KR20100007668A - Chewing soft capsule containing red ginseng - Google Patents

Abstract

PURPOSE: A soft capsule for mastication containing ginseng or red ginseng is provided to reduce uncomfortable texture and improve color reference. CONSTITUTION: A soft capsule for mastication contains: a drug liquid of ginseng or red ginseng, concentration or solid; and a composition for coating soft capsule containing 35-55 weight% of gelatin, 20-30 weight% of glycerin, and 25-35 weight% of sorbitol. The soft capsule additionally contains perfume to remove specific smell of ginseng or red ginseng. The composition for coating soft capsule further contains cochineal extract dye and sugar syrup. The thickness of coating film is 0.3-0.5 mm.

Description

Chewing Soft Capsule Containing Red Ginseng

The present invention (a) a drug containing a liquid, concentrate or solid of ginseng or red ginseng; And (b) relates to a low-action soft capsule containing ginseng or red ginseng comprising a composition for soft capsule coating comprising gelatin, glycerin and sorbitol.

Recently, as interest in health has increased, the use of various health functional foods, such as ginseng and red ginseng products, which have efficacy such as boosting immunity and restoring energy, has increased. However, ginseng and red ginseng products, especially red ginseng concentrates tend to be less palatable to consumers due to their delicacies. Various formulations for these ginseng and red ginseng products are being developed.

Capsules include hard capsules filled with medicines in gelatin capsules and soft capsules formed by foreskin formation with an elastic gelatin membrane. Capsules are encapsulated in gelatin, which makes it impossible to detect unpleasant tastes or odors, and can be easily swallowed when soaked in water. This has the advantage of being possible, and is widely used as the mainstream of solidifying agents with tablets.

In the absence of water, it is easy to take and easy to carry, and research is being conducted to improve the chewability and doseability that can be dissolved or chewed in the mouth as it is, and Japanese Patent Laid-Open Nos. 10-273436 and WO 87/01034 In order to soften the soft capsule film, a method of increasing a plasticizer compounding ratio is disclosed, and Korean Laid-Open Patent Publication No. 1999-31274 discloses a content of improving starch by mixing starch into a soft capsule film composition. Korean Patent Laid-Open Publication No. 2002-000544 discloses soft capsules, such as cocoa powder, bitter chocolate and cacao oil, which are suitably blended with soft capsule contents to improve dosage. 2005-0081892 discloses the use of succinate gelatin to improve chewability.

In addition, in the case of conventional soft capsules, the soft capsules generally prepared using the gelatin content of about 65-70% have to be swallowed or chewed with a thick film as it is, so the foreign body of the relatively tough film Children and the elderly are very uncomfortable to take.

On the other hand, conventional soft capsules express the reddish brown color of the capsule film by using a caramel pigment derived from corn together with cochinyl pigments, and there is a concern about genetic recombination.

 Therefore, the present inventors improve the taste, safety and convenience of taking ginseng or red ginseng by preparing a thin capsule of thin ginseng containing syrup, which has no concern for genetic recombination while improving the smell and taste of ginseng and red ginseng. do.

Throughout this specification many patent documents are referenced and their citations are indicated. The disclosures of the cited patent documents are incorporated by reference herein in their entirety, and the level of the technical field to which the present invention belongs and the contents of the present invention are more clearly described.

The present inventors have tried to develop a low-performance soft capsule containing ginseng or red ginseng with improved taste and ease of taking chew to improve the smell and taste of ginseng or red ginseng. As a result, when a soft capsule is prepared by additionally containing ginseng or red ginseng, an additive or a fragrance for removing flavors, and a syrup that is free of genetic recombination (GMO) in the soft capsule coating composition, The present invention has been completed by confirming that ginseng or red ginseng has improved functionalities such as taste and odor, and has a more improved thin film of soft capsule coating, reduced film weight, and color symbolism better than conventional caramel pigments.

Accordingly, an object of the present invention is to provide a low-action soft capsule containing ginseng or red ginseng.

Other objects and advantages of the present invention will become apparent from the following detailed description, claims and drawings.

According to one aspect of the invention, the present invention (a) a drug containing a liquid, concentrate or solid of ginseng or red ginseng; And (b) provides a low-action soft capsule containing ginseng or red ginseng comprising a composition for a soft capsule coating comprising gelatin, glycerin and sorbitol.

