CN115245493A - Sodium butyrate sustained-release tablet for delaying vascular aging - Google Patents

Sodium butyrate sustained-release tablet for delaying vascular aging Download PDF

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CN115245493A
CN115245493A CN202210485388.3A CN202210485388A CN115245493A CN 115245493 A CN115245493 A CN 115245493A CN 202210485388 A CN202210485388 A CN 202210485388A CN 115245493 A CN115245493 A CN 115245493A
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sodium butyrate
release
release layer
sustained
slow
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洪华山
谢文辉
柯一郎
李珰
游沁怡
陈璐
王润
余杰
颜万红
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Union Medical College Hospital of Fujian Medical University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61J3/06Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of pills, lozenges or dragees
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P39/06Free radical scavengers or antioxidants

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Abstract

The invention discloses a sodium butyrate sustained-release tablet for delaying vascular aging, which relates to the technical field of aging resistance, and the technical scheme of the tablet comprises a sodium butyrate sustained-release layer, wherein the sodium butyrate sustained-release layer is prepared from the following components in parts by weight of 1:0.8-1 parts of sodium butyrate and slow-release auxiliary materials, wherein the hardness of the sodium butyrate slow-release layer is 70-90N, and the viscosity of the slow-release auxiliary materials is 30-40mPa. The sodium butyrate sustained-release tablet for delaying vascular aging is prepared by taking sodium butyrate as a core material, so that the preparation difficulty of the sodium butyrate sustained-release tablet for delaying vascular aging is remarkably reduced while the sodium butyrate sustained-release tablet with stable release degree is obtained for effectively delaying vascular aging, and the sodium butyrate sustained-release tablet for delaying vascular aging has the effects of comfort in use and effective delay of vascular aging.

Description

Sodium butyrate sustained-release tablet for delaying vascular aging
Technical Field
The invention relates to the technical field of anti-aging, in particular to a sodium butyrate sustained-release tablet for delaying vascular aging.
Background
The aging occurs at different time in different animals and different tissues and organs of the same animal, and the aging degree and the aging speed of different individuals of the same age are different, namely the chronological age is different from the biological age, and the reason is closely related to the difference of the vascular aging occurrence and development speed of different individuals, organs and tissues. The vascular aging is an important pathophysiological basis for causing aging of each organ system of an organism and is a common morbidity basis of a plurality of chronic diseases of the old organism; vascular aging is a risk factor for Atherosclerosis (AS) -related diseases, and the interaction of vascular structural and functional changes with pathophysiological mechanisms resulting from vascular aging determines the threshold, severity and prognosis for cardiovascular disease development in the elderly, which accounts for 50% of clinical cardiovascular disease in the elderly.
In the prior art, it has been explored that butyric acid, which is one of the main fermentation products of intestinal flora, is a link connecting the intestinal flora with the physiological functions and pathological changes of a host. And in the action mechanism of butyric acid, the butyric acid can be used for regulating the function of immune cells and playing an anti-inflammatory role besides the functions of providing energy and maintaining the integrity of the intestinal tract, thereby playing a protective role in intestinal inflammation diseases, cancers, metabolic diseases and cardiovascular and cerebrovascular diseases.
However, the current drug treatment means aiming at vascular aging is insufficient, so that the focusing on the research related to the drug treatment of vascular aging has important theoretical and practical significance for delaying aging and preventing and treating aging-related diseases, and the current drug treatment means mainly aims at regulating blood pressure, so that the delaying effect directly aiming at vascular aging is difficult to achieve and needs to be improved.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide the sodium butyrate sustained-release tablet for delaying vascular aging, and the sodium butyrate sustained-release tablet for delaying vascular aging has the effects of comfort in use and effective delay of vascular aging.
In order to realize the purpose, the invention provides the following technical scheme:
the sodium butyrate sustained-release tablet for delaying vascular aging comprises a sodium butyrate sustained-release layer, wherein the sodium butyrate sustained-release layer is prepared from a raw material of sodium butyrate in parts by weight of 1:0.8-1 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of the sodium butyrate slow-release layer is 70-90N, and the viscosity of the slow-release auxiliary material is 30-40mPa.
The invention is further configured to: the slow release auxiliary materials consist of penetration enhancer, filler, slow release powder and magnesium stearate; and the penetration enhancer, the filler, the slow release powder and the magnesium stearate are mixed according to the weight part ratio of 0.83-1.17:0.73-0.82:1:1.33-1.42.
