JP2005028361A - Crushing and sieving apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide the subject apparatus whereby masses can be certainly crushed and sieved by simple operation, guaranteed levels of sterility and dust-freeness in a crushing step and a sieving step can be easily improved, and simple maintenance thereof is enabled. <P>SOLUTION: A sieve (5) is disposed on the bottom of a crushing chamber (4) containing masses (10) therein. A rotating shaft (12) is disposed in the vertical orientation in this cracking chamber (4). The rotating shaft (12) is turned horizontally. Wing parts (14) are provided at the lower end part of the rotating shaft (12), so that the wing parts (14) are turned within the crushing chamber (4) together with the rotation of the rotating shaft (12). Under surfaces (15) of the wing parts (14) are formed so that they slant downwardly to the turning direction. Small gaps are provided between the rear ends of the wing parts (14) and the upper surface of the above sieve (5). <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to a crushing sieving apparatus for finely pulverizing a lump obtained by freeze drying, for example, and sieving it. More specifically, the lump can be reliably crushed by a simple operation and sieved. Further, the present invention relates to a crushing and sieving device that can easily improve the assurance level of sterility and dust-freeness in the crushing step and the sieving step, and can be easily maintained.

The microencapsulated powder used for injections and the like is obtained by, for example, emulsifying into W / O / W type, drying this in water, centrifuging and sieving, and then freeze-drying. is there.
The cake (block) obtained by the above freeze-drying is relatively brittle, so it has been conventionally finely pulverized manually using a tool such as a spatula, and sieved with a predetermined sieve to form a powder. Had been.

In the above prior art, since the lump is processed manually, the work of crushing into a uniform powder and sieving is complicated, and it is easy to improve the assurance level of sterility and dust-freeness. There wasn't.
The present invention solves the above-mentioned problems, can reliably crush and block a lump with a simple operation, and can easily improve the sterility and dust-free guarantee level of the crushing process and the sieving process. Moreover, it is a technical problem to provide a crushing and sieving device that can be easily maintained.

In order to solve the above-described problems, the present invention is configured as follows, for example, based on FIG. 1 and FIG. 2 showing an embodiment of the present invention.
That is, a crushing and sieving apparatus for finely crushing the lump (10) into a powder form and sieving it, a crushing chamber (4) for accommodating the lump (10) and a crushing chamber (4 ), A rotating shaft (12) arranged vertically in the crushing chamber (4) and rotating in the horizontal direction, and a lower end of the rotating shaft (12). And a wing part (14) which is integrated with the rotary shaft (12) and swirls in the crushing chamber (4), and the lower surface (15) of the wing part (14) is arranged with respect to the swiveling direction. It is characterized by being formed on an inclined surface that falls rearward.

  The lump obtained by freeze-drying or the like falls downward when it is put into the crushing chamber, and is disposed at the bottom of the crushing chamber below the wing portion swirling with the rotating shaft in the crushing chamber. Get in between the sieving bodies. Since the lower surface of the wing part is formed on an inclined surface that descends rearwardly, the above-mentioned lump is rubbed while being pressed against the upper surface of the sieve body by the lower surface of the swirling wing part. Thereby, said lump is crushed finely and passes said sieve when it becomes predetermined fineness.

  If a minute gap of a predetermined size is provided between the rear end of the wing part and the upper surface of the sieve body, there is no possibility of contact between the wing part and the sieve body. In addition, it can be prevented, and the lump is efficiently crushed into a uniform powder, which is more preferable.

It is preferable to dispose a support plate for supporting the sieve body on the lower side of the sieve body so that the minute gaps can be easily maintained and the lump can be efficiently and uniformly crushed.
The support plate is usually formed with a large number of through holes so that the powder that has passed through the sieve can be guided downward.

  The lump and finely pulverized powder in the crushing chamber are easily pushed toward the outer peripheral edge of the crushing chamber bottom by being pushed by the swirling wing. For this reason, when the rotary shaft is formed with a larger diameter in the lower part than in the upper part, the wing part is provided closer to the outer peripheral edge of the bottom part, so that the mass can be efficiently crushed and sieved. Moreover, since the wing portion can be shortened, it can be firmly supported on the rotating shaft, and is more preferable.