The present inventors have tried to develop a low-performance soft capsule containing ginseng or red ginseng with improved taste and ease of taking chew to improve the smell and taste of ginseng or red ginseng. As a result, when a soft capsule is prepared by additionally containing ginseng or red ginseng, an additive or a fragrance for removing flavors, and a syrup that is free of genetic recombination (GMO) in the soft capsule coating composition, It was confirmed that the functional properties such as taste or odor of ginseng or red ginseng were improved, and the thin film of the soft capsule film had improved color, reduced film weight, and better color symbolism than the conventional caramel pigment.

As used herein, the term “ginseng” refers to Korean ginseng ( Panax ginseng), three sessions (P. quiquefolius), jeonchilsam (P. notoginseng), jukjeol three (P. japonicus), three yeopsam (P. trifolium), Himalayan cedar (P. pseudoginseng), Vietnam, three (P. vietnamensis) and American hemp ( Panax quinquefolium ), but is not limited thereto. Preferably, the ginseng used in the present invention is Korean ginseng ( Panax ginseng ).

As used herein, the term “red ginseng” means prepared by heating ginseng through steam or sun-drying, preferably steam.

The term "liquid, concentrate or solid of ginseng or red ginseng" means any type of liquid, concentrate or solid product (powder) derived from ginseng or red ginseng.

In addition, ginseng or red ginseng extract may be included in the drug substance of the soft capsule of the present invention, and the ginseng or red ginseng extract includes an extract that can be obtained by a conventional extraction process known in the art. For example, (a) water, (b) anhydrous or hydrous lower alcohol having 1 to 4 carbon atoms (methanol, ethanol, propanol, butanol, etc.), (c) a mixed solvent of the lower alcohol with water, (d) acetone The extract obtained by using (e) ethyl acetate, (f) chloroform, (g) butyl acetate or (h) 1,3-butylene glycol as an extraction solvent is included in ginseng or red ginseng extract. Preferably, the ginseng or red ginseng extract is obtained by using water, ethanol or a mixed solvent of ethanol and water as an extraction solvent, and most preferably, water is used as an extraction solvent.

On the other hand, it will be apparent to those skilled in the art that the extract of the present invention can be obtained ginseng or red ginseng extract having substantially the same effect using not only the aforementioned extraction solvent but also other extraction solvents. In addition, the extract of the present invention includes not only the extract by the above-described extraction solvent, but also the extract that has undergone a conventional purification process. Obtained by various additional purification methods, such as, for example, separation using ultrafiltration membranes having a constant molecular weight cut-off value, separation by various chromatography (manufactured for separation according to size, charge, hydrophobicity or affinity). The fraction is also included in the ginseng or red ginseng extract of the present invention.

The ginseng or red ginseng extract of the present invention may be prepared in a powder state by an additional process such as distillation under reduced pressure and freeze drying or spray drying.

According to a preferred embodiment of the present invention, the solution, concentrate or solid of ginseng or red ginseng used in the present invention comprises 0.1-35% by weight based on the total weight of the drug substance, more preferably 1-25% by weight. %, Most preferably 5-20% by weight. If the content of liquid, concentrate or solids of ginseng or red ginseng exceeds 35% by weight, the content of other additives or fragrances is relatively low, which reduces the effect of improving the preference of red ginseng. Ginseng or red ginseng has a weak efficacy.

The soft capsule coating composition used in the present invention includes gelatin, glycerin and sorbitol. As used herein, the term “gelatin” includes gelatin, acid gelatin, alkaline gelatin, peptide gelatin, low molecular weight gelatin, gelatin derivatives, and the like, but the most preferred gelatin for achieving the effect of the present invention is donpi or whoopee gelatin, Succinate gelatin, which has been used in functional soft capsules, is excluded from the gelatin of the present invention.

The plasticizer included in the soft capsule coating composition of the present invention is glycerin or glycerin, crystalline or amorphous sorbitol, sorbitan or carbide-based, sucrose, D-mannitol, xylitol, erythritol, maltose, reduction Maltose syrup or maltitol, more preferably glycerin or glycerin, or crystalline or amorphous sorbitol, most preferably glycerin and sorbitol.