The invention is further configured to: the slow release powder is polyoxyethylene powder.
The invention is further configured to: the penetration enhancer is at least one of magnesium chloride, sodium sulfate, magnesium sulfate and potassium sulfate.
The invention is further configured to: the filler is at least one of lactose, sucrose, starch and mannitol.
The invention is further configured to: the outer side of the sodium butyrate slow-release layer is wrapped with a sodium butyrate quick-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 8.46-10.32% and 89.68-91.54% of the total mass.
The invention is further configured to: the sodium butyrate quick-release layer comprises a sodium butyrate quick-release layer and a sodium butyrate quick-release layer, wherein the sodium butyrate quick-release layer comprises the following components in parts by weight: 0.8-1 parts of sodium butyrate and quick-release auxiliary materials; the quick-release auxiliary material consists of a filling agent, an adhesive and talcum powder; and the weight portion ratio of the filler, the adhesive and the talcum powder is 1.9-2.1:1.6-1.7:1.1-1.3.
The invention is further configured to: the filler is at least one of lactose, sucrose, starch and mannitol; the adhesive is hydroxypropyl methylcellulose.
The invention is further configured to: the preparation method of the sodium butyrate sustained-release tablet for delaying vascular aging comprises the following steps of (1) raw material treatment: sieving the raw materials for later use; (2) preparation of a sodium butyrate quick-release layer: mixing and stirring sodium butyrate and quick-release auxiliary materials, and then placing the mixture into a press to press and form a semicircular hollow sodium butyrate quick-release layer half tablet; (3) preparing a sodium butyrate sustained-release layer: mixing and stirring sodium butyrate and a sustained-release auxiliary material, putting the mixture into a tablet press, and pressing and forming a spherical sodium butyrate sustained-release layer; (4) the spherical sodium butyrate slow-release layer is placed into two semicircular hollow sodium butyrate fast-release layer half pieces, and is pressed and formed by a tablet machine.
The invention is further configured to: the semicircular hollow sodium butyrate quick-release layer half piece comprises a semicircular inclusion part and embedded semicircular grooves positioned in the semicircular inclusion part, and the two embedded semicircular grooves are matched with each other to embed the spherical sodium butyrate slow-release layer; a bulge is arranged on the upper side of one end of the semicircular wrapping body, and an inner hole matched with the bulge is formed in the other end of the semicircular wrapping body; the pressing machine comprises a pressing rack, wherein the upper end and the lower end of the pressing rack are respectively provided with a limiting transverse groove which is parallel to each other, a driving threaded rod is inserted in the limiting transverse groove, one end of the driving threaded rod is connected with a threaded motor for driving rotation, and is sleeved with a limiting moving block which is positioned in the limiting transverse groove and moves along the length direction of the limiting transverse groove; the limiting moving block positioned in the limiting transverse groove at the lower end is fixedly connected with a transverse moving die.
By adopting the technical scheme, the two semicircular hollow sodium butyrate quick-release layer halves are prepared, and the embedded spherical sodium butyrate slow-release layer is wrapped by the embedded semicircular grooves in the two semicircular hollow sodium butyrate quick-release layer halves, so that the aims of obviously reducing the preparation difficulty and improving the preparation efficiency are fulfilled; when the semicircular hollow sodium butyrate quick-release layer half piece is prepared by a pressing machine, two semicircular hollow sodium butyrate quick-release layer half pieces positioned at the upper end and the lower end are prepared through a transverse moving die and a lifting die respectively, the lifting die is driven by a rotating motor to rotate in the circumferential direction for 180 degrees in cooperation, so that an inner die of the lifting die rotates from an upward opening to a downward opening, the lifting die is driven by a telescopic motor to ascend, a driving threaded rod is driven by a corresponding threaded motor to rotate in the circumferential direction, the lifting die moves to a position corresponding to the transverse moving die in an up-and-down matching mode, the transverse moving die and the lifting die are matched after a manipulator places a spherical sodium butyrate slow-release layer in an embedded semicircular groove of the semicircular hollow sodium butyrate quick-release layer half piece in the transverse moving die, the two semicircular hollow sodium butyrate quick-release layer half pieces and the embedded spherical sodium butyrate slow-release layer half piece are matched, the manipulator moves to the pressing forming in the pressing machine, and therefore the sodium butyrate slow-release layer slow-release tablet for delaying blood vessel aging has the effects of convenience, high efficiency and high efficiency in preparation and stable connection structure, and the sodium butyrate slow-release effect of the slow-release and the slow-release of the sodium butyrate slow-release tablet for delaying blood vessel aging, and the slow-release of the slow-release sodium butyrate slow-release of the blood vessel can be comfortably used for the slow-release of the blood vessel.
