Vaginal expansion suppository and preparation method thereof

Abstract

The invention provides a vaginal expansion suppository and a preparation method thereof, and relates to the technical field of suppositories. The composite drug-loading layer with a double-layer structure is designed on the surface of the expansion suppository body, and the two layers of the composite drug-loading layer are respectively prepared from materials with different expansion coefficients, so that when water absorption expansion deformation occurs, stress change is generated by humidity imbalance expansion, and the composite drug-loading layer is curled; on the other hand, the curled composite medicine carrying layer on the expansion suppository body is also beneficial to increasing the volume of the vaginal expansion suppository and increasing the contact area between the expansion suppository and the inner wall of the vagina.

Description

Technical Field

[0001] The present invention relates to the technical field of suppositories, in particular to a vaginal expansion suppository and a preparation method thereof. Background Art

[0002] Vaginal expansion suppository is a drug used to treat gynecological diseases such as vaginal relaxation and urinary incontinence. When placed in the vagina, it can absorb moisture in the vagina and thus expand, filling and supporting the vaginal wall. At the same time, it also increases the contact area between the expansion suppository and the vaginal wall, allowing the drug to act more in the vagina and better exert its efficacy.

[0003] The expansion plug usually includes an expansion carrier and a drug loaded thereon. The expansion carrier is usually made of an expansion material and has the property of swelling upon absorbing water. In order to improve the swelling performance of the expansion plug and better contact the inner wall of the vagina, a material with high water absorption performance is usually selected to make the expansion carrier, such as high-quality pure cotton fiber, or a synthetic fiber material with high water absorption capacity, such as polyester fiber, polypropylene fiber, etc. However, these common fiber materials have a low hygroscopic expansion rate, and the water absorption and swelling performance of the expansion tampon made of them are not ideal. In addition, since the tensile and elastic properties of the material are also poor, when it expands to a certain extent, it will break or break, thereby affecting the normal use of the expansion plug. Summary of the invention

[0004] The problem solved by the invention is that when conventional fiber materials are used as expansion plug carriers, the expansion performance and mechanical properties of the expansion plugs are poor due to the limitations of the water absorption expansion rate and tensile properties of the materials themselves, thus affecting normal use.

[0005] In order to solve the above problems, the present invention provides a vaginal expansion plug and a preparation method thereof.

[0006] In a first aspect, the present invention provides a vaginal expansion plug, comprising: an expansion plug body and a composite drug-carrying layer, wherein the composite drug-carrying layer is arranged on the surface of the expansion plug body, and the composite drug-carrying layer comprises a fixing portion, and the fixing portion is used to be fixedly connected to the expansion plug body; the composite drug-carrying layer comprises a carrier layer and a shell layer arranged in a stacked manner, wherein a side of the carrier layer facing the expansion plug body is loaded with drugs, and a side of the carrier layer facing away from the expansion plug body is connected to the shell layer; wherein the carrier layer comprises a first water-absorbing expansion material, and the shell layer comprises a second water-absorbing expansion material, and the expansion coefficient of the first water-absorbing expansion material is greater than the expansion coefficient of the second water-absorbing expansion material;

[0007] When the vaginal expansion plug is not in a humid environment, the composite drug-carrying layer is laid on the surface of the expansion plug body;

[0008] When the vaginal expansion plug is in a humid environment, the end of the composite drug-carrying layer away from the fixing portion curls toward the fixing portion.

[0009] Optionally, one end of the composite drug-carrying layer is configured as the fixing portion, and the other end of the composite drug-carrying layer is a free end; when the vaginal expansion plug is in a humid environment, the composite drug-carrying layer curls from its free end toward the fixing portion.

[0010] Optionally, the portion of the composite drug-carrying layer other than the two ends is configured as the fixing portion, and when the vaginal expansion plug is in a humid environment, the two ends of the composite drug-carrying layer are respectively curled toward the fixing portion.

[0011] Optionally, a plurality of the composite drug-carrying layers are distributed along the first direction of the expansion plug body and constitute a strip-shaped composite drug-carrying unit, and two adjacent composite drug-carrying layers in the composite drug-carrying unit are stacked in sequence.

[0012] Optionally, two adjacent composite drug-carrying layers in the composite drug-carrying unit have an overlapping region, and the length of the overlapping region is 1 / 3-1 / 2 of the length of the composite drug-carrying layer.

[0013] Optionally, the vaginal expansion plug comprises a plurality of the composite drug-carrying units, and the composite drug-carrying layers in two adjacent composite drug-carrying units are staggered.

[0014] Optionally, the first water-swellable material comprises 50%-60% viscose fiber, 25%-35% polyvinyl alcohol and 10%-15% cellulose, and the second water-swellable material comprises 5%-10% viscose fiber, 40%-60% cotton and 35%-50% cellulose, in percentage by mass.

