CN113696534A

CN113696534A - Medicament pressing process

Info

Publication number: CN113696534A
Application number: CN202110951475.9A
Authority: CN
Inventors: 毛龙; 陈淑娟; 常智俐; 肖辉; 张浩军; 李毅; 郑强
Original assignee: Hubei Institute of Aerospace Chemical Technology
Current assignee: Hubei Institute of Aerospace Chemical Technology
Priority date: 2021-08-18
Filing date: 2021-08-18
Publication date: 2021-11-26

Abstract

The scheme discloses a medicament pressing process, which comprises the following steps: placing a core mold in a hollow annular tubular shell with openings at two ends, sleeving a soft film on the outer surface of the core mold, and filling medicament powder in a space between the soft film and the shell; two end covers with first through holes are respectively used for plugging openings at two ends of the annular shell; injecting liquid into the core mold through the end cover; under the pressure of an isostatic press, the liquid applies pressure to the medicament powder to form a compressed medicament. Can satisfy the gas generator medicament press forming of various dysmorphism, utilize the mode shaping that the mantle warp from inside to outside, the casing bears external pressure and interior pressure effect simultaneously, can bear the superhigh pressure of hydraulic press and reinforce, and the medicament shaping back in the casing need not the drawing of patterns, and the medicament becomes an organic whole with the casing, can use after the appropriate plastic.

Description

Medicament pressing process

Technical Field

The invention relates to the technical field of powder medicament compression molding, in particular to a medicament compression process.

Background

Generally, the powder column of the gas generator is formed by putting powder into a die, pressing an upper punch and a lower punch from the forward direction and the reverse direction by a hydraulic machine under a certain pressure, reducing the volume after the upper end surface and the lower end surface of the powder column move, increasing the density, forming the powder column into a die cavity shape, and forming after demoulding. Generally, the mold cavity is in a sheet or cylindrical shape, the pressed powder grains are also in a sheet or cylindrical state, and the like, which are easy to be demolded, and for a special-shaped generator, the mold cavity is also in a special shape, so that the pressing of the powder cannot be realized by using the original pressing method.

The isostatic compaction process is widely applied to the industries of powder metallurgy and metal smelting, and has the advantages of uniform compaction density and high density. The die is particularly suitable for pressing tubular blanks with high length-diameter ratio, the die is convenient to manufacture, and a plurality of products can be pressed at one time. The isostatic pressing machine is used for pressing tubular powder, generally, a soft film is coated on the outer layer of the powder, a core mold is arranged on the inner layer of the powder, and the soft film deforms under the action of water pressure or oil pressure to reduce the volume of the medicament from outside to inside and increase the density of the medicament.

Disclosure of Invention

An aim at of this scheme provides a medicament suppression technology, can satisfy the gas generator medicament compression molding of various dysmorphism, utilizes the mode shaping that the mantle warp from inside to outside, and the casing bears external pressure and interior pressure effect simultaneously, can bear the superhigh pressure of hydraulic press by force, and the medicament shaping back in the casing need not the drawing of patterns, and the medicament becomes an organic whole with the casing, can use after suitable plastic.

In order to achieve the purpose, the scheme is as follows:

a process for compressing a pharmaceutical dosage form, the process comprising the steps of:

placing a core mold in a hollow annular tubular shell with openings at two ends, sleeving a soft film on the outer surface of the core mold, and filling medicament powder in a space between the soft film and the shell;

two end covers with first through holes are respectively used for plugging openings at two ends of the annular shell;

injecting a liquid into the mandrel through either of the end caps;

under the pressure of an isostatic press, the liquid applies pressure to the medicament powder to form a compressed medicament.

Preferably, the pressurizing pressure is 3MPa to 300MPa, a step pressurizing mode is adopted during pressurizing, and the pressure maintaining time is more than 2min at each pressurizing pressure.

Preferably, the soft film is made of an elastic material and comprises polyurethane or a rubber material, and the shore hardness of the soft film is greater than 90.

Preferably, the core mold is made of metal, and the shell is made of metal.

Preferably, the core mold is tubular, and the same axial section of the core mold and the shell has the same circle center.

Preferably, the pipe wall of the core mould is provided with a second through hole; the liquid flows out through the second through hole and is pressurized to the soft membrane.

Preferably, the core mold is formed by combining a plurality of blocks, and the liquid flows out through gaps between the plurality of blocks to pressurize the flexible film.

Preferably, a sealing structure is arranged between the end cover and the shell, and the sealing structure comprises an O-shaped end face sealing ring and/or an axial sealing ring arranged between the end cover and the shell and/or a welding seal arranged between the end cover and the shell.

Preferably, a first through hole capable of penetrating through a soft membrane is formed in the middle of the end cover, and the soft membrane is fixed through tight fit with the first through hole formed in the end cover; and a sealing ring is arranged between the soft membrane and the end cover.

Preferably, when the density of the compressed pharmaceutical agent is lower than a preset value, the core molds of different diameters may be replaced and the isostatic pressing step may be performed again.