In conclusion, the invention has the following beneficial effects: the sodium butyrate sustained-release tablet is prepared by respectively taking sodium butyrate as a core material and integrating the sodium butyrate rapid-release layer and the sodium butyrate rapid-release layer by a press and a tablet press to form a complete spherical sodium butyrate sustained-release tablet for delaying vascular aging, so that the preparation difficulty of the sodium butyrate sustained-release tablet for delaying vascular aging is remarkably reduced while the sodium butyrate sustained-release tablet with stable release degree is obtained for effectively delaying vascular aging, and a production and preparation production line of the sodium butyrate sustained-release tablet with high preparation efficiency and stable product use is formed and the purpose of effectively delaying vascular aging is realized.
Drawings
FIG. 1 is a schematic diagram of the explosive structure of the sodium butyrate sustained-release tablet for delaying vascular aging according to the present application;
fig. 2 is a schematic view of the structure of the press of the application.
Description of the reference numerals: 1. a semi-circular hull portion; 11. a semicircular groove is embedded; 12. a protrusion; 13. An inner bore; 2. a spherical sodium butyrate sustained-release layer; 3. pressing the rack; 31. a limiting transverse groove; 4. driving the threaded rod; 41. a thread motor; 5. a telescopic motor; 6. a fixed block; 7. lifting the mould; 8. and (5) transversely moving the die.
Detailed Description
In order to make the technical solutions and advantages of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
The following specifically describes the sodium butyrate sustained-release tablet for delaying vascular aging according to the embodiment of the present invention:
the sodium butyrate sustained-release tablet for delaying vascular aging comprises a sodium butyrate sustained-release layer, wherein the sodium butyrate sustained-release layer is prepared from a raw material of sodium butyrate in parts by weight of 1:0.8-1 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of the sodium butyrate slow-release layer is 70-90N, and the viscosity of the slow-release auxiliary material is 30-40mPa.
Wherein the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are in a weight ratio of 0.83-1.17:0.73-0.82:1:1.33-1.42. The slow release powder is polyoxyethylene powder. The penetration enhancer is at least one of magnesium chloride, sodium sulfate, magnesium sulfate and potassium sulfate. The filler is at least one of lactose, sucrose, starch and mannitol.
Meanwhile, the outer side of the sodium butyrate slow-release layer is wrapped with a sodium butyrate quick-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 8.46-10.32% and 89.68-91.54% of the total mass.
The sodium butyrate quick-release layer comprises the components in parts by weight of 1:0.8-1 of sodium butyrate and quick-release auxiliary materials. The quick-release auxiliary material consists of a filling agent, an adhesive and talcum powder, and the weight part ratio of the filling agent to the adhesive to the talcum powder is 1.9-2.1:1.6-1.7:1.1-1.3. Wherein the filler is at least one of lactose, sucrose, starch and mannitol. The adhesive is hydroxypropyl methylcellulose.
It is to be mentioned that the preparation method of the sodium butyrate sustained-release tablet for delaying vascular aging comprises the following steps (1) of raw material treatment: sieving the raw materials for later use; (2) preparation of a sodium butyrate quick-release layer: mixing and stirring sodium butyrate and quick-release auxiliary materials, putting the mixture into a press, and press-forming a semicircular hollow sodium butyrate quick-release layer half tablet; (3) preparing a sodium butyrate sustained-release layer: mixing and stirring sodium butyrate and sustained-release auxiliary materials, putting the mixture into a tabletting machine, and pressing and molding the spherical sodium butyrate sustained-release layer 22; (4) the spherical sodium butyrate slow-release layer 22 is placed into two semicircular hollow sodium butyrate fast-release layer half pieces, and is pressed and formed by a tablet machine.
