JPH055808B2 - - Google Patents

Description

[Detailed description of the invention]

[Industrial Field of Application] The present invention relates to a band sealing liquid for hard gelatin capsules. More particularly, the present invention relates to a band sealing fluid used to more completely bond the normally mechanically locked hard gelatin capsule body and cap. [Prior Art] To completely bond the body and cap of, for example, a hard gelatin capsule filled with a liquid or slurry-like substance, it has heretofore been possible to band seal the seam using an aqueous solution of gelatin of the same composition. It was considered the most desirable and common thing. [Problems to be Solved by the Invention] However, during band sealing, the sealing liquid will adhere to the surface of the formed and sufficiently dried gelatin capsule. At this time, a large amount of water contained in the sealing liquid transfers to the dry capsule and softens it. On the band sticker,
Since a subsequent drying step is essential, the softened capsules are dried in a distorted state, resulting in a brittle structure and a tendency for cracks to occur in the seal area. Further, when mechanical processing is performed at high speed, it is desirable that the seal film be dried as quickly as possible in the drying process. Here, apparent drying (removal of mutual adhesion) is more important than true drying. [Means for Solving the Problems] The present invention attempts to solve the above problems by adding an edible surfactant to the sealing liquid. That is, according to the present invention, gelatin is 15 to 30% and edible surfactant is 0.1 to 30% by weight.
There is provided a band sealing liquid for hard gelatin capsules, characterized in that the liquid contains 10% and the balance is water (preferably purified water). The term "edible surfactant" as used herein refers to a surfactant that can be taken orally and is approved for use in pharmaceuticals or foods. The concentration of gelatin may be within the above range, but it is usually somewhat lower than that of jelly for capsule production, and is most preferably about 22% by weight.
As the edible surfactant, polyoxyethylene sorbitan aliphatic ester (polysorbate
80), glycerin aliphatic ester, sucrose aliphatic ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, saponin, and soybean phospholipid. Among these, polyoxyethylene sorbitan aliphatic ester (polysorbate 80) is one of the most suitable. The edible surfactant starts to be effective when added in an amount of 0.1% by weight or more, and the effect increases as the amount added increases. Although it depends on the type of surfactant, if the amount added is 3% by weight or more, the film after drying becomes translucent and milky white, which limits its uses. However, if the film does not need to be colorless and transparent, 10% by weight
It can be added to a certain degree, and the corresponding effect can be expected. On the other hand, if you need a colorless and transparent film
The effect becomes noticeable when adding 0.5 to 1.5% by weight, but 1
It is appropriate to add about % by weight. [Effect] By adding the edible surfactant, the migration of water in the sealing liquid to the capsule portion was significantly reduced, and the occurrence of distortion, embrittlement, and cracking of the capsule was reduced. Additionally, the drying properties of the sealing liquid have been greatly improved.
Particularly in the case of mechanical processing, the ability to follow high machine speeds has been improved to an extent that could not be obtained by other means. This is supported by the following description of examples, including control examples. [Example] A sealing liquid (temperature: 50℃, viscosity: 340cps.) according to the formulation shown in the table below was prepared by a conventional method, and a sealing experiment was conducted using a high-speed band sealing machine manufactured by Nippon Elanco (drying at 25℃,
Forced drying at 50% RH) was performed to obtain the test results (dry product, cracking incidence) shown in the same table.

[Table] In the above table, % means % by weight, water means purified water and P bolysorbate 80, and each sample commonly contains gelatin 22. Evaluation method and other conditions (1) Drying performance: After the sealed capsules are air-dried as described above, they are taken out into a stainless steel vat, and when the vat is tilted, the sealed portion does not stick and all the capsules slide off. time required to dry. (2) Occurrence of cracking: After sealing, the dried capsule was placed horizontally and a static pressure load of 8 kg was gradually applied to the entire capsule using a pressure testing machine manufactured by Tester Sangyo to confirm the occurrence of cracks in the sealed portion. (3) Filling content: Fallen raw oil, 80, beeswax, 5, and polyoxyl stearate 40, 15% by weight each
Composition of. (4) Disintegratability: Sealable hard gelatin capsules (100 capsules each) made using Sample C in Table 1 and Sample ) was subjected to a disintegration test using Liquid 1 of the Japanese Pharmacopoeia under specified conditions, and the following results were obtained.

[Table] (5) As another measure of apparent dryness, follow-up machine speed was taken, and using a high-speed band sealing machine manufactured by Nippon Elanco Co., Ltd., the polysorbate in the above samples C and 80 or a sealing liquid (sample Y) containing 10% by weight of liquid paraffin instead of glycerin.
As a result, the maximum tracking speed for sample C was 7
10,000 capsules/hour, whereas sample X had 50,000 capsules/hour and sample Y had 65,000 capsules/hour. [Effects] As described above, according to the present invention, a simple operation of adding an edible surfactant to the band sealing liquid makes it possible to completely adhere the capsule seams using the sealing liquid. In addition, it has good drying properties after sealing, enables high-speed mechanical processing, and has fewer cracks in the capsule. Furthermore, it has a wide variety of industrial effects, such as superior disintegration properties of sealed capsules.

Claims (1)

[Scope of Claims] 1. A band sealing liquid for hard gelatin capsules, which contains 15 to 30% gelatin, 0.1 to 10% edible surfactant, and the balance is water, by weight. 2. The band sealing liquid for hard gelatin capsules according to claim 1, which contains 20 to 25% gelatin, 0.5 to 1.5% edible surfactant, and the remainder is water in weight ratio. 3. The band sealing liquid for hard gelatin capsules according to claim 2, which contains about 22% by weight of gelatin, 1% by weight of an edible surfactant, and about 77% of purified water. 4 The edible surfactant is polyoxyethylene sorbitan fatty acid ester (polysorbate 80),
The hard gelatin capsule according to claim 1, which is selected from the group consisting of glycerin fatty acid ester, sucrose fatty acid ester, sorbitan fatty acid ester, propylene glycol fatty acid ester, saponin, and soybean phospholipid. band sealing liquid. 5. The band sealing liquid for hard gelatin capsules according to claim 1, wherein the edible surfactant is polyoxyethylene sorbitan aliphatic ester.