JPH07550B2 - Essential oil containing soft capsule - Google Patents

Description

TECHNICAL FIELD The present invention relates to a gelatin soft capsule. More specifically, it relates to a gelatin soft capsule which prevents insolubilization of a gelatin film and exhibits stable solubility.

[Prior Art] Conventionally, as a technology for preventing insolubilization of a gelatin film, a method of blending various additives with gelatin (Japanese Patent Publication No. 60-9011).
Japanese Patent Publication No. 57-30008 and Japanese Patent Publication No. 59-39834) and a method using so-called modified gelatin in which the amino group in the gelatin molecule is blocked with an organic acid (Japanese Patent Publication No. 50-106).
No. 876) is known.

[Problems to be Solved by the Invention] However, the type of contents, for example, cinnamon oil, fennel oil, clove oil, peppermint oil, ginger oil, ginger oil, lemon oil, spruce oil, gelatin such as l-menthol When a compound that easily reacts with the amino group of 1) is contained, the solubility of the gelatin film may deteriorate with time or the gelatin film may be discolored.

[Means for Solving the Problems] In order to prevent deterioration of the solubility and discoloration of the gelatin film, the present inventors blended various additives such as surfactants and plasticizers with gelatin to make it insoluble. As a result of examining the state of discoloration (shown in Test Example 2 described later), it was found that a gelatin soft capsule prepared by powdering a polypeptide and blending it with gelatin fulfills the object, and based on this finding, completed the present invention. Came to do.

The present invention contains one or two or more of the group consisting of cinnamon oil, fennel oil, clove oil, peppermint oil, ginger oil, oleander oil, lemon oil, spruce oil, and l-menthol as contents, and a polypeptide. Is a gelatin soft capsule comprising a film containing 15 to 70% by weight of the total amount of polypeptide and gelatin.

The polypeptide of the present invention is preferably used by powdering a polypeptide having a molecular weight of 5,000 to 10,000 in order to prevent deterioration of solubility and discoloration with time. The amount of the polypeptide mixed with gelatin is 15 to 70% by weight.
It is preferably 20 to 50% by weight.

The production method of the present invention may be a usual method for producing soft capsules, such as a punching method, a dropping method or a dipping method, but a rotary punching method is preferred. Further, depending on the contents, a method of producing seamless so-called seamless capsules by a dropping method is preferable. The following is an example of one of the production methods of the present invention.

Gelatin and polypeptide are mixed, purified water is added in an appropriate amount and the mixture is stirred, and then allowed to stand for 10 to 20 minutes to swell. 60 this
It is heated to a temperature of ℃ and dissolved to obtain a uniform gelatin aqueous solution. The aqueous gelatin solution was defoamed to obtain a film composition,
An aldehyde-containing natural vegetable oil such as cinnamon oil and an essential oil extract which easily reacts with gelatin amino groups are encapsulated in the capsule-making machine. The capsules thus obtained are placed in a manufacturing room where the temperature is controlled to 23 ° C and the humidity is controlled to 40%.
Dry for 16 to 60 hours to obtain a molded product.

Further, the soft capsule of the present invention has gelatin as a main base, and to it, glycerin, D-sorbitol, a preservative and the like are appropriately added as a plasticizer to prepare a gelatin solution to form a film composition. You can also do it.

[Effects of the Invention] The gelatin capsule of the present invention does not insolubilize aldehyde-containing natural vegetable oils such as cinnamon oil and essential oil extracts that easily react with amino groups of gelatin.
In addition, the gelatin capsule has neither deterioration of solubility nor discoloration over time.

[Examples] The present invention will be specifically described with reference to Examples, Reference Examples and Test Examples.

Examples 1-7 Gelatin (molecular weight: about 100,000) and polypeptide powder [trade name; water-soluble gelatin U (Nitta Gelatin Co., Ltd.)] were mixed in the proportions shown in Table 1 and shaken in a polyethylene bag of volume 2 for a total of 1 kg. After mixing, put it in a dissolution tank with a defoaming device with a capacity of 10 and add 2500 g of purified water (25 ° C) and stir it. Then, leave it at 60 ° C for 10 minutes to dissolve it and stir it while depressurizing the tank. To give a uniform aqueous solution. A coating composition was prepared using this aqueous solution as a coating base.

A capsule manufacturing machine (Japanese Patent Application Laid-Open No. Sho 61-61) was prepared by using a preliminarily prepared content liquid of the formulation shown in Table 2 (prepared by adding an essential oil component as a main ingredient to the mixture and stirring the mixture uniformly). -1
4915-14954) to produce capsules.

The capsules thus obtained are dried for about 6 hours in a manufacturing room controlled at a temperature of 23 ° C and a humidity of 40%, and then dried for 48 hours in a shelf type dehumidifying dryer (temperature 23 ° C, humidity 40% or less) to obtain molded articles. did.

Reference Examples 1 to 3 Produced in the same manner as in Example except that gelatin (molecular weight: about 100,000) and polypeptide powder [trade name; water-soluble gelatin U (Nitta Gelatin Co., Ltd.)] were mixed in the proportions shown in Table 3, Molded.

Test Example 1 (disintegration test, discoloration state, film strength) (Sample) Samples 1 to 7; 20 capsules each of Examples 1 to 7.

Control samples 1 to 3; 20 capsules each of Reference Examples 1 to 3.

Control sample 4: 20 capsules having the same contents as in the example, the same capsule making machine and the same drying conditions as the composition of 1 kg of gelatin and 2.5 kg of purified water.

(Test method) The disintegration test immediately after production was measured according to the operation method of the capsule preparation of (4) Disintegration test method of 11th revised Japanese Pharmacopoeia, General test method 38, Disintegration test method.

The degree of disintegration after 1 month is as follows: Put the sample in a glass bottle (with a cap) and let it stand for 1 month at a temperature of 40 ° C and a humidity of 75%.
The sample was taken out and measured in the same manner as the disintegration degree immediately after production.

As the film strength, a rheometer (NMR-2030D / D type, manufactured by Fudo Kogyo Co., Ltd.) is used, and the breaking strength when crushed at a speed of 6 cm for 1 minute is shown as an average value. The 20 capsules used for this measurement had an inner diameter of 5.0 mm and a thickness of the film immediately after production.
A 0.2 mm one was used.

(Results) Shown in Table 4.

Control sample 4 has a degree of disintegration (immediately) within 3 minutes, (after 1 month) 20
The color was discolored (immediately after), yellow (after one month), brown, and film strength was over 10 kg.

Test Example 2 (Disintegration test and discoloration test) (Sample) 20 capsules each having the same contents as in the example and the film composition of Table 5
Individual.

(Test method) The same as in Test Example 1.

(Results) Shown in Table 6.

In order to prevent deterioration of the solubility and discoloration of the gelatin film,
Although a modified gelatin, an antioxidant, a surfactant, and a plasticizer were added, a sufficiently satisfactory capsule could not be obtained.

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Masato Takahashi, 3-24-1 Takada, Toshima-ku, Tokyo Within Taisho Pharmaceutical Co., Ltd. (72) Inventor Noriichi Ito 2-33 Mamitakita, Koryo-cho, Kitakatsuragi-gun, Nara (56) Reference JP-A-58-62120 (JP, A)

Claims (1)

[Claims] 1. A content of one or more selected from the group consisting of cinnamon oil, fennel oil, clove oil, peppermint oil, oleander oil, oleander oil, lemon oil, spruce oil, and l-menthol as contents. A gelatin soft capsule comprising a film containing a peptide in an amount of 15 to 70% by weight based on the total weight of the polypeptide and gelatin.