As shown in fig. 1, the semicircular hollow half of the quick release layer of sodium butyrate in step (2) comprises a semicircular inclusion part 11 and an embedded semicircular groove 1111 located in the semicircular inclusion part 11. The two embedded semicircular grooves 1111 are matched with each other to embed the spherical sodium butyrate sustained-release layer 22. Meanwhile, a protrusion 1212 is arranged on the upper side of one end of the semicircular inclusion part 11, and an inner hole 1313 matched with the protrusion 1212 is arranged at the other end of the semicircular inclusion part, so that when the sodium butyrate sustained-release tablet for delaying vascular aging is prepared, two semicircular hollow sodium butyrate quick-release layer halves are prepared, and then the embedded spherical sodium butyrate sustained-release layer 22 is wrapped by the embedded semicircular groove 1111 in the two semicircular hollow sodium butyrate quick-release layer halves, so that the purposes of obviously reducing the preparation difficulty and improving the preparation efficiency are achieved, and the connection structure stability of the two semicircular hollow sodium butyrate quick-release layer halves is improved by the protrusion 1212 and the inner hole 1313 which are matched with each other, so that the sodium butyrate sustained-release tablet for delaying vascular aging is stable in use.
As shown in fig. 2, the press includes a press stand 33. The upper and lower ends of the pressing stage 33 are provided with limiting transverse grooves 3131 parallel to each other, and a driving threaded rod 44 is inserted into the limiting transverse groove 3131. One end of the driving threaded rod 44 is connected with a threaded motor 4141 for driving the driving threaded rod 44 to rotate circumferentially and a limiting moving block is sleeved on the driving threaded rod 44. The shape of the limiting moving block is matched with that of the corresponding limiting transverse groove 3131, and the limiting moving block is driven to move along the length direction of the limiting transverse groove 3131 when the threaded motor 4141 drives the driving threaded rod 44 to do circumferential rotation motion. It should be mentioned that a telescopic motor 55 is fixedly connected to the limit moving block in the limit transverse groove 3131 at the upper end. The movable end of the telescopic motor 55 is connected with a fixed block 66 downwards. A rotating motor is inserted into one side of the fixed block 66 far away from the pressing rack 33, and the movable end of the rotating motor is connected with a lifting module. Meanwhile, a lateral moving mold 88 is fixedly connected to the limiting moving block in the limiting lateral groove 3131 at the lower end. The traverse dies 88 have the same shape and structure as the lifting modules, and are all formed with inner die openings for press-forming semicircular hollow sodium butyrate quick-release layer halves and are all used as lower dies to be matched with upper dies. Therefore, when the semicircular hollow sodium butyrate quick-release layer half piece is prepared by a pressing machine, two semicircular hollow sodium butyrate quick-release layer half pieces positioned at the upper end and the lower end are prepared by the transverse moving die 88 and the lifting die 77 respectively, and when the semicircular hollow sodium butyrate quick-release layer half pieces are matched, the rotating motor drives the lifting die 77 to rotate for 180 degrees in the circumferential direction, so that the inner die of the lifting die 77 rotates from an upward opening to a downward opening, and the lifting die 77 moves to a position corresponding to the transverse moving die 88 in the up-and-down matching way while being driven by the telescopic motor 55 to ascend and the corresponding threaded motor 4141 to drive the driving threaded rod 44 to rotate in the circumferential direction, and after the spherical sodium butyrate slow-release layer 22 is placed in the embedded semicircular groove 1111 of the semicircular hollow sodium butyrate quick-release layer half piece in the transverse moving die 88 by the manipulator, matching and assembling a transverse moving die 88 and a lifting die 77, completing pairing of the two semicircular hollow sodium butyrate quick-release layer halves and the embedded spherical sodium butyrate slow-release layer 22, and moving the two semicircular hollow sodium butyrate quick-release layer halves to a tablet press machine for press forming, so that the sodium butyrate slow-release tablet for delaying vascular aging has the effects of convenience, high efficiency and stable connection structure, and when the sodium butyrate slow-release tablet for delaying vascular aging is used, firstly, after the two semicircular hollow sodium butyrate quick-release layer halves are quickly released, the embedded spherical sodium butyrate slow-release layer 22 on the inner side is slowly released, so that the purposes of comfort in use and effective vascular aging delaying effect are achieved.
The transverse moving die 88 and the lifting module are both provided with ejector pins to eject half pieces of the semicircular hollow sodium butyrate quick-release layer from the inner die.
