JPH0353873A - Soft capsule - Google Patents

Abstract

PURPOSE:To obtain a soft capsule capable of packing a hydrophilic substance into a soft capsule film agent constituted of a natural product without using any synthetic article by blending a natural water soluble polymer and hydrophilic substance into a natural oil. CONSTITUTION:The aimed soft capsule obtained by blending a natural water soluble polymer (e.g. carrageenan, guar gum, pullulan or casein) and hydrophilic substance (preferably Glychyrrhizae Radix extract) into a natural oil.

Description

[Detailed Description of the Invention] [Industrial Application IF] The present invention is directed to pharmaceuticals and foods that are made of natural products without using any preservatives or emulsifiers, and which contain highly hydrophilic substances. Soft capsules useful in the field, etc., have a concentration of 1κ{J.

``Prior Art'' Conventionally, pharmaceuticals, cosmetics, foods, etc., have been produced by filling capsules with various substances in the form of liquids, pastes, suspensions, powders, etc., or by coating them with a capsule base. When filling soft capsules with substances that are highly wood-loving or hygroscopic, a Hei emulsifier is added.

[Problem to be Solved by the Invention 1] However, there are limitations to the capsule contents that can be filled into soft capsules. It is difficult to fill hydrophilic or hygroscopic plant extracts, drugs, etc. into soft capsules.

In other words, the capsule coating agent (base) of soft capsules is generally mainly made of water-soluble gelatin, so it is difficult to fill the capsule with contents that would dissolve or soften the capsule coating agent. Met.

That is, when a soft capsule is filled with a highly hydrophilic substance, the water content itself moves toward the capsule coating agent, dissolving or deforming the capsule coating agent. Even if the water content of the hydrophilic substance is removed, the capsule coating agent must be made thicker because the moisture that permeates through the soft capsule coating agent softens the capsule coating. When filling soft capsules with hydrophilic substances, the solid content of the capsule coating agent must be increased to prevent the contents from cooling, for example with wheat germ oil.

If the solid content of the contents is increased, the flow characteristics during filling will deteriorate, resulting in poor workability.

This increases the manufacturing cost of soft capsules, and also has the disadvantage that the capsule coating agent is made thicker, thereby reducing the disintegration properties of the capsule.

In addition, when filling a soft capsule coating agent with a hydrophilic substance, etc., it is necessary to use a combination of glycerin fatty acid ester, propylene glycol fatty acid ester, sorbitan fatty acid ester, etc. to emulsify or suspend the oil component in the hydrophilic substance, etc. Emulsifiers (surfactants) are used. Today's social situation is health-oriented and nature-oriented, and there are growing concerns and concerns about these emulsifiers, which do not fit with the current situation.

[A Thousand Steps to Solve the Problems] As a result of various studies on means for achieving the above object, the present invention proposes that a natural oil component is blended into a composition in which a natural water-soluble polymer is dispersed and dissolved in a hydrophilic substance. Therefore, they discovered a soft capsule that does not deform or dissolve, and brought the present invention to fruition.

By using licorice extract, which is a hydrophilic substance, as an essential ingredient and adding natural water-soluble polysaccharides, organic acids, and/or salts thereof, a gel composition with excellent fluidity and no moisture movement was obtained. . A certain amount of natural i+h was added to this gel composition, and the emulsified composition was filled into a soft capsule coating agent.

The natural water-soluble polymer of the present invention is not particularly limited as long as it retains properties such as gelling properties and thickening stability.

For example, seaweed substances such as carrageenan, facellulan, agar, and alginic acid are used, and plant water-soluble polymers include guar gum, tamarind, oral bean gum, gum arabic, pectin, starch, dextrin,
Examples of microorganism-produced sticky water-soluble polymers include pullulan and xanta gum.

Other water-soluble animal and vegetable proteins include casein, gelatin, soybean protein, and wheat gluten.

These natural ice-melting polysaccharides can be used alone or in combination of several types. Preferably, it is a combination of substances that have a surface tension adjusting effect. The amount of natural water-soluble polymer used is determined by the concentration and amount of the hydrophilic substance added and the fluidity of the contents.

It is preferable to add the natural water-soluble polymer so that the viscosity of the gel composite obtained from the hydrophilic substance and the natural water-soluble polymer becomes 1000 centipoise or more at 30°C.

If the amount of natural water-soluble polysaccharide added is such that the viscosity of the gel composite bottom is 1,000 centivoids or less, it is not preferable because moisture migration is likely to occur when it is filled into a soft capsule coating agent.

The hydrophilic substance of the present invention may include licorice extract as an essential component and other hydrophilic substances.

As for the essential component, a water-soluble extract containing triterpenes such as glycyrrhetinic acid and flaponoids is particularly preferable.

It may also be a product in which active ingredients such as glycyrrhetinic acid, which is a licorice ingredient, have been separated and purified.

The amount of licorice extract used varies depending on other ingredients and licorice extract components and is not particularly limited, but it is preferable that the glycyrrhetinic acid derivative is contained in an amount of 0.01% by weight or more.

Examples of the hydrophilic substance of the present invention include medicinal plants, fruit juices, extracts of seafood, etc. or their powders, drugs, raw royal jelly, and the like.

The organic acid or its salt is added to the natural water-soluble polymer for the purpose of stabilizing the contents, promoting gelation, and the like. Examples include citric acid, malic acid, tartaric acid,
Examples include fumaric acid, edible vinegar, citrus fruit juice, etc., or salts thereof. Inorganic acids or salts thereof (for example, phosphoric acid, sodium phosphoric acid, etc.) can also be used, but their addition is not preferred for the reasons described above.