The soft capsule coating composition of the present invention includes various color expression agents known in the art. More preferably, it is cochinyl extract pigment and syrup, and most preferably it is cochinyl extract pigment and sugar derived syrup. One of the characteristics of the present invention is to express the color including the caramel pigment derived from corn which may be genetically recombined in the conventional coating composition, while the composition for soft capsule coating of the present invention is a color at the time there is no concern of genetic recombination. Expression to improve safety and color acceptability.

      The syrup as a color expression agent used in the present invention is characterized by browning sugars, etc., which are free of genetic recombination, by physical methods such as heating.

According to another preferred embodiment of the present invention, the soft capsule coating composition used in the present invention is based on the total weight of the coating composition of the gelatin 35-55% by weight, glycerin 20-30% by weight and sorbitol 10-35 weight %, Gelatin 37-50 wt%, glycerin 23-29 wt% and sorbitol 20-34 wt%, most preferably gelatin 40-45 wt%, glycerin 25-28 wt% and sorbitol 30-32% by weight.

According to another preferred embodiment of the present invention, the soft capsule coating composition used in the present invention is based on the total weight of the coating composition of the gelatin 35-55% by weight, glycerin 20-30% by weight, sorbitol 10-35 Wt%, 0.1-2 wt% cochinyl extract pigment and 0.1-5 wt% sucrose, more preferably 37-50 wt% gelatin, 23-29 wt% glycerin, 20-34 wt% sorbitol, coach 0.5-1.5% by weight of the Neil extract pigment and 0.5-3% by weight of the syrup, most preferably 39-44% by weight gelatin, 24-25.8% by weight glycerin, 30.4-32% by weight sorbitol, 0.8-1.2 % By weight and 0.8-2% by weight at that time.

Another feature of the present invention is that the gelatin content is contained 65-70% by weight, while the gel content is reduced to 55% by weight or less to produce a soft capsule of the thin film to feel the foreign body due to the film of the soft capsule It is an improvement.

      According to another preferred embodiment of the present invention, the thickness of the film formed by the composition for soft capsule film used in the present invention is 0.3-0.5 mm. If the thickness of the film is less than 0.3 mm, the soft capsule film is too thin, so that the drug substance flows out of the joint of the capsule, and the formulation is unstable. If the film thickness exceeds 0.5 mm, the soft capsule film is thick and chewed. There is a problem of increasing foreign body feeling.

Another one of the features of the present invention significantly improved the functionality of ginseng or red ginseng by additionally including an additive or flavor to be described later in the drug substance.

Soft capsules containing red ginseng are difficult to be swallowed by children, and are additionally included in the drug substance of the soft capsules of the present invention as suspending agents and thickeners for oils and fats selected from vegetable oils, animal oils, refined covalent and mineral oils. , Solubilizers, dispersants, emulsifiers, sweeteners and surfactants may be selected by adding one or more of the components, more preferably with such additives, refined covalent, apple flavor powder, vitamin E, glycerin Fatty acid esters, citric acid, apple flavor oil, sucralose or lecithin, most preferably refined covalent, apple flavor powder, vitamin E, glycerin fatty acid esters, citric acid, apple flavor oil, sucralose and lecithin.

According to a preferred embodiment of the present invention, the content drug included in the soft capsule of the present invention is 0.1-35% by weight of the ginseng or red ginseng, concentrate or solid, 40-80% by weight of the tablet, 5-15 wt% apple flavor powder, 2-10 wt% vitamin E, 2-10 wt% glycerin fatty acid ester, 0.5-2 wt% citric acid, 0.5-2 wt% apple flavor oil, 0.05-0.2 wt% sucralose and 0.05 lecithin -0.2% by weight, more preferably 1-25% by weight of ginseng or red ginseng, concentrate or solid, 55-70% by weight of refined milk, 7-13% by weight of apple flavor powder, 3-8% by weight of vitamin E , Glycerin fatty acid ester 3-8% by weight, citric acid 0.7-1.5% by weight, apple flavor oil 0.7-1.5% by weight, sucralose 0.07-0.15% by weight and lecithin 0.07-0.15% by weight, most preferably liquid of ginseng or red ginseng, 5-18.77% by weight of concentrate or solids, 55.57-65% by weight of refined milk, apple flavor 8-11 wt%, Vitamin E 3-6 wt%, Glycerin fatty acid ester 3-6 wt%, Citric acid 0.8-1.2 wt%, Apple flavor oil 0.8-1.2 wt%, Sucralose 0.1-0.14 wt% and Lecithin 0.08-0.12 wt% %to be.