Example one
A sodium butyrate sustained-release tablet for delaying vascular aging comprises a sodium butyrate sustained-release layer. The sodium butyrate slow-release layer is prepared from the following components in parts by weight of 1:0.8 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of the sodium butyrate slow-release layer is 70N, and the viscosity of the slow-release auxiliary material is 30mPa.
Wherein, the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are 0.83:0.73:1:1.33. the slow release powder is polyoxyethylene powder. The penetration promoter is magnesium chloride and sodium sulfate. The bulking agent is lactose and mannitol.
Meanwhile, the sodium butyrate quick-release layer wraps the outer side of the sodium butyrate slow-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 8.46% and 91.54% of the total mass.
The sodium butyrate quick-release layer comprises a mixture of sodium butyrate quick-release layer and sodium butyrate quick-release layer, wherein the sodium butyrate quick-release layer comprises the following components in parts by weight: 0.8 of sodium butyrate and quick-release auxiliary materials. The quick-release auxiliary material consists of a filler, an adhesive and talcum powder, and the weight part ratio of the filler to the adhesive to the talcum powder is 1.9:1.6:1.1. wherein the filler is starch and mannitol. The adhesive is hydroxypropyl methylcellulose.
It is to be mentioned that the preparation method of the sodium butyrate sustained-release tablet for delaying vascular aging comprises the following steps (1) of raw material treatment: sieving the raw materials for later use; (2) preparation of a sodium butyrate quick-release layer: mixing and stirring sodium butyrate and quick-release auxiliary materials, putting the mixture into a press, and press-forming a semicircular hollow sodium butyrate quick-release layer half tablet; (3) preparing a sodium butyrate sustained-release layer: mixing and stirring sodium butyrate and sustained-release auxiliary materials, putting the mixture into a tabletting machine, and pressing and molding the spherical sodium butyrate sustained-release layer 22; (4) the spherical sodium butyrate slow-release layer 22 is placed into two semicircular hollow sodium butyrate fast-release layer half pieces, and is pressed and formed by a tablet machine.
As shown in fig. 1, the semicircular hollow half of the quick release layer of sodium butyrate in step (2) comprises a semicircular inclusion part 11 and an embedded semicircular groove 1111 located in the semicircular inclusion part 11. The two embedded semicircular grooves 1111 are matched with each other to embed the spherical sodium butyrate slow-release layer 22. Meanwhile, a protrusion 1212 is arranged on the upper side of one end of the semicircular inclusion part 11, and an inner hole 1313 matched with the protrusion 1212 is arranged at the other end of the semicircular inclusion part, so that when the sodium butyrate sustained-release tablet for delaying vascular aging is prepared, two semicircular hollow sodium butyrate quick-release layer halves are prepared, and then the embedded spherical sodium butyrate sustained-release layer 22 is wrapped by the embedded semicircular groove 1111 in the two semicircular hollow sodium butyrate quick-release layer halves, so that the purposes of obviously reducing the preparation difficulty and improving the preparation efficiency are achieved, and the connection structure stability of the two semicircular hollow sodium butyrate quick-release layer halves is improved by the protrusion 1212 and the inner hole 1313 which are matched with each other, so that the sodium butyrate sustained-release tablet for delaying vascular aging is stable in use.
