Connecting piece, dialysis device and dialysis system

Abstract

The utility model provides a connecting piece, a dialysis device and a dialysis system. The connecting piece comprises a body, a mounting part and a connecting part are arranged on the body, the mounting part is used for mounting a dialysis piece comprising a shell and a dialysis membrane arranged in the shell, and the connecting part is used for being connected with at least one of a stirring shaft and a stirring paddle of the stirring mechanism, so that the stirring mechanism drives the dialysis piece to rotate. In this way, the dialysis effect can be improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of dialysis, in particular to a connecting piece, a dialysis device and a dialysis system. BACKGROUND

[0002] Dialysis is a method for separating small molecules in solution from large molecules by using a dialysis membrane (or semi-permeable membrane), which is widely used in concentration and purification.

[0003] In the conventional dialysis method, the dialysis piece is directly placed in the container containing the solution. However, in this case, the dialysis effect is poor. CONTENT OF THE INVENTION

[0004] One of the technical problems to be solved by the present application is to improve the dialysis effect.

[0005] In order to solve the above technical problem, the present application provides a connecting piece, which comprises:

[0006] The body is provided with a mounting portion and a connecting portion, the mounting portion is used for mounting a dialysis piece comprising a shell and a dialysis membrane arranged in the shell, and the connecting portion is used for connecting with at least one of a stirring shaft and a stirring paddle of a stirring mechanism, so as to drive the dialysis piece to rotate by the stirring mechanism.

[0007] In some embodiments, the mounting portion comprises a clamping groove for clamping the dialysis piece; and / or, the connecting portion comprises at least one of a jack and a shaft hole, the jack is for inserting the stirring paddle, and the shaft hole is for inserting the stirring shaft.

[0008] In some embodiments, the body comprises a back plate, a bottom plate, a top plate and two side plates, the bottom plate and the top plate are connected to two ends of the back plate along a first direction, the two side plates are connected to two ends of the back plate along a second direction, the first direction and the second direction are perpendicular to each other and perpendicular to the thickness direction of the back plate, and the clamping groove is located between the back plate, the bottom plate, the top plate and the two side plates.

[0009] In some embodiments, the top plate comprises two plate bodies, the two plate bodies are arranged in a spaced manner along the second direction, so as to correspond to two top surfaces of the shell which are arranged in a spaced manner along the second direction; and / or, at least one of the two side plates has a spacing with the bottom plate in the first direction.

[0010] In some embodiments, in the direction from the edge to the middle of the back plate along the second direction, both of the two plate bodies are inclined in the direction away from the bottom plate.

[0011] In some embodiments, the side of the back plate away from the clamping groove is provided with a jack for inserting the stirring paddle; and / or, the side of the back plate away from the clamping groove is provided with a shaft hole for inserting the stirring shaft.

[0012] In some embodiments, the back plate comprises a first plate and a second plate, the second plate is arranged on a side of the first plate away from the card slot, and forms a receptacle with the first plate.

[0013] In some embodiments, the back plate comprises two second plates, to form two receptacles with the first plate, the two receptacles are respectively for inserting two stirring paddles of the stirring mechanism.

[0014] In some embodiments, the body is provided with a stopper, the stopper limits the displacement of the dialysis piece in a direction away from the back plate, to prevent the dialysis piece from being pulled out of the card slot in the direction away from the back plate.

[0015] In some embodiments, the stopper is arranged on the top plate of the body and is bent from the top plate to the side of the bottom plate; and / or, the stopper is arranged on the bottom plate of the body and is bent from the bottom plate to the side of the top plate.

[0016] In some embodiments, the stopper arranged on the top plate is inclined to the side of the back plate in a direction from top to bottom; and / or, the two plate bodies arranged in the second direction are both provided with a stopper.

[0017] In some embodiments, the stopper arranged on the bottom plate extends in the first direction.

[0018] In some embodiments, the body is provided with an opening; and / or, the mounting portion is adjustable in size to mount dialysis pieces of different sizes.

[0019] In some embodiments, the body is provided with at least two openings.

[0020] In addition, the present application also provides a dialysis device, comprising:

[0021] a dialysis piece arranged in a container containing a first agent, and comprising a shell for containing a second agent, and a dialysis membrane arranged in the shell, so that a target substance in a sample contained in one of the first agent and the second agent enters the other one not containing the sample through the dialysis membrane; and

[0022] the connecting piece of any one of the embodiments, the dialysis piece is mounted on the mounting portion of the connecting piece.

[0023] In some embodiments, the dialysis device further comprises a stirring mechanism, the stirring mechanism is arranged rotatably in the container and comprises a stirring shaft and a stirring paddle arranged on the stirring shaft to stir the first agent in the container, and the connecting portion of the connecting piece is connected with at least one of the stirring shaft and the stirring paddle.

[0024] In addition, the present application also provides a dialysis system, comprising:

[0025] a container for containing a first agent; and

[0026] The dialysis device of any embodiment.

[0027] In some embodiments, the dialysis system is a drug dissolution detection system or an encapsulation rate detection system, the sample is a medicament, and the target substance is a drug component in the medicament.

[0028] By arranging the connecting piece, the hard dialysis piece is connected to the stirring mechanism, which is conducive to accurately controlling the rotating speed of the dialysis piece and improving the dialysis effect.

[0029] Other features and advantages of the present application will become apparent from the following detailed description of illustrative embodiments thereof, which proceeds with reference to the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

[0030] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the drawings needed to be used in the embodiments or prior art description will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative effort on the basis of these drawings.

[0031] Figure 1 It is a perspective view of the dialysis system in the embodiment of the present application.

[0032] Figure 2 It is an exploded schematic view of the dialysis system in the embodiment of the present application.

[0033] Figure 3 It is a first perspective schematic view of the dialysis device in the embodiment of the present application.

[0034] Figure 4 It is a second perspective schematic view of the dialysis device in the embodiment of the present application.

[0035] Figure 5 It is a perspective schematic view of the stirring mechanism in the embodiment of the present application.

[0036] Figure 6 It is a first perspective schematic view of the combined structure of the dialysis piece and the connecting piece in the embodiment of the present application.

[0037] Figure 7 It is a second perspective schematic view of the combined structure of the dialysis piece and the connecting piece in the embodiment of the present application.

[0038] Figure 8 It is a perspective schematic view of the dialysis piece in the embodiment of the present application.

[0039] Figure 9 It is a first perspective schematic view of the connecting piece in the embodiment of the present application.

[0040] Figure 10 Fig. 2 is a second perspective view of the connecting piece in the embodiments of the present application.

[0041] Figure 11 Fig. 4 is the dissolution curve of three samples with different drug-lipid ratios in the test example 1 of the present application.

[0042] Figure 12 Fig. 5 is the dissolution curve of three samples with different particle sizes in the test example 2 of the present application.

[0043] Explanation of reference signs:

[0044] 100, dialysis system; 101, dialysis device;

[0045] 1, container;

[0046] 2, stirring mechanism; 21, stirring shaft; 22, stirring paddle;

[0047] 3, dialysis piece; 31, shell; 32, dialysis membrane; 33, top surface; 34, filling part; 35, filling port;

[0048] 4, connecting piece; 41, body; 42, back plate; 43, side plate; 44, bottom plate; 45, top plate; 46, plate body; 47, stop portion; 48, first plate; 49, second plate;

[0049] 5, mounting part; 51, clamping groove;

[0050] 6, connecting part; 61, insertion hole; 62, shaft hole;

[0051] 7, opening;

[0052] 8, sampling piece;

[0053] H, first direction; L, second direction; W, thickness direction. DETAILED DESCRIPTION

[0054] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, but not all the embodiments. The following description of at least one exemplary embodiment is actually only illustrative, but not as any limitation on the present application and its application or use. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without carrying out creative labor are within the scope of protection of the present application.