According to another preferred embodiment of the present invention, the ginseng or red ginseng by removing the flavor of ginseng or red ginseng additionally included in the drug substance used in the present invention. As used herein, the term “gummy” corresponds to the English “bittering taste”, and is a kind of low palatability caused by a combination of bitterness, astringent taste, sour taste, and spicy taste. The flavor used in the present invention is Ginseng or red ginseng effectively masks the bitter, astringent, sour and spicy tastes of the ginseng, while the taste and sweet taste of good taste are effectively raised to remove gummy and excellent sensory taste Or red ginseng.

The pharmaceuticals used in the soft capsule of the present invention are mainly composed of aldehyde allyl phenol, aliphatic ketone, vanillin, maltol or a combination thereof. The term “main ingredient” means the main ingredient that causes the generation of flavor in a pharmaceutical composition.

According to the present invention, flavors based on aldehyde allyl phenol, aliphatic ketone, vanillin, maltol, or a combination thereof are added to the ginseng or red ginseng solution, concentrate or solid to obtain ginseng or red ginseng.

Preferably, the fragrance used in the present invention further comprises proline, propylene glycol, glycerin, acetaldehyde, ethanol or combinations thereof. The term "auxiliary component" means components other than the main component in the pharmaceutical composition, such as excipients and solubilizers and the like.

To remove bitumen from ginseng or red ginseng, flavors developed by the present inventors can be broadly divided into two types: (i) flavors mainly comprising aldehyde allyl phenol and aliphatic ketone; And (ii) fragrances based on vanillin and maltol.

Flavors based on aldehyde allyl phenol and aliphatic ketones preferably include aldehyde allyl phenol, aliphatic ketone, vanillin, proline, propylene glycol and glycerin. More preferably, the flavoring agent is 0.2-1.0% by weight of aldehyde allyl phenol, 0.2-1.0% by weight of aliphatic ketone, 0.2-1.0% by weight of vanillin, 0.2-1.0% by weight of proline, and propylene glycol based on the total weight of the perfume. 36.2-56 weight percent and glycerin 40-63 weight percent. Most preferably, the fragrance is 0.5 wt% aldehyde allyl phenol, 0.5 wt% aliphatic ketone, 0.5 wt% vanillin, 0.5 wt% proline, 48 wt% propylene glycol and 50 wt% glycerin, based on the total weight of the fragrance. It includes.

Flavors based on vanillin and maltol preferably include vanillin, maltol, acetaldehyde, ethanol, propylene glycol, and glycerin. More preferably, the medicament further comprises ethyl vanillin and ethyl maltol. Even more preferably, the flavoring agent is 0.7-2.0% by weight of vanillin, 0.05-0.5% by weight, 0.05-0.5% by weight of acetaldehyde, 0.7-2.0% by weight of ethanol, propylene glycol 35.5- based on the total weight of the perfume. 57 weight percent and 38-63 weight percent glycerin. Even more preferably, the flavoring agent is 0.7-2.0 wt% vanillin, 0.05-0.5 wt% ethyl vanillin, malol 0.05-0.5 wt%, ethyl maltol 0.05-0.5 wt%, acetaldehyde, based on the total weight of the fragrance. 0.05-0.5 weight percent, 0.7-2.0 weight percent ethanol, 35.4-57 weight percent propylene glycol and 37-63 weight percent glycerin.

According to a preferred embodiment of the present invention, the above-mentioned medicine is added to the solution, concentrate or solid of ginseng or red ginseng at a ratio of 0.001-5.0 wt%, more preferably 0.02-5.0 wt%, even more preferably 0.1- 3.0% by weight, most preferably 0.3-2.0% by weight.

The fragrance used in the present invention can be used in addition to various products, such as foods, but in particular, it can be added to ginseng or red ginseng to remove gourd, thereby greatly improving the functionality such as taste and flavor.

The features and advantages of the present invention are summarized as follows:

(Iii) In addition to the ginseng or red ginseng, which is the main ingredient contained in the soft capsule of the present invention, additives or flavors are added, and the functional properties such as taste and flavor are greatly improved.

