KR101294614B1 - Soft capsule film composition using modified tapioca starch as main base material - Google Patents
Soft capsule film composition using modified tapioca starch as main base material Download PDFInfo
- Publication number
- KR101294614B1 KR101294614B1 KR1020120026920A KR20120026920A KR101294614B1 KR 101294614 B1 KR101294614 B1 KR 101294614B1 KR 1020120026920 A KR1020120026920 A KR 1020120026920A KR 20120026920 A KR20120026920 A KR 20120026920A KR 101294614 B1 KR101294614 B1 KR 101294614B1
- Authority
- KR
- South Korea
- Prior art keywords
- starch
- soft capsule
- weight
- carrageenan
- months
- Prior art date
Links
- 239000007901 soft capsule Substances 0.000 title claims abstract description 87
- 240000003183 Manihot esculenta Species 0.000 title claims abstract description 28
- 235000016735 Manihot esculenta subsp esculenta Nutrition 0.000 title claims abstract description 28
- 229920002472 Starch Polymers 0.000 title description 80
- 235000019698 starch Nutrition 0.000 title description 80
- 239000008107 starch Substances 0.000 title description 76
- 239000000203 mixture Substances 0.000 title description 22
- 239000000463 material Substances 0.000 title description 10
- 229920001525 carrageenan Polymers 0.000 claims abstract description 37
- 229920000881 Modified starch Polymers 0.000 claims abstract description 36
- 239000000679 carrageenan Substances 0.000 claims abstract description 36
- 229940113118 carrageenan Drugs 0.000 claims abstract description 36
- 239000004368 Modified starch Substances 0.000 claims abstract description 31
- 235000019426 modified starch Nutrition 0.000 claims abstract description 30
- 239000008199 coating composition Substances 0.000 claims abstract description 28
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- 239000003963 antioxidant agent Substances 0.000 claims abstract description 13
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 13
- 239000008213 purified water Substances 0.000 claims abstract description 9
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 12
- ZNOZWUKQPJXOIG-XSBHQQIPSA-L [(2r,3s,4r,5r,6s)-6-[[(1r,3s,4r,5r,8s)-3,4-dihydroxy-2,6-dioxabicyclo[3.2.1]octan-8-yl]oxy]-4-[[(1r,3r,4r,5r,8s)-8-[(2s,3r,4r,5r,6r)-3,4-dihydroxy-6-(hydroxymethyl)-5-sulfonatooxyoxan-2-yl]oxy-4-hydroxy-2,6-dioxabicyclo[3.2.1]octan-3-yl]oxy]-5-hydroxy-2-( Chemical compound O[C@@H]1[C@@H](O)[C@@H](OS([O-])(=O)=O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H]2OC[C@H]1O[C@H](O[C@H]1[C@H]([C@@H](CO)O[C@@H](O[C@@H]3[C@@H]4OC[C@H]3O[C@H](O)[C@@H]4O)[C@@H]1O)OS([O-])(=O)=O)[C@@H]2O ZNOZWUKQPJXOIG-XSBHQQIPSA-L 0.000 claims description 11
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- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 6
- LNTHITQWFMADLM-UHFFFAOYSA-N gallic acid Chemical compound OC(=O)C1=CC(O)=C(O)C(O)=C1 LNTHITQWFMADLM-UHFFFAOYSA-N 0.000 claims description 6
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- AGNTUZCMJBTHOG-UHFFFAOYSA-N 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol Chemical compound OCC(O)COCC(O)COCC(O)CO AGNTUZCMJBTHOG-UHFFFAOYSA-N 0.000 claims description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
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- GPLRAVKSCUXZTP-UHFFFAOYSA-N diglycerol Chemical compound OCC(O)COCC(O)CO GPLRAVKSCUXZTP-UHFFFAOYSA-N 0.000 claims description 3
- 235000019414 erythritol Nutrition 0.000 claims description 3
- UNXHWFMMPAWVPI-ZXZARUISSA-N erythritol Chemical compound OC[C@H](O)[C@H](O)CO UNXHWFMMPAWVPI-ZXZARUISSA-N 0.000 claims description 3
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- FQENQNTWSFEDLI-UHFFFAOYSA-J sodium diphosphate Chemical group [Na+].[Na+].[Na+].[Na+].[O-]P([O-])(=O)OP([O-])([O-])=O FQENQNTWSFEDLI-UHFFFAOYSA-J 0.000 claims description 2
- RYCLIXPGLDDLTM-UHFFFAOYSA-J tetrapotassium;phosphonato phosphate Chemical compound [K+].[K+].[K+].[K+].[O-]P([O-])(=O)OP([O-])([O-])=O RYCLIXPGLDDLTM-UHFFFAOYSA-J 0.000 claims 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
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- A23L29/206—Foods or foodstuffs containing additives; Preparation or treatment thereof containing gelling or thickening agents of vegetable origin
- A23L29/212—Starch; Modified starch; Starch derivatives, e.g. esters or ethers
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Abstract
Description
본 발명은 타피오카 변성전분을 주기재로 사용한 연질 캡슐 피막 조성물에 관한 것이다. 더욱 상세하게는 타피오카 변성전분을 주기재로 사용하고 카라기난 계열의 겔화제를 사용하여 가소제, 완충제, 붕해 보조제 및 산화 방지제를 첨가시켜 연질 캡슐 피막 조성물의 피막 경도 및 붕해 안정성을 개선한 타피오카 변성전분을 주기재로 사용한 연질 캡슐 피막 조성물에 관한 것이다.
The present invention relates to a soft capsule coating composition using tapioca modified starch as a base material. More specifically, tapioca-modified starch, which uses tapioca-modified starch as a base material and a carrageenan-based gelling agent, is added to a plasticizer, a buffer, a disintegration aid and an antioxidant to improve the film hardness and disintegration stability of the soft capsule coating composition. It relates to a soft capsule coating composition used as the base material.
통상 연질캡슐제 피막은 주로 젤라틴을 사용하여 제조되지만 젤라틴의 경우 동물 기원 원료라는 이유로 채식주의자 및 종교적 배경으로 인하여 기피하는 경향이 있어 자연주의 소비 경향과 맞물려 동물성보다는 식물성 소재에 관심을 보이는 소비층의 영향으로 제조 및 품질 상 우수한 젤라틴의 물리적 성질에도 불구하고 비동물성 캡슐제 개발이 촉진되었다.
Generally, soft capsules are produced by using gelatin. However, since gelatin is an ingredient of animal origin, it tends to be avoided due to vegetarian and religious backgrounds. Despite the physical properties of good gelatin in terms of manufacture and quality, the development of non-animal capsules has been promoted.
이에 따라 현재 비동물성 유래 경질 및 연질 캡슐 제품으로는 전분을 주기재로 사용한 연질캡슐제가 개발되고 있다. 또한 이때 상기 전분의 겔화를 위한 겔화제로서 카라기난이 공지되어 있다.
Accordingly, soft capsules using starch as a main ingredient have been developed as hard and soft capsule products derived from non-animal origin. Also, at this time, carrageenan is known as a gelling agent for gelation of the starch.
