JPS6055950A - Suppositry producing method and mold - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] [Technical Field of the Invention] The present invention relates to a method for manufacturing a full-throttle mold and a mold used in the method, and more particularly, to a method for manufacturing a full-throttle mold with a smooth bottom by a melting method and a mold used for the method. Regarding molds.

[Technical background of the invention and its problems]

Currently, full-scale manufacturing methods include manual methods, pressing methods, and melting methods. Among these, the melting method is frequently used as an industrially advantageous method.

However, in this method, the full-open composition is filled into the full-open mold in a heated molten state, so when it is cooled and solidified, the full-open volume decreases, and the side of the full-open composition injection port is depressed. was there.

[Purpose of the invention]

An object of the present invention is to provide a fully open manufacturing method in which the side of the fully open composition injection port does not cave in while employing an industrially advantageous melting method, and a mold for use in the method.

[Summary of the invention]

The inventor of the present invention has conducted various researches in order to manufacture a full-opening composition in which the inlet side of the full-opening composition does not cave in using the melting method, which is currently the most productive method. We have now completed the present invention, which allows the bottom to be fully opened with a smooth surface.

That is, one of the present inventions is to insert a nozzle having an outer diameter smaller than the inner diameter of the constricted part into a fully open mold having an injection port at the upper end consisting of a constricted part and an idle part continuing above the constricted part, Next, the full-open composition is injected through the nozzle up to the play area of the full-open mold, and the full-open composition is cooled and solidified.

The other type is a fully open mold with an injection port at the upper end consisting of a constricted part and a loose part continuing above the constricted part.

The present invention will be described in more detail below, but in order to facilitate understanding of the invention, the latter fully open mold will be described first.

An example of the fully open mold of the present invention is shown in FIG.

In the figure, 1 represents a fully open mold, 2 represents a constricted portion, and 3 represents a play portion. The internal shape of the fully open mold 1 is appropriately designed to match the desired shape of the stopper.

Generally, both ends of the mold 1 are rounded, but the bottom may not be rounded. Generally, the internal size of the mold is 20 to 50mm in length and 5 to 20mm in inner diameter for anal suppositories, and 20 to 60mm in length for vaginal suppositories.
If the inner diameter is 5-30 mm and the urethra is fully open, the length is 20-15 mm.
0, and the inner diameter is 2 to 8 mm. The mold 1 is provided at its upper end with an inlet for inserting a nozzle for injecting the fully open composition into the mold, which inlet consists of a constricted part 2 and an idle part 3 continuing above it. The constriction part 2 corresponds to the part where the inner diameter of the fin part 2 is the smallest when the inner diameter of the type 1 is gradually reduced toward the upper end. Preferably, the amount is 5.5
If it is less than nm, the surplus of the full-opening composition that is integrally bonded to the bottom of the stopper on the side of the full-opening composition injection port can be easily removed, making it easier to produce a smooth full-opening composition at the bottom. If the diameter is 2.5 mm or more, the diameter (outer diameter) of the nozzle for injecting the fully opened composition is usually 1.5 nm or more, so insert the nozzle deeper than the constriction 2 of the mold 1. This is convenient for the purpose of obtaining a full opening without air being trapped. It goes without saying that in the case of an extremely small diameter such as a urethral stopper, the inner diameters of the mold 1 and the constricted portion 2 should be made smaller accordingly. The play portion 3 has a shape such that its inner diameter increases upward from the constriction portion 2. However, the part 3 may have any shape as long as it has the same or larger inner diameter than the constricted part 2. The fully open mold is usually a mold or a puncture (packaging). For example, in the case of packaging packs, aluminum (molding molds made of this material are called aluminum containers) or plastics such as polyethylene or polyvinyl chloride (molding molds made of this material) are used. It is preferable to use a mold consisting of a plastic container (called a plastic container). When these materials are used, the waist portion 2 can be heat-sealed and the product can be offered to the market as is.