  When a rough crushing portion is provided on the outer peripheral surface of the rotating shaft or the inner surface of the crushing chamber, the lump is roughly crushed by the rough crushing portion. This coarsely crushed lump is easy to enter between the wing portion and the sieve body, and the contact area with the sieve body as a whole is increased, so that it can be efficiently crushed into a powder and is more preferable. In addition, although said coarse crushing part is not limited to a specific number or shape, it is still more preferable if it provides in both the outer peripheral surface of a rotating shaft, and the inner surface of a crushing chamber.

  Since the present invention is configured and operates as described above, the following effects can be obtained.

  (1) By putting the lump into the crushing chamber and swirling the wing, the lump can be crushed and the powder is passed through a series of fine powders passing through the sieve. The lump can be reliably crushed until.

  (2) Since the lump is crushed in the crushing chamber and sieved as it is, it is possible to easily improve the assurance level of sterility and dust-freeness in the crushing process and the sieving process.

  (3) The crushing chamber has a simple structure in which a sieve is provided at the bottom, a rotating shaft and blades are arranged inside, and a support plate and a coarse crushing part are provided as necessary. Maintenance such as disassembly and cleaning can be easily performed.

Hereinafter, embodiments of the present invention will be described with reference to the drawings.
1 and 2 show an embodiment of the present invention, FIG. 1 is a sectional view of a crushing and sieving device, and FIG. 2 is an enlarged sectional view in the vicinity of a wing part.

As shown in FIG. 1, this crushing and sieving device (1) includes a main body portion (2) formed in a cylindrical shape with a lower constriction, and a discharge portion (attached in a tightly detachable manner below). 3), and a crushing chamber (4) is formed inside the main body (2).
At the bottom of the crushing chamber (4), a screen (5) having a predetermined fineness, for example, 420 μm, is arranged in the horizontal direction between the main body (2) and the discharge part (3). . The sieve body (5) is securely held in a horizontal plane by a support plate (6) disposed below. As shown in FIG. 2, the support plate (6) is provided with a number of through holes (7) so that the powder sieved by the sieve body (5) can pass through the through holes (7). It is configured.

As shown in FIG. 1, the upper surface of the main body (2) is covered with a detachable lid (8), and an inlet (9) is provided in the lid (8). A lump (10) such as cake obtained by freeze-drying is charged into the crushing chamber (4) from the charging port (9).
A shaft insertion hole (11) is provided in the center of the lid (8), the rotation shaft (12) is inserted into the shaft insertion hole (11), and the lower portion of the rotation shaft (12) is crushed. It arrange | positions in the up-down direction in the chamber (4). The upper portion of the rotating shaft (12) is linked to the motor (13), and the rotating shaft (12) rotates horizontally in the crushing chamber (4) by driving the motor (13).

  The rotating shaft (12) has a lower diameter larger than the upper diameter, and a wing (14) is provided at the lower end of the large diameter. The wing (14) is flat and has one end fixed to the rotary shaft (12) and the other end close to the inner surface of the main body (2) as long as it does not come into contact. (15) is in a slanted shape that descends later.

  As shown in FIG. 2, a minute gap (17) is provided between the rear end (16) of the wing part (14) and the upper surface of the sieve body (5). ) Is configured to rotate in the horizontal direction in the crushing chamber (4) without contacting the sieve (5). The minute gap (17) has a substantially uniform dimension over the entire surface of the sieve body (5) because the sieve body (5) is firmly supported in the horizontal direction by the support plate (6). Is formed.

  As shown in FIG. 1, a first crushing rod (18) is fixed to the rotating shaft (12) above the blade (14). On the other hand, the second crushing bar (19) is fixed to the inner surface of the crushing chamber (4) at a position where it does not interfere with the first crushing bar (18). That is, a mounting cylinder (20) is provided on the outer surface of the main body (2), and the crushing rod support (21) is inserted and fixed in the mounting cylinder (20). A second crushing rod (19) is projected from the inner tip of 21).

Next, the operation in which the mass (10) is pulverized and sieved by the pulverization sieving apparatus (1) will be described.
A lump (10) such as cake obtained by freeze-drying in the microcapsule manufacturing process is charged into the crushing chamber (4) from the charging port (9) as shown in FIG. In the crushing chamber (4), together with the rotating shaft (12), the first crushing rod (18) fixed to this rotates in the horizontal direction, while on the inner surface of the crushing chamber (4). Since the fixed second crushing bar (19) is stationary, the lump (10) put into the crushing chamber (4) is placed between the crushing bars (18, 19). It is sandwiched and crushed roughly.