비동물성 유래 경질 및 연질 캡슐 제품에 사용되는 전분으로는 생전분; 산처리화 전분, 하이드록시프로필화 전분, α화 전분, 가교결합시킨 전분 및 전분 분해물로 된 1종 이상의 변성 전분; 또는 생전분과 변성전분의 혼합된 혼합 전분을 사용할 수 있다. 또한 주요 전분 원료로는 옥수수, 밀 등 곡류 및 감자, 고구마, 타피오카 전분 등을 열거할 수 있다.
Starches used in non-animal derived hard and soft capsule products include raw starch; At least one modified starch consisting of acid-treated starch, hydroxypropylated starch, pregelatinized starch, cross-linked starch and starch hydrolyzate; Or a mixed starch of a raw starch and modified starch may be used. In addition, the main starch raw materials include corn, wheat and wheat, potatoes, sweet potatoes, tapioca starch and the like.
그러나 상기 전분 중에서 어느 전분이 비동물성 유래 경질 및 연질 캡슐 제품의 주기재 성분으로 가장 유용한지는 아직까지 알려진 바 없다.
However, it is not yet known which starch of the starch is most useful as a main ingredient of non-animal derived hard and soft capsule products.
홍조류에 속하는 돌가사리과, 솔리에리아과, 부채살과 및 가시우무과 등의 천연 해조류 계통으로부터 수성 추출하여 수득되는 갈락토즈와 무수갈락토즈를 주성분으로 하는 복합 다당류인 카라기난은 지난 수십년 동안 유용한 식품 첨가물로 알려져 왔다. 카라기난은 1,4-α-D-결합 뿐 아니라 1,3-β-D-결합에 의해 연결된 갈락토스 단위가 교대 단위 당 골격을 가진 선형 다당류 형태의 수용성 검이다.
Carrageenan, a complex polysaccharide based on galactose and anhydrous galactose, obtained by aqueous extraction from natural seaweed systems such as staphylococci, solanaria, fanny and gassuum, belonging to red algae has been known as a useful food additive for decades . Carrageenan is a water-soluble gum in the form of a linear polysaccharide having galactose units linked by 1,3- [beta] -D-linkages as well as 1,4- [alpha] -D-linkages.
카라기난은 겔화 형태에 따라 아이오타, 카파 및 람다 카라기난 등 3종류의 카라기난으로 분류되고 있다.
Carrageenan is classified into three types of carrageenans, iota, kappa and lambda carrageenan, depending on the type of gelation.
그 중 람다-카라기난은 칼륨 이온이나 칼슘 이온에 의해 겔화하는 특성이 약하고 반면 고점성으로 인해 점착력이 크다. 또한 다른 카라기난류에 비해 많은 황산염을 지니고 있으며 분자량 역시 가장 큰 것으로 알려져 있어 전분 겔화제로는 적합지 않은 것으로 판단된다.
Among them, lambda-carrageenan is weak in the property of gelling by potassium ion or calcium ion, but it has high adhesion due to high viscosity. In addition, it has more sulfate than other carrageenan, and its molecular weight is also known to be the largest, so it is not suitable as a starch gelling agent.
한편 카파-카라기난은 홍조류 중 Cottonii로 부터 추출되며 칼륨 이온과 가장 강하게 겔화되는 특성이 있고, 유단백질인 카제인과 반응성이 크지만 온도 변화에 따른 점도 변화 역시 크기 때문에 이 역시 열 가역성으로 인해 전분 겔화제로 사용되는 경우는 많지 않다.
On the other hand, kappa-carrageenan is extracted from Cottonii among red algae, and has the strongest gelling property with potassium ion, and is highly reactive with casein, which is a milk protein. However, since it has a large viscosity change with temperature change, it is also used as a starch gelling agent Is not much.
아이오타-카라기난은 대략 32 중량% 정도의 황산에스테르 염과 30 중량% 정도의 3,6 무수-D-갈락토스로 구성되어 있으며 분자량은 100,000∼500,000 정도이다. 아이오타-카라기난은 칼슘 이온(Ca++)을 지닌 강력한 겔화제로 작용하며 이는 매우 탄력적이면서도 식품에 적용하기 위한 0.5∼2 중량%의 정상 농도에서 쉽게 유리된다.
Iota-carrageenan is composed of about 32% by weight of sulfuric acid ester salt and about 30% by weight of 3,6-anhydro-D-galactose and has a molecular weight of about 100,000 to 500,000. Iota-carrageenan acts as a powerful gelling agent with calcium ions (Ca ++ ), which is very elastic and readily released at normal concentrations of 0.5 to 2% by weight for food applications.
상기한 바와 같이 3 종류의 카라기난은 각각 그 겔화제로서의 특징이 서로 상이하므로 통상 아이오타-카라기난을 강력한 겔화제로 사용하기는 하나 특정 카라기난만을 겔화제로 사용하는 것은 예기치 못한 연질캡슐제의 물성을 저하시킬 수 있는 가능성이 있는 것이다.
As described above, the three kinds of carrageenan have different characteristics as their gelling agents, and therefore, Iota-carrageenan is generally used as a powerful gelling agent, but using only a specific carrageenan as a gelling agent can reduce unexpected physical properties of the soft capsule. There is a possibility.
PCT 국제특허공보 WO 2001/03677 A1 '변성전분과 아이오타 카라기난을 포함하는 필름 형성 조성물 및 그것을 이용한 연질캡슐의 제조 방법'에서는 변성전분 혼합물 및 아이오타-카라기난을 포함하는 연질캡슐용 필름 조성물이 개시되어 있다. 특히 상기 국제특허공보에서는 아이오타-카라기난 및 변형 전분의 혼합물을 포함하는 42-84 중량%의 겔 형성제; 물; 가소제; 및 완충제로 구성되는 연질 캡슐에 적합한 필름 조성물이 개시되어 있다.
PCT International Patent Publication No. WO 2001/03677 A1 'Film-forming compositions comprising modified starch and Iota carrageenan and a process for producing soft capsules using the same', a film composition for soft capsules comprising a modified starch mixture and an iota-carrageenan is disclosed . In particular, the International Patent Publication discloses 42-84% by weight of a gel-forming agent comprising a mixture of iota-carrageenan and modified starch; water; Plasticizers; ≪ / RTI > and a buffer.
더욱 상세하게는 하이드록시프로필화 타피오카 전분, 하이드록시프로필화 옥수수 전분, 산 희석 하이드록시프로필화 콘 전분, 감자 전분 또는 호화 변형 콘 전분 중에서 선택되는 적어도 하나의 변형 전분 및 아이오타-카라기난을 포함하고, 상기 전분의 수화온도가 약 90℃ 이하이며, 변형 전분 대 아이오타-카라기난의 중량비가 1.5:1 내지 4.0:1 범위인 연질 캡슐 형성에 적합한 조성물이 개시되어 있다.
More particularly, at least one modified starch selected from hydroxypropylated tapioca starch, hydroxypropylated corn starch, acid diluted hydroxypropylated cone starch, potato starch or gellant modified corn starch, and iota-carrageenan , Wherein the starch has a hydration temperature of about 90 ° C or less and a weight ratio of modified starch to isota-carrageenan is in the range of 1.5: 1 to 4.0: 1.