[0055] The technologies, methods and devices known to those of ordinary skill in the relevant art can not be discussed in detail, but should be considered as part of the specification when appropriate.

[0056] In the description of the present application, it should be understood that the orientation words such as "front, back, up, down, left, right", "transverse, vertical, perpendicular, horizontal" and "top, bottom" and the like indicated orientation or position relationship is generally based on the orientation or position relationship shown in the drawings, only for the convenience of describing the present application and simplifying the description, without making the opposite statement, these orientation words do not indicate and imply that the device or element referred to must have a particular orientation or be constructed and operated in a particular orientation, therefore, it cannot be understood as a limitation on the scope of protection of the present application; the orientation words "inner, outer" refer to the inner and outer of the contour of the components themselves.

[0057] In the description of the present application, it should be understood that the use of "first", "second" and the like words to limit the parts, only for the convenience of distinguishing the corresponding parts, like no other declaration, the above words have no special meaning, therefore, it cannot be understood as a limitation on the scope of protection of the present application.

[0058] In addition, the technical features involved in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other.

[0059] In order to improve the dialysis efficiency, the present application provides a dialysis system, a dialysis device and a connecting piece.

[0060] Figures 1-10 The structure of the dialysis system, the dialysis device and the connecting piece in the present application is exemplarily shown.

[0061] Referring to Figure 1 In the present application, the dialysis system 100 includes a container 1 and a dialysis device 101. The container 1 is used to contain a first preparation. The dialysis device 101 includes a dialysis piece 3. The dialysis piece 3 is arranged in the container 1 and is used to contain a second preparation. One of the first preparation and the second preparation contains a sample. The dialysis piece 3 is configured to allow a target substance in the sample to pass through the dialysis piece 3 from the one containing the sample to the other not containing the sample, so as to separate the target substance from the sample, achieve the purposes of concentration, purification, desalination, equilibrium dialysis, buffer replacement, drug dissolution detection and encapsulation rate detection, etc.

[0062] For example, when the dialysis system 100 is a drug dissolution detection device, the sample is a medicament, and the target substance is a drug component. The drug component in the medicament passes through the dialysis piece 3 from the one containing the medicament to the other not containing the medicament, so that by detecting the drug component in the liquid not containing the sample in the first preparation and the second preparation according to the set time, the dissolution rate and degree of the drug component can be determined, that is, the drug dissolution detection can be realized, the release ability of the medicament in the human body can be evaluated, and the clinical use effectiveness and safety of the medicament can be improved.

[0063] For another example, when the dialysis system 100 is a dialysis system for detecting the encapsulation rate, the sample is a medicament, the target substance is a drug component, and the drug component in the medicament is transferred from the one containing the medicament to the other not containing the medicament via the dialysis member 3. Thus, by detecting the drug component in the one not containing the sample in the first preparation and the second preparation at a set time, the degree of encapsulation of the drug by the carrier can be determined, i.e. the encapsulation rate detection can be achieved.

[0064] In the conventional dialysis system 100, the dialysis member 3 is usually a dialysis bag. The dialysis bag is a bag-shaped container made of a semi-permeable membrane. In use, the second preparation is filled into the dialysis bag, the dialysis bag is sealed, and then the sealed dialysis bag is placed in the first preparation in the container 1, so that the target substance in the sample is gradually transferred from the one containing the sample to the other not containing the sample via the dialysis bag, thereby achieving separation from the sample.

[0065] Although the dialysis bag can meet the basic requirements of dialysis, it is relatively soft, and it is difficult to add and take the sample, and the risk of sample loss is high. Moreover, the dialysis bag is easy to damage, especially when it is rotated at high speed, and it is easy to bend and fold during the dialysis process, which makes it difficult to control the dialysis surface area, which has an adverse effect on the dialysis process and affects the dialysis efficiency and effect.

[0066] In view of the above, a new type of dialysis member 3 has emerged. Figure 8 The structure of the corresponding new dialysis member 3 is exemplarily shown. Referring to Figure 8 The corresponding dialysis member 3 is no longer a dialysis bag, but includes a housing 31 and a dialysis membrane 32. The housing 31 is used to contain the second preparation, and the dialysis membrane 32 is arranged in the housing 31. The housing 31 is provided with a filling part 34, and the filling part 34 is used to fill the second preparation into the housing 31. The filling port 35 of the filling part 34 is sealed by a sealing member (not shown, such as a cover or a plug) to prevent leakage.

[0067] Since the new dialysis member 3 includes the dialysis membrane 32, the new dialysis member 3 has a dialysis function, which can make the target substance from the one containing the sample to the other not containing the sample in the first preparation and the second preparation, effectively meeting the dialysis demand.

[0068] Moreover, since the new dialysis member 3 not only includes the dialysis membrane 32, but also includes the housing 31, the housing 31 can effectively support the dialysis membrane 32, so that the whole dialysis member 3 is no longer soft like the dialysis bag, but becomes a hard dialysis member. It is more convenient to add and take the sample, the risk of sample loss is lower, it is not easy to damage, and the dialysis area will not change easily. Therefore, a series of problems caused by the soft dialysis bag can be effectively solved, and the purposes of reducing the operation difficulty, reducing the sample loss, improving the dialysis efficiency, and improving the dialysis effect can be achieved.

[0069] However, the dialysis part 3 including the shell 31 and the dialysis membrane 32 is usually directly put into the container 1, stands alone in the first preparation, and rotates under the driving of the first preparation rotating under the magnetic force. In this case, it is difficult to accurately control the rotation speed of the dialysis part 3, the randomness is strong, the repeatability is poor, and the dialysis effect is affected. This problem is more prominent in occasions with high requirements for rotation speed accuracy, and also limits the application of the corresponding dialysis part 3 in occasions with high requirements for rotation speed accuracy. For example, during the drug dissolution detection process, it is usually desired that the rotation speed of the dialysis part can reflect the true intestinal peristalsis to more accurately evaluate the in-vivo release ability of the drug. However, when the dialysis part 3 stands alone in the first preparation and only rotates under the driving of the first preparation rotating under the magnetic force, it is difficult to accurately control the rotation speed of the dialysis part 3, and it is difficult to accurately simulate the intestinal peristalsis speed. Therefore, it is easy to affect the dialysis effect, cause the dialysis result to be inaccurate, and difficult to accurately reflect the true release ability of the drug in the body. At the same time, when the dialysis part 3 stands alone in the first preparation and only rotates under the driving of the first preparation rotating under the magnetic force, the rotation speed of the dialysis part 3 is usually low, which affects the dialysis efficiency. These all limit the application of the corresponding new dialysis part 3 in dissolution detection and other occasions with high requirements for rotation speed accuracy.

[0070] In view of the above, in the present application, the dialysis device 101 not only includes the dialysis part 3 (which can be referred to as a hard dialysis part or a hard dialysis part 3) including the shell 31 and the dialysis membrane 32, but also includes a connecting part 4. The connecting part 4 includes a body 41, the body 41 is provided with a mounting part 5 and a connecting part 6. The mounting part 5 is used to mount the dialysis part 3 including the shell 31 and the dialysis membrane 32 arranged in the shell 31. The connecting part 6 is used to connect with at least one of the stirring shaft 21 and the stirring paddle 22 of the stirring mechanism 2, so as to drive the dialysis part 3 to rotate by the stirring mechanism 2.

[0071] Since the above-mentioned dialysis device 101 uses a hard dialysis part to replace a dialysis bag for dialysis, a series of problems brought by the dialysis bag can be solved by using the hard dialysis part, the operation difficulty is effectively reduced, the sample loss is reduced, the dialysis efficiency is improved, and the dialysis quality is improved.

