JPS6043046B2 - gelatin capsules - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to gelatin capsules that have no safety problems, have good coloring stability, and can be produced commercially.

Conventionally, capsules have been made using synthetic chemicals listed in the Japanese Food Additives Official Standards, with the main purpose of preventing misuse through product identification and convenience during drug manufacturing, and with the secondary purpose of improving product value through distinctive color tones. Tar pigments alone or in combination with titanium dioxide in accordance with the standards of the Japanese Pharmacopoeia have been commonly used for coloring.

Recently, as a result of advances in science, a number of synthetic tar pigments that exhibit undesirable chemical toxicity have been discovered one after another, and there is growing concern in society regarding their safety to the human body.

Recently, attention has been paid to natural coloring agents commonly used in foods as substitutes for synthetic tar colorants. For example, caramel is used alone or mixed with titanium dioxide to a certain extent; in this case, The caramel had blackish brown minute spots that were clearly visible to the naked eye.

Particularly when the product is used for medical purposes, such spots are considered to be foreign substances, and there is a big problem in that they generally significantly impair commercial value. In order to improve this point, as a result of intensive research, we succeeded in preventing spots by adding condensed phosphate, and it has a beautiful color tone and gloss, and is stable against heat and light.
It has been found that good gelatin capsules can be obtained under actual production conditions. That is, the present invention relates to gelatin capsules colored by uniformly dispersing caramel and condensed phosphate, and gelatin capsules further containing titanium dioxide, preferably in an amount of caramel of 0.05 to 5.0.
% by weight, the amount of condensed phosphate is 0.01-0.1% by weight,
The present invention relates to gelatin capsules in which the amount of titanium dioxide is 0.1 to 3.0% by weight.

The above caramels are made by heat treating food carbohydrates such as glucose, sucrose, invert sugar, starch syrup, starch hydrolysates, molasses and other types, or by adding small amounts of acids, alkalis or other food carbohydrates. In addition, it is obtained by heat treatment, and is approved by FAO/WHO) America and EC.
It is permitted as a food coloring agent in some countries.

In Japan, it is widely used in medicines, soft drinks, confectionery, soy sauce, etc. Condensed phosphates are used in the food industry for purposes such as metal ion sequestering agents and acidic components of synthetic swelling agents, and are listed in the Third Edition of the Official Standards of Food Additives.

The general chemical formula of condensed phosphate is Mn+2pn03n+1
or (MOP3) n, where M is an alkali metal such as sodium or potassium, and n indicates the degree of condensation, and there are sodium pyrophosphate, sodium polyphosphate, potassium polyphosphate, sodium metaphosphate, etc. Various other condensed phosphates can be used without limitation. If titanium dioxide is used in the form of a fine powder that complies with the Japanese Pharmacopoeia, the purpose can be fully achieved. Condensed phosphates are added alone or in combination to prevent spots from forming when coloring with caramel, but an aqueous solution of condensed phosphates and caramel is created and this is poured into gelatin capsules. The order of addition is particularly important, such as adding condensed phosphate to gelatin stock solution for manufacturing, adding condensed phosphate to gelatin solution pre-colored with caramel, or adding caramel to gelatin solution to which condensed phosphate has been added in advance. Not limited.

Titanium dioxide is also not limited to the order of addition, and can be added so as to be uniformly dispersed in the gelatin stock solution. Therefore, there is a method of adding caramel and condensed phosphate to a gelatin solution in which titanium dioxide is uniformly dispersed, or Any method may be used, such as a method in which titanium dioxide is dispersed in a gelatin solution that has been colored in advance with caramel and condensed phosphate.

The gelatin solution used here is prepared by dissolving gelatin in hot water and adding a preservative if necessary.

The concentration of this gelatin solution is about 35% by weight, and the viscosity is 800 to 100 PS (45°C). For uniform dispersion, no special machine is required; dispersion using known devices and methods is sufficient and beautiful capsules can be obtained. Furthermore, caramel can sufficiently achieve the purpose of coloring even in the presence of plasticizers, preservatives, dispersants, and other additives necessary for producing gelatin capsules on a processing machine. Furthermore, the molded capsules exhibit a brownish color, which is stable to temperature and light.

Moreover, the color tone of the capsules can be continuously varied by the amounts of caramel and titanium dioxide used.

The gelatin capsules referred to in the present invention are capsules defined in the Ninth Edition Japanese Pharmacopoeia.
It has the same meaning as ``latae''.

In other words, the capsules colored with caramel mixed with condensed phosphate have no safety problems, meet the capsule quality, appearance, and purity tests stipulated by the Japanese Pharmacopoeia, and also pass the general test method. Even when the degree of disintegration was tested by the No. 33 disintegration test method, it showed exactly the same degree of disintegration as conventional capsules, and can be used for pharmaceuticals or foods.

EXAMPLES Hereinafter, the present invention will be explained in more detail based on Examples and Comparative Examples, but these are not intended to limit the present invention. Example 1 Gelatin was dissolved in boiling water to give a concentration of about 35% by weight and a viscosity of 90%.
A gelatin solution of 0:) PS (45, C) was prepared.

``To this gelatin solution, an aqueous solution of caramel and an aqueous solution of condensed phosphate were added and mixed uniformly.The amounts of caramel and condensed phosphate added to gelatin are shown in Table 1. Hard capsules were molded.The resulting capsules exhibit various transparent and spotless brownish tones depending on the amount of caramel added.As is clear from Table 1, caramel and condensed phosphorus Capsules colored with acid salts have extremely good stability over time and against light, etc. Example 2 Titanium dioxide was mixed uniformly with water and colored with caramel and condensed phosphates in the same manner as in Example 1. A capsule was molded.

The amounts of caramel, condensed phosphate and titanium dioxide added are as shown in Table 2. The resulting caramel exhibits a good brownish color with varying opacity and no spots. As is clear from Table 2, capsules colored with caramel, condensed phosphate and titanium dioxide are
It has extremely good stability over time and against light.

Comparative Example 1 Capsules colored only with caramel without adding condensed phosphate were molded.

The amount of caramel added to the gelatin is as shown in Table 3. The obtained capsules exhibited various transparent and brownish tones and had spots, which significantly impaired their commercial value. As is clear from Table 3, when 3.0% by weight of caramel was added without the addition of condensed phosphate, spots were produced.

Comparative Example 2 Titanium dioxide was mixed uniformly and capsules colored with caramel were molded in the same manner as in Comparative Example 1.

Claims (1)

[Claims] 1. A gelatin capsule colored by uniformly dispersing caramel and condensed phosphate. 2. The gelatin capsule according to claim 1, wherein the amount of caramel is 0.05 to 5.0% by weight, and the amount of condensed phosphate is 0.01 to 0.1% by weight. 3 Gelatin capsules made by adding titanium dioxide to caramel and condensed phosphate, uniformly dispersing it, and coloring it. 4 The amounts of caramel, condensed phosphate and titanium dioxide are
0.05-5.0% by weight, 0.01-0.1, respectively.
% by weight and from 0.1 to 3.0% by weight.