그러나 상기 특허 공보에 개시된 연질캡슐용 필름 조성물의 경우 전분의 노화와 호화 현상에 의한 연질캡슐 피막의 붕해 지연 및 피막 경도의 상승이라는 문제점을 지녀 그 상용화에 문제가 있었던 것이다.
However, in the case of the film composition for soft capsules disclosed in the above patent publications, there was a problem in commercialization due to the problem of delayed disintegration of the soft capsule coating and increase of hardness of the capsule due to the aging of the starch and the gelation phenomenon.
전분을 주기재로 사용하는 연질캡슐제는 전분 혹은 전분유도체와 검류, 가소제, 완충제(금속염) 및 정제수로 이루어져 있다. 피막 필름을 형성하는데 가장 높은 배합 비율을 차지하는 전분은 방치해두면 점점 굳어져서 원래의 결정성을 띤 상태로 되돌아가는 노화(retrogradation) 현상을 나타낸다.
Soft capsules using starch as a base material consist of starch or starch derivatives, gums, plasticizers, buffer (metal salts) and purified water. Starch, which occupies the highest mixing ratio in forming a film, shows a phenomenon of retrogradation in which the starch is hardened and returned to its original crystalline state.
한편 전분에 물을 첨가시켜 호화(gelatinization)된 전분 분자는 실온에 이르면 가까이 있는 다른 분자와 수소결합을 야기하게 되고 이러한 수소결합은 두 전분 분자가 물분자를 사이에 두고 형성되기도 하며 부근에 있는 전분 분자의 하이드록시(-OH)기와 직접 형성하기도 한다. 이에 따라 분자의 회합점에서 접합 구역이 형성되고 궁극적으로는 전분의 결합 형태가 그물 분자(Net molecular) 구조를 이루게 되어 연질캡슐 피막의 붕해 지연 및 피막 경도(hardness)의 상승이라는 문제점을 야기하게 되는 것이다.
On the other hand, when starch is added with water, the gelatinized starch molecule causes hydrogen bonding with other nearby molecules at room temperature. Such hydrogen bonding may be caused by the formation of two starch molecules between water molecules, It also forms directly with the hydroxy (-OH) group of the molecule. As a result, the junction area is formed at the molecular junction point and ultimately the binding form of the starch forms a net molecular structure, which causes a problem of delay in disintegration of the soft capsule shell and increase of hardness of the capsule will be.
상기와 같은 붕해 지연 및 피막 경도를 상승시키는 문제점들을 보완하기 위해서는 노화 현상에 영향을 미치는 인자를 통제할 필요가 있으며 무엇보다 전분의 선택이 중요하다. 일반적으로 옥수수, 밀 등 곡류의 전분은 노화되기 쉽고, 감자, 고구마, 타피오카 등 서류의 전분은 노화 현상이 더디지만 일반 전분보다는 산처리 전분, 하이드록시프로필 전분 또는 가교결합 전분과 같은 변성전분을 사용하는 것이 바람직하다.
In order to overcome the disadvantages of such disintegration retardation and film hardness increase, it is necessary to control factors affecting the aging phenomenon, and above all, selection of starch is important. Generally, starches of cereals such as corn and wheat are aging easily, and starches of documents such as potatoes, sweet potatoes, and tapioca are slower in aging, but modified starches such as acid-treated starch, hydroxypropyl starch or crosslinked starch are used rather than general starch. It is desirable to.
따라서 본 발명자들은 이와 같은 전분을 주기재로 하는 연질캡슐 피막의 붕해 지연 및 피막 경도 증가의 개선을 위한 개발을 통해 대한민국 특허출원 제10-2011-36823호 '붕해도 및 피막 경도를 개선한 비동물성 연질 캡슐 피막 조성물'을 개발하고 이를 특허출원한 바 있다.
Therefore, the inventors of the present invention have found that, by developing such a starch-based soft capsule coating to improve the disintegration delay and increase in hardness of the coating, Korean Patent Application No. 10-2011-36823 discloses a non- Soft capsule coating composition "and applied for a patent.
즉 전분을 주기재로 하는 연질캡슐 제조 시 사용하는 주요 캡슐기제로 노화 지연 전분을 사용하고 붕해 지연 현상과 피막 경도 증가를 개선하기 위해 산화방지제와 붕해 보조제를 사용하여 그물 분자 형성을 억제하고 전분이 원래 결정성을 띤 상태로 되돌아가려는 노화 현상을 지연시켜 전분을 주기재로 하는 연질캡슐 필름의 붕해 지연 및 피막 경도를 크게 개선한 것이었다.
In other words, as a main capsule base used in the production of soft capsules containing starch as a main ingredient, antioxidants and disintegration aids are used to inhibit the formation of net molecules and to inhibit starch Retarding the aging phenomenon to return to the originally crystalline state and greatly improving the disintegration delay and the film hardness of the soft capsule film based on starch.
그러나 상기한 본 발명자들의 선행 특허출원은 일반적 전분 기재를 중심으로 그 전분 기재에 적합한 겔화제를 선택하여 제조한 전분을 주기재로 하는 연질캡슐 피막 조성물이기 때문에 타피오카 변성전분과 같은 연질캡슐 필름에 가장 적합한 물리적 특성을 지닌 전분에 대한 연질캡슐 조성을 개발한 것은 아니었다.
However, the above-described prior patent applications of the present inventors are most preferred for soft capsule films such as tapioca-modified starch, because the starch-based soft capsule coating composition is prepared by selecting a suitable gelling agent based on the starch substrate. No soft capsule composition has been developed for starches with adequate physical properties.
타피오카 전분은 열대작물인 카사바(casava)의 뿌리에서 채취한 식용 녹말이며, 카사바의 뿌리는 25∼35%의 녹말을 함유하고 있고, 이를 압착하여 녹말을 물로 세척 침전시킨 후 건조시켜 타피오카 전분을 제조한다. 이는 동남아시아의 중요한 녹말자원으로 녹말당, 캐러멜, 과자 제조 등의 식용 외에도 방직용 풀로 이용된다.
Tapioca starch is an edible starch taken from the roots of cassava, a tropical crop, and cassava root contains 25-35% starch, and it is compressed, washed, precipitated, and dried to make tapioca starch. do. It is an important starch resource in Southeast Asia, and is used as a weaving paste in addition to food products such as starch sugar, caramel, and confectionery.
타피오카 전분은 아밀로펙틴 함량이 높아 비교적 부드럽고 탄력과 점성을 가져 쫄깃한 식감을 나타내고, 섭취시 기호감과 매끄러운 느낌이 상당히 양호하고 호화온도가 낮기 때문에 생체 내 흡수가 용이하고 전분 호화액의 점도가 높아 점성이 좋고 약간의 고무감을 느끼는 식감을 부여하는 특징이 있다.
Tapioca starch has high amylopectin content and is relatively soft, has elasticity and viscosity, and exhibits a chewy texture. It has good taste and smooth feeling at the time of ingestion and has a low gelatinization temperature, so it is easy to absorb in vivo and viscosity of starch hydrolyzate is high, There is a feature to give a feeling of feeling a little rubber feeling.