[0015] Optionally, the material of the expansion plug body is selected from one of absorbent fibers, cotton, absorbent resins, polymer absorbent materials, hydrogels, superabsorbents, expansion agents, polyurethane sponges and foam materials.

[0016] Optionally, a receiving groove is provided on a side of the carrier layer facing away from the shell layer, and the receiving groove is used to place the drug-loaded cotton body with the drug dropped thereon.

[0017] In a second aspect, the present invention provides a method for preparing a vaginal expansile plug, which is used to prepare the vaginal expansile plug as described in any one of the above items, comprising:

[0018] Pressing one of absorbent fiber, cotton, absorbent resin, polymer absorbent material, hydrogel, super absorbent, expander, polyurethane sponge and foam material into an expansion plug body;

[0019] Pressing the first water-swellable material into a first planar layer, pressing the second water-swellable material into a second planar layer, bonding the first planar layer to the second planar layer, and loading drugs on a side of the first planar layer away from the second planar layer to obtain a composite drug-loaded layer;

[0020] A local area of ​​the composite drug-carrying layer is bonded to the surface of the expansion plug body, and a surface of the composite drug-carrying layer loaded with the drug faces the expansion plug body.

[0021] The beneficial effects of the vaginal expansion plug of the present invention are:

[0022] The present invention designs a composite drug-carrying layer with a double-layer structure on the surface of the expansion plug body, and the two layers of the composite drug-carrying layer are prepared by materials with different expansion coefficients. Therefore, when water absorption and expansion deformation occur, the stress change is generated by humidity imbalance expansion, so that the composite drug-carrying layer curls. On the one hand, the side loaded with drugs is exposed in the vagina to facilitate drug administration. On the other hand, the curled composite drug-carrying layer on the expansion plug body also helps to increase the volume of the vaginal expansion plug and increase the contact area between the expansion plug and the inner wall of the vagina. Compared with only pursuing to increase the water absorption of the material used for the expansion plug from a single dimension of the material and having to lose mechanical properties, the present invention can select materials that can meet mechanical related properties and have good water absorption and expansion properties when selecting the material used for the expansion plug, and at the same time use the curling and expansion of the composite drug-carrying layer to make up for part of the expansion performance lost due to giving up excessive pursuit of water absorption. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is a schematic diagram of the overall structure of a vaginal expansion plug in an embodiment of the present invention;

[0024] Figure 2 It is a schematic diagram of the local structure of the vaginal expansion plug that is bent and deformed in the embodiment of the present invention;

[0025] Figure 3 Schematic diagram of the partial structure of the composite drug carrying unit in an embodiment of the present invention;

[0026] Figure 4 for Figure 3 Schematic diagram of the structure of the composite drug-carrying unit bending deformation;

[0027] Figure 5 for Figure 4 A schematic diagram of the structure from another perspective;

[0028] Figure 6 A schematic diagram of two adjacent composite drug-carrying layers overlapping in an embodiment of the present invention;

[0029] Figure 7 for Figure 6Schematic diagram of the composite drug-carrying layer after complete deformation;

[0030] Figure 8 Another schematic diagram of two adjacent composite drug-carrying layers overlapping in an embodiment of the present invention;

[0031] Fig. 9 for Figure 8 Schematic diagram of the composite drug-carrying layer after complete deformation.

[0032] Description of reference numerals:

[0033] 1. expansion plug body; 2. composite drug-carrying layer; 21. fixing portion; 22. curling portion; 3. composite drug-carrying unit; 4. overlapping area. DETAILED DESCRIPTION

[0034] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. Although certain embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be interpreted as being limited to the embodiments described herein. On the contrary, these embodiments are provided to provide a more thorough and complete understanding of the present invention. It should be understood that the drawings and embodiments of the present invention are only for exemplary purposes and are not intended to limit the scope of protection of the present invention.

[0035] Unless otherwise defined, all technical and scientific terms used in this application have the same meanings as those commonly understood by those skilled in the art to which this application belongs; the terms used in the specification of this application are only for the purpose of describing specific implementation methods and are not intended to limit this application;

[0036] The term "including" and its variations used in this article are open inclusions, that is, "including but not limited to"; the term "based on" is "based at least in part on"; the term "one embodiment" means "at least one embodiment"; the term "another embodiment" means "at least one other embodiment"; the term "some embodiments" means "at least some embodiments"; the term "optionally" means "optional embodiments". The relevant definitions of other terms will be given in the following description. It should be noted that the concepts of "first" and "second" mentioned in the present invention are used to distinguish different objects, rather than to describe a specific order or a primary and secondary relationship. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, unless otherwise specified, the meaning of "multiple" is two or more.