The scheme has the following beneficial effects:

1. the scheme is suitable for charging the special-shaped gas generator, and solves the problem that the medicament in the special-shaped gas generator cannot be integrally charged;

2. the powder column and the shell are integrated after compression molding, so that a demolding procedure is avoided, and the gas generator has good assembly performance;

3. compared with the traditional die pressing method, the density of the end surface of the grain is high, the density of the center is low, and the grain with larger length-diameter ratio can not be pressed;

4. the inside and the outside of the annular shell are wholly pressurized, the inside and the outside of the annular shell are uniformly stressed, and the shell can bear higher pressure and cannot break.

Drawings

In order to illustrate the implementation of the solution more clearly, the drawings that are needed in the description of the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the solution, and that other drawings may be derived from these drawings by a person skilled in the art without inventive effort.

FIG. 1 is a schematic illustration of an embodiment of a medicament assembly;

FIG. 2 is a schematic structural view of an end cap according to an embodiment;

FIG. 3 is a schematic view of a mandrel configuration according to an embodiment;

FIG. 4 is a schematic view of a core mold structure of the composite structure of the embodiment;

FIG. 5 is a schematic view of a sealing structure of an end cap and a housing according to an embodiment.

Detailed Description

Embodiments of the present solution will be described in further detail below with reference to the accompanying drawings. It is clear that the described embodiments are only a part of the embodiments of the present solution, and not an exhaustive list of all embodiments. It should be noted that, in the present embodiment, features of the embodiment and the embodiment may be combined with each other without conflict.

The terms "first," "second," and the like in the description and in the claims, and in the drawings described above, if any, are used for distinguishing between similar elements and not necessarily for describing a particular sequential or chronological order. 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," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, 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, article, or apparatus.

It should be understood that the term "and/or" as used herein is merely one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

The scheme relates to a medicament pressing process of a gas generator with a special-shaped shape, wherein the gas generator is designed into a circular ring or other special-shaped shapes. The shape of the common gas generator is usually a long cylinder or a cake, but a ring-shaped gas generator needs to be designed in some special use places, and the conventionally used medicament pressing method is not suitable for assembling medicaments in the ring-shaped gas generator. Therefore, the inventor of the scheme pressurizes the soft membrane by virtue of an isostatic pressing machine, so that the soft membrane expands towards the shell to pressurize the medicament powder, the medicament powder is pressurized and molded, the medicament charging of the annular gas generator is realized, and a novel medicament compression molding process is provided.

As shown in fig. 1 to 5, a medicament compression molding process includes the following steps:

the soft film 3 is sleeved on the outer surface of the core mold 4 and is arranged in the annular shell 1, and two ends of the soft film 3 and two ends of the core mold 4 respectively penetrate out of two ends of the shell 1 and are arranged in the first through holes on the first end cover 5 and the second end cover 6.

The first end cover 5 is arranged at one end of the shell 1, one end of the soft membrane 3 is inserted into a first through hole of the first end cover 5, a sealing ring is arranged between the outer side of the soft membrane 3 and the first through hole on the first end cover 5 for sealing, the first end cover 5 is sealed and fastened, the center line of the soft membrane 3 is kept to be superposed with the center line of the shell 1, namely the center axis lines of the soft membrane 3 and the shell 1 are kept to be superposed, the position of the soft membrane 3 is kept to be basically unchanged, the center position is kept in the process of charging, when the soft membrane is charged, the soft membrane 3 can be fixed by using a tool, one end of the soft membrane can be charged, and the two ends of the soft membrane can be charged together; the medicinal powder is filled into the gap between the soft membrane 3 and the shell 1 from the opening at the other end of the shell 1, the medicinal powder is filled in batches during filling, and the medicinal powder is vibrated while being filled, compressed and compacted as much as possible, so that the effect of the granulated high-density medicinal powder is better;

after the medicament is filled, the soft membrane 3 is inserted into the first through hole on the second end cover 6, and the second end cover 6 is arranged at the other end of the shell 1 for fastening and sealing.

In one embodiment, the core mold 4 is in a hollow tubular shape, the wall of the core mold is provided with a second through hole 41, for better sealing, two ends of the core film 4 respectively extending into the holes of the first end cover 5 and the second end cover 6 are sealed by using O-ring seals, the matching part of the two ends of the core film 4 and the first through holes on the first end cover 5 and the second end cover 6 is a straight line, and the sealing part of the O-ring seals is a straight line, so that the assembly is convenient and the sealing is also facilitated; the mandrel 4 may function to support the biofilm 3 when pressurized by the injection of liquid into the mandrel 4 through the first end cap 5 or the second end cap 6, the liquid flowing out through the second through-holes 41 in the pipe wall squeezes the biofilm.

The combined medicament pressing mould is placed into an isostatic pressing machine, liquid enters from a second through hole on a core mould, a soft membrane expands to extrude medicinal powder, the powder density is improved, stepped pressurization is carried out during pressurization, particularly, pressure maintaining is carried out for a certain time of more than 5 minutes at the stage of low pressure of 3 MPa-10 MPa, air in the powder is driven to enter spaces at two ends of a generator and is gradually pressurized to more than 70MPa, the highest forming pressure can reach 300MPa, a plurality of pressure steps can be arranged in the process of pressure maintaining, and the pressure maintaining time is more than 2 minutes.