[0072] Moreover, the dialysis device 101 not only uses the hard dialysis piece to replace the dialysis bag to perform dialysis, but also is equipped with the connecting piece 4 for the hard dialysis piece, and the hard dialysis piece is connected to the stirring mechanism 2 by the connecting piece 4. In this way, in the process of dialysis based on the hard dialysis piece, the hard dialysis piece does not need to stand alone in the first preparation any more, but can be connected to the stirring mechanism 2 through the connecting piece 4 and rotates under the driving of the stirring mechanism 2. Since this is the case, the dialysis piece 3 is no longer passively rotated under the action of the first preparation, but is actively rotated under the action of the stirring mechanism 2. By controlling the rotating speed of the stirring mechanism 2, the rotating speed of the dialysis piece 3 can be accurately controlled. Therefore, it is more convenient to accurately control the rotating speed of the dialysis piece 3, so that the rotating speed of the dialysis piece 3 is more matched with the actual demand, a better dialysis effect is achieved, and it is more suitable for occasions with high accuracy requirements for rotating speed, for example, the rotating speed of the dialysis piece 3 can be controlled to more accurately simulate the peristaltic speed of the intestines and stomach, so as to more accurately evaluate the in-vivo release capability of the medicament, and improve the applicability of the dialysis piece 3 in occasions such as drug dissolution detection or encapsulation rate detection which have high accuracy requirements for rotating speed.

[0073] It can be seen that the connecting piece 4 is arranged to connect the hard dialysis piece 3 and the stirring mechanism 2, which is conducive to accurately controlling the rotating speed of the dialysis piece 3 and improving the dialysis effect.

[0074] Moreover, the connecting piece 4 connects the dialysis piece 3 to the stirring mechanism 2, which is also conducive to accelerating the rotating speed of the dialysis piece 3 and improving the dialysis efficiency.

[0075] In addition, since the connecting piece 4 connects the dialysis piece 3 to the stirring mechanism 2 instead of other rotating components, the stirring mechanism 2 not only drives the dialysis piece 3 to rotate, but also stirs the first preparation in the container 1. Therefore, it is conducive to realizing more sufficient contact between the first preparation and the dialysis piece 3, and from this point of view, it is also conducive to improving the dialysis effect.

[0076] Meanwhile, the connecting piece 4 is used to connect the dialysis piece 3 to the stirring mechanism 2, so that the stirring of the first preparation and the rotation of the dialysis piece 3 are both realized by the stirring mechanism 2, without the need to separately arrange two components. Therefore, the structure is also simpler.

[0077] In addition, the connecting piece 4 with the mounting part 5 and the connecting part 6 is specially arranged to connect the dialysis piece 3 and the stirring mechanism 2, instead of simply using other methods such as binding to realize the connection between the dialysis piece 3 and the stirring mechanism 2. This is also conducive to realizing more firm connection between the dialysis piece 3 and the stirring mechanism 2, effectively preventing the dialysis piece 3 from falling off during the rotation dialysis process. In this way, it is also conducive to improving the dialysis efficiency and improving the dialysis effect.

[0078] And, the connecting piece 4 connects the dialysis piece 3 to the stirring mechanism 2, and also makes the dialysis piece 3 not easy to change the position during the rotation, but can keep in the same position during the rotation, so that the sampling part 8 and other sampling components can be conveniently arranged in the container 1 to carry out sampling measurement. Since the position of the dialysis piece 3 is fixed during the rotation, only the relative position of the sampling piece 8 and the dialysis piece 3 needs to be designed in advance, so that the sampling piece 8 is located outside the rotation radius of the dialysis piece 3, so that the sampling piece 8 does not collide with the rotating dialysis piece 3 during the entire dialysis process, so that the sampling piece 8 and other sampling components can be placed in the container 1 at any time under the condition of non-stop sampling. The non-stop sampling method can avoid the error caused by stopping and manual sampling, so that the sampling result is more accurate and more conducive to improving the accuracy of the measurement result. It can be seen that the connecting piece 4 is arranged to connect the dialysis piece 3 and the stirring mechanism 2, which is also conducive to realizing automatic sampling under the condition of non-stop, and improving the accuracy of the measurement result.

[0079] It can be seen that by arranging the connecting piece 4 to connect the hard dialysis piece 3 to the stirring mechanism 2, the dialysis effect can be effectively improved, the dialysis efficiency can be improved, and the accuracy of the measurement result can be improved. The structure is simple and reliable.

[0080] As described above, the connecting piece 4 is connected with the dialysis piece 3 through the mounting portion 5 to realize the arrangement of the dialysis piece 3 on the connecting piece 4. Among them, the mounting portion 5 can adopt various structure forms. As one of them, see Figures 1-10 The mounting portion 5 includes a clamping groove 51, and the clamping groove 51 is clamped with the dialysis piece 3. At this time, the connecting piece 4 is clamped with the dialysis piece 3, and only the dialysis piece 3 is clamped on the clamping groove 51 to realize the arrangement of the dialysis piece 3 on the connecting piece 4, which is simple and convenient. Although the mounting portion 5 can also adopt a threaded connection structure or a hooking connection structure and other structure forms, so that the connecting piece 4 and the dialysis piece 3 are connected by threaded connection or hooking connection and other ways, when the mounting portion 5 includes the clamping groove 51, the connecting piece 4 and the dialysis piece 3 are clamped through the clamping groove 51. Not only the connection operation is more simple and convenient, but also the original structure of the dialysis piece 3 does not need to be changed, the structure is simpler, and the cost is lower.

[0081] In addition, in order to realize the connection of the connecting piece 4 and the stirring mechanism 2, the connecting part 6 of the connecting piece 4 can also adopt various structural forms. For example, in some embodiments, the connecting part 6 comprises a socket 61 for inserting the stirring paddle 22, so that the connecting piece 4 can be connected to the stirring paddle 22 by simply inserting the stirring paddle 22 into the socket 61, realizing the connection of the connecting piece 4 and the stirring mechanism 2, and the dialysis piece 3 is driven to rotate by the stirring mechanism 2 while stirring the first preparation, which is simple in structure and convenient to operate. For another example, in some embodiments, the connecting part 6 comprises a shaft hole 62 for inserting the stirring shaft 21, so that the connecting piece 4 can be connected to the stirring shaft 21 by simply inserting the stirring shaft 21 into the shaft hole 62, realizing the connection of the connecting piece 4 and the stirring mechanism 2, and the dialysis piece 3 is driven to rotate by the stirring mechanism 2 while stirring the first preparation, which is simple in structure and convenient to operate. When the connecting part 6 comprises both the socket 61 and the shaft hole 62, the connecting piece 4 is connected to both the stirring paddle 22 and the stirring shaft 21, which is more stable and less likely to be disconnected during rotation, thus, it is beneficial to further improve the connection reliability of the dialysis piece 3 and the stirring mechanism 2, reduce the risk of rotation disconnection of the dialysis piece 3, and realize a more smooth and efficient rotation dialysis process.

[0082] As an example of the connecting piece 4 in the foregoing embodiments, referring to Figures 1-10 The body 41 of the connecting piece 4 comprises a back plate 42, a bottom plate 44, a top plate 45 and two side plates 43, the bottom plate 44 and the top plate 45 are connected to both ends of the back plate 42 along the first direction H, the two side plates 43 are connected to both ends of the back plate 42 along the second direction L, and the clamping groove 51 is located between the back plate 42, the bottom plate 44, the top plate 45 and the two side plates 43. Among them, the first direction H and the second direction L are perpendicular to each other and perpendicular to the thickness direction W of the back plate 42. In the actual dialysis process, the first direction H is usually along the up-down direction, parallel to the axial direction of the stirring shaft 21, and the top plate 45 is on the top and the bottom plate 44 is on the bottom, therefore, the first direction H can also be called the up-down direction, one end of the connecting piece 4 provided with the top plate 45 is called the top end, and the other end provided with the bottom plate 44 is called the bottom end. In the case of referring to the first direction H as the up-down direction, the second direction H and the thickness direction W of the back plate 42 can become the left-right direction and the front-back direction respectively.