  The coarsely crushed lump (10) falls in the crushing chamber (4) and is received on the upper surface of the sieve (5). Above the sieve body (5), the wing part (14) swivels together with the rotary shaft (12), and the coarsely crushed lump (10) is formed on the lower surface of the wing part (14) ( It is pressed in 15) and rubbed against the upper surface of the sieve body (5), thereby being crushed into a fine powder. At this time, a minute gap (17) having a predetermined dimension is provided between the rear end (16) of the wing portion (14) and the upper surface of the sieve body (5). Without contacting the body (5), the lump (10) is efficiently crushed into a uniform powder according to the size of the micro gap (17).

  When the powder becomes a predetermined fineness, it passes through the sieve body (5), passes through the through hole (7) of the support plate (6), and is disposed below the discharge part (3). Guided to stored storage containers.

When the varieties of the lump (10) are exchanged, the crushing and sieving device (1) is disassembled and cleaned as follows.
The rotary shaft (12) and the wing (14) at the tip of the rotary shaft (12) are first pulled out of the second crushing rod (19) from the mounting cylinder (20), and then the lid (8). Is removed and removed from the crushing chamber (4). On the other hand, the sieve body (5) and the support plate (6) are easily taken out by removing the discharge part (3) from the main body part (2). After that, each part is cleaned and then assembled in the previous state. At this time, the sieve body (5) may be replaced with one having a predetermined roughness according to the fineness of the powder obtained by crushing and sieving. Other parts can be replaced with new ones as needed.

Next, a microcapsule powder (hereinafter referred to as MC powder) of an injection (main ingredient = leuprorelin acetate) prepared as a pilot scale in an amount of about 1/24 of the production scale, and freeze-dried cake The pulverization sieving of the (bulky body) was carried out with the above sieving sieving apparatus.
(Example 1) Microcapsules (sustained release preparation) having a sustained effect for 1 month were prepared, and about 120 g of cake after freeze-drying was crushed and sieved.
(Example 2) A microcapsule (sustained release preparation) having a sustained effect of 3 months was prepared, and about 100 g of cake after lyophilization was crushed and sieved.
(Example 3) A microcapsule (sustained release preparation) having a sustained effect for 1 month and excluding gelatin in the formulation was prepared, and about 120 g of cake after freeze-drying was crushed and sieved.

  For comparison, about the same amount of cake as in Examples 1 to 3 above was subjected to crushing and sieving by conventional manual work, and it took about 15 to 30 minutes to complete. On the other hand, in each of the above Examples 1 to 3, the pulverization sieving is completed in about 5 minutes without any manual intervention, and a uniform powdery MC powder that does not contain a small lump can be easily obtained. I was able to. Accordingly, the use of the above-described apparatus of the present invention eliminates the need for manual intervention and shortens the work time, so that the assurance level of sterility and dust-freeness can be improved, and workability can be improved. It was.

Next, the same injection as in Examples 1 to 3 above was prepared in a production scale amount, and the cake (block) obtained by freeze-drying was crushed and sieved using the above crushed and sieve device. carry out.
(Example 4) A microcapsule was prepared with a so-called placebo without the active ingredient, and about 2.3 kg of cake after freeze-drying was crushed and sieved.
(Example 5) A microcapsule (sustained release preparation) having a sustained effect for 1 month is prepared, and about 3.3 kg of cake after freeze-drying is crushed and sieved.
(Example 6) A microcapsule (sustained release preparation) having a sustained effect of 3 months is prepared, and about 2.5 kg of cake after freeze-drying is crushed and sieved.
(Example 7) A microcapsule (sustained release preparation) having a sustained effect for 1 month and excluding gelatin in the formulation is prepared, and about 3.3 kg of cake after freeze-drying is crushed and sieved.

  For comparison, when the same amount of cake as in Example 4 was crushed and sieved by conventional manual work, it took about 1.5 hours to complete. On the other hand, in Example 4 described above, pulverization sieving was completed in about 20 minutes without manual intervention, and a uniform powdery MC powder containing no small lumps could be easily obtained. Moreover, crushing sieving is possible similarly about Examples 5-7. Therefore, in the case of this production scale, as in the case of the pilot scale, the use of the above-described device of the present invention eliminates the need for manual intervention and shortens the work time. A guarantee level can be improved and workability | operativity can be improved.

  The structure and shape of each component of the present invention are not limited to those of the above embodiment, and can be changed as follows, for example.

In the above embodiment, the main body portion is formed in a cylindrical shape with a narrow bottom, but the main body portion of the present invention may have other shapes such as a cylindrical shape.
In the above embodiment, the lower portion of the rotating shaft is formed to have a large diameter, but the rotating shaft used in the present invention may be formed to have the same thickness on both the upper and lower sides.