하이드록시프로필 변성이란 전분의 호화 온도 저하, 냉동 내성 향상, 노화 속도 지연 및 부드럽고 쫄깃한 식감 향상을 위한 것으로 이는 전분과 산화프로필렌의 반응을 통해 알칼리 촉매 하에서 전분 현탁 수용액에 산화프로필렌을 첨가하여 제조하는 것이다.
Hydroxypropyl modification is intended to improve starch's gelatinization temperature, to improve frozen resistance, delay in aging speed, and to improve smooth and chewy texture, which is prepared by adding propylene oxide to an aqueous starch suspension solution under an alkaline catalyst through reaction of starch and propylene oxide .
따라서 하이드록시프로필 타피오카 변성전분은 타피오카에서 유래한 전분을 알칼리 촉매 존재하에서 프로필렌옥사이드로 처리하여 하이드록시기와 반응 물질 사이의 반응에 의해 화학적으로 변성시키거나 호화한 것으로 전분 본래의 물리적 특성을 변성시킨 것이다.
Therefore, the hydroxypropyl tapioca modified starch is a starch derived from tapioca which is chemically modified or gelatinized by the reaction between propylene oxide and hydroxy group in the presence of an alkali catalyst to modify the physical properties inherent in the starch .
따라서 본 발명자들은 전분으로서 하이드록시프로필 타피오카 변성전분을 사용하고 본 발명자들의 선행 특허 출원에 기재된 가소제, 완충제, 붕해 보조제, 산화 방지제 등을 조합시켜 전분 기재 연질캡슐 피막 조성물을 제조할 경우 하이드록시프로필 타피오카 변성전분과 그 전분에 상응하는 최적의 겔화제를 연구하던 중 아이오타-카라기난과 카파-카라기난을 특정 함량으로 혼합시켰을 때 연질캡슐의 필름 붕해 지연 및 피막 경도를 크게 개선시킨 연질캡슐 피막 조성물을 개발함으로써 하이드록시프로필 타피오카 변성전분을 주기재로 사용한 연질캡슐 피막 조성물을 개발하고 본 발명을 완성하게 된 것이다.
Therefore, the present inventors use hydroxypropyl tapioca modified starch as starch and combine the plasticizers, buffers, disintegration aids, antioxidants, and the like described in the prior patent applications of the present inventors to produce hydroxypropyl tapioca when the soft capsule coating composition is prepared. While researching modified starch and the optimum gelling agent corresponding to starch, we developed a soft capsule film composition that greatly improved the film disintegration delay and film hardness of soft capsules when Iota-carrageenan and kappa-carrageenan were mixed in specific contents. By developing a soft capsule coating composition using the hydroxypropyl tapioca modified starch as a base material and to complete the present invention.
이에 본 발명이 해결하려는 과제는 전분으로서 하이드록시프로필 타피오카 변성전분을 사용하고 가소제, 완충제, 붕해 보조제, 산화 방지제 등을 조합시켜 전분 기재 연질캡슐 피막 조성물을 제조할 경우 아이오타-카라기난과 카파-카라기난을 특정 함량으로 혼합시켰을 때 연질캡슐의 필름 붕해 지연 및 피막 경도를 크게 개선시킨 연질캡슐 피막 조성물을 개발코자 한 것이다. 하이드록시프로필 타피오카 변성전분을 주기재로 사용한 연질캡슐 피막 조성물을 개발코자 한 것이다.
The problem to be solved by the present invention is to use a starch-based soft capsule coating composition by using a hydroxypropyl tapioca modified starch as a starch, plasticizers, buffers, disintegration aids, antioxidants, etc. Iota-carrageenan and kappa-carrageenan It is intended to develop a soft capsule coating composition that greatly improves the film disintegration delay and film hardness of the soft capsule when mixed to a specific content. To develop a soft capsule coating composition using hydroxypropyl tapioca modified starch as a base material.
본 발명의 목적은 하이드록시프로필 타피오카 변성전분 18∼25 중량%에 대해 겔화제로 아이오타-카라기난 2∼4 중량% 및 카파-카라기난 0.5∼1.5 중량%, 가소제 5∼20 중량%, 완충제 0.01∼3 중량%, 붕해보조제 0.01∼2 중량%, 산화방지제 0.01∼1 중량% 및 45∼60 중량%의 정제수를 포함하는 연질캡슐 피막 조성물을 제공하는 것이다.
It is an object of the present invention to use 2 to 4% by weight of iota-carrageenan and 0.5 to 1.5% by weight of kappa-carrageenan, 5 to 20% by weight of plasticizer, and 0.01 to 3 buffering agent based on 18 to 25% by weight of hydroxypropyl tapioca modified starch. It is to provide a soft capsule coating composition comprising a weight%, 0.01 to 2% by weight of disintegration aid, 0.01 to 1% by weight of antioxidant and 45 to 60% by weight of purified water.
또한 상기 아이오타-카라기난의 함량은 2.5∼3.5 중량%이고 카파-카라기난의 함량은 0.8∼1.2 중량%임을 특징으로 한다.
In addition, the content of the iota-carrageenan is 2.5 to 3.5% by weight and the content of kappa-carrageenan is 0.8 to 1.2% by weight.
한편 상기 가소제는 만니톨, 결정성 또는 비결정성의 소르비톨, 솔비탄, 슈크로오스, 자일리톨, 에리스리톨, 말티톨, 올리고당, 이소말토올리고당, 글리세린, 다이글리세롤 또는 트리글리세롤에서 선택된 1종 이상 임을 특징으로 한다.
The plasticizer may be at least one selected from mannitol, crystalline or amorphous sorbitol, sorbitan, sucrose, xylitol, erythritol, maltitol, oligosaccharide, isomaltooligosaccharide, glycerin, diglycerol or triglycerol.
또한 상기 완충제는 제2인산나트륨 또는 제2인산칼륨이고, 상기 붕해 보조제는 글루코아밀라아제, 말토제닉아밀라아제, 알파-아밀라아제, 베타-아밀라아제, 이소아밀라아제 또는 풀루라나아제에서 선택된 1종 이상이고, 상기 산화 방지제는 로즈마리 추출물, 녹차 추출물, 토코페롤 또는 몰식자산에서 선택된 1종 이상임을 특징으로 한다.
Wherein the buffer is at least one selected from the group consisting of sodium phosphate or potassium phosphate and the disintegration aid is at least one selected from the group consisting of glucoamylase, maltogenic amylase, alpha-amylase, beta-amylase, isoamylase or plulanase, Is at least one selected from rosemary extract, green tea extract, tocopherol or gallic acid.
본 발명의 효과는 전분으로서 하이드록시프로필 타피오카 변성전분을 사용하고 가소제, 완충제, 붕해 보조제, 산화 방지제 등을 조합시켜 전분 기재 연질캡슐 피막 조성물을 제조할 경우 아이오타-카라기난과 카파-카라기난을 특정 함량으로 혼합시켰을 때 연질캡슐의 필름 붕해 지연 및 피막 경도를 크게 개선시킨 연질캡슐 피막 조성물을 제공하는 것이다. 하이드록시프로필 타피오카 변성전분을 주기재로 사용한 연질캡슐 피막 조성물을 제공하는 것이다.