As shown in fig. 2, the press includes a press stand 33. The upper and lower ends of the pressing stage 33 are provided with limiting transverse grooves 3131 parallel to each other, and a driving threaded rod 44 is inserted into the limiting transverse groove 3131. One end of the driving threaded rod 44 is connected with a threaded motor 4141 for driving the driving threaded rod 44 to rotate circumferentially and a limiting moving block is sleeved on the driving threaded rod 44. The shape of the limiting moving block is matched with that of the corresponding limiting transverse groove 3131, and the limiting moving block is driven to move along the length direction of the limiting transverse groove 3131 when the threaded motor 4141 drives the driving threaded rod 44 to do circumferential rotation motion. It should be mentioned that a telescopic motor 55 is fixedly connected to the limit moving block in the limit transverse groove 3131 at the upper end. The movable end of the telescopic motor 55 is connected with a fixing block 66 in a downward direction. A rotating motor is inserted into one side of the fixing block 66 far away from the pressing rack 33, and the movable end of the rotating motor is connected with a lifting module. Meanwhile, a lateral moving mold 88 is fixedly connected to the limiting moving block in the limiting lateral groove 3131 at the lower end. The traverse dies 88 have the same shape and structure as the lifting modules, and are all formed with inner die openings for press-forming semicircular hollow sodium butyrate quick-release layer halves and are all used as lower dies to be matched with upper dies. Therefore, when the semicircular hollow sodium butyrate quick-release layer half piece is prepared by a pressing machine, two semicircular hollow sodium butyrate quick-release layer half pieces positioned at the upper end and the lower end are respectively prepared by the transverse moving die 88 and the lifting die 77, and when the semicircular hollow sodium butyrate quick-release layer half piece is matched, the rotating motor drives the lifting die 77 to rotate in the circumferential direction by 180 degrees, so that the inner die of the lifting die 77 rotates from an upward opening to a downward opening, and the lifting die rises under the driving of the telescopic motor 55 and drives the driving threaded rod 44 to rotate in the circumferential direction by the corresponding threaded motor 4141, the lifting die 77 moves to a position corresponding to the transverse moving die 88 in the up-down matching way, and after the spherical sodium butyrate slow-release layer 22 is placed in the embedded semicircular groove 1111 of the semicircular hollow sodium butyrate quick-release layer half piece in the transverse moving die 88 by the manipulator, matching and assembling a transverse moving die 88 and a lifting die 77, completing pairing of the two semicircular hollow sodium butyrate quick-release layer halves and the embedded spherical sodium butyrate slow-release layer 22, and moving the two semicircular hollow sodium butyrate quick-release layer halves to a tablet press machine for press forming, so that the sodium butyrate slow-release tablet for delaying vascular aging has the effects of convenience, high efficiency and stable connection structure, and when the sodium butyrate slow-release tablet for delaying vascular aging is used, firstly, after the two semicircular hollow sodium butyrate quick-release layer halves are quickly released, the embedded spherical sodium butyrate slow-release layer 22 on the inner side is slowly released, so that the purposes of comfort in use and effective vascular aging delaying effect are achieved.
The transverse moving die 88 and the lifting module are both provided with ejector pins to eject half pieces of the semicircular hollow sodium butyrate quick-release layer from the inner die.
Example two
The difference between the second embodiment and the first embodiment is that the sodium butyrate sustained-release layer in the second embodiment is prepared by mixing the following components in parts by weight of 1:0.9 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of a sodium butyrate slow-release layer is 80N, and the viscosity of the slow-release auxiliary material is 35mPa.
Wherein, the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are mixed according to the weight ratio of 1.01:0.75:1:1.36. the slow release powder is polyoxyethylene powder. The penetration enhancer is at least one of magnesium chloride, sodium sulfate, magnesium sulfate and potassium sulfate. The filler is at least one of lactose, sucrose, starch and mannitol.
Meanwhile, the sodium butyrate quick-release layer wraps the outer side of the sodium butyrate slow-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 9.38% and 90.62% of the total mass.
The sodium butyrate quick-release layer comprises the components in parts by weight of 1:0.9 of sodium butyrate and an immediate release auxiliary material. The quick-release auxiliary material consists of a filler, an adhesive and talcum powder, and the weight ratio of the filler to the adhesive to the talcum powder is 2:1.65:1.2. wherein the filler is sucrose. The adhesive is hydroxypropyl methylcellulose.
EXAMPLE III
The difference between the third embodiment and the first embodiment is that the sodium butyrate sustained-release layer in the third embodiment is prepared from the following components in parts by weight of 1:1 and a sustained-release auxiliary material, wherein the hardness of the sodium butyrate sustained-release layer is 90N, and the viscosity of the sustained-release auxiliary material is 40mPa.
Wherein, the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are mixed according to the weight ratio of 1.17:0.82:1:1.42. the slow release powder is polyoxyethylene powder. The penetration enhancer is sodium sulfate. The filler is starch.
Meanwhile, the outer side of the sodium butyrate slow-release layer is wrapped by the sodium butyrate quick-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 10.32% and 89.68% of the total mass.
The sodium butyrate quick-release layer comprises the components in parts by weight of 1:1 and quick-release auxiliary materials. The quick-release auxiliary material consists of a filler, an adhesive and talcum powder, and the weight part ratio of the filler, the adhesive and the talcum powder is 2.1:1.7:1.3. wherein the bulking agent is mannitol. The adhesive is hydroxypropyl methylcellulose.
