JP2748563B2 - Tablet manufacturing method - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention relates to pharmaceuticals, quasi-drugs, cosmetics, pesticides, feeds,
The present invention relates to a method for producing tablets in the food, powder metallurgy, and the like. More specifically, the present invention relates to a tablet manufacturing method that can significantly reduce friction between a lower punch and a die during tableting.

[Prior Art] Using a tableting machine having a die having a penetrating inner hole, and an upper punch and a lower punch fitted into the die, the raw material is placed between the upper punch and the lower punch inside the inner hole. A tablet manufacturing method in which a tablet is formed by compression is widely used (for example, Japanese Patent Publication No.
No. 11273, No. 47-31827, No. 48-20103).

By the way, when producing tablets using a tableting machine, the raw material powder is generally a fine powder, its surface activity is high,
Obstacles such as sticking binding easily occur. In particular, the fine powder enters between the lower punch and the mortar, and the friction increases, so that the lower punch moves poorly (kisimi). As a result, the lower punch is damaged, and stable continuous tableting becomes impossible.

Therefore, lubricants (talc, stearic acid, magnesium stearate, hydrogenated vegetable oil, sucrose fatty acid, etc.) have been used for the purpose of reducing friction between the inner wall surface of the mortar or the upper and lower punch surfaces and removing obstacles such as sticking binding. Ester and the like are mixed in advance in powder and then compression molded.

In addition, Japanese Patent Publication No. 41-11273 discloses that after the lower punch is located at the lowermost part of the die, the lubricant is sprayed onto the powder contact surface of the upper punch, the lower punch and the inner surface of the die, and then the powder is injected into the die. And compression molding.

In Japanese Patent Publication No. 47-31827, solid lubricant particles are introduced into a pressing die of a compression molding machine, and the lubricant is compressed in the pressing die.
A method is described in which the lubricant is removed from the stamp except for the lubricant film remaining on the wall of the stamp, a processing substance is introduced into the stamp, and the processing substance is molded.

In Japanese Patent Publication No. 48-20103, after the fine powder of the lubricant is sprayed as powder on the powder contact part of the upper punch and the lower punch and the inner surface of the die, the powder to be compression-molded into the die is filled continuously. A compression molding method is described.

[Problems to be Solved by the Invention] In the method of mixing a lubricant into the raw material powder, in order to sufficiently reduce the friction between the punch and the die, a considerably large amount of lubricant is generally used. Need an agent. Further, it is necessary to adjust the amount of the lubricant depending on the particle size distribution of the powder to be compressed and the moisture contained in the powder. However, in this case, if the amount of the lubricant is excessive, the strength of the compression-molded product is often reduced, and the disintegration of the tablet is often significantly deteriorated.

JP-B-41-11273, JP-B-47-31827 and JP-B-48-20103
In the method described in the above item, the amount of the lubricant adhering to the sliding surface with the lower punch and the side peripheral surface of the lower punch among the inner hole surfaces of the mill is not constant, and the physical properties of the obtained tablet (for example, disintegration) However, there was a drawback that the properties differed from one another. Particularly in the case of pharmaceutical tablets, the fact that their disintegration properties differ from one another means that the expected efficacy and effects cannot be sufficiently exhibited, which is not preferable in terms of therapeutic effects.

An object of the present invention is to solve the above-mentioned conventional problems and to provide a method that does not cause damage to a lower punch and enables stable tablet production using an existing tableting machine as it is. is there.

[Means and Actions for Solving the Problems] The present invention uses a tableting machine having a die having an inner hole penetrating therethrough and an upper punch and a lower punch fitted into the die, and having In the tablet manufacturing method in which the raw material is compressed between a punch and a lower punch to form a tablet, a gap is formed between the lower punch and the inner peripheral surface of the die at a portion other than the tip of the lower punch, and the powder is formed. The friction between the lower punch and the die is reduced by supplying the lubricant as a powder between the lower punch and the inner peripheral surface of the die by an injection method using an inert gas such as air or nitrogen. It is a feature.