The effect of the present invention is that when starch-based soft capsule coating composition is prepared by using hydroxypropyl tapioca modified starch as a starch and combining a plasticizer, a buffer, a disintegration aid, and an antioxidant, a specific content of iota-carrageenan and kappa-carrageenan It is to provide a soft capsule coating composition that greatly improves the film disintegration delay and film hardness of the soft capsule when mixed. It is to provide a soft capsule coating composition using hydroxypropyl tapioca modified starch as a base material.
본 발명은 하이드록시프로필 타피오카 변성전분 18∼25 중량%에 대해 겔화제로 아이오타-카라기난 3∼12 중량%, 가소제 5∼20 중량%, 완충제 0.01∼3 중량%, 붕해보조제 0.01∼2 중량%, 산화방지제 0.01∼1 중량% 및 45∼60 중량%의 정제수를 포함하는 연질캡슐 피막 조성물을 제공하는 것이다.
The present invention relates to 18 to 25% by weight of hydroxypropyl tapioca modified starch, 3 to 12% by weight of iota-carrageenan, 5 to 20% by weight of plasticizer, 0.01 to 3% by weight of buffer, 0.01 to 2% by weight of disintegration aid, To provide a soft capsule coating composition comprising 0.01 to 1% by weight of antioxidant and 45 to 60% by weight of purified water.
이하 본 발명을 더욱 상세히 설명한다.
Hereinafter, the present invention will be described in more detail.
피막의 기제 성분으로 사용될 수 있는 전분을 살펴보면 생전분; 산처리화 전분, 하이드록시프로필화 전분, α화 전분, 가교결합시킨 전분 및 전분 분해물로 된 1종 이상의 변성 전분; 또는 생전분과 변성전분의 혼합된 혼합 전분을 사용할 수 있다. 또한 주요 전분 원료로는 옥수수, 밀 등 곡류 및 감자, 고구마, 타피오카 전분 등을 열거할 수 있다.
Looking at the starch that can be used as a base component of the coating is raw starch; At least one modified starch consisting of acid-treated starch, hydroxypropylated starch, pregelatinized starch, cross-linked starch and starch hydrolyzate; Or a mixed starch of a raw starch and modified starch may be used. In addition, the main starch raw materials include corn, wheat and wheat, potatoes, sweet potatoes, tapioca starch and the like.
그러나 본 발명에서는 통상적인 전분 중 가장 노화 및 호화를 통한 전분의 변성이 억제되고 연질캡슐 피막 조성물의 물성을 충족할 수 있는 하이드록시프로필 타피오카 변성전분을 전분 주기재로 사용한다.
However, in the present invention, hydroxypropyl tapioca modified starch, which can inhibit the degeneration of starch through aging and gelatinization and satisfy the properties of the soft capsule coating composition, is used as a starch main material.
한편 통상의 연질캡슐 전분의 겔화제로 사용되는 검류는 아라비아(Arabic)검, 트라가칸트(tragacanth)검, 카라야(karaya)검, 가티(ghatti)검, 구아(guar)검, 로거스트콩(locustbeen)검, 타라(tara)검, 곤약(konjac)검, 알긴(algin), 한천(agar), 카라기난(carrageenan), 플루란(furcellaran), 펙틴(pectin), 젤란(gellan), 만난 또는 산탄검 등을 들 수 있으나 본 발명에서는 가장 겔화제로서의 성능이 우수한 카라기난이 사용된다.
On the other hand, gum used as a gelling agent of conventional soft capsule starch is Arabian gum, tragacanth gum, karaya gum, ghatti gum, guar gum, logger bean beans ( locustbeen gum, tara gum, konjac gum, algin, agar, carrageenan, furcellaran, pectin, gellan, met or pellets Although gum etc. are mentioned, Carrageenan excellent in the performance as a gelling agent is used for this invention.
한편 본 발명에서는 겔화제로서 연질캡슐 필름 조성물 전체 중량 대비 아이오타-카라기난 2∼4 중량% 및 카파-카라기난 0.5∼1.5 중량%의 혼합물을 사용한다.
In the present invention, as a gelling agent, a mixture of 2 to 4 wt% of iota-carrageenan and 0.5 to 1.5 wt% of kappa-carrageenan is used relative to the total weight of the soft capsule film composition.
또한 연질캡슐 피막에 사용되는 가소제로는 만니톨, 결정성 또는 비결정성의 소르비톨, 솔비탄, 슈크로오스, 자일리톨, 에리스리톨, 말티톨, 올리고당, 이소말토올리고당, 글리세린, 다이글리세롤 또는 트리글리세롤에서 선택된 1종 이상을 들 수 있다.
The plasticizer used in the soft capsule coating may also include one or more selected from mannitol, crystalline or amorphous sorbitol, sorbitan, sucrose, xylitol, erythritol, maltitol, oligosaccharide, isomaltooligosaccharide, glycerin, diglycerol or triglycerol Or more.
또한 본 발명에 사용되는 완충제는 제2인산나트륨 또는 제2인산칼륨이고, 붕해 보조제는 글루코아밀라아제, 말토제닉아밀라아제, 알파-아밀라아제, 베타-아밀라아제, 이소아밀라아제 또는 풀루라나아제에서 선택된 1종 이상을 사용할 수 있다.
Also, the buffer used in the present invention is sodium diphosphate or dibasic potassium phosphate, and the disintegration aid is at least one selected from the group consisting of glucoamylase, maltogenic amylase, alpha-amylase, beta-amylase, isoamylase or plulanase .
한편 산화 방지제로는 로즈마리 추출물, 녹차 추출물, 토코페롤 또는 몰식자산에서 선택된 1종 이상을 사용할 수 있다.
On the other hand, as the antioxidant, at least one selected from rosemary extract, green tea extract, tocopherol or gallic acid can be used.
상기 연질캡슐 피막 구성 성분에 정제수, 착색제, 차광제 및 착향제 등을 적량 함유하는 전분을 주기재로 하는 연질캡슐제의 피막 필름(film)을 제조하고 로터리식 연질캡슐 자동충전기를 사용하여 내용물을 충전한다.
A film of a soft capsule made mainly of starch containing an appropriate amount of purified water, a colorant, a light shielding agent and a flavoring agent, etc. was prepared in the above soft capsule shell component, and the contents were filled with a rotary type soft capsule automatic charger Charge.
또한 상기 내용물은 약리학적 유효 성분 또는 기능성 식품의 성분 1종 이상을 포함하고 충전할 수 있는 내용물은 특히 한정하는 것은 아니며 내용물로 가용화되거나 현탁화시킬수 있으면 가능하다.
In addition, the contents include at least one component of the pharmacologically active ingredient or the functional food, and the contents which can be filled are not particularly limited and can be solubilized or suspended in the contents.
이하 본 발명을 제조실시예 및 실시예를 통하여 더욱 상세히 설명한다. 그러나 이러한 실시예들로 본 발명의 범위를 한정하는 것은 아니다.