Example four
The difference between the example four and the example one is that the sodium butyrate sustained-release layer in the example four is prepared by mixing the following components in parts by weight of 1:0.92 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of a sodium butyrate slow-release layer is 76N, and the viscosity of the slow-release auxiliary material is 36mPa.
Wherein, the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are mixed according to the weight ratio of 1.09:0.80:1:1.37. the slow release powder is polyoxyethylene powder. The penetration enhancer is magnesium sulfate. The filler comprises lactose, sucrose and starch according to the weight ratio of 1.
Meanwhile, the sodium butyrate quick-release layer wraps the outer side of the sodium butyrate slow-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 10.32% and 89.68% of the total mass.
The sodium butyrate quick-release layer comprises a mixture of sodium butyrate quick-release layer and sodium butyrate quick-release layer, wherein the sodium butyrate quick-release layer comprises the following components in parts by weight: 1 sodium butyrate and immediate release excipients. The quick-release auxiliary material consists of a filling agent, an adhesive and talcum powder, and the weight part ratio of the filling agent to the adhesive to the talcum powder is 1.9:1.6:1.3. wherein the filler is sucrose and mannitol with the weight portion ratio of 1. The adhesive is hydroxypropyl methylcellulose.
EXAMPLE five
The difference between the fifth embodiment and the first embodiment is that the sodium butyrate sustained-release layer in the fifth embodiment is prepared from the following components in parts by weight of 1:0.95 of sodium butyrate and a slow-release auxiliary material, wherein the hardness of a sodium butyrate slow-release layer is 83N, and the viscosity of the slow-release auxiliary material is 37mPa.
Wherein, the slow release auxiliary materials comprise penetration enhancer, filler, slow release powder and magnesium stearate. The penetration enhancer, the filler, the slow release powder and the magnesium stearate are 0.95:0.76:1:1.42. the slow release powder is polyoxyethylene powder. The penetration enhancer is magnesium chloride, sodium sulfate and potassium sulfate according to the weight ratio of 1. The bulking agent is mannitol.
Meanwhile, the sodium butyrate quick-release layer wraps the outer side of the sodium butyrate slow-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 9.12% and 90.88% of the total mass.
The sodium butyrate quick-release layer comprises a mixture of sodium butyrate quick-release layer and sodium butyrate quick-release layer, wherein the sodium butyrate quick-release layer comprises the following components in parts by weight: 0.92 of sodium butyrate and quick-release auxiliary materials. The quick-release auxiliary material consists of a filler, an adhesive and talcum powder, and the weight part ratio of the filler to the adhesive to the talcum powder is 1.9:1.65:1.22. wherein the filler is starch. The adhesive is hydroxypropyl methylcellulose.
Through detection, the sodium butyrate sustained-release tablets for delaying vascular aging, which are obtained in the first to fifth embodiments, have the effect of delaying aging-increasing vascular aging when in use.
In conclusion, the invention has the following beneficial effects: the sodium butyrate slow-release layer and the sodium butyrate quick-release layer are respectively prepared by taking sodium butyrate as a core material, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer are integrated by a press machine and a tablet press to form a complete spherical sodium butyrate slow-release tablet for delaying vascular aging, so that the preparation difficulty of the sodium butyrate slow-release tablet for delaying vascular aging is remarkably reduced while the sodium butyrate slow-release tablet with stable release degree is obtained for effectively delaying vascular aging, and a production and preparation production line of the sodium butyrate slow-release tablet with high preparation efficiency, stable product use and the purpose of effectively delaying vascular aging is formed.
References in this application to "first," "second," "third," "fourth," etc., if any, are intended to distinguish between similar elements and not necessarily to describe a particular order or sequence. It will be appreciated that the data so used may be interchanged under appropriate circumstances such that the embodiments described herein may be practiced otherwise than as specifically illustrated or described herein. Furthermore, the terms "comprises" and "comprising," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed, but may include other steps or elements not expressly listed or inherent to such process, method, or apparatus.
It should be noted that the descriptions in this application referring to "first", "second", etc. are for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between the embodiments may be combined with each other, but must be based on the realization of the technical solutions by a person skilled in the art, and when the technical solutions are contradictory to each other or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope claimed in the present application.