[0083] Based on the above settings, the dialysis piece 3 can be set on the connecting piece 4 by simply clamping it into the clamping groove 51 between the back plate 42, the bottom plate 44, the top plate 45 and the two side plates 43, which is simple and convenient. Since the back plate 42, the bottom plate 44, the top plate 45 and the two side plates 43 can restrict the displacement of the dialysis piece 3 from different directions, the reliable setting of the dialysis piece 3 on the connecting piece 4 can be realized.

[0084] Among them, the top plate 45 can be designed in one piece or in two pieces.

[0085] For example, referring toFigures 1-10 In some embodiments, the filling part 34 of the dialysis part 3 is located between two ends of the shell 31 along the second direction L, and divides the surface of the end of the shell 31 of the dialysis part 3 facing the top plate 45 (i.e., the top end of the dialysis part 3) into two parts (referred to as two top surfaces 33 of the shell 31) arranged along the second direction L, and the top plate 45 is configured to include two plate bodies 46 arranged along the second direction L and corresponding to the two top surfaces 33 of the end of the shell 31 facing the top plate 45. At this time, the top plate 45 is designed as two plate bodies 46 arranged separately, which not only can effectively limit the two top surfaces 33 of the shell 31 of the dialysis part 3 through the two plate bodies 46 to prevent the dialysis part 3 from being separated from the connecting part 4 in the direction away from the bottom plate 44 (i.e., from the top side), but also can effectively avoid the filling part 34 of the dialysis part 3, facilitating the disassembly and assembly of the dialysis part 3. At the same time, the top plate 45 is configured to include two plate bodies 46 arranged along the second direction L, which is also conducive to saving materials and reducing the weight of the connecting part 4. The reduction of the weight of the connecting part 4 enables the stirring mechanism 2 to drive the connecting part 4 and the dialysis part 3 to rotate more quickly under the same energy consumption, thereby also being conducive to increasing the rotation speed of the dialysis part 3, improving the dialysis efficiency, and improving the dialysis effect.

[0086] In the case where the top plate 45 includes two plate bodies 46 arranged along the second direction L, the two plate bodies 46 can be parallel to the second direction L or intersect the second direction L. For example, referring to Figures 1-10 In some embodiments, in the direction from the edge to the middle of the back plate 42 along the second direction L, the two top surfaces 33 of the shell 31 of the dialysis part 3 gradually tilt away from the bottom plate 44, and correspondingly, the two plate bodies 46 gradually tilt away from the bottom plate 44. In this way, the two plate bodies 46 are consistent with the tilt direction of the two top surfaces 33, so that better cooperation between the two plate bodies 46 and the two top surfaces 33 can be achieved, and the two plate bodies 46 can better limit the two top surfaces 33 and more reliably prevent the dialysis part 3 from being separated from the clamping groove 51 from the top side, thereby facilitating the more reliable arrangement of the dialysis part 3 on the connecting part 4.

[0087] In addition, referring to Figures 1-10In some embodiments, at least one of the two side plates 43 has a spacing with the bottom plate 44 in the first direction H. At this time, at least one of the two side plates 43 does not extend to the bottom plate 44 all the time, but has a spacing with the bottom plate 44, in which case, at least one of the two side plates 43 is smaller in size (i.e. shorter in length) in the first direction H, which can reduce the restriction on the dialysis component 3 during the disassembly and assembly of the dialysis component 3 while achieving effective limiting, thus making it more convenient to disassemble and assemble the dialysis component 3, and at least one of the two side plates 43 being smaller in size (i.e. shorter in length) in the first direction H is also conducive to saving materials, reducing the weight of the connecting component 4, thereby increasing the speed of the dialysis component 3, improving the dialysis efficiency, and improving the dialysis effect.

[0088] In the case where the body 41 includes the aforementioned back plate 42, side plate 43, bottom plate 44 and top plate 45, in order to enable the body 41 to be connected with the stirring mechanism 2 while being clamped with the dialysis component 3, see Figures 1-10 In some embodiments, the side of the back plate 42 away from the clamping groove 51 is provided with a plug hole 61 for inserting the stirring paddle 22 and / or a shaft hole 62 for inserting the stirring shaft 21. In this way, the back plate 42 can also be connected with the stirring paddle 22 through the plug hole 61 and / or connected with the stirring shaft 21 through the shaft hole 62, achieving the connection of the connecting component 4 with the stirring mechanism 2, so that the stirring mechanism 2 can drive the connecting component 4 and the dialysis component 3 to rotate together while stirring the first agent, completing an efficient and sufficient dialysis process. Among them, the plug hole 61 for inserting the stirring paddle 22 and / or the shaft hole 62 for inserting the stirring shaft 21 is arranged on the side of the back plate 42 away from the clamping groove 51, so that the dialysis component 3 and the stirring mechanism 2 are respectively located on the front and rear sides of the connecting component 4, which can not only make the dialysis component 3 and the stirring mechanism 2 not interfere with each other, but also make full use of the space, so that the connection and installation requirements of the dialysis component 3 and the stirring mechanism 2 can be effectively met based on a relatively simple and compact structure.

[0089] As an example of the plug hole 61 being arranged on the side of the back plate 42 away from the clamping groove 51, see Figures 1-10 The back plate 42 includes a first plate 48 and a second plate 49, the second plate 49 is arranged on the side of the first plate 48 away from the clamping groove 51, and the plug hole 61 is formed between the second plate 49 and the first plate 48. At this time, the plug hole 61 is formed by the spacing of the second plate 49 and the first plate 48 in the thickness direction W, which is more convenient for processing and manufacturing.

[0090] Further, see Figures 1-10In some embodiments, the back plate 42 comprises two second plates 49 to form two insertion holes 61 with the first plate 48, respectively, for the two stirring paddles 22 of the stirring mechanism 2 to be inserted into. In this way, the connecting piece 4 is connected with not only one stirring paddle 22 but also two stirring paddles 22, which is not only more stable but also more balanced, and is more conducive to the driving of the dialysis piece 3 to rotate stably and reliably by the stirring mechanism 2.

[0091] As a further improvement of the foregoing embodiments, see Figures 1-10 In some embodiments, the body 41 is not only provided with the clamping groove 51 between the top plate 45, the bottom plate 44, the two side plates 43 and the back plate 42, but also provided with a stop portion 47, which limits the displacement of the dialysis piece 3 in the direction away from the back plate 42 to prevent the dialysis piece 3 from being pulled out of the clamping groove 51 in the direction away from the back plate 42. In this way, the connecting piece 4 can not only limit the dialysis piece 3 from the top, bottom, left and right sides and the back side by the top plate 45, the bottom plate 44, the two side plates 43 and the back plate 42, but also limit the dialysis piece 3 from the front side by the stop portion 47, which realizes more reliable setting of the dialysis piece 3 on the connecting piece 4 and further reduces the risk of the dialysis piece 3 falling off the connecting piece 4 during rotation.

[0092] The stop portion 47 can be arranged at any position of the body 41 of the connecting piece 4.