Hereinafter, the present invention will be described in more detail by way of Examples and Examples. However, these embodiments are not intended to limit the scope of the present invention.
(제조실시예 1∼3) 본 발명의 연질캡슐제 피막 조성물의 제조
(Production Examples 1 to 3) Preparation of soft capsule coating composition of the present invention
하기 표 1에 나타난 조성으로 연질캡슐제 피막 용액 100kg을 제조하여 1 캡슐당 피막 중량을 250mg이 되도록 한다.
100 kg of a soft capsule coating solution is prepared in the composition shown in the following Table 1 so that the coating weight per capsule is 250 mg.
연질캡슐 내용물을 충전하기 위하여 개선된 전분을 주기재로 하는 연질캡슐제 피막 용액 100kg을 제조하여 1캡슐 당 피막 중량을 250mg이 되도록 한다.
In order to fill the soft capsule contents, 100 kg of a soft capsule coating solution based on the improved starch as a main ingredient is prepared and the coating weight per capsule is 250 mg.
상기의 조성으로된 피막 용액의 제조 방법은 멜팅 탱크(Melting Tank)에 HP 타피오카 변성전분, 글리세린, D-소르비톨액, 아이오타-카라기난, 카파-카라기난, 제2인산나트륨, 몰식자산, 정제수를 소량부터 순차적으로 투입한 뒤, 85∼95℃에서 120분 동안 가온하며 교반속도 40∼45 rpm으로 교반한다. 용해가 끝나고 600∼760 mmHg에서 감압, 탈기한 뒤 용액 탱크에 이송하여 75∼85℃에서 1∼2시간 숙성 대기하여 본 발명의 전분 기재 연질캡슐제 피막 용액을 얻는다. 상기 용액을 이용하여 연질캡슐 성형하기 2시간 전에 α-아밀라아제를 용액 탱크에 추가 투입하여 균질하게 30분간 혼합 방치 후 사용한다.
Method for producing a coating solution of the above composition is HP tapioca modified starch, glycerin, D-sorbitol solution, iota-carrageenan, kappa-carrageenan, dibasic sodium phosphate, molar asset, purified water in a melting tank (Melting Tank) After sequentially adding, the mixture was warmed at 85 to 95 ° C. for 120 minutes and stirred at a stirring speed of 40 to 45 rpm. After dissolution, the mixture is decompressed and degassed at 600 to 760 mmHg, transferred to a solution tank, and aged at 75 to 85 ° C for 1 to 2 hours to obtain a starch-based soft capsule coating solution of the present invention. Amylase is added to the solution tank 2 hours before the soft capsule is formed by using the above solution, and the solution is homogeneously mixed for 30 minutes before use.
본 제조실시예 1∼3에서는 보라지종자유 오일 100%를 연질캡슐 내용물로 하여 일반적으로 사용하고 있는 비동물성 연질캡슐 로타리식 자동충전기로 OVAL 모양의 몰드에 1캡슐 중량 500mg을 통상의 충전 방법으로 진행하고 텀블러에서 16∼20시간 건조한 뒤 2차 트레이(tray) 건조를 진행한다. 건조가 완료되면 선별공정을 거쳐 시제품을 얻어 제작된 시제품에 대하여 24개월 동안 안정성시험을 진행한다.
In the present Manufacturing Examples 1 to 3, one capsule of 500 mg was charged into an OVAL-shaped mold using a non-animal soft capsule rotary charger commonly used as a soft capsule content in which 100% of borax free oil was contained in a normal filling method And dried in a tumbler for 16 to 20 hours, followed by drying of the second tray. Upon completion of the drying process, the sample is subjected to a screening process to obtain a prototype product, and the manufactured prototype is subjected to a stability test for 24 months.
(제조비교예 1) 전분 함량을 변화시킨 연질 캡슐제 피막 조성물의 제조
(Preparation Comparative Example 1) Preparation of soft capsule coating composition with varying starch content
하기 표 2에 나타난 조성으로 연질캡슐제 피막 용액 100kg을 제조하여 1 캡슐당 피막 중량을 250mg이 되도록 한다. 연질캡슐제 피막의 제조 및 연질캡슐의 성형 및 건조는 제조실시예 1에서와 동일한 조건으로 실시하였다.
100 kg of a soft capsule coating solution is prepared in the composition shown in Table 2 below, and the coating weight per capsule is 250 mg. The preparation of the soft capsule coating and the molding and drying of the soft capsule were carried out under the same conditions as in Production Example 1. [
(제조비교예 2) 전분의 조성을 변화시킨 연질 캡슐제 피막 조성물의 제조
(Preparation Comparative Example 2) Preparation of soft capsule coating composition in which the composition of starch was changed
하기 표 2에 나타난 조성으로 연질캡슐제 피막 용액 100kg을 제조하여 1 캡슐당 피막 중량을 250mg이 되도록 한다. 연질캡슐제 피막의 제조 및 연질캡슐의 성형 및 건조는 제조실시예 1에서와 동일한 조건으로 실시하였다.
100 kg of a soft capsule coating solution is prepared in the composition shown in Table 2 below, and the coating weight per capsule is 250 mg. The preparation of the soft capsule coating and the molding and drying of the soft capsule were carried out under the same conditions as in Production Example 1. [
(제조비교예 3) 카라기난의 조성을 변화시킨 연질 캡슐제 피막 조성물의 제조
(Production Comparative Example 3) Preparation of Soft Capsule Coating Composition with Varying Composition of Carrageenan
하기 표 2에 나타난 조성으로 연질캡슐제 피막 용액 100kg을 제조하여 1 캡슐당 피막 중량을 250mg이 되도록 한다. 연질캡슐제 피막의 제조 및 연질캡슐의 성형 및 건조는 제조실시예 1에서와 동일한 조건으로 실시하였다.
100 kg of a soft capsule coating solution is prepared in the composition shown in Table 2 below, and the coating weight per capsule is 250 mg. The preparation of the soft capsule coating and the molding and drying of the soft capsule were carried out under the same conditions as in Production Example 1. [
(제조비교예 4) 카라기난의 조성을 변화시킨 연질 캡슐제 피막 조성물의 제조
(Manufacturing Comparative Example 4) Production of soft capsule coating composition in which the composition of carrageenan was changed
하기 표 2에 나타난 조성으로 연질캡슐제 피막 용액 100kg을 제조하여 1 캡슐당 피막 중량을 250mg이 되도록 한다. 연질캡슐제 피막의 제조 및 연질캡슐의 성형 및 건조는 제조실시예 1에서와 동일한 조건으로 실시하였다.