The assembly of the pressurized medicament pressing mold is taken out, and the soft membrane is naturally contracted and naturally separated from the side wall of the medicament column after the pressure is released due to the higher Shore hardness of the soft membrane material, so that the soft membrane and the core mold can be taken out;

the soft membrane deformation amount at the joint position is small generally, the density of the medicine powder is not pressed in place, and the joint position of the end cover and the annular shell can be properly shaped to meet the use requirement;

if the density of one-time molding does not reach the required value, a core mold and a soft film with slightly larger outer diameters can be selected for multiple times of pressing until the density reaches the required value.

In one embodiment, the medicament compression mold is placed into an isostatic press, the pressure is increased to 5MPa for 5min, the air in the powder is exhausted to the positions of two end covers, the pressure is increased to 30MPa for 5min, the pressure is increased to 150MPa for 5min, and the pressure in the isostatic press is released.

In one embodiment, the soft membrane is made of an elastic material with high hardness, typically polyurethane or rubber, with a shore hardness of more than 90, which is beneficial to rebound after pressure release without bonding with the powder.

In one embodiment, a sealing structure is provided between each of the first end cap 5, the second end cap 6 and the housing 1, the sealing structure includes an O-ring 51 or an axial seal 52 provided between each end cap and the housing, and the end caps and the housing can be sealed by welding.

In another embodiment, the core form 4 is a composite core form, such as a core form comprising a plurality of segments that are assembled to form a tubular shape, wherein when fluid is injected into the core form 4 through the first end cap 5 or the second end cap 6, the fluid exits through the gaps between the plurality of segments to squeeze the mantle, and wherein the tubular shape of the core form facilitates assembly and disassembly of the core form and the mantle.

In one embodiment, the soft film 3 is sleeved on the outer side of the core mold 4 or the combined core film, the inner diameter of the soft film 3 is preferably sized to be conveniently sleeved on the outer diameter of the core film, or the shape of the combined core film can be kept, and the length of the hole on the end cover can be reserved at the two ends of the soft film.

In one embodiment, sealing rings are arranged between the flexible membrane 3 and the first end cover 5 and the second end cover 6; the soft membrane is fixed through the tight fit with the first through hole that sets up on every end cover, and the soft membrane inflation is inseparabler with the sealed of the mesopore in the end cover when the pressure boost.

In one embodiment, the shape of the medicament pressing container shell can be other than a ring shape, and any shape which can penetrate into the core film can be adopted. The cross section of the shell of the medicament pressing container is generally circular, the central line of the shell cross section perpendicular to the circular cross section can be arc-shaped, irregular-shaped or spiral-shaped, and after the core membrane penetrates into the medicament pressing container, the cross section of the core membrane and the cross section of the shell of the pressing container are generally concentric circles.

It should be understood that the above-mentioned embodiments of the present invention are only examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention, and it will be obvious to those skilled in the art that other variations or modifications may be made on the basis of the above description, and all embodiments may not be exhaustive, and all obvious variations or modifications may be included within the scope of the present invention.

Claims

1. A process for compressing pharmaceutical dosage forms, the process comprising the steps of:

injecting a liquid into the mandrel through either of the end caps;

2. The process for compressing pharmaceutical preparations according to claim 1, wherein the pressurization pressure is 3MPa to 300MPa, and the pressurization is performed in a step pressurization manner, and the dwell time is more than 2min at each pressurization pressure.

3. The drug compression process of claim 1, wherein the soft membrane is made of an elastic material, and comprises a polyurethane or rubber material, and the shore hardness of the soft membrane is greater than 90.

4. The process of claim 1 wherein the core is a metal and the shell is a metal.

5. The process for compressing pharmaceutical dosage of claim 4, wherein said core is tubular and has the same center as the same axial section of said shell.

6. The medicament pressing process according to claim 5, wherein the pipe wall of the core mold is provided with a second through hole; the liquid flows out through the second through hole and is pressurized to the soft membrane.

7. The process of claim 5 wherein the mandrel is formed from a plurality of strips, and the fluid exits through the interstices between the plurality of strips to pressurize the flexible membrane.

8. A medicament compression process according to claim 1 in which a seal is provided between the end cap and the housing, the seal comprising an O-ring seal and/or an axial seal and/or a welded seal between the end cap and the housing.

9. A medicament pressing process according to claim 1, wherein a first through hole is formed in the middle of the end cap and can pass through a soft membrane, and the soft membrane is fixed by tight fit with the first through hole formed in the end cap; and a sealing ring is arranged between the soft membrane and the end cover.

10. The process for compacting pharmaceutical dosage form according to claim 1, wherein when the density of the compacted pharmaceutical dosage form is lower than a predetermined value, the cores of different diameters can be replaced and the isostatic compaction step can be performed again.