[0093] For example, see Figures 1-10 In some embodiments, the stop portion 47 is arranged on the bottom plate 44 of the body 41 and is bent from the bottom plate 44 to the side of the top plate 45. In this way, the connecting piece 4 can limit the lower part of the dialysis piece 3 from the front side by the stop portion 47 arranged on the bottom plate 44, effectively preventing the dialysis piece 3 from being pulled out of the connecting piece 4 from the front side. The stop portion 47 arranged on the bottom plate 44 can extend in the first direction H or extend in a direction deviating from the first direction H, i.e., extend in a direction close to or away from the back plate 42. When the stop portion 47 arranged on the bottom plate 44 extends in the first direction H, the stop portion 47 arranged on the bottom plate 44 is vertically arranged and is not inclined, which not only facilitates processing but also facilitates disassembly and assembly of the dialysis piece 3.

[0094] For another example, see Figures 1-10In some embodiments, the stopper 47 is arranged on the top plate 45 of the body 41 and is bent from the top plate 45 to the side of the bottom plate 44. In this way, the connecting piece 4 can limit the upper part of the dialysis piece 3 from the front side through the stopper 47 arranged on the top plate 45, effectively preventing the dialysis piece 3 from being separated from the connecting piece 4 from the front side. The stopper 47 arranged on the top plate 45 can extend along the first direction H or extend along a direction deviating from the first direction H, that is, extend along a direction close to or away from the back plate 42. When the stopper 47 arranged on the bottom plate 44 extends along the direction close to the back plate 42, the stopper 47 arranged on the top plate 45 is inclined to the side of the back plate 42, which can more reliably prevent the dialysis piece 3 from being separated from the connecting piece 4 from the front side. In addition, the stopper 47 inclined accordingly can also play a certain guiding role during the clamping of the dialysis piece 3, so it is also more convenient to install the dialysis piece 3.

[0095] The number of stoppers 47 on the top plate 45 and the bottom plate 44 is not limited and can be one, two or more. For example, when the top plate 45 includes two plate bodies 46 arranged at intervals along the second direction L, stoppers 47 can be arranged on both plate bodies 46. In this case, two stoppers 47 are arranged on the top plate 45, which can not only reliably limit the position, but also avoid the filling part 34 of the dialysis piece 3, facilitating the disassembly and assembly of the dialysis piece 3.

[0096] As a further improvement of the foregoing embodiments, referring to Figures 1-10 The body 41 is not only provided with the mounting part 5 and the connecting part 6, but also provided with the opening 7. Based on the opening 7, the first agent in the container 1 can be in more sufficient contact with the dialysis piece 3 through the opening 7 during the rotation of the dialysis piece 3 driven by the stirring mechanism 2, thereby facilitating the further improvement of the dialysis effect and the improvement of the dialysis efficiency. At the same time, the opening 7 can also reduce the weight, so that the connecting piece 4 is lighter in weight, facilitating the stirring mechanism 2 to drive the connecting piece 4 and the dialysis piece 3 to rotate more quickly, further improving the dialysis effect and the dialysis efficiency.

[0097] The number of openings 7 can be one, two or more (at least three). When at least two openings 7 are arranged on the body 41, the first agent can be in more sufficient contact with the dialysis piece 3, and the weight reduction effect is better, thereby facilitating the further improvement of the dialysis effect and the improvement of the dialysis efficiency.

[0098] The size of the mounting part 5 of the connecting piece 4 in the foregoing embodiments can be constant or adjustable. When the size of the mounting part 5 is adjustable, the mounting part 5 can be used to install dialysis pieces 3 of different sizes, so that the connecting piece 4 is more flexible in use and has a wider range of applications, and can better meet more diverse dialysis needs.

[0099] Next, the application will be further described in conjunction with the embodiments shown in Figures 1-10 .

[0100] For the convenience of description, the following will be based on the orientation shown in the figure to position the orientation. Figure 1 The up-down direction of the figure is consistent with the first direction H, the left-right direction is consistent with the second direction L, and the front-back direction is consistent with the thickness direction W, and Figure 1 The "up" and "down" of the figure respectively correspond to the side where the top plate 45 and the bottom plate 44 are located. Figure 1 Figure 1 In this embodiment, the dialysis system 100 is a drug dissolution detection system, and is mainly used for drug dissolution detection of a nanopharmaceutical preparation taking liposomes as a drug carrier, that is, in this embodiment, the sample is a nanopharmaceutical preparation taking liposomes as a drug carrier, and the target substance is a drug component wrapped by the liposomes in the corresponding nanopharmaceutical preparation.

[0101] The nanopharmaceutical preparation is a nanopharmaceutical preparation formed by using nanometer preparation technology to prepare raw drug into particles of nanometer size, or by combining a suitable carrier material with raw drug, and the size or structural unit is in the nanometer size range (1-100 nm).

[0102] The liposome is a commonly used drug carrier for nanopharmaceutical preparations, and has significant advantages, including controlling the release rate of the drug, reducing the side effects of the drug, improving the therapeutic effect of the drug, and improving the water solubility and bioavailability of the drug, etc. These advantages make the liposome technology widely used in the pharmaceutical industry, and has been applied to anti-tumor drugs, cardiovascular drugs, antibiotics and other fields. With the continuous innovation and improvement of technology, the research and application prospect of liposome drugs will be more and more broad. In the future, liposome technology is expected to be applied to more disease treatment fields, such as nervous system diseases, infectious diseases, etc., so as to make greater contribution to human health. In the Chinese medicine market, the market size of improved new drugs continues to grow, among which innovative preparations become an important driving force for market growth. As one of the improved new drugs, liposome injection has significant advantages in effectiveness, safety and patient compliance compared with traditional drugs through means such as dosage form improvement and drug delivery route optimization.

[0103] In the research and development process of nanopharmaceutical preparations such as liposome nanopharmaceuticals, preparation quality control is a very important problem, and in vitro release study is a commonly used quality control means. In vitro release study is a method for evaluating the ability of a drug preparation to release a drug in the human body, which can reflect the in vivo behavior of the drug to some extent, predict the in vivo absorption characteristics, and thus effectively improve the effectiveness and safety of the drug in clinical use.

[0104] In the research and development process of nanopharmaceutical preparations such as liposome nanopharmaceuticals, preparation quality control is a very important problem, and in vitro release study is a commonly used quality control means. In vitro release study is a method for evaluating the ability of a drug preparation to release a drug in the human body, which can reflect the in vivo behavior of the drug to some extent, predict the in vivo absorption characteristics, and thus effectively improve the effectiveness and safety of the drug in clinical use.

[0105] ​Drug dissolution testing is an important means of in vitro release study, which measures the speed and degree of drug components in a medicament dissolving from the medicament under certain conditions to evaluate the drug release capacity of the medicament in the human body. Drug dissolution testing of liposome nanodrug preparation has important significance for predicting and evaluating the in vivo release capacity of liposome nanodrug preparation and improving the safety and effectiveness of liposome nanodrug preparation in clinical use.

[0106] Common methods of drug dissolution testing include sampling separation method, dialysis method and flow cell method. Among them, the dialysis method mainly uses a dialysis membrane to physically separate the released free drug from the drug encapsulated by the liposome, and samples according to the set time to measure the drug concentration and evaluate the release behavior of the liposome nanodrug preparation. Its operation is relatively simple and widely used.

[0107] In related technologies, when using the dialysis method to perform dissolution testing on liposome nanodrug preparations, a dialysis bag is usually used to separate the released free drug from the drug encapsulated by the liposome. However, the shape of the dialysis bag is not fixed, resulting in differences in drug release surface area, and the position of the dialysis bag is difficult to fix, and it is difficult to add and sample. These all have adverse effects on dissolution testing, making it difficult to accurately measure the true dissolution of nanodrugs and accurately predict and evaluate the in vivo release capacity of nanodrugs.