100 kg of a soft capsule coating solution is prepared in the composition shown in Table 2 below, and the coating weight per capsule is 250 mg. The preparation of the soft capsule coating and the molding and drying of the soft capsule were carried out under the same conditions as in Production Example 1. [
(실시예 1) 성상 누액(Leak) 및 붕해 안정성시험 비교 평가
(Example 1) Comparative Evaluation of Leakage and Disintegration Stability Test
본 발명의 조성물과 제조방법으로 제조한 제조실시예 1∼3 및 제조비교예 1∼4의 시제품을 갖고 성상, 누액(Leak) 및 붕해에 관한 안정성시험을 진행하여 결과를 평가하였다. 안정성시험은 장기보관조건 25℃, 60%(RH) 24개월, 40℃, 75%(RH)의 가속조건에서 6개월 간 실시하였으며, 보관 조건은 안정성 시험용 HDPE병에 넣은 상태로 진행하여 연질캡슐의 안정성을 평가하였다.The stability test of properties, leakage and disintegration was carried out with the prototypes of Production Examples 1 to 3 and Comparative Production Examples 1 to 4 prepared by the composition of the present invention and the production method, and the results were evaluated. The stability test was carried out for 6 months under the conditions of 25 ℃, 60% (RH) 24 months, 40 ℃ and 75% (RH) for 6 months. Storage conditions were kept in HDPE bottles for stability test, Were evaluated for stability.
붕해 시간 측정을 위해 건강기능식품 공전의 일반시험법 중 붕해시험법에 따라 물을 시험액으로 사용하고 보조판을 넣어 20분간 상하운동을 시킨 다음 관찰할 때 시료의 잔류물이 유리관 내에 전혀 없거나 피막 또는 연질의 물질 또는 니상(泥狀)의 물질이 소량 잔류하였을 때에는 적합한 것으로 판단하였다.
In order to measure the disintegration time, water was used as a test solution according to the disintegration test method in the General Test Methods for Health Functional Foods, and the supernatant was placed in an up / down motion for 20 minutes. Or a small amount of muddy matter.
시료 6개 중 원형상태로 머무르는 것이 1개 또는 피막이 용해, 개구 또는 박리 되었더라도 내용물의 방출이 되지 않은 것이 1개 남았을 때에는 새로 시료 6개를 가지고 이 시험을 되풀이하여 시료의 잔류물이 유리관 내에 전혀 없거나 피막 또는 연질의 물질 또는 니상의 물질이 소량 잔류하였을 때에는 적합한 것으로 처리하여 실시하였으며 개구 시간과 붕해 완료 시간을 측정하였다.
If one of the six specimens remains in a circular state or one of the specimens does not release the content even if the film is dissolved, opened or peeled, repeat the test with six new specimens and the specimen remains in the glass tube When a small amount of film or soft substance or nickel phase material remained, treatment was carried out as appropriate, and the opening time and disintegration completion time were measured.
제조실시예 1∼3 및 제조비교예 1∼4에서 제조된 연질캡슐의 성상 및 누액(Leak)에 관한 안정성 시험을 가속조건 40℃에서 75%(RH) 하에서 실시하고 그 결과를 표 3에 나타내었다.
The stability tests on the properties and leaks of the soft capsules prepared in Production Examples 1 to 3 and Comparative Production Examples 1 to 4 were carried out under accelerated conditions of 40 ° C and 75% (RH). The results are shown in Table 3 .
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
(누액 캡슐의 수/100캡슐)
(Number of leakage capsules / 100 capsules)
표 3에 나타난 바와 같이 본 발명의 연질캡슐과 통상의 연질캡슐 간의 안정성에는 6개월 이내에는 큰 차이가 나타나지 않았다. 그러나 제조비교예 4에서 제조된 연질캡슐의 경우 40℃ 가속조건 하에서 6개월 이후 누액이 발생하였다.
As shown in Table 3, the stability between the soft capsule of the present invention and the conventional soft capsule did not show any great difference within six months. However, in the case of the soft capsule prepared in Comparative Production Example 4, leakage occurred after 6 months under an accelerated condition of 40 ° C.
한편 제조실시예 1∼3 및 제조비교예 1∼4에서 제조된 연질캡슐의 가속 조건 40℃, 75%(RH) 하에서 붕해 안정성시험 결과를 표 4에 나타내었다.
The results of the disintegration stability test of the soft capsules prepared in Production Examples 1 to 3 and Comparative Production Examples 1 to 4 under the acceleration conditions of 40 ° C and 75% (RH) are shown in Table 4.
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
상기의 시험 결과로 알 수 있듯이, 본 발명의 제조 방법으로 제조한 제조실시예 1∼3의 연질캡슐은 붕해 안정성시험에서 문제점을 나타내지 않았으며 따라서 가속조건 하에서 6개월 기간이 경과하여도 붕해 안정성에 큰 문제는 없었다. 그러나 제조비교예 4에서 제조된 연질캡슐제의 경우 40℃, 75%(RH) 조건에서 6개월경과 후 붕해 조건을 만족하지 못하였다. 따라서 본원 발명의 전분 기재 연질캡슐 피막조성물이 통상의 전분기재 연질캡슐 피막조성물에 비해 우수한 붕해 안정성을 지니는 것으로 확인되었다.
As can be seen from the above test results, the soft capsules of Production Examples 1 to 3 produced by the production method of the present invention showed no problems in the disintegration stability test, and therefore, even after a period of 6 months under accelerated conditions, There was no big problem. However, the soft capsules prepared in Comparative Example 4 did not satisfy the disintegration condition after 6 months at 40 ° C and 75% (RH). Thus, it has been found that the starch-based soft capsule coating composition of the present invention has excellent disintegration stability compared to conventional starch-based soft capsule coating compositions.
(실시예 2) 경도 비교 측정 및 깨짐성(Brittle) 시험
(Example 2) Hardness comparative measurement and Brittle test
다음은 본 발명의 제조방법으로 제조한 제조실시예 1∼3의 시제품 및 제조비교예 1∼4에 대하여 실시예1의 안정성시험 조건 중 25℃, 75%(RH), 냉장 4℃ 조건에서 24개월 경도를 비교 측정하고 깨짐성(Brittle) 시험을 진행하여 비교 평가하였다.The results are shown in Table 1. The following demonstrates that the test samples of Preparation Examples 1 to 3 and Preparation Examples 1 to 3 of Preparation Examples 1 to 3 produced by the production method of the present invention were stable at 25 ° C, 75% (RH) Month hardness was compared and the Brittle test was conducted and compared.
경도란 20초 동안 누르는 힘의 단위를 N(Newton)으로 나타낸 것으로 ERWEKA TBH 225 TD 경도계를 사용하여 실험을 진행하였다. 각 검체 10 캡슐을 취하여 지시부(침)로 20초 동안 힘을 가하여 경도를 측정한다.
The hardness is the unit of the force applied for 20 seconds, expressed in N (Newton), and the experiment was carried out using an ERWEKA TBH 225 TD hardness meter. Take 10 capsules of each specimen and measure the hardness by applying a force for 20 seconds with an indicator (needle).
표 5는 장기보관조건 25℃, 60%(RH) 경도(Hardness) 비교 측정 결과를 나타낸 것이고, 표 6은 냉장조건 4℃, 경도(Hardness) 비교 측정 결과를 나타낸 것이다.
Table 5 shows the result of comparative measurement of long-term storage conditions of 25 ° C and 60% (RH) hardness, and Table 6 shows the result of comparative measurement of the refrigerating condition of 4 ° C and hardness.