(Ii) The soft capsule coating composition of the present invention, including a certain amount of pork skin or cowhide gelatin, has a thin film thickness of the soft calf and reduces the weight of the film, so as to chew the soft capsule containing ginseng or red ginseng. Reduced.

(Iii) The soft capsule coating composition of the present invention eliminates the concern about genetic recombination by using a certain amount of syrup, that is, improves safety and improves color acceptability.

(Iii) Soft capsules containing ginseng or red ginseng of the present invention are not burdened by children or elderly people who do not like bitter taste of ginseng or red ginseng or have weak teeth.

As described in detail above, the present invention is (a) a liquid, concentrated liquid or solid of ginseng or red ginseng; And (b) provides a low-action soft capsule containing ginseng or red ginseng comprising a composition for a soft capsule coating comprising gelatin, glycerin and sorbitol. In addition to the ginseng or red ginseng which is the main ingredient contained in the soft capsule of the present invention, additives or flavors are added, and the functionalities such as taste and flavor are greatly improved. The soft capsule coating composition of the present invention, including a certain amount of pig skin or woo gelatin, the thickness of the thin film of the soft calf and reduced the weight of the film, reducing the foreign body in chewing soft capsule containing ginseng or red ginseng . The soft capsule coating composition of the present invention eliminates the concern about genetic recombination by using a certain amount of syrup, that is, improves safety and improves color acceptability. Soft capsules containing ginseng or red ginseng of the present invention is not burdened by ingestion of the ginseng or red ginseng, such as bitter taste or weak children or the elderly.

Hereinafter, the present invention will be described in more detail with reference to Examples. These examples are only for illustrating the present invention in more detail, it will be apparent to those skilled in the art that the scope of the present invention is not limited by these examples in accordance with the gist of the present invention. .

Example

Preparation Example 1 Preparation of Thin Film Soft Capsule Using Red Ginseng

Composition ratio of the soft capsule containing red ginseng (KGC provided) without removing the goji are as shown in Table 1 below:

Configuration Ingredient Soft capsule 1 (for red ginseng) Soft capsule 2 (red ginseng extract) Soft capsule 3 (for red ginseng extract) Soft capsule 4 (red ginseng extract) Drug substance Refinery 62.78 62.78 62.78 62.78 Apple Flavored Powder 10 10 10 10 Vitamin E 5 5 5 5 Glycerin Fatty Acid Ester 5 5 5 5 Red ginseng 15 15 15 15 Citric acid One One One One Apple flavor oil One One One One Sucralose 0.12 0.12 0.12 0.12 lecithin 0.1 0.1 0.1 0.1 Sum 100 wt% 100 wt% 100 wt% 100 wt% Coating composition Pork Gelatin 41.79 41.79 60.29 60.29 glycerin 24.37 24.37 37.91 12.91 D-sorbitol 31.34 31.34 - 25.00 Cochineal Extract Pigment One One One One Caramel Pigment - - 0.8 0.8 Back then 1.5 1.5 - - Sum 100 wt% 100 wt% 100 wt% 100 wt%

Soft capsule 3 and 4 is less than the content of the donpi gelatin contained in the general soft capsule coating composition, but increases its content than the soft capsules 1 and 2 of the present invention, it is used as a comparative group of the soft capsules 1 and 2 of the present invention. It was.

Production Example  1-1: Drug substance  pharmacy

Formulation of the drug substance of the soft capsules 1 to 4 of the present invention in the composition of Table 1, first, 2,260.08 g tablets, 360 g of apple flavor powder, 36 g of apple flavored oil, 4.32 g of sucralose, vitamin E 180.00 g, glycerin fatty acid ester 180.00 g, red ginseng extract or red ginseng extract 540.00 g, citric acid 36.00 g and lecithin 3.60 g were added from a small amount, and homogenized at room temperature with a TK stirrer (TK Homo Mixer2M-2 / Tokushu Kika) at about 2000-2500 rpm.

The mixture was treated with a colloid mill (MKPB 6-2 / Masuko Sangyo), filtered through 100 mesh, bubbles were removed using a vacuum pump, and then 12,000 capsules of soft capsule contents were prepared.