[0108] To address the above situation, the embodiment provides a dialysis system 100 as shown in Figures 1-10 By replacing the commonly used dialysis bag with a hard dialysis piece 3 and providing a special connecting piece 4 for the dialysis piece 3, the dialysis piece 3 is connected to the stirring mechanism 2, to realize more efficient and high-quality dissolution testing of liposome nanodrug preparations and more accurate measurement of the dissolution of liposome nanodrug preparations.

[0109] As shown in Figures 1-10 In this embodiment, the dialysis system 100 includes a container 1, a dialysis device 101 and a sampling piece 8, and the dialysis device 101 includes a stirring mechanism 2, a dialysis piece 3 and a connecting piece 4.

[0110] The container 1 is used to contain the first preparation and provide space for dissolution testing. As shown in Figures 1-2 In this embodiment, the container 1 is cylindrical and has an open top.

[0111] The stirring mechanism 2 is used to stir the first preparation in the container 1, and at the same time, the dialysis piece 3 is driven to rotate by the connecting piece 4. As shown in Figures 1-5As shown, in this embodiment, the stirring mechanism 2 comprises a stirring shaft 21 and two stirring paddles 22. The stirring shaft 21 is vertically arranged, with its axial direction along the up-down direction (i.e. the first direction H), and it extends into the interior of the container 1 to contact the first preparation. The two stirring paddles 22 are arranged on opposite sides of the lower end of the stirring shaft 21. In this way, when the stirring shaft 21 is rotated under the drive of a power mechanism (such as a motor), it can drive the two stirring paddles 22 to rotate, thereby achieving stirring of the first preparation in the container 1 and rotational driving of the connecting member 4 and the dialysis member 3.

[0112] The dialysis member 3 is used to accommodate the second preparation and to achieve separation of the dissociated drug components from the liposome nanopharmaceutical preparation. As shown, Figures 1-8 As shown, in this embodiment, the dialysis member 3 comprises a housing 31 and a dialysis membrane 32. The housing 31 is made of a hard material such as plastic and is substantially cuboid-shaped, so that the dialysis member 3 is a substantially cuboid-shaped hard dialysis member. The housing 31 has an internal cavity for accommodating the second preparation. The dialysis membrane 32 is a regenerated cellulose membrane, which is arranged in the housing 31 and located on the front and back end faces of the internal cavity of the housing 31, and achieves separation of the dissociated drug components by allowing the dissociated drug components to pass through and preventing the liposomes from passing through. The housing 31 is provided with a filling portion 34. The filling portion 34 is in communication with the internal cavity of the housing 31 and has a filling port 35 to inject the second preparation into the internal cavity of the housing 31. In this embodiment, the filling portion 34 is located at the top end of the housing 31 and at the middle of the left-right direction of the housing 31, dividing the top end surface of the housing 31 into two top faces 33. The two top faces 33 are located on the left and right sides of the filling portion 34 and are both inclined downward along the direction from the middle of the left-right direction to the edge.

[0113] Since the dialysis member 3 is a hard dialysis member, its dialysis membrane 32 is effectively supported and protected by the housing 31, has a relatively constant surface area and is not easily damaged, and even if the rotational speed is too high, it is not easy to break and leak medicine. At the same time, the whole dialysis member 3 is convenient to fix and easy to sample, and it is not easy to lose medicine, so it is more convenient to use in the drug dissolution detection process. Compared with the case of using a dialysis bag for drug dissolution detection, it is more conducive to improving the efficiency of drug dissolution detection and improving the accuracy of drug dissolution detection results.

[0114] In this embodiment, the second preparation contains the liposome nanopharmaceutical preparation, and the first preparation does not contain the liposome nanopharmaceutical preparation, which can be referred to as a blank liquid or a release medium for receiving the dissociated drug components. Of course, in other embodiments, the first preparation can contain the liposome nanopharmaceutical preparation, and the second preparation does not contain the liposome nanopharmaceutical preparation, and the dissociated drug components are received by the second preparation.

[0115] The connecting member 4 is used to connect the dialysis member 3 and the stirring mechanism 2, so that the dialysis member 3 is driven to rotate by the stirring mechanism 2. As shown in the figure, in this embodiment, the connecting member 4 comprises a back plate 42, two side plates 43, a bottom plate 44 and a top plate 45. Figures 1-10

[0116] The back plate 42 is vertically arranged and comprises a first plate 48 and two second plates 49. The two second plates 49 are arranged in a spaced manner along the left-right direction and are connected to the rear side of the first plate 48. The two second plates 49 and the first plate 48 are both spaced in the front-rear direction, so that the two second plates 49 and the first plate 48 form a jack 61. In addition, an axle hole 62 is arranged between the two second plates 49. In this way, the rear side of the back plate 42 is provided with two jacks 61 and an axle hole 62, and the axle hole 62 is located between the two jacks 61. At this time, the relative position relationship between the two jacks 61 and between the two jacks 61 and the axle hole 62 is consistent with the relative position relationship between the two stirring paddles 22 and between the two stirring paddles 22 and the stirring shaft 21, so that when the stirring shaft 21 is inserted into the axle hole 62 and connected with the connecting member 4, the two stirring paddles 22 can also be conveniently inserted into the two jacks 61 and connected with the connecting member 4. In this way, the connection between the connecting member 4 and the stirring mechanism 2 is more stable and reliable and is not easy to fall off.

[0117] The top plate 45 and the bottom plate 44 are connected to the upper and lower ends of the back plate 42 and respectively extend from the back plate 42 to the front side. Specifically, the top plate 45 and the bottom plate 44 are connected to the upper and lower ends of the first plate 48 and respectively extend from the first plate 48 to the direction away from the second plate 49. The top plate 45 comprises two plate bodies 46, which are arranged in a spaced manner along the left-right direction and are located on the left and right sides of the filling part 34 and correspond to the two top surfaces 33 of the shell 31 of the dialysis member 3. In addition, the two plate bodies 46 are inclined downward along the direction from the middle to the edge of the left-right direction, like the two top surfaces 33. In addition, a stop portion 47 is arranged on each of the two plate bodies 46 and the bottom plate 44. The two stop portions 47 on the two plate bodies 46 are stop plates and are bent downward and rearward from the two plate bodies 46. The stop portion 47 on the bottom plate 44 is also a stop plate and extends vertically upward.

[0118] The two side plates 43 are connected to the left and right sides of the back plate 42 and extend from the back plate 42 to the front side and are spaced from the two bottom plates 44 in the up-down direction. Specifically, the two side plates 43 are connected to the left and right sides of the first plate 48 and extend from the first plate 48 to the direction away from the second plate 49 and are located on the upper part of the first plate 48, close to the top plate 45 and away from the bottom plate 44.

[0119] ​Based on the above setting, the back plate 42, the two side plates 43, the bottom plate 44, the top plate 45 and the stop portion 47 together enclose the clamping groove 51 located at the front side of the back plate 42, and the corresponding clamping groove 51 is used for clamping with the shell 31 of the dialysis piece 3 to realize the setting of the dialysis piece 3 on the connecting piece 4. The stop portion 47, the back plate 42, the top plate 45, the bottom plate 44 and the two side plates 43 respectively limit the front side, the rear side, the upper side, the lower side and the left and right sides of the dialysis piece 3, so that the dialysis piece 3 can be stably and reliably set on the connecting piece 4 and is not easy to fall off.