[0037] In the related art, water-absorbing and swelling materials are usually used to make expansion plugs, and the humid environment in the vagina is used to stimulate the expansion plug to absorb water and swell, fill and support the inner wall of the vagina, and at the same time, the drug loaded on the expansion plug can be applied to the lesion area in the vagina. Therefore, in order to better achieve the expansion performance of the expansion plug, it is beneficial to improve the water absorption of the material as much as possible, such as using materials such as fibers with better water absorption performance, or improving the water absorption performance of the material through relevant treatments such as surface treatment or cross-linking treatment of the fibers, but these fiber materials will undergo a certain degree of hydrolysis reaction after absorbing water, resulting in changes in the internal structure of the fibers, which in turn causes a significant decrease in the mechanical properties of the fibers, such as poor tensile or elastic properties, which are easy to cause breakage or fragmentation, etc., and the improvement of water absorption also has certain limitations, so the improvement of expansion performance is also relatively limited.

[0038] In view of the problems existing in the above-mentioned related technologies, this embodiment provides a vaginal expansion plug and a preparation method thereof.

[0039] like Figure 1 and Figure 2 As shown, a vaginal expansion plug provided by an embodiment of the present invention comprises: an expansion plug body 1 and a composite drug-carrying layer 2, wherein the composite drug-carrying layer 2 is arranged on the surface of the expansion plug body 1, and the composite drug-carrying layer 2 comprises a fixing portion 21, and the fixing portion 21 is used to be fixedly connected to the expansion plug body 1; the composite drug-carrying layer 2 comprises a carrier layer and a shell layer arranged in a stacked manner, wherein a side of the carrier layer facing the expansion plug body 1 is loaded with drugs, and a side of the carrier layer facing away from the expansion plug body 1 is connected to the shell layer; wherein the carrier layer comprises a first water-absorbing expansion material, the shell layer comprises a second water-absorbing expansion material, and the expansion coefficient of the first water-absorbing expansion material is greater than the expansion coefficient of the second water-absorbing expansion material;

[0040] When the vaginal expansion plug is not in a humid environment, the composite drug-carrying layer 2 is laid on the surface of the expansion plug body 1;

[0041] When the vaginal expansion plug is in a humid environment, the end of the composite drug-carrying layer 2 away from the fixing portion 21 curls toward the fixing portion 21 .

[0042] In this embodiment, a composite drug-carrying layer 2 is arranged on the expansion plug body 1. The composite drug-carrying layer 2 has a double-layer structure and is mainly composed of a carrier layer and a shell layer. The carrier layer is used to load drugs, and the shell layer can be used as a protective layer to protect the expansion plug body 1. The water absorption expansion coefficient of the material used for the carrier layer is greater than the water absorption expansion coefficient of the material used for the shell layer. In this way, the composite drug-carrying layer 2 is arranged on the surface of the expansion plug body 1. When the environment is a humid environment, it is deformed due to the increase in humidity. Since the water absorption expansion coefficients of the shell layer and the carrier layer are different, the stress changes caused by the expansion deformation are different, so that the layer that expands faster in response to humidity bends toward the layer that expands slower, thereby causing the composite drug-carrying layer 2 to bend and deform as a whole, and curling occurs on the expansion plug body 1, from the part that is not fixed to the expansion plug body 1 to the part that is fixed to the expansion plug body 1 (such as Figure 2 As shown), the volume of the vaginal expansion plug increases. If the expansion plug body 1 also increases in volume due to water absorption and expansion, the overall volume of the vaginal expansion plug increases, which can better support and fill the vagina, and help the vaginal expansion plug to have good contact with the inner wall of the vagina. In addition, the expansion plug body 1 absorbs water and expands, which can further promote the composite drug-carrying layer 2 on its surface to bend and deform. In addition, since the side of the carrier layer facing the expansion plug body 1 is loaded with drugs, that is, in the composite drug-carrying layer 2, the side of the carrier layer facing away from the shell layer is loaded with drugs, and the side containing drugs is connected to the expansion plug body 1. Therefore, when curling occurs due to water absorption and expansion of the composite drug-carrying layer 2, the side of the carrier layer loaded with drugs will be exposed in the vagina, and is used to contact with the lesion area in the vagina to facilitate drug administration.

[0043] Therefore, in this embodiment, a composite drug-carrying layer 2 with a double-layer structure is designed on the surface of the expansion plug body 1, and the two layers of the composite drug-carrying layer 2 are prepared by materials with different expansion coefficients. As a result, when water absorption and expansion deformation occur, the stress change is generated by the humidity unbalanced expansion, causing the composite drug-carrying layer 2 to curl. On the one hand, the side loaded with the drug is exposed in the vagina to facilitate drug administration. On the other hand, the curled composite drug-carrying layer 2 on the expansion plug body 1 also helps to increase the volume of the vaginal expansion plug and increase the contact area between the expansion plug and the inner wall of the vagina.