Production Example  1-2: Preparation of Soft Capsule Film

Preparation of the soft capsule film constituting the soft capsules 1 and 2 of the present invention is prepared by gelatin-plasticizer film solution in a generally known method, 62.685 mg of donpi gelatin (Geltec), glycerin 36.555 mg, sorbitol (D-sorbitol) per capsule ) 47.01 mg, cochineal extract pigment 1.5 mg, then syrup 2.25 mg and a suitable amount of purified water. In addition, the comparative capsule soft capsule 3 is 90.435 mg of pork skin gelatin, 56.865 mg glycerin, 1.5 mg of carcinyl extract pigment, 1.2 mg of caramel pigment and a suitable amount of purified water, and the comparative capsule soft capsule 4 is 90.435 mg per capsule. , 19.365 mg of glycerin, 37.5 mg of sorbitol (D-sorbitol), 1.5 mg of cochineal extract, 1.2 mg of caramel pigment, and an appropriate amount of purified water.

Production Example  1-3: Molding and drying of soft capsule

Production of soft capsules 1 to 4 is carried out by a conventional filling method using a rotary type automatic charger, which is generally used, and the thickness of the film is 0.30 mm-0.50 mm with a dry content of 300.0 mg. After the screening process was produced as a prototype.

Production Example  2: Gummy  Preparation of Thin Film Soft Capsule Using Removed Red Ginseng

Flavors that can remove the red ginseng are as described in Tables 2 and 3 below:

Ingredient Name Compounding ratio (% by weight) Aldehyde allyl phenol 0.5% Alphatic keton 0.5% Vanilla extract 0.5% Amino acid-proline 0.5% Propylene glycol 48% glycerin 50% Sum 100.0%

Ingredient Name Compounding ratio (% by weight) Vanilla 2-Fold Blend 1.1% Ethyl maltol 0.2% Ethyl vanillin 0.1% Maltol 0.1% Acetaldehyde 0.1% Fermentation alcohol (ethanol) 1.2% glycerin 49.6% Propylene glycol 47.6% Sum 100.0%

In Table 3, the vanilla 2-fold blend is an extract obtained from Bourbon Vanilla beans [Vanilla planifolia] and contains vanillin (4-hydroxy-3-methoxybenzaldehyde).

Production Example  2-1: with spices Drug substance  pharmacy

Add the fragrances of Tables 2 and 3 to the red ginseng liquid product (red ginseng beverage products marketed by Korea Ginseng Corporation) or red ginseng concentrate product (commercial product of 36% water content manufactured by Korea Ginseng Co., Ltd.) It was homogenized and dried at room temperature with a TK stirrer (TK Homo Mixer2M-2 / Tokushu Kika) at about 2000-2500 rpm.

The mixture was treated with a colloid mill (MKPB 6-2 / Masuko Sangyo), filtered through 100 mesh, bubbles were removed using a vacuum pump, and then 12,000 capsules of soft capsule contents were prepared.

The drug substance prepared by adding the perfume of Tables 2 and 3 to the red ginseng liquid was used as the soft capsule drug substance of soft capsules 5 and 7, respectively. The drug substance prepared by adding the perfume of Tables 2 and 3 to the red ginseng concentrate. Was used as the soft capsule internal drug of the soft capsules 6 and 8.

Production Example  2-2: Preparation of Soft Capsule Film

Preparation of the soft capsule coating comprising the soft capsules 5 (dehydrated red ginseng liquid) and 6 (degreased red ginseng concentrate) of the present invention is a known method to prepare a gelatine-plasticizer coating solution to prepare donpi gelatin 20.9 per capsule. mg, glycerin 13.45 mg, sorbitol (D-sorbitol) 15.65 mg and an appropriate amount of purified water were included. In addition, the comparative group soft capsule 7 (depleted red ginseng liquid) is 30.15 mg of pork skin gelatin, glycerin 19.85 mg and an appropriate amount of purified water per capsule, and the comparative group soft capsule 8 (red ginseng concentrate without delicacy) is pork skin gelatin per capsule 30.15 mg, glycerin 7.35 mg, 12.5 mg D-sorbitol and an appropriate amount of purified water were included.