[0120] Since the connecting piece 4 is reliably clamped with the dialysis piece 3, and the connecting piece 4 is reliably connected with the stirring shaft 21 and the two stirring paddles 22 of the stirring mechanism 2, the connecting piece 4 can realize reliable connection of the dialysis piece 3 and the stirring mechanism 2, so that the stirring mechanism 2 can drive the dialysis piece 3 to stably rotate while stirring the first preparation, and the dialysis piece 3 is not easy to fall off during rotation. Therefore, it is beneficial to accurately control the rotation speed of the dialysis piece 3 based on a relatively simple structure, so that the rotation speed of the dialysis piece 3 can accurately reflect the intestinal peristalsis speed, and promote the second preparation in the dialysis piece 3 to fully contact with the first preparation in the container 1, thereby effectively improving the efficiency and sufficiency of the dissolution process. Moreover, since the rotation speed of the dialysis piece 3 is controllable and has strong repeatability, it is convenient to detect different drug-fat ratios or different particle size pharmaceutical products at the same rotation speed to better distinguish the dissolution capacity of different drug-fat ratios or different particle size pharmaceutical products. That is, it has good distinguishing ability for different drug-fat ratios or different particle size pharmaceutical products. Moreover, it is also convenient to detect the same pharmaceutical sample multiple times to obtain detection results with small deviation and good repeatability. That is, it also has good repeatability for the same pharmaceutical sample. Therefore, it can provide a basis for prescription development, preparation process control and monitoring of product preparation quality in the stability process.

[0121] As shown in Figure 9 and Figure 10 , in this embodiment, a plurality of openings 7 are arranged on the bottom plate 44, the first plate 48 and the second plate 49, and the plurality of openings 7 on the same plate are arranged in the left-right direction. Therefore, the weight can be effectively reduced while better promoting the contact sufficiency of the first preparation and the dialysis piece 3, especially the contact sufficiency of the first preparation stirred by the stirring mechanism 2, to realize a more sufficient dissolution process.

[0122] The sampling piece 8 is used for sampling. As shown in Figure 1 , in this embodiment, the sampling piece 8 extends into the container 1 Figure 1The sampling member 8 is located in the container 1, but it can be understood that the sampling member 8 can also be located only partially in the container 1, and is located outside the rotating radius of the dialysis device 101, so that during the rotating dialysis process, the sampling member 8 does not interfere with the dialysis device 101, so that the sampling member 8 can be kept in the container 1 during the rotating dialysis process, and sampling at any time. Based on this, as long as the sampling member 8 is connected to the sampling instrument, automatic sampling can be realized, and the automatic sampling does not need to stop, that is, non-stop automatic sampling can be realized. This non-stop automatic sampling method can effectively prevent the result error and manpower waste caused by manual sampling after stopping, so as to effectively improve the accuracy of the determination result under the condition of saving manpower.

[0123] When the dialysis system 100 of the embodiment is used for liposome drug dissolution detection, 2 ml of the preparation product (i.e., the second preparation) can be precisely measured and added to the dialysis member 3, and 1 ml of water can be added to the inner wall of the dialysis member 3 for wetting by using a pipette gun. Then, the sealing member of the dialysis member 3 is tightened to block the filling port 35. After that, the dialysis member 3 is clamped in the clamping groove 51 of the connecting member 4, and the connecting member 4 is connected to the stirring shaft 21 and the two stirring paddles 22 to form the dialysis device 101. Then, the dialysis device 101 is placed in 900 ml of 30 mM sodium acetate buffer (i.e., the first preparation, the pH is adjusted to 7.4 by acetic acid) in the container 1, the temperature is controlled at 37.0°C±0.5°C (simulating human body temperature), and 1 ml of sample is taken at the set time point (the total sampling amount is 2 ml, 1 ml is taken and 1 ml is discarded) for dissolution detection.

[0124] Since the hard dialysis member 3 is used to replace the dialysis bag, and the hard dialysis member 3 is provided with a special connecting member 4, the hard dialysis member 3 can be reliably connected to the stirring shaft 21 and the stirring paddles 22 of the stirring mechanism 2, so that the sampling of the dialysis member 3 is more convenient, the dialysis area of the dialysis member 3 does not change easily, the dialysis member 3 can rotate more quickly, the rotation speed is controllable, the repeatability is strong, and it has good distinguishing ability for different drug-lipid ratios or different particle sizes of the drug product, has good repeatability for the same drug product, and at the same time, the dialysis member 3 does not easily fall off or collide with the sampling member 8 during rotation, so that convenient and efficient drug dissolution process and non-stop automatic sampling process can be realized. Therefore, the drug dissolution detection efficiency and the accuracy of the drug dissolution detection result can be effectively improved.

[0125] It can be understood that, Figures 1-10 The structure of the dialysis system 100 shown does not constitute the only limitation of the present application, but there can be many variations.

[0126] As an example, in some other embodiments, the size of the card slot 51 is not constant, but adjustable. For example, in some embodiments, at least one of the top plate 45 and the bottom plate 44 is movably arranged on the back plate 42 in the up-down direction (the first direction H), so that the height of the card slot 51 is variable. In this way, the card slot 51 can be used to install dialysis pieces 3 of different height sizes, thereby meeting more diverse dialysis needs.

[0127] Based on the dialysis device 101 or the dialysis system 100 of the present application, the present application also provides a method for detecting the dissolution or encapsulation rate of a drug. The corresponding method uses the dialysis device 101 or the dialysis system 100 of any embodiment to detect the dissolution or encapsulation rate of a drug. In this way, since the rotation speed of the dialysis piece 3 of the dialysis device 101 or the dialysis system 100 is controllable and has strong repeatability, it has good discrimination for different drug-lipid ratios or different particle sizes of drug products, and good repeatability for the same drug product. The corresponding effects are illustrated in the following three test examples.

[0128] Test Example 1

[0129] Preparation of test samples: 4 mg of distearoyl phosphatidylcholine (DSPC), cholesterol, and dimyristoyl phosphatidyl ethanolamine (DMPE) (molar ratio of 4:1:1) were weighed and dissolved in 10 mL of chloroform with the drug ozagrel (molar ratio of total drug amount to lipid of 1:5, 1:6, and 1:7). The organic solvent was removed by slow rotary evaporation (65°C water bath, 90 r / min, 30 min) to form a thin film on the wall of the container. The thin film was placed in a constant temperature water bath at 50°C to fully hydrate and form a crude liposome nanovesicle suspension. The crude liposome nanovesicle suspension was sonicated in a water bath, and finally treated with a probe sonicator for 3 min (amplitude 20, interval 3 s). The unencapsulated drug in the refined liposome nanovesicle suspension was removed using a dextran gel column G-100. The three samples obtained were A-1 (drug-lipid ratio of 1:5), A-2 (drug-lipid ratio of 1:6), and A-3 (drug-lipid ratio of 1:7). The above three samples A-1 (drug-lipid ratio of 1:5), A-2 (drug-lipid ratio of 1:6), and A-3 (drug-lipid ratio of 1:7) were subjected to dissolution detection using the above dialysis system 100, and sampling detection was performed at different time points. The results are shown in Table 1 and Figure 11 .

[0130] Table 1 Dissolution of three different drug-lipid ratio samples at different sampling points

[0131]

[0132] The results show that the dissolution results of drugs with different drug-lipid ratios tested using the dialysis system of the present application have good discrimination among groups.

[0133] Test Example 2

[0134] Preparation of test sample: 4 mg of dimyristoyl phosphatidyl choline (DMPC), short-chain bis-n-heptadecanoyl phosphatidyl choline (DHPC), and dimyristoyl phosphatidyl ethanolamine (DMPE) were weighed according to a molar ratio of 7:2:1, and the drug tirofiban was added (molar ratio of drug to lipid was 1:10) to 10 mL of chloroform. The organic solvent was removed by slow rotary evaporation (65°C water bath, 90 r / min, 30 min) to form a film on the wall of the container. 10 mL of an aqueous solution (concentration of 1.0 mg / mL) was added to the round-bottom flask, and the flask was placed in a constant-temperature water bath at 50°C to fully hydrate the film to form a crude liposome nanodisc suspension. The crude liposome nanodisc suspension was sonicated in a water bath, and finally treated with a probe sonicator for 3 min (amplitude 20, interval 3 s). The unencapsulated drug was removed by a dextran gel column G-100 to obtain sample C with a drug to lipid ratio of 1:10 and a particle size of 90 nm.