[0044] Compared with the prior art that only pursues to increase the water absorption of the material used for the expansion plug from a single material dimension and has to sacrifice mechanical properties, this embodiment, through the combined effect of structure and material, can select materials that can meet mechanical-related properties and have good water absorption and expansion properties when selecting the material used for the expansion plug. At the same time, the curling expansion of the composite drug-carrying layer 2 is used to compensate for part of the expansion performance lost due to giving up excessive pursuit of water absorption.

[0045] Optionally, one end of the composite drug-carrying layer 2 is configured as the fixing portion 21 , and the other end of the composite drug-carrying layer 2 is a free end; when the vaginal expansion plug is in a humid environment, the composite drug-carrying layer 2 curls from its free end toward the fixing portion 21 .

[0046] In this optional embodiment, one end of the composite drug-carrying layer 2 is fixed to the expansion plug body 1, and the other end is a free end. Therefore, when the vaginal expansion plug is in a humid environment, for example, when the vaginal expansion plug is placed in the vagina, since the fixing portion 21 of the composite drug-carrying layer 2 is fixed to the expansion plug body 1, when the stress changes due to the unbalanced expansion of humidity, the composite drug-carrying layer 2 may curl from its free end to the fixing portion 21, such as Figure 2 shown.

[0047] It can be understood that the composite drug-carrying layer 2 is arranged on the surface of the expansion plug body 1. The composite drug-carrying layer 2 can be connected to the expansion plug body 1 in a local area, and the rest of the composite drug-carrying layer 2 is only laid on the surface of the expansion plug body 1. It can also be connected to the expansion plug body 1 in its entirety, but in order to achieve subsequent curling, only a partial area of ​​the composite drug-carrying layer 2 is connected to the expansion plug body 1, and the portion where the composite drug-carrying layer 2 is fixed to the expansion plug body 1 is called the fixing portion 21. In a preferred embodiment, in order to prevent the composite drug-loaded layer 2 from curling during the entry of the vaginal expansion plug, the fixing portion 21 is arranged in an area close to the entry end of the vaginal expansion plug. The so-called entry end refers to the end of the vaginal expansion plug that first enters the vagina. Since a plurality of composite drug-loaded layers 2 are arranged on the surface of the expansion plug body 1, each composite drug-loaded layer 2 has two ends close to and far from the entry end. The fixing portion 21 is arranged at an end close to the entry end. Therefore, during the entry of the vaginal expansion plug, the composite drug-loaded layer 2 will not curl up prematurely due to interference with the inner wall of the vagina due to expansion. Instead, after the vaginal expansibility reaches the set position, the expansion plug body 1 and the composite drug-loaded layer 2 absorb water and expand, and curl due to different expansion stresses generated on the composite drug-loaded layer 2.

[0048] Optionally, the portion of the composite drug-carrying layer 2 except the two ends is configured as the fixing portion 21 , and when the vaginal expansion plug is in a humid environment, the two ends of the composite drug-carrying layer 2 curl toward the fixing portion 21 respectively.

[0049] In this optional embodiment, the composite drug-carrying layer 2 has two free ends, the middle area of ​​the composite drug-carrying layer 2 is fixed on the expansion plug body 1, and the two ends are free ends. When expansion and deformation occur, the two ends of the composite drug-carrying layer 2 curl toward the fixing portion 21. It should be understood that the middle area here refers to all areas except the two ends. Compared with the method of setting it at one end, setting the fixing portion 21 in the middle area, the curling is performed from the two ends to the middle direction, which helps to improve the overall stability of the expansion plug.

[0050] Optionally, a plurality of the composite drug-carrying layers 2 are distributed along the first direction of the expansion plug body 1 and form a strip-shaped composite drug-carrying unit 3, and two adjacent composite drug-carrying layers 2 in the composite drug-carrying unit 3 are stacked in sequence.

[0051] In this optional embodiment, a plurality of composite drug-carrying layers 2 are arranged on the expansion plug body 1, wherein the plurality of composite drug-carrying layers 2 are distributed along a first direction of the expansion plug body 1, and the plurality of composite drug-carrying layers 2 distributed along the first direction are referred to as a composite drug-carrying unit 3. Figure 1 In the figure, shadows are used to distinguish the composite drug-carrying units 3 in two adjacent rows. The so-called first direction refers to a direction parallel or approximately parallel to the axial direction of the expansion plug body 1. It can be understood that in order to facilitate the vaginal expansion plug to enter the vagina smoothly, the expansion plug body 1 is generally designed to be cylindrical, spherical, oval or duck-billed. Taking the cylindrical shape as an example, the first direction is a direction parallel or approximately parallel to the axial direction of the expansion plug body 1. This direction is usually also consistent with the direction in which the expansion plug enters the vagina, that is, the expansion plug is generally inserted into the vagina along its axial direction. Therefore, the first direction can also be described as being consistent or substantially consistent with the direction in which the expansion plug body 1 enters the vagina.