Production Example  2-3: Forming and Drying Soft Capsules

Production of soft capsules 5 to 8 is carried out by a conventional filling method using a rotary type automatic charger, which is generally used, and the thickness of the film is 0.30 mm-0.50 mm with a content filling amount of 300.0 mg. After the screening process was produced as a prototype.

Production Example  3: Preparation of General Soft Capsule

Production Example  3-1: soft capsule Drug substance  Creation costs and Drug substance  pharmacy

In the same manner as in Table 1, the contents were prepared in the same manner as in Preparation Example 1-2.

Production Example  3-2: Preparation of Soft Capsule Film

The preparation of the soft capsule coating is generally made by preparing a gelatine-plasticizer coating solution using a known method.The gel capsule (donpi) 91.0 mg (70% by weight), glycerin 12.66 mg (9.74% by weight), sorbitol (24.0) per capsule mg (18.46 wt.%), cochineal extract pigment 1.3 mg (1 wt%), caramel pigment 1.04 mg (0.8 wt%) and an appropriate amount of purified water were included.

Production Example  3-3: Forming and Drying Soft Capsules

The soft capsule manufacturing process proceeds with the normal filling method using the rotary type automatic charger which is generally used, and after forming and drying the thickness of the film to 0.60 mm-0.70 mm with the content filling amount of 300.0 mg, Prototypes were produced. And this was used as a control.

Test Example  1: Film thickness and weight comparison of general manufactured soft capsule and low-acting soft capsule

The film thickness and weight of the low-action soft capsules prepared according to Preparation Examples 1-3 and 2-3 and the general manufactured soft capsules prepared according to Preparation Examples 3-3 are shown in Tables 5 and 6 below.

General manufacturing soft capsule TYPE Average film thickness Average film weight 3 ROUND 0.5-0.7 mm 65 mg

Low-action soft capsule film prepared according to Production Examples 1-3 and 2-3 TYPE Average film thickness Average film weight 3 ROUND 0.3-0.5 mm 32 mg

Test Example  2: soft capsules 1 and 2 of the present invention and soft capsules 3, 4 and Production Example  Comparison with 3 soft capsules

Chewable soft capsules 1 and 2 of the present invention containing chewable red ginseng prepared in the preparation example, soft capsules 3 and 4 of the comparative group and chewability, taste, color preference for the general soft capsule obtained in Preparation Example 3 as a control group, Sensory tests such as overall acceptability were performed by the 5-point scale method, and the results are shown in Table 7 below.

The sensory test was conducted in a way that 20 people (10 men and women each) who had 3 to 5 years of experience in the food field were given a maximum score of 5 points and a minimum of 1 point.

Item Mastication flavor Color symbol Overall preference Soft capsule 1 4.4 4.3 4.1 4.5 Soft capsule 2 4.5 4.5 4.3 4.5 Soft capsule 3 (comparative group) 2.2 3.2 3.5 1.8 Soft capsule 4 (comparative group) 2.1 3.4 3.6 1.9 Preparation Example 3 (Control Group) 1.3 2.1 3.5 1.5

In Table 7, the numerical values for chewing degree, taste, color acceptability and overall acceptability are shown by rounding off the sum of the scores of the sensory test agents by the number of sensory test agents and then rounding to the second decimal place.

As can be seen in Table 7, it can be seen that the numerical value of the sensory test results of the soft capsules 1 and 2 prepared from the coating composition adopted in the present invention is high. This is because the soft capsule of the present invention is superior in chewing degree, taste, color acceptability and overall acceptability than the comparative group and the control group, and the thickness of the soft capsule film produced by the adoption of the components included in the coating composition and the composition ratio thereof is thin. It is judged that the film weight is small.

Specifically, as confirmed in Test Example 2, the soft capsules 1 and 2 of the present invention and the comparative group (soft capsules 3 and 4) form a thin film, but the difference in chewing degree, taste, and overall preference is for the film. Due to the difference in the physical properties (light level) due to the difference in the content of the donpi gelatin contained in the composition and the difference in the color preference is due to the difference in the chromaticity of the syrup and caramel color. In addition, the difference between the chewability, taste and overall preference of the soft capsules 1 and 2 of the present invention and the control group is due to the difference in the thickness of the film and the content of the donpi gelatin, and the difference in the color preference is due to the difference in the chromaticity of the syrup and the caramel color ( The same is true between the comparison group and the control group).