According to the method of the present invention, a required amount of the lubricant is uniformly supplied between the inner peripheral surface of the die and the outer peripheral surface of the lower punch,
The lower punch can move up and down very smoothly.

In the present invention, various lubricants such as talc, stearic acid, magnesium stearate, hydrogenated vegetable oil, and sucrose fatty acid ester can be used.

Hereinafter, the present invention will be described in detail with reference to the drawings, which limits the types of components constituting the tablet, the shape of the tablet, the type of the lubricant, the supply amount, the supply method, the tableting machine, and the like. Not necessarily.

FIG. 1 is a schematic longitudinal sectional view showing a state where the present invention is carried out using a rotary tableting machine.

In FIG. 1, a mortar 2 is attached to a rotary plate 1 of a rotary tableting machine.
Is installed. A lower punch 4 is fitted into the inner hole 2a of the mill 2 so as to be vertically movable. Reference numeral 3 denotes a guide device for the lower punch 4.

The part of the lower punch 4 that is inserted into the die inner hole 2a has a required diameter smaller than that of the die inner hole 2a except for the tip 4a, and is located between the die inner peripheral surface and the lower punch outer peripheral surface. A gap A is formed. The tip 4a is slightly smaller (for example, about 10 to 20 μm) than the inner diameter of the die inner hole 2a.
Is smoothly slid with the die inner hole 2a, and is structured such that the lubricant supplied to the gap A is not mixed into the product tablet.

A pipe 5 is provided to supply the lubricant to the gap A in a spray form. In addition, the lower punch passage hole of the rotary plate 1
Reference numeral 1a denotes a tapered hole whose diameter gradually increases downward, so that the lubricant ejected from the pipe 5 is easily supplied into the gap A.

The rear end of the pipe 5 is connected to the upper part of the lubricant S container 6. An air supply pipe 7 is inserted into the container 6, and compressed air can be introduced into the lower part of the container 6 via a valve 8 and a flow meter 9. Container 6 is a valve generator
It is installed so that it can be excited by 10.

The rotary tableting machine has a cover case to which a suction duct 11 is connected to suck and discharge excess lubricant.
There are twelve.

A method of manufacturing a tablet using the apparatus shown in FIG. 1 will be described below.

The turntable 1 on which the mortar 2 is mounted is rotated about a vertical axis by a driving device (not shown) together with the upper punch (not shown) and the punch 4.

The lubricant is continuously ejected from the pipe 5 toward the gap A, and the lubricant is uniformly attached to the inner peripheral surface of the inner hole 2 a of the die 2 and the outer peripheral surface of the lower punch 4. As the lower punch 4 descends, the excess lubricant is scraped off by the tip 4a of the lower punch 4, and the lubricant is evenly distributed on the inner peripheral surface of the mill 2 and the outer peripheral surface of the lower punch 4 in a small amount. And remains. The lubricant remaining adhered is interposed between the outer peripheral surface of the lower punch tip portion 4a and the inner peripheral surface of the die inner hole 2a.
It moves up and down inside.

After the lower punch 4 is lowered to the lower limit, the raw material powder P to be tabletted is supplied into the inner hole 2a of the die 2. Then, the inner hole 2a
An upper punch (not shown) is inserted from above into the upper punch, and an upper punch and a lower punch 4 are inserted therein.
The raw material powder is strongly compressed to form a tablet.

Thereafter, the upper punch is pulled out of the die, and the lower punch 4 is lifted to push up the tablet so as to protrude from the upper surface of the turntable 1. Then, the tablets are transferred from the lower punch 4 onto the turntable 1 and dropped into a chute (not shown) on the side of the turntable 1 to be collected.

By repeating the above steps, tablets are manufactured continuously.