The amount of the organic acid and/or its salt to be used is not particularly limited, as long as the content of the capsule is thoroughly contained.

Preferably, the amount is such that the pH of the capsule contents is 1.7 to 3.6.

The organic acid and/or its salt can be added simultaneously with the natural water-soluble polymer.

The natural oil of the present invention is added to form a ura phase so that water contained in or attached to a hydrophilic substance does not migrate to the surface of the capsule coating agent. In addition, the pharmacology of natural oils,
It is blended to have nutritional effects as well. As a natural oil,
Animal oil. Vegetable oil, flora and fauna from Yamaki no Ura. Extract i+b Doshihara Hanaura, Zanflower oil, Evening primrose oil, Coconut oil, Soybean oil. Olive oil, hohoha oil, avocado ura. Wheat germ oil, etc., and animal oils such as squalene. Examples of oils derived from animals and plants include linoleic acid, linoleic acid, eicopencitric acid, and docozahexaenoic acid.

Preferably, one or several types of natural oils that do not precipitate crystals at low temperatures may be used. The amount of natural oil used is
2% or more, preferably 3% based on the weight of the capsule contents
It is 0 to 60% by weight. If the amount added is less than 2% by weight, the stability of the product is poor and moisture migration is likely to occur, causing the capsule capsule to melt or deform, which is not preferable.

Furthermore, additives such as vitamins, coloring agents, antioxidants, etc. for nutritional enrichment may be optionally added to the contents as long as the purpose of the present invention is not impaired.

The soft capsule coating agent used in the present invention is not particularly limited, but gelatin is preferred. The amount of gelatin used is usually 50 to 80% by weight of the total weight of the capsule coating agent. The capsule coating agent can be produced by the usual cylindrical method.

The method of filling the capsule contents into the soft capsule coating agent is not particularly limited. It can be manufactured by conventional methods such as dipping, punching, and dropping methods.

[Example] The present invention will be explained in more detail with reference to Examples below. The present invention is not limited to these examples.

Example 1 7 parts of licorice extract, 15 parts of company extract, 5 parts of ginseng extract,
Mix 18 parts of purified water, add 2 parts of gum arahya to this solution,
Add 6 parts of pullulan, 12 parts of dextrin, and 2.5 parts of citric acid and disperse uniformly. This dispersion is heated to 65°C and melted. 45 parts of evening primrose oil heated to 65°C is added little by little to this solution and stirred until homogeneous to form the capsule contents.

Separately, 50 parts of purified gelatin, 15 parts of sorbitol, and 60 parts of purified water are added to the mixture to absorb water and swell, and the mixture is heated to 80° C. to uniformly melt to obtain a capsule coating agent.

The capsule coating agent was filled with the previously prepared capsule contents and molded using a rotary punching method to obtain soft capsules.

The content of soft capsules is 400mg and the coating agent is 110%.
It was mg.

Example 2 In Example 1, dextrin was replaced with microcrystalline cellulose 11
．． 5 parts, 0.5 parts of tamarind polymorph, 45 parts of evening primrose oil and natural vitamin EO. A soft capsule of the present invention was obtained in the same manner as in Example 1, except that 5 parts were used.

Example 3 In Example 1, evening primrose oil was mixed with 20 parts of wheat germ oil, 25 parts of eicosampene citric acid, and natural vitamin EO. A soft capsule of the present invention was obtained in the same manner as in Example 1 except that the amount was changed to 5 parts.

Example 4 7 parts of grass extract, 35 parts of fresh royal jelly, 13 parts of purified water
A soft capsule of the present invention was obtained in the same manner as in Example 1.

Comparative Example 1 A soft capsule of the present invention was obtained in the same manner as in Example 1, except that 7 parts of licorice extract used in Example 1 and 2.5 parts of citric acid were not blended.

Comparative Example 2 35 parts of raw royal jelly and 12 parts of purified water were dispersed, and 45 parts of evening primrose oil and 2.0 parts of sorbicun fatty acid ester were added to this solution.
Add the 5-part mixture little by little and stir until homogeneous to form the capsule contents. Thereafter, a soft capsule of the present invention was obtained in the same manner as in Example 1.

Regarding each of the soft capsules of Examples 1 to 4 and Comparative Examples 1 and 2, the active water content of the capsule contents, room temperature, and
0℃ (each relative humidity R H 5 0%, change over time 2
Table 1 shows the results of the investigation.

Attached Table 1 l) Canolefinscher method 1L [Effect of the invention 1 The soft capsule according to the present invention can be filled into a soft capsule film containing a hydrophilic substance, and can also be used for water-soluble substances that are unstable to heat. This has the effect of widening the range of applications. Furthermore, the present invention is a soft capsule that can satisfy market needs by using all natural products or naturally derived raw materials.

Claims (1)

[Scope of Claims] 1) A soft capsule comprising a natural water-soluble polymer and a hydrophilic substance mixed in natural oil. 2) The soft capsule according to claim 1, which contains licorice extract as an essential ingredient as the hydrophilic substance. 3) The soft capsule according to claim 1, wherein the natural oil is selected from animal oils, vegetable oils, and oils derived from animals and plants. 4) The soft capsule according to claim 1, wherein the natural water-soluble polymer is blended with an organic acid and/or a salt thereof.