogen filling is 10 L / min, the injection speed of the injection needle into the ampoule is 350 needles / minute, and in the fourth step, the sealing position is 7 cm away from the bottom of the ampoule.

[0038] When the ampoule has a capacity of 10 ml, the first nitrogen filling needle and the second nitrogen filling needle are 3.5 cm away from the bottom of the ampoule, the nitrogen flow rate in the first and second nitrogen filling is 13 L / min, the injection speed of the injection needle into the ampoule is 300 needles / minute, and in the fourth step, the sealing position is 8 cm away from the bottom of the ampoule.

[0039] When the ampoule has a capacity of 20 ml, the first nitrogen filling needle and the second nitrogen filling needle are 4 cm away from the bottom of the ampoule, the nitrogen flow rate in the first and second nitrogen filling is 15 L / min, the injection speed of the injection needle into the ampoule is 200 needles / minute, and in the fourth step, the sealing position is 11 cm away from the bottom of the ampoule.

[0040] Because when facing ampoules of different capacities, the height of the second nitrogen filling needle from the bottom of the ampoule is different, and the corresponding nitrogen filling flow rate is also different. During the secondary nitrogen filling, there is already liquid medicine in the ampoule. If the size of the airflow channel on the flower mouth structure cannot be adjusted, the airflow velocity discharged through the airflow channel may be too high, causing the liquid medicine to fluctuate. Therefore, when the flower mouth structure and the liquid level height of the liquid medicine are small, the driving sleeve goes up to expand the width of the airflow channel, reduce the airflow velocity when the airflow is discharged, and avoid the liquid level fluctuation caused by excessive airflow velocity; when the flower mouth structure and the liquid level height of the liquid medicine are large, the driving sleeve goes down to reduce the width of the airflow channel, and appropriately increase the airflow velocity when the airflow is discharged, so that the nitrogen can quickly reach the liquid surface of the liquid medicine, thereby discharging the oxygen in the ampoule. In the present invention, the driving sleeve drives the air barrier flap to swing around the hinge axis of the hinge structure, thereby realizing the adjustment of the size of the airflow channel, so that the second nitrogen filling needle can be applied to the secondary nitrogen filling of ampoules of various specifications, and has good versatility.

[0041] In order to verify the technical effect of the corresponding technical solution of the present invention, the following detection method is adopted: add water for injection into the preparation tank, set the preparation temperature to about 30°C, and use 0.45μm and 0.22μm polyethersulfone filter membranes to filter the liquid for the second step of filling. During the entire filling process, the ambient temperature is maintained between 20°C and 25°C, and the humidity is controlled between 40% and 60% to further improve the accuracy of residual oxygen control, and high-purity nitrogen (purity ≥99.99%) is used to ensure the quality of the filled gas. Fill 200 tubes according to each condition in the table, and randomly select 6 tubes for testing, as shown in the following figure:

[0042]

[0043]

[0044] In the above figure, the oblique mouth indicates that the needle with an oblique mouth structure is used for nitrogen charging, and the flower mouth indicates that the needle with a flower mouth structure is used for nitrogen charging. The fifth column from left to right in the table indicates the height of the nitrogen charging needle from the bottom of the ampoule bottle during the primary and secondary nitrogen charging processes. The sixth column from left to right in the table indicates the nitrogen flow rate during the primary and secondary nitrogen charging processes; the seventh column from left to right in the table indicates the order of the switch valve and the flow meter in the nitrogen delivery path; it can be clearly known from the above figure:

[0045] When the ampoule has a capacity of 1 ml, the height of the first and second nitrogen filling needles from the bottom of the ampoule is 0.7 cm, the nitrogen flow rate in the first and second nitrogen filling is 7 L / min, the injection speed of the injection needle into the ampoule is 550 needles / min, and in the fourth step, the height of the sealing position from the bottom of the ampoule is 4.5 cm. The residual oxygen content in the ampoule is the lowest, which is the optimal solution.

[0046] When the ampoule has a capacity of 2 ml, the height of the first and second nitrogen filling needles from the bottom of the ampoule is 2 cm, the nitrogen flow rate in the first and second nitrogen filling is 8 L / min, the injection speed of the injection needle into the ampoule is 500 needles / min, and in the fourth step, the height of the sealing position from the bottom of the ampoule is 5.5 cm. The residual oxygen content in the ampoule is the lowest, which is the optimal solution.