[0052] In this optional embodiment, if Figure 3 As shown, in the composite drug-carrying unit 3, two adjacent composite drug-carrying layers 2 are sequentially stacked, that is, a part of the composite drug-carrying layer 2 is stacked by the composite drug-carrying layer 2 before it, and at the same time, another part of the composite drug-carrying layer 2 is stacked on the composite drug-carrying layer 2 after it, thereby, one composite drug-carrying layer 2 presses another composite drug-carrying layer 2, thus forming a mutually stacked composite drug-carrying unit 3. With such a design, when the expansion plug is placed in the vagina, due to the unbalanced stress change caused by the moisture absorption expansion deformation, when multiple composite drug-carrying layers 2 curl on the surface of the expansion plug body 1, the surface of the expansion plug body 1 will curl into a state similar to curled hair, thereby improving the overall expansion performance of the vaginal expansion plug and releasing the drugs in each composite drug-carrying layer 2 at the same time. Figure 3 In the figure, for ease of understanding, three thick solid rectangular frames are drawn with dotted lines to represent three composite drug-carrying layers 2.

[0053] like Figure 4 , Figure 5 As shown, assuming that the expansion plug body 1 is a regular cylindrical shape, the expanded shape of the surface of the expansion plug body 1 is a rectangle, and multiple composite drug-carrying layers 2 form strip-shaped composite drug-carrying units 3 on the surface of the expansion plug body 1. The multiple composite drug-carrying layers 2 are stacked in sequence. When each composite drug-carrying layer 2 is curled in sequence, the following is obtained: Figure 4 , Figure 5In the shape shown, each composite drug-carrying layer 2 is rolled up and one side of the drug-carrying carrier layer is exposed to the vagina, so as to contact the inner wall of the vagina to release the drug. At the same time, the rolled-up and parallel form of multiple composite drug-carrying layers 2 also helps to improve the elasticity of the expansion plug, which can not only realize the expansion and deformation of the expansion plug, but also will not cause the expansion to break or break. Figure 4 for Figure 3 Schematic diagram of the composite drug-carrying layer 2 after rolling up, in order to clearly show the rolling up of the composite drug-carrying layer 2, Figure 5 Shown Figure 4 The cross-sectional diagram shows that if Figure 5 When each composite drug-carrying layer 2 recovers its deformation, each composite drug-carrying layer 2 is stacked in sequence.

[0054] Optionally, two adjacent composite drug-carrying layers 2 in the composite drug-carrying unit 3 have an overlapping region 4 , and the length of the overlapping region 4 is 1 / 3-1 / 2 of the length of the composite drug-carrying layer 2 .

[0055] Specifically, Figure 6 As shown, the length of the overlapping region 4 of two adjacent composite drug-carrying layers 2 is 1 / 2 of the length of the composite drug-carrying layer 2. The thick black solid line in the figure shows one of the composite drug-carrying layers 2 to distinguish it from the other composite drug-carrying layer 2. Figure 7 As shown, Figure 6 In the case where two composite drug-carrying layers 2 are curled, the gap between the rolled composite drug-carrying layers 2 is reduced, which helps to increase the drug coverage area and improve the drug loading amount. For ease of explanation, the curled portion of the composite drug-carrying layer 2 is referred to as the curled portion 22. Figure 7 As shown in the middle shaded area, Figure 7 Two overlapping composite drug-carrying layers 2 are shown. After curling, the curled portions 22 of the two composite drug-carrying layers 2 are represented by different shadows to distinguish them.

[0056] like Figure 8 As shown, the length of the overlapping region 4 of two adjacent composite drug-carrying layers 2 is 1 / 3 of the length of the composite drug-carrying layer 2. Fig. 9 As shown, Figure 8 The situation after the two composite drug-carrying layers 2 are curled is Fig. 9 It can be seen that there is a certain gap between the two rolled composite drug-carrying layers 2, but the gap is not too large, so that the drug loading amount is ensured while ensuring that the composite drug-carrying layer 2 has a certain size for rolling.

[0057] In this optional embodiment, in the composite drug carrier unit 3, the overlapping length of two adjacent composite drug carrier layers 2 is 1 / 3-1 / 2, thereby ensuring that the composite drug carrier layer 2 has a certain roll-up size, while also preventing the gap between the two composite drug carrier layers 2 after rolling from being too large, resulting in a smaller contact area between the drug-containing side of the carrier layer and the inner wall of the vagina, affecting the drug release amount.