In the above step, the valve 8 is opened to eject the lubricant, and compressed air is introduced into the container 6. This air rises in the container 6 and flows out of the pipe 5 with the powder of the lubricant S, whereby the lubricant is ejected from the pipe 5. This ejection amount can be controlled by adjusting the opening of the valve 8.

The lubricant scattered below the turntable 1 at the time of the ejection and the lubricant scraped off when the lower punch 4 is moved down are discharged through the duct 11, collected and reused as necessary. .

In the present invention, the lubricant may be ejected intermittently from the pipe 5.

Although only one pipe 5 is shown in FIG. 1, a plurality of pipes 5 may be provided, and the lubricant may be supplied from two or more pipes toward the same inner hole. Note that the pipe 5 may be branched into a plurality of pipes.

The valve generator 10 is operated constantly or intermittently (either periodically or irregularly), and the tip of the air supply pipe 7 in the container 6 is always buried sufficiently deep in the lubricant. State.

The above description is based on a rotary tablet press,
It goes without saying that the present invention can be carried out in the same manner for an eccentric tableting machine.

 Hereinafter, specific examples and comparative examples will be described.

Example 1 Powders having the mixing ratios shown in Table 1 were mixed well, and 8 mmφ lens tablets were produced at a rate of 720 tablets per minute using the rotary tableting machine shown in FIG.

Lubricant (talc in this example) from pipe 5 per minute
It was ejected continuously at a rate of 10 mg.

As a result, even in the case of Formulation 2 in which the amount of the lubricant was small, the lower punch 4 always moved up and down very smoothly, and the hardness of the manufactured tablet was sufficiently high.

Comparative Example 1 In Example 1, when the lubricant was not ejected from the pipe 5, in the case of Formulation 2 in which the amount of the lubricant was small, the lower punch 4 was stained and continuous tableting could not be performed. Was. In Formulation 1 in which the amount of the lubricant was large, the hardness of the obtained tablet was low, and there was a problem in practical use.

Example 2 Powders having the mixing ratios shown in Table 2 were mixed well, and flat tablets of 10 mmφ were crushed with an eccentric tableting machine for 24 minutes per minute.
It was made in tablet proportions.

A lubricant (magnesium stearate in this example) was continuously ejected from the pipe 5 at a rate of 2 mg per minute.

As a result, in the case of Formulation 4 containing a small amount of lubricant, the lower punch 4 always moved up and down very smoothly.

Comparative Example 2 In Example 2, when the lubricant was not ejected from the pipe 5, not only the case of the formulation 4 with a small amount of the lubricant but also the case of the formulation 3 with a large amount of the lubricant Even though sticking and binding occurred, normal tableting was not possible.

[Effects of the Invention] As is clear from the above Examples and Comparative Examples, according to the present invention, the following excellent effects can be obtained.

There is no occurrence of blemishes and the like on the lower punch, and extremely stable tableting becomes possible.

It is possible to reduce the amount of the lubricant to be mixed in advance with the raw material powder to be made into tablets, and it is possible to prevent deterioration of disintegration and decrease in tablet hardness due to the lubricant.

The lubricant adheres evenly in a small amount between the die and the lower punch, and does not enter the powder layer to be compression molded. For this reason, the compression molded product always has uniform and stable properties.

[Brief description of the drawings]

FIG. 1 is an explanatory diagram of the method of the embodiment. 2 ... mortar, 2a ... inner hole of mortar, 4 ... lower punch, 5 ... pipe, 6 ... container, 9 ... flow meter.

Claims (1)

(57) [Claims] 1. A tablet machine having a die having an inner hole penetrating therethrough and an upper punch and a lower punch fitted into the die, and the raw material is transferred between the upper punch and the lower punch inside the inner hole. In the tablet manufacturing method of forming a tablet by compressing, a gap is formed between the lower punch and the inner peripheral surface of the die at a portion other than the tip of the lower punch, and the powder lubricant is kept in powder form with the lower punch. A tablet manufacturing method characterized in that friction between a lower punch and a die is reduced by supplying the powder between the lower punch and the die.