FIG. 2 shows a mold of the present invention for producing a fully open mold with rounded ends. In the figure, numeral 4 represents a protrusion protruding inside the mold IQ to provide a dividing line at full opening. The protrusion 4 is usually provided approximately at the center inside the mold, and when it is provided, it is preferable that the bottom of the mold 1 be rounded. When manufacturing a full opening using such a mold,
Since both ends of the resulting fully opened product are rounded, it can be smoothly inserted into the application site not only for normal administration but also for divided administration. Further, since the full opening can be accurately and easily divided along the score line, it is convenient for divided administration.

The mold of the present invention may each have several molding parts for the molding agent, as shown in FIG. In this case, if the above-mentioned packaging material is used as the material of the mold, a pack for direct molding can be obtained in which a large number of fully opened molds are packaged together.

Next, the full-throttle manufacturing method of the present invention using the above-mentioned mold will be explained based on FIG. 4. In the figure, 5 represents a nozzle for injecting the fully opened composition into the mold. First, the nozzle 5 is inserted into the mold 1, and the base composition is filled into the mold 1 through the nozzle 5.

At this time, it is preferable to insert the nozzle 5 deeper than the constricted portion 2 in order to obtain a good full opening without trapping air. In addition, at this time, it is necessary to fill the main ingredient composition into an appropriate part of the play area 3. This is because the base composition shrinks when it is cooled and solidified. The extent to which the base composition should be filled into the play area 3 can be adjusted by repeating the same method several times to find out in advance how much the volume will be reduced.

Incidentally, even if the filling amount is excessive, no inconvenience will occur because the excess amount can be easily and cleanly removed by manually folding the part corresponding to the constriction of the mold. When a metal mold is used as a mold, the solidified fully-opened product is taken out from the mold and then packaged. On the other hand, when a packaging pack is used as a mold, the constricted part 2 is directly heat-sealed and sold without taking out the solidified fully-opened product.

The method of the present invention can be applied to all kinds of full-scale production methods such as anal preparations, vaginal suppositories, urethral preparations, etc. obtained by conventional melting methods. Therefore, as the base composition used in the method of the present invention, an appropriate base material is selected from among oil-based bases, emulsion bases, water-soluble bases, etc., depending on the type of full-throttle to be manufactured. A mixture of the main drug and, if necessary, appropriate additives is used.

〔Effect of the invention〕

According to the present invention, when the base composition is cooled and solidified, it can be adjusted so that it is filled exactly to the constriction in the mold, so there is no depression on the injection port side and smooth full opening is produced. In addition, even if there is a surplus due to excess filling, this part can be easily removed from the part corresponding to the constriction of the mold.
The inlet side is smooth and a full opening can be manufactured with only the required amount. Furthermore, if a mold with a rounded bottom and a protrusion inside is used, the resulting full opening can be accurately and easily divided along the dividing line, and each divided full opening can be divided into two sections. [Embodiments of the invention] Example 1 Indomethacin anal base agent prescription Indomethacin 50m9 Uitepzol H-12195 (Lip2000■
(1 inhibitor) Leitepsol H-12 (saturated fatty acid glycerin ester; manufactured by Dynamit Nobel, West Germany) 487.5
1 was heated and melted at about 45℃, and indomethacin 12 was added to this.
．． 5 # was added to produce a molten mixture. Pre-formed aluminum molded pack 1 for the stopper 211 shown in FIG.
was filled with the molten mixture. The aluminum molded/f-tsuku 1 has a constricted part 2, a loose part 3, and a protruding part 4 at the upper end of the main body, and the diameter of the obtained one stopper is 9 mm.The length of the suppository book when fully opened is 40 mm. It is designed so that the width of the section is 4 mm and the height is 1.5 mm. Pour the molten mixture into this 74 piece 1, and put the molten mixture into the play part 3 above the constriction part 2.
It was filled until it reached . Next, after cooling this, the injection port (neck portion 2) was heat-sealed. 200 samples were arbitrarily taken from the completed aluminum stopper pack, and the weight of each stopper and the two divided pieces was measured as shown in Table 1, and the uniformity of the two divided main ingredients was measured.