[0058] Optionally, there are multiple composite drug-carrying units 3 , and the multiple composite drug-carrying units 3 are distributed along the second direction of the expansion plug body 1 .

[0059] In this optional embodiment, multiple composite drug-carrying units 3 are distributed in the second direction of the expansion plug body 1, and the so-called second direction refers to a direction perpendicular or approximately perpendicular to the first direction. Thus, multiple composite drug-carrying layers 2 are arranged horizontally and vertically on the surface of the expansion plug body 1, and the so-called horizontal direction refers to the arrangement in the second direction, and the so-called vertical direction refers to the arrangement in the first direction, so that more composite drug-carrying layers 2 can be arranged on the surface of the expansion plug body 1 to meet the requirements of applying drugs in different lesion areas on the inner wall of the vagina.

[0060] Optionally, the vaginal expansion plug includes a plurality of composite drug-carrying units 3, and the composite drug-carrying layers 2 in two adjacent composite drug-carrying units 3 are staggered.

[0061] In this optional embodiment, the composite drug loading layers 2 in two adjacent composite drug loading units 3 are staggered, so as to avoid interference when the composite drug loading layers 2 in adjacent composite drug loading units 3 are rolled up, thereby affecting the normal rolling up of the composite drug loading layers 2 .

[0062] Optionally, the first water-swellable material comprises 50%-60% viscose fiber, 25%-35% polyvinyl alcohol and 10%-15% cellulose, and the second water-swellable material comprises 5%-10% viscose fiber, 40%-60% cotton and 35%-50% cellulose, in percentage by mass.

[0063] In this optional embodiment, viscose fiber and polyvinyl alcohol (PVA) usually show higher expansion performance when absorbing water and swelling, while cotton and cellulose and other materials have slightly lower expansion performance after absorbing water. Among them, in the molecular structure of polyvinyl alcohol, because it contains a large number of hydroxyl (-OH) groups, it has good hydrophilicity, can form hydrogen bonds with water molecules, absorb water quickly and swell, so it has high water absorption. Viscose fiber has excellent water absorption performance, and viscose fiber usually forms a gel-like network structure after absorbing water, and fixes water molecules therein, thereby causing the fiber to expand as a whole. The first water-absorbing and swelling material is designed to be a composite of PVA and viscose fiber, and the rapid water absorption of PVA and the gel structure of viscose fiber act together to make the water absorption speed of the material faster and the water absorption amount larger, thereby enhancing the overall water absorption and swelling effect of the material. In addition, by adding cellulose in the composite system, due to the presence of hydroxyl groups in cellulose, it is promoted to form hydrogen bonds with PVA, so that PVA is combined with cellulose, therefore, by the hydrogen bond interaction between polyvinyl alcohol and cellulose, the mechanical properties of the carrier layer can be kept stable. In the second water-swellable material, the content of viscose fiber with good water absorption is appropriately reduced, and the content of cotton and cellulose with average water absorption and swelling performance is increased, so as to reduce the overall water absorption and swelling performance of the second water-swellable material. At the same time, since the use of polyvinyl alcohol is eliminated, the hydrogen bonding effect between PVA and cellulose disappears, and the mechanical properties such as mechanical strength of the shell layer made of the second water-swellable material are weakened, which is beneficial to the overall curling of the composite drug-carrying layer 2 (curling from the carrier layer side to the shell layer side).

[0064] In this optional embodiment, by adjusting the types and contents of the materials used in the shell layer and the carrier layer, the expansion coefficient of the first water-absorbing and expanding material is made greater than the expansion coefficient of the second water-absorbing and expanding material, thereby making the carrier layer have higher expansion properties, including a higher expansion speed, expansion amount, etc., thereby causing uneven expansion in the composite drug carrier layer 2, thereby causing the composite drug carrier layer 2 to curl.

[0065] Optionally, the thickness of the carrier layer is 0.3 mm-0.8 mm, the thickness of the shell layer is 0.1-0.5 mm, and the thickness of the composite drug-carrying layer 2 does not exceed 1 mm.

[0066] In this optional embodiment, by appropriately adjusting the thickness of each layer, the composite drug-carrying layer 2 is made thinner as a whole, which is conducive to curling and controls the degree of curling after expansion within a suitable range.

[0067] Optionally, the material of the expansion plug body 1 is selected from one of absorbent fibers, cotton, absorbent resins, polymer absorbent materials, hydrogels, superabsorbents, expansion agents, polyurethane sponges and foam materials.

[0068] In this optional embodiment, most of these materials have good water absorption properties and can quickly absorb a large amount of water after absorbing water to achieve an expansion effect.

[0069] Optionally, the expansion agent includes sodium chloride and sodium sulfate, which can quickly absorb and expand after contacting moisture.