[0135] The above three samples B-1 (particle size of 158.3 nm), B-2 (particle size of 149.3 nm), and B-3 (particle size of 134.0 nm) were subjected to dissolution detection using the above dialysis system 100, and samples were taken at different time points for detection. The results are shown in Table 2 and Figure 12 .

[0136] Table 2 Dissolution of three samples with different particle sizes at different sampling points

[0137]

[0138] The results show that the dissolution results of samples with different particle sizes tested using the dialysis system of the present application have good discrimination among groups.

[0139] Test Example 3

[0140] Preparation of test sample: 4 mg of dimyristoyl phosphatidyl choline (DMPC), short-chain bis-n-heptadecanoyl phosphatidyl choline (DHPC), and dimyristoyl phosphatidyl ethanolamine (DMPE) were weighed according to a molar ratio of 7:2:1, and the drug tirofiban was added (molar ratio of drug to lipid was 1:10) to 10 mL of chloroform. The organic solvent was removed by slow rotary evaporation (65°C water bath, 90 r / min, 30 min) to form a film on the wall of the container. 10 mL of an aqueous solution (concentration of 1.0 mg / mL) was added to the round-bottom flask, and the flask was placed in a constant-temperature water bath at 50°C to fully hydrate the film to form a crude liposome nanodisc suspension. The crude liposome nanodisc suspension was sonicated in a water bath, and finally treated with a probe sonicator for 3 min (amplitude 20, interval 3 s). The unencapsulated drug was removed by a dextran gel column G-100 to obtain sample C with a drug to lipid ratio of 1:10 and a particle size of 90 nm.

[0141] Test sample C was subjected to dissolution testing using the dialysis system 100 described above, and samples (sample 1, sample 2, sample 3, sample 4, sample 5, sample 6) were placed in six identical dialysis systems 100 for testing. Samples were taken at 2h, 8h and 24h for dissolution testing, and the results are shown in Table 3.

[0142] Table 3 Dissolution results of the same sample in six dialysis systems at different time points

[0143] The results show that the RSD (relative standard deviation) of the six tests of the same sample using the dialysis system 100 of the present application is much smaller than the acceptable standard, indicating that the dialysis system 100 of the present application has good repeatability for dissolution testing.

[0144] The above description is merely exemplary embodiments of this application, and is not intended to limit the application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the application shall be included in the protection scope of the application.

Claims

1. A connection piece (4), characterized in that The body (41) is provided with a mounting portion (5) for mounting a dialysis piece (3) comprising a shell (31) and a dialysis membrane (32) arranged in the shell (31), and a connecting portion (6) for connecting with at least one of a stirring shaft (21) and a stirring paddle (22) of a stirring mechanism (2) to drive the dialysis piece (3) to rotate by the stirring mechanism (2). The mounting portion (5) comprises a clamping groove (51) for clamping the dialysis piece (3); and / or the connecting portion (6) comprises at least one of a plug hole (61) for inserting the stirring paddle (22) and a shaft hole (62) for inserting the stirring shaft (21).

2. The connection (4) according to claim 1, characterized in that The body (41) comprises a back plate (42), a bottom plate (44), a top plate (45), and two side plates (43), the bottom plate (44) and the top plate (45) are connected to both ends of the back plate (42) along a first direction (H), the two side plates (43) are connected to both ends of the back plate (42) along a second direction (L), the first direction (H) and the second direction (L) are perpendicular to each other and perpendicular to the thickness direction (W) of the back plate (42), and the clamping groove (51) is located between the back plate (42), the bottom plate (44), the top plate (45), and the two side plates (43).

3. The connection (4) according to claim 2, characterized in that The top plate (45) comprises two plate bodies (46) arranged in the second direction (L) to correspond to two top surfaces (33) of the shell (31) arranged in the second direction (L) at one end of the shell (31) facing the top plate (45); and / or at least one of the two side plates (43) has a spacing in the first direction (H) with the bottom plate (44).

4. The connection (4) according to claim 3, characterized in that In the direction from the edge to the middle of the back plate (42) in the second direction (L), both plate bodies (46) gradually tilt away from the bottom plate (44).

5. The connection (4) according to claim 4, characterized in that The side of the back plate (42) away from the clamping groove (51) is provided with a plug hole (61) for inserting the stirring paddle (22); and / or the side of the back plate (42) away from the clamping groove (51) is provided with a shaft hole (62) for inserting the stirring shaft (21).

6. The connection (4) according to claim 3, characterized in that The back plate (42) comprises a first plate (48) and a second plate (49), the second plate (49) is arranged on the side of the first plate (48) away from the clamping groove (51), and forms the plug hole (61) with the first plate (48).

7. The connection (4) according to claim 6, characterized in that The back plate (42) comprises two second plates (49) to form two plug holes (61) with the first plate (48), and the two plug holes (61) are respectively for inserting two stirring paddles (22) of the stirring mechanism (2).

8. The connection (4) according to claim 7, characterized in that ​ 9. The connection (4) according to any one of claims 3-8, characterized in that The body (41) is provided with a stop portion (47) for limiting displacement of the dialysis member (3) in a direction away from the back plate (42) to prevent the dialysis member (3) from being pulled out of the clamping groove (51) in the direction away from the back plate (42).

10. The connection (4) according to claim 9, characterized in that The stop portion (47) is arranged on the top plate (45) of the body (41) and is bent from the top plate (45) to the bottom plate (44) side; and / or the stop portion (47) is arranged on the bottom plate (44) of the body (41) and is bent from the bottom plate (44) to the top plate (45) side.

11. The connection (4) according to claim 10, characterized in that In a direction from top to bottom, the stop portion (47) arranged on the top plate (45) is inclined to the back plate (42) side; and / or the two plate bodies (46) of the top plate (45) arranged in the second direction (L) are both provided with the stop portion (47).

12. The connection (4) according to claim 10, characterized in that The stop portion (47) arranged on the bottom plate (44) extends in the first direction (H).

13. The connection (4) according to any one of claims 1-8, characterized in that The body (41) is provided with an opening (7); and / or the mounting portion (5) is adjustable in size to mount dialysis members (3) of different sizes.

14. The connection (4) according to claim 13, characterized in that The body (41) is provided with at least two openings (7).

15. A dialysis device (101), characterized in that The dialysis device (101) comprises: The dialysis member (3) is arranged in the container (1) for containing a first agent and comprises a shell (31) for containing a second agent and a dialysis membrane (32), one of the first agent and the second agent containing a sample, the dialysis membrane (32) being arranged in the shell (31) to allow a target substance in the sample to pass through the dialysis membrane (32) from the one containing the sample to the other not containing the sample; and The connecting member (4) of any one of claims 1-14, the dialysis member (3) being mounted on the mounting portion (5) of the connecting member (4).

16. The dialysis device (101 ) according to claim 15, characterized in that The dialysis device (101) further comprises a stirring mechanism (2) arranged rotatably in the container (1) and comprising a stirring shaft (21) and a stirring paddle (22) arranged on the stirring shaft (21) to stir the first agent in the container (1), the connecting portion (6) of the connecting member (4) being connected with at least one of the stirring shaft (21) and the stirring paddle (22).

17. A dialysis system (100), characterized by The dialysis device (101) comprises: The container (1) is used for containing a first agent; and The dialysis device (101) of any one of claims 15-16.

18. The dialysis system (100) of claim 17, characterized in that The dialysis system (100) is a drug dissolution detection system or an encapsulation rate detection system, the sample is a medicament, and the target substance is a drug component in the medicament.

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