Furthermore, the indomethacin content was measured as shown in Table 2 for one antidepressant and two divided antidepressants.

Table 1 Fully loaded weight Table 2 Determination of main drug (indomethacin): Average weight or average content R: Weight range or content range σ: Standard deviation Cν: Coefficient of variation Based on the results shown in Tables 1 and 2 above , weight (content)
It can be seen that the range, standard deviation, and coefficient of variation are fairly small, indicating that the partial full openings are approximately equally distributed.

Example 2 Aspirin anal base formulation Aspirin 500■ Polyethylene cream: ]-ru 4000 1350 m9
Glycerin 150m9 20001n9 (1 fully opened) Polyethylene glycol/l/4000, 337.5
37.5 g of glycerin were heated and dissolved at about 65°C, and aspirin 125# was added thereto to produce a molten mixture. 2 g of each was placed in a fully open mold 200 as shown in Fig. 2.
The container was filled up to the play area and cooled. When the fully opened mold was removed from the mold, a fully opened mold with a shape corresponding to the internal shape of the mold and a smooth tip on the injection port side was obtained. The weights of the 100 fully opened pieces taken out in this manner and the 100 pieces cut in half were measured. Furthermore, the aspirin content contained in one fully opened sample and one divided into two pieces was also measured. The results are shown in Tables 3 and 4.

Further, TRI σ and Cν have the same meanings as in Example 1.

Example 3 Lytepsol H-12 (saturated fatty acid glycerin ester; manufactured by Dynamit Nopel) 487.5/about 4
Melt it by heating to 5℃, add 12.5 ml of nochlorofenac sodium,! i' was added to produce a molten mixture.

This molten mixture was filled into an aluminum pack for base material 29 in the same manner as in Example 1, cooled, and heat-sealed. When the solidified fully opened tube was removed from the aluminum pack and examined for appearance, it was found that both tips had smooth surfaces.

Example 4 Prescription Gelatin 600 Tn9 Glycerin 20001 ng Purified water 300 ■ Nitric acid 0 Miconazole A/IQQm2 3000 m9 (per full opening) Gelatin 120 I swollen in purified water 60.9 1 Glycerin 400 g and Miconazole nitrate 20 Y The pre-dissolved material was added and heated to about 35°C to produce a molten mixture.
Each sample was filled into a pre-formed aluminum pack. The shape of the aluminum pack is similar to that shown in Figure 3, but the inner diameter of the mold is 12 mm, the length is 40 mm, the width of the protrusion is 4 mm, and the height is 1.5 mm. The same procedure as in Example 1 was carried out to obtain 3 g of miconazole nitrate vaginal suppositories. When the solidified fully opened tube was removed from the aluminum pack and examined for appearance, it was found that both tips had smooth surfaces.

[Brief explanation of drawings]

Fig. 1 is a cross-sectional view of the main ingredient mold of the present invention provided with a fin portion and a loose portion, and Fig. 2 is a cross-sectional view of the main ingredient mold of the present invention provided with a protrusion inside the mold shown in Fig. 1. FIG. 3 is a cross-sectional view of the main ingredient mold of the present invention having a plurality of confinement molding parts,
FIG. 4 is a schematic diagram showing the full-scale manufacturing method of the present invention. DESCRIPTION OF SYMBOLS 1...Main ingredient mold, 2...Neck part, 3...Play part, 4...Protrusion part, 5...Nozzle. 1st day 2nd plate 3rd sea A 401

Claims (3)

[Claims] (1) A nozzle having an outer diameter smaller than the inner diameter of the neck is inserted into a fully open mold with an injection port at the upper end, which consists of a neck and a play area continuing above the neck, and then the injection molding is carried out through the nozzle. A method for producing a full-open mold, characterized by injecting a full-open composition up to the play area of the full-open mold, and cooling and solidifying the full-open composition. (2) A fully open mold with an injection port at the upper end consisting of a constricted part and a loose part continuing above the constricted part. (3) The fully open mold according to claim 2, wherein the fully open mold is a metal mold, an aluminum container, or a plastic container.