[0070] Optionally, the water-absorbent fibers include cellulose fibers, wood fibers, etc. These materials not only have good water-absorbent properties, but also have biodegradability and good mechanical properties to provide better support and strength.

[0071] Optionally, the water-absorbent resin includes polyacrylamide-based water-absorbent resin, polyacrylamide adenate-based water-absorbent resin, etc. These resins expand into a gel state after absorbing moisture and can maintain a wet state for a long time, making the material soft and reducing discomfort when in contact with the human body.

[0072] Optionally, a receiving groove is provided on a side of the carrier layer facing away from the shell layer, and the receiving groove is used to place the drug-loaded cotton body with the drug dropped thereon.

[0073] In this optional embodiment, the receiving groove is used to place the drug-loaded cotton body with the drug dripped on it, so that the drug and other components can be effectively separated and stored. This helps to protect the stability and safety of the drug, and can also effectively improve the utilization rate of the drug, reduce waste, and thus achieve better treatment effects.

[0074] A method for preparing a vaginal expansile plug provided in an embodiment of the present invention is used to prepare a vaginal expansile plug as described in any one of the above items, comprising:

[0075] Pressing one of absorbent fiber, cotton, absorbent resin, polymer absorbent material, hydrogel, superabsorbent, expander, polyurethane sponge and foam material into an expansion plug body 1;

[0076] The first water-swellable material is pressed into a first plane layer, the second water-swellable material is pressed into a second plane layer, the first plane layer is bonded to the second plane layer, and a drug is loaded on a side of the first plane layer away from the second plane layer to obtain a composite drug-loaded layer 2;

[0077] A local area of ​​the composite drug-carrying layer 2 is bonded to the surface of the expansion plug body 1 , and a side of the composite drug-carrying layer 2 loaded with the drug faces the expansion plug body 1 .

[0078] In this embodiment, the expansion plug body 1, the first plane layer and the second plane layer are prepared by pressing, and the first plane layer and the second plane layer are bonded together, and then bonded to the surface of the expansion plug body 1, so as to obtain a vaginal expansion plug. Among them, the drug is loaded on the side of the second plane layer away from the second plane layer, so that the drug faces the expansion plug body 1, and the drug is well protected, so as to avoid contamination caused by the drug loaded on the surface of the expansion plug body 1 during the use of the vaginal expansion plug, or cause drug loss. In addition, the preparation method of this embodiment is simple to operate and low in cost.

[0079] The present invention is further described below in conjunction with specific embodiments.

[0080] Example 1

[0081] This embodiment provides a method for preparing a vaginal expansion plug, comprising the following steps:

[0082] (1) pressing cotton strips as expansion plug body 1;

[0083] (2) weighing viscose fiber, PVA and cellulose in a mass ratio of 50%:35%:15% to obtain a first water-swellable material, weighing viscose fiber, cotton and cellulose in a mass ratio of 5%:60%:35% to obtain a second water-swellable material, respectively pressing the first water-swellable material and the second water-swellable material into two planes, wherein the first water-swellable material is pressed into a plane with a thickness of 0.5 mm, and the second water-swellable material is pressed into a plane with a thickness of 0.2 mm, and the two planes are bonded together, and a suitable drug is added dropwise; repeating the above operation to prepare a plurality of composite drug-carrying layers 2;

[0084] (3) One ends of the plurality of composite drug-carrying layers 2 obtained above are respectively bonded to the surface of the expansion plug body 1, and the plurality of composite drug-carrying layers 2 are arranged in rows and columns, and two adjacent composite drug-carrying layers 2 in each row are stacked in sequence, and the stacking repetition area is 1 / 2 of the composite drug-carrying layers 2.

[0085] Example 2

[0086] The difference between this embodiment and embodiment 1 is that the ratio of the first water-swellable material to the second water-swellable material in step (2) is different. In this embodiment, viscose fiber, PVA and cellulose are weighed in a mass ratio of 60%:25%:15% to obtain the first water-swellable material, which is pressed into a carrier layer with a thickness of 0.6 mm, and viscose fiber, cotton and cellulose are weighed in a mass ratio of 5%:50%:45% to obtain the second water-swellable material, which is pressed into a shell layer with a thickness of 0.3 mm.

[0087] Example 3

[0088] The difference between this embodiment and embodiment 1 is that the ratio of the first water-swellable material to the second water-swellable material in step (2) is different. In this embodiment, viscose fiber, PVA and cellulose are weighed in a mass ratio of 55%:35%:10% to obtain the first water-swellable material, which is pressed into a carrier layer with a thickness of 0.3 mm, and viscose fiber, cotton and cellulose are weighed in a mass ratio of 10%:40%:50% to obtain the second water-swellable material, which is pressed into a shell layer with a thickness of 0.5 mm.