[0047] When the ampoule has a capacity of 5 ml, the height of the first and second nitrogen filling needles from the bottom of the ampoule is 2 cm, the nitrogen flow rate in the first and second nitrogen filling is 10 L / min, the injection speed of the injection needle into the ampoule is 350 needles / minute, and in the fourth step, the height of the sealing position from the bottom of the ampoule is 7 cm. The residual oxygen content in the ampoule is the lowest, which is the optimal solution.

[0048] When the ampoule has a capacity of 10 ml, the height of the first and second nitrogen filling needles from the bottom of the ampoule is 3.5 cm, the nitrogen flow rate in the first and second nitrogen filling is 13 L / min, the injection speed of the injection needle into the ampoule is 300 needles / min, and in the fourth step, the height of the sealing position from the bottom of the ampoule is 8 cm. The residual oxygen content in the ampoule is the lowest, which is the optimal solution.

[0049] When the ampoule has a capacity of 20 ml, the height of the first and second nitrogen filling needles from the bottom of the ampoule is 4 cm, the nitrogen flow rate in the first and second nitrogen filling is 15 L / min, the injection speed of the injection needle into the ampoule is 200 needles / minute, and in the fourth step, the height of the sealing position from the bottom of the ampoule is 11 cm. The residual oxygen content in the ampoule is the lowest, which is the optimal solution.

[0050] The filling sequence of the present invention is as follows Figure 1 As shown, the ampoule bottle of corresponding specifications is driven by the conveying mechanism to move stepwise from left to right. When the ampoule bottle moves to the lower side of the first nitrogen filling needle, the first nitrogen filling needle extends downward into the ampoule bottle to realize primary nitrogen filling; then, when the ampoule bottle is moved from left to right to the lower side of the liquid injection needle by the conveying mechanism, the liquid injection needle extends downward into the ampoule bottle to inject liquid; then, the ampoule bottle is moved from left to right to the lower side of the second nitrogen filling needle by the conveying mechanism, and the second nitrogen filling needle extends downward into the ampoule bottle to perform secondary nitrogen filling; then, the conveying mechanism continues to move rightward with the ampoule bottle to perform flame sealing operation.

[0051] In the above description of this specification, unless otherwise clearly specified and limited, the terms "fixed", "installed", "connected" or "connected" should be understood in a broad sense. For example, with regard to the term "connection", it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, or it can be the internal connection of two elements or the interaction relationship between two elements. Therefore, unless otherwise clearly defined in this specification, those skilled in the art can understand the specific meanings of the above terms in the present invention according to the specific circumstances.

[0052] According to the above description of this specification, those skilled in the art may also understand that the terms used below, such as "up", "down", "front", "back", "left", "right", "length", "width", "thickness", "vertical", "horizontal", "top", "bottom", "inside", "outside", "axial", "radial", "circumferential", "center", "longitudinal", "lateral", "clockwise" or "counterclockwise", etc., which indicate the orientation or position relationship, are based on the orientation or position relationship shown in the drawings of this specification, and are only for the purpose of facilitating the explanation of the scheme of the present invention and simplifying the description, rather than explicitly or implicitly indicating that the device or element involved must have the specific orientation, be constructed and operate in a specific orientation. Therefore, the above-mentioned orientation or position relationship terms cannot be understood or interpreted as limitations on the scheme of the present invention.

[0053] In addition, the terms "first" or "second" used in this specification to refer to numbers or ordinals are only used for descriptive purposes and cannot be understood as explicitly or implicitly indicating relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of this specification, the meaning of "plurality" is at least two, such as two, three or more, etc., unless otherwise clearly and specifically defined.