The principle and the embodiment of the present application are explained by applying specific examples, and the above description of the embodiments is only used to help understand the method and the core idea of the present application; meanwhile, for a person skilled in the art, according to the idea of the present application, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present application.

Claims (10)

1. A sodium butyrate sustained-release tablet for delaying vascular aging is characterized in that: the sodium butyrate sustained-release tablet comprises a sodium butyrate sustained-release layer, wherein the sodium butyrate sustained-release layer is prepared from the following components in parts by weight of 1:0.8-1 parts of sodium butyrate and slow-release auxiliary materials, wherein the hardness of the sodium butyrate slow-release layer is 70-90N, and the viscosity of the slow-release auxiliary materials is 30-40mPa.
2. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 1, which is characterized in that: the slow release auxiliary materials consist of penetration enhancer, filler, slow release powder and magnesium stearate; and the penetration enhancer, the filler, the slow release powder and the magnesium stearate are mixed according to the weight part ratio of 0.83-1.17:0.73-0.82:1:1.33-1.42.
3. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 2, is characterized in that: the slow release powder is polyoxyethylene powder.
4. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 2, is characterized in that: the penetration enhancer is at least one of magnesium chloride, sodium sulfate, magnesium sulfate and potassium sulfate.
5. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 2, is characterized in that: the filler is at least one of lactose, sucrose, starch and mannitol.
6. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 1, is characterized in that: the outer side of the sodium butyrate slow-release layer is wrapped with a sodium butyrate quick-release layer, and the sodium butyrate quick-release layer and the sodium butyrate slow-release layer respectively account for 8.46-10.32% and 89.68-91.54% of the total mass.
7. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 6, is characterized in that: the sodium butyrate quick-release layer comprises a sodium butyrate quick-release layer and a sodium butyrate quick-release layer, wherein the sodium butyrate quick-release layer comprises the following components in parts by weight: 0.8-1 parts of sodium butyrate and quick-release auxiliary materials; the quick-release auxiliary material consists of a filling agent, an adhesive and talcum powder; and the weight portion ratio of the filler, the adhesive and the talcum powder is 1.9-2.1:1.6-1.7:1.1-1.3.
8. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 7, is characterized in that: the filler is at least one of lactose, sucrose, starch and mannitol; the adhesive is hydroxypropyl methylcellulose.
9. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 6, wherein the preparation method of the sodium butyrate sustained-release tablet for delaying vascular aging comprises the following steps (1) of raw material treatment: sieving the raw materials for later use; (2) preparation of a sodium butyrate quick-release layer: mixing and stirring sodium butyrate and quick-release auxiliary materials, putting the mixture into a press, and press-forming a semicircular hollow sodium butyrate quick-release layer half tablet; (3) preparing a sodium butyrate sustained-release layer: mixing and stirring sodium butyrate and sustained-release auxiliary materials, putting the mixture into a tabletting machine, and pressing and molding a spherical sodium butyrate sustained-release layer; (4) the spherical sodium butyrate slow-release layer is placed into two semicircular hollow sodium butyrate fast-release layer half pieces, and is pressed and formed by a tablet machine.
10. The sodium butyrate sustained-release tablet for delaying vascular aging according to claim 9, which is characterized in that: the semicircular hollow sodium butyrate quick-release layer half piece comprises a semicircular inclusion part and embedded semicircular grooves positioned in the semicircular inclusion part, and the two embedded semicircular grooves are matched with each other to embed the spherical sodium butyrate slow-release layer; a bulge is arranged on the upper side of one end of the semicircular wrapping body, and an inner hole matched with the bulge is formed in the other end of the semicircular wrapping body; the pressing machine comprises a pressing rack, wherein the upper end and the lower end of the pressing rack are respectively provided with a limiting transverse groove which is parallel to each other, a driving threaded rod is inserted in the limiting transverse groove, one end of the driving threaded rod is connected with a threaded motor for driving rotation, and is sleeved with a limiting moving block which is positioned in the limiting transverse groove and moves along the length direction of the limiting transverse groove; the limiting moving block positioned in the limiting transverse groove at the lower end is fixedly connected with a transverse moving die.
CN202210485388.3A 2022-05-06 2022-05-06 Sodium butyrate sustained-release tablet for delaying vascular aging Pending CN115245493A (en)

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