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
N(Newton)
N (Newton)
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
N(Newton)
N (Newton)
상기의 시험 결과로 알 수 있듯이, 본 발명의 제조 방법으로 제조한 제조실시예 1∼3의 연질캡슐은 경도의 큰 증가를 나타내지 않았으나 제조비교예 1의 경우 25℃, 65%(RH) 조건 하에서 18개월경과 후 경도가 7N으로 증가하고 24개월 경과 후에는 8N으로 증가하였으며 냉장 4℃ 조건 하에서도 6개월 경과 후에 7N, 12개월 경과 후에는 8N, 18개월 경과 후에는 10N, 24개월 경과 후에는 14N으로 증가하였다. 제조비교예 2∼4의 경우도 제조비교예 1과 비슷한 양상으로 경도의 증가를 나타내었다.
As can be seen from the above test results, the soft capsules of Preparation Examples 1 to 3 produced by the production method of the present invention did not show a large increase in hardness, but in Comparative Example 1 under 25 ° C. and 65% (RH) conditions. After 18 months, the hardness increased to 7N and after 24 months, it increased to 8N. Even under 4 ℃ cold condition, 7N after 6 months, 8N after 12 months, 10N after 18 months, and 10N after 24 months Increased to 14N. Production of Comparative Examples 2 to 4 also showed an increase in hardness in a manner similar to that of Comparative Production Example 1.
표 7은 장기보관조건 25℃, 60%(RH) 깨짐성 비교 측정 결과를 나타낸 것이고, 표 8은 냉장조건 4℃에서의 깨짐성 비교 측정 결과를 나타낸 것이다.
Table 7 shows the results of comparative measurements of long-term storage conditions of 25 ° C and 60% (RH), and Table 8 shows the results of comparative measurements of cracking at 4 ° C in a refrigerated condition.
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
(범례) 깨짐 - ○, 양호 - ×
(Legend) Broken - ○, Good - ×
실시예 1Produce
Example 1
실시예 2Produce
Example 2
실시예 3Produce
Example 3
비교예 1Produce
Comparative Example 1
비교예 2Produce
Comparative Example 2
비교예 3Produce
Comparative Example 3
비교예 4Produce
Comparative Example 4
(범례) 깨짐 - ○, 양호 - ×
(Legend) Broken - ○, Good - ×
깨짐성(Brittle) 시험은 30g의 플라스틱 추를 30cm 높이에서 원통형 지지대 상단부에서 하단부로 자유 낙하 시켜 깨짐성을 테스트하였다.
The brittle test tested the brittleness by freely dropping 30 g of the plastic weight from the upper end to the lower end of the cylindrical support at a height of 30 cm.
상기의 시험 결과로 알 수 있듯이 본 발명의 제조 방법으로 제조한 제조실시예 1∼3의 연질캡슐은 깨짐성의 변화가 없었으나 제조비교예 1의 경우 25℃, 65%(RH) 조건 하에서 18개월경과 후 깨짐이 발생하였으며 냉장 4℃ 조건 하에서는 12개월경과 후 깨짐이 발생하였다. 제조비교예 2∼4의 경우도 25℃, 65%(RH) 조건 하에서 18개월 또는 24개월경과 후에 깨짐이 발생하였으며 냉장 4℃ 조건 하에서는 12개월 또는 18개월경과 후 깨짐이 발생하였다. 따라서 본 발명의 연질캡슐제가 깨짐성을 개선시킨 연질캡슐제 임을 확인할 수 있었다.As can be seen from the above test results, the soft capsules of Preparation Examples 1 to 3 prepared by the production method of the present invention showed no change in cracking resistance, but in Comparative Preparation Example 1, Cracking occurred after aging and cracking occurred after 12 months at 4 ℃. In Comparative Examples 2 to 4, cracking occurred after 18 months or 24 months under 25 ° C and 65% (RH), and after 12 months or 18 months under cold 4 ° C. Therefore, it was confirmed that the soft capsule of the present invention is a soft capsule having improved crack resistance.
Claims (4)
2 to 4% by weight of iota-carrageenan and 0.5 to 1.5% by weight of kappa-carrageenan, 5 to 20% by weight of plasticizer, 0.01 to 3% by weight of buffer, and a disintegration aid with respect to 18-25% by weight of hydroxypropyl tapioca modified starch. Soft capsule coating composition comprising 0.01 to 2% by weight, 0.01 to 1% by weight of antioxidant and 45 to 60% by weight of purified water
The soft capsule coating composition according to claim 1, wherein the content of iota-carrageenan is 2.5 to 3.5% by weight and the content of kappa-carrageenan is 0.8 to 1.2% by weight.
The method of claim 1, wherein the plasticizer is at least one selected from mannitol, crystalline or amorphous sorbitol, sorbitan, sucrose, xylitol, erythritol, maltitol, oligosaccharide, isomaltoligosaccharide, glycerin, diglycerol or triglycerol Soft capsule coating composition characterized in that
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020120026920A KR101294614B1 (en) | 2012-03-16 | 2012-03-16 | Soft capsule film composition using modified tapioca starch as main base material |
| JP2013530105A JP5597770B2 (en) | 2011-04-20 | 2012-04-18 | Non-animal soft capsule coating composition with improved disintegration and coating hardness |
| PCT/KR2012/002926 WO2012144789A2 (en) | 2011-04-20 | 2012-04-18 | Non-animal soft capsule shell composition having improved disintegration and shell hardness |
| EP12774763.2A EP2700415B1 (en) | 2011-04-20 | 2012-04-18 | Non-animal soft capsule shell composition having improved disintegration and shell hardness |
| US13/825,304 US8992971B2 (en) | 2011-04-20 | 2012-04-18 | Non-animal soft capsule shell composition having improved disintegration and shell hardness |
| ES12774763.2T ES2617654T3 (en) | 2011-04-20 | 2012-04-18 | Composition of the soft capsule shell of non-animal origin having improved hardness of the shell and disintegration |
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| KR1020120026920A KR101294614B1 (en) | 2012-03-16 | 2012-03-16 | Soft capsule film composition using modified tapioca starch as main base material |
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| KR101294614B1 true KR101294614B1 (en) | 2013-08-08 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR102626286B1 (en) * | 2023-04-18 | 2024-01-18 | 종근당건강 주식회사 | Composition for vegetable soft capsule shell and vegetable soft capsule shell prepared from the same |
| CN118020938A (en) * | 2024-03-27 | 2024-05-14 | 广东润科生物科技有限公司 | Preparation method of fish oil soft capsule for reducing blood fat |
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| KR20020082460A (en) * | 1999-11-19 | 2002-10-31 | 스위스 캅스 레흐테 운트 리첸첸 아게 | Method for producing a moulded body containing starch |
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| KR102626286B1 (en) * | 2023-04-18 | 2024-01-18 | 종근당건강 주식회사 | Composition for vegetable soft capsule shell and vegetable soft capsule shell prepared from the same |
| CN118020938A (en) * | 2024-03-27 | 2024-05-14 | 广东润科生物科技有限公司 | Preparation method of fish oil soft capsule for reducing blood fat |
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