Test Example  3: soft capsule 5-8 Drug substance  Sensory test

Of the contents of the soft capsules 5 and 6 of the present invention prepared in Preparation Example 2-1 (red ginseng liquid and red ginseng concentrate) and red ginseng concentrate products (commercially available product of 36% water content prepared by Korea Ginseng Co., Ltd.) Sensory changes with the flavor-free product were investigated. Odors were examined for odors, sweet, bitter, sour and burnt, and tastes for delicious, sweet, bitter, sour and spicy.

In order to determine the effect of the addition of fragrance on the sensory properties of the red ginseng liquid and red ginseng concentrate, the temperature of all the samples used in the sensory evaluation was prepared to be at room temperature, each sample (red ginseng liquid or red ginseng concentrate in Table 2 or Table 3 15 ml of the sample added 0.5% by weight of fragrance) into the mouth, evenly stimulate the oral epidermis for 20 seconds, spit out, and after each evaluation of one sample, wash the mouth with water, and after 10 minutes, evaluate the next sample. The sensory elements were expressed on a 9-point box scale. Sensory evaluation personnel consisted of 10 panelists trained on basic taste and flavor assessments, and the 9-point scale used both ends as “none” (left) and “very strong” (right).

As can be seen in Figures 2 and 3, in the group of adding the fragrance of Table 2 (Fragrance 1) and 3 (Fragrance 2), sweet smell, sweet taste, sweet smell and sweet taste were improved, bitter smell, bitter taste, astringent taste, Astringent smell, sour smell, sour taste, pungent smell and pungent taste were suppressed.

Therefore, the red ginseng containing the fragrances of Table 2 (Fragrance 1) and 3 (Fragrance 2) may be improved in smell and taste, and thus, a low-acting soft capsule containing the same may be improved in dosage and chewability. Judging.

Having described the specific part of the present invention in detail, it is apparent to those skilled in the art that the specific technology is merely a preferred embodiment, and the scope of the present invention is not limited thereto. Thus, the substantial scope of the present invention will be defined by the appended claims and equivalents thereof.

1 is a cross-sectional view of a chewable soft capsule containing red ginseng prepared in an embodiment of the present invention.

Figure 2 is a sensory analysis result of the smell of the group without the flavor added to the red ginseng liquid product, group added with flavor 1 (see Table 2) and group added with flavor 2 (see Table 3) in the present invention It is also.

Figure 3 is a sensory test analysis results for the taste of the group without the flavor added to the red ginseng liquid product, the group added with flavor 1 (see Table 2) and the group added with flavor 2 (see Table 3) in the present invention It is also.

Claims (9)

(a) a parent drug comprising liquid, concentrate or solid of ginseng or red ginseng; And (b) ginseng or red ginseng comprising a composition for soft capsule coating comprising gelatin, glycerin and sorbitol. According to claim 1, wherein the soft capsule further comprises a flavoring agent of ginseng or red ginseng by adding a fragrance to the drug substance. The soft capsule according to claim 1, further comprising a cochinyl extract pigment and a syrup in the soft capsule coating composition. The soft capsule of claim 1, wherein the ginseng or red ginseng liquid, concentrate or solid comprises 0.1-35% by weight based on the total weight of the drug substance. According to claim 1, wherein the soft capsule coating composition comprises 35-55% by weight of gelatin, 20-30% by weight of glycerin and 25-35% by weight of sorbitol based on the total weight of the coating composition. Soft capsules. According to claim 3, wherein the soft capsule coating composition is based on the total weight of the coating composition of the gelatin 35-55% by weight, glycerin 20-30% by weight and sorbitol 10-35% by weight, cochinyl extract pigment 0.1- A soft capsule comprising 2% by weight and 0.1-5% by weight of syrup. The soft capsule according to claim 5 or 6, wherein the thickness of the film formed by the soft capsule film composition is 0.3-0.5 mm. 3. The soft capsule of claim 2, wherein the fragrance includes aldehyde allyl phenol, aliphatic ketone, and vanillin as main components, and proline, propylene glycol, and glycerin as auxiliary components. The soft capsule of claim 2, wherein the fragrance includes vanillin and maltol as main components, and acetaldehyde, ethanol, propylene glycol, and glycerin as auxiliary components.

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