[0089] Example 4

[0090] The difference between this embodiment and embodiment 1 is that in step (3), the repeated area where two adjacent composite drug-carrying layers 2 in each row are sequentially laminated is 1 / 3 of the composite drug-carrying layer 2 .

[0091] Example 5

[0092] The difference between this embodiment and embodiment 1 is that in step (3), the middle area of ​​the composite drug-carrying layer 2 is bonded to the surface of the expansion plug body 1 .

[0093] Although the present invention is disclosed as above, the protection scope of the present invention is not limited thereto. Those skilled in the art may make various changes and modifications without departing from the spirit and scope of the present invention, and these changes and modifications will fall within the protection scope of the present invention.

Claims

1. A vaginal expansion plug, characterized in that: include: An expansion plug body (1) and a composite drug-carrying layer (2), wherein the composite drug-carrying layer (2) is arranged on the surface of the expansion plug body (1), and the composite drug-carrying layer (2) comprises a fixing portion (21), and the fixing portion (21) is used to be fixedly connected to the expansion plug body (1); the composite drug-carrying layer (2) comprises a carrier layer and a shell layer which are stacked, wherein a side of the carrier layer facing the expansion plug body (1) is loaded with drugs, and a side of the carrier layer facing away from the expansion plug body (1) is connected to the shell layer; wherein the carrier layer comprises a first water-swellable material, and the shell layer comprises a second water-swellable material, and the expansion coefficient of the first water-swellable material is greater than the expansion coefficient of the second water-swellable material; When the vaginal expansion plug is not in a humid environment, the composite drug-carrying layer (2) is laid on the surface of the expansion plug body (1); When the vaginal expansion plug is in a humid environment, the end of the composite drug-carrying layer (2) away from the fixing portion (21) curls toward the fixing portion (21).

2. The vaginal expansion plug according to claim 1, characterized in that: One end of the composite drug-carrying layer (2) is configured as the fixing portion (21), and the other end of the composite drug-carrying layer (2) is a free end; when the vaginal expansion plug is in a humid environment, the composite drug-carrying layer (2) curls from its free end toward the fixing portion (21).

3. The vaginal expansion plug according to claim 1, characterized in that: The portion of the composite drug-carrying layer (2) other than the two ends is configured as the fixing portion (21). When the vaginal expansion plug is in a humid environment, the two ends of the composite drug-carrying layer (2) are respectively curled toward the fixing portion (21).

4. The vaginal expansion plug according to claim 1, characterized in that: The plurality of composite drug-carrying layers (2) are distributed along the first direction of the expansion plug body (1) to form a strip-shaped composite drug-carrying unit (3), and two adjacent composite drug-carrying layers (2) in the composite drug-carrying unit (3) are sequentially stacked.

5. The vaginal expansion plug according to claim 4, characterized in that: Two adjacent composite drug-carrying layers (2) in the composite drug-carrying unit (3) have an overlapping region (4), and the length of the overlapping region (4) is 1 / 3 to 1 / 2 of the length of the composite drug-carrying layer (2).

6. The vaginal expansion plug according to claim 4, characterized in that: It comprises a plurality of the composite drug-carrying units (3), wherein the composite drug-carrying layers (2) in two adjacent composite drug-carrying units (3) are arranged in a staggered manner.

7. The vaginal expansion plug according to claim 1, characterized in that: By mass percentage, the first water-swellable material comprises 50%-60% viscose fiber, 25%-35% polyvinyl alcohol and 10%-15% cellulose, and the second water-swellable material comprises 5%-10% viscose fiber, 40%-60% cotton and 35%-50% cellulose.

8. The vaginal expansion plug according to claim 1, characterized in that: The material of the expansion plug body (1) is selected from one of absorbent fibers, cotton, absorbent resin, polymer absorbent material, hydrogel, superabsorbent, expansion agent, polyurethane sponge and foam material.

9. The vaginal expansion plug according to claim 1, characterized in that: A receiving groove is arranged on a side of the carrier layer facing away from the shell layer, and the receiving groove is used for placing the drug-loaded cotton body dripped with the drug.

10. A method for preparing a vaginal expansion plug, characterized in that: For preparing the vaginal expansion plug according to any one of claims 1 to 9, comprising: Pressing one of absorbent fiber, cotton, absorbent resin, polymer absorbent material, hydrogel, super absorbent, expansion agent, polyurethane sponge and foam material into an expansion plug body (1); The first water-swellable material is pressed into a first plane layer, the second water-swellable material is pressed into a second plane layer, the first plane layer is bonded to the second plane layer, and a drug is loaded on a side of the first plane layer away from the second plane layer to obtain a composite drug-loaded layer (2); A local area of ​​the composite drug-carrying layer (2) is bonded to the surface of the expansion plug body (1), and a side of the composite drug-carrying layer (2) loaded with the drug faces the expansion plug body (1).

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