[0054] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for controlling residual oxygen content during ampoule liquid infusion, characterized in that: The method comprises the following steps: a first step, charging nitrogen into an empty ampoule bottle through a first nitrogen-charging needle with an oblique mouth structure to realize primary nitrogen charging, wherein the nitrogen flows to the first nitrogen-charging needle through a nitrogen pipeline, and a flow meter and a switch valve are sequentially arranged on the nitrogen pipeline along the flow direction of the nitrogen; a second step, injecting liquid medicine into the empty ampoule bottle through a liquid injection needle; a third step, charging nitrogen into the ampoule bottle through a second nitrogen-charging needle to realize secondary nitrogen charging, wherein a flower-mouth structure is arranged at the gas outlet of the second nitrogen-charging needle, wherein the flower-mouth structure comprises a plurality of air-blocking flaps arranged at intervals along the circumferential direction, and air flow channels are arranged between two adjacent air-blocking flaps in the circumferential direction and between the bottoms of each group of air flaps; and a fourth step, pulling out the second nitrogen-charging needle to seal the ampoule bottle.

2. The residual oxygen control method according to claim 1, characterized in that: The second nitrogen filling needle includes a second needle tube, the upper end of each air-blocking flap is hingedly connected to the bottom of the second needle tube, the outer periphery of each air-blocking flap is connected with an elastic ring for forcing the lower ends of each air-blocking flap to move closer to each other, the outer periphery of the second needle tube is guided and moved along the up-and-down direction with a driving sleeve, the driving sleeve is driven by a driving sleeve driving mechanism, and the lower end of the driving sleeve is provided with an air-blocking flap pull rope respectively connected to the outer periphery bottom of each air-blocking flap.

3. The residual oxygen control method according to claim 2, characterized in that: The outer periphery of each air blocking flap is provided with an elastic ring positioning groove along the circumferential direction, and the elastic ring is located in the corresponding elastic ring positioning groove.

4. The residual oxygen control method according to claim 3, characterized in that: The elastic ring is bonded and connected to the groove wall of the elastic ring positioning groove.

5. The residual oxygen control method according to claim 2, characterized in that: The driving mechanism of the driving sleeve includes a left driving roller and a right driving roller located on the left and right sides of the driving sleeve, the left driving roller is driven by a left motor, and the right driving roller is driven by a right motor. The outer peripheries of the left driving roller and the right driving roller have arc grooves that are adapted to the outer periphery of the driving sleeve, and the driving mechanism of the driving sleeve also includes a power component for driving the left driving roller and the right driving roller to move relative to each other to achieve contact between the arc groove and the outer periphery of the driving sleeve.

6. The residual oxygen control method according to any one of claims 1 to 5, characterized in that: The ampoule has a capacity of 1 ml, the first nitrogen filling needle and the second nitrogen filling needle are 0.7 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 7 L / min, the injection speed of the injection needle into the ampoule is 550 needles / minute, and in the fourth step, the sealing position is 4.5 cm away from the bottom of the ampoule.

7. The residual oxygen control method according to any one of claims 1 to 5, characterized in that: The ampoule has a capacity of 2 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 8 L / min, the injection speed of the injection needle into the ampoule is 500 needles / minute, and in the fourth step, the sealing position is 5.5 cm away from the bottom of the ampoule.

8. The residual oxygen control method according to any one of claims 1 to 5, characterized in that: The ampoule has a capacity of 5 ml, the first nitrogen filling needle and the second nitrogen filling needle are 2 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 10 L / min, the injection speed of the injection needle into the ampoule is 350 needles / minute, and in the fourth step, the sealing position is 7 cm away from the bottom of the ampoule.

9. The residual oxygen control method according to any one of claims 1 to 5, characterized in that: The ampoule has a capacity of 10 ml, the first nitrogen filling needle and the second nitrogen filling needle are 3.5 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 13 L / min, the injection speed of the injection needle into the ampoule is 300 needles / minute, and in the fourth step, the sealing position is 8 cm away from the bottom of the ampoule.

10. The residual oxygen control method according to any one of claims 1 to 5, characterized in that: The ampoule has a capacity of 20 ml, the first nitrogen filling needle and the second nitrogen filling needle are 4 cm away from the bottom of the ampoule, the nitrogen flow rate in the first nitrogen filling and the second nitrogen filling is 15 L / min, the injection speed of the injection needle into the ampoule is 200 needles / minute, and in the fourth step, the sealing position is 11 cm away from the bottom of the ampoule.

Images