  In the above embodiment, the rough crushing portion is formed in a bar shape and arranged in the horizontal direction. However, the rough crushing portions used in the present invention do not interfere with each other and may be inclined with respect to the horizontal plane. The number of installed coarse crushing units can be arbitrarily set. However, if too many are provided, the lump may be received by the rough crushing portion and may not fall downward, so the number of installations is limited according to the size of the lump to be charged. Further, the rough crushing portion fixed to the inner surface of the crushing chamber may be fixed to the lower surface of the lid portion instead of the main body portion. Further, the shape of the rough crushing portion may be a complex shape such as a bifurcated shape or a comb tooth shape instead of the rod-shaped one, and may be configured to be more effectively coarsely crushed. On the other hand, if this rough crushing part is formed in a simple rod shape as in the above embodiment, the risk of the lump being caught on this rough crushing part can be reduced, and washing at the time of decomposition is easy and simple. There is an advantage that can be maintained.

  In the above embodiment, a flat wing portion is used. However, the above wing portion only needs to be formed on an inclined surface whose lower surface is rearwardly lowered with respect to the turning direction, and the cross section may have another shape. . For example, when the rear part of the wing part has a thick triangular section, the rigidity of the wing part is increased, which is preferable. On the other hand, when the wing portion is formed in a flat plate shape as in the above embodiment, there is an advantage that the wing portion can be lightened. The wing portion may be formed integrally with the rotating shaft, or may be formed separately and fixed to the rotating shaft. Furthermore, in the above embodiment, four blades are formed on the rotating shaft, but it goes without saying that the number of blades formed according to the present invention is not limited to a specific number, for example, eight. .

Although the above-mentioned sieve body is a flat one, for example, a conical surface may be used. In this case, the wing portion and the support plate are also shaped along the sieve body.
In the above embodiment, the support plate is formed of a perforated plate, but may be formed of a lattice-shaped frame plate.
Furthermore, the discharge unit is not limited to the cylindrical shape of the lower constriction as in the above embodiment, as long as it can guide the powder obtained by crushing and sieving, and may have other shapes and structures. .
Further, in the above embodiment, the case where the mass obtained by freeze-drying is crushed and sieved is described. However, in the present invention, the mass obtained by other methods such as dehydration and drying treatment is crushed and sieved. It can also be applied to cases where the

  Since the present invention can process crushing and sieving in a series in the apparatus, it can be suitably used particularly for obtaining microencapsulated powder for use in pharmaceuticals, but can also be used for other applications such as food and industrial products. Needless to say.

It is sectional drawing of the crushing sieving apparatus which shows embodiment of this invention. It is an expanded sectional view near a wing part.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Crushing sieve apparatus 4 ... Crushing chamber 5 ... Sieve body 6 ... Support plate
10 ... Lump
12 ... Rotation axis
14 ... Wings
15 ... lower surface of the wing (14)
16 ... Rear end of wing (14)
17 ... micro gap
18 ... Rough crushing part (first crushing bar)
19 ... Rough crushing part (second crushing bar)

Claims (5)

A crushing and sieving device for crushing and pulverizing the lump (10) into powder,
A crushing chamber (4) for accommodating the lump (10), a sieve (5) disposed at the bottom of the crushing chamber (4), and a vertical direction in the crushing chamber (4) The rotating shaft (12) that is disposed in the horizontal direction and that rotates in the horizontal direction, and the blade portion that is provided at the lower end of the rotating shaft (12) and swirls in the crushing chamber (4) integrally with the rotating shaft (12) (14)
A crushing and sieving device, wherein the lower surface (15) of the wing portion (14) is formed on an inclined surface that is rearwardly lowered with respect to the turning direction.   The crushing and sieving device according to claim 1, wherein a minute gap (17) is provided between the rear end (16) of the wing portion (14) and the upper surface of the sieve body (5).   The crushing sieving apparatus according to claim 1 or 2, wherein a support plate (6) for supporting the sieve body (5) is disposed below the sieve body (5).   The crushing and sieving device according to any one of claims 1 to 3, wherein the rotating shaft (12) is formed such that the lower part has a larger diameter than the upper part.   The coarse crushing part (18, 19) is projected from at least one of the outer peripheral surface of the rotating shaft (12) and the inner surface of the crushing chamber (4). The crushing sieving apparatus according to item.

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