KR100493413B1 - Chewable film coating composition and preparation method using the same - Google Patents
Chewable film coating composition and preparation method using the same Download PDFInfo
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- KR100493413B1 KR100493413B1 KR1019970063602A KR19970063602A KR100493413B1 KR 100493413 B1 KR100493413 B1 KR 100493413B1 KR 1019970063602 A KR1019970063602 A KR 1019970063602A KR 19970063602 A KR19970063602 A KR 19970063602A KR 100493413 B1 KR100493413 B1 KR 100493413B1
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- tablet
- film coating
- chewable
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- 239000000203 mixture Substances 0.000 title claims abstract description 18
- 239000007888 film coating Substances 0.000 title claims abstract description 11
- 238000009501 film coating Methods 0.000 title claims abstract description 11
- 238000002360 preparation method Methods 0.000 title description 2
- DLRVVLDZNNYCBX-UHFFFAOYSA-N Polydextrose Polymers OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(O)O1 DLRVVLDZNNYCBX-UHFFFAOYSA-N 0.000 claims abstract description 22
- 229920001800 Shellac Polymers 0.000 claims abstract description 19
- 239000004208 shellac Substances 0.000 claims abstract description 18
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 claims abstract description 18
- 229940113147 shellac Drugs 0.000 claims abstract description 18
- 235000013874 shellac Nutrition 0.000 claims abstract description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229920001100 Polydextrose Polymers 0.000 claims abstract description 11
- 239000001259 polydextrose Substances 0.000 claims abstract description 11
- 235000013856 polydextrose Nutrition 0.000 claims abstract description 11
- 229940035035 polydextrose Drugs 0.000 claims abstract description 11
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 10
- 239000008101 lactose Substances 0.000 claims abstract description 10
- 229920002472 Starch Polymers 0.000 claims abstract description 9
- 229910010413 TiO 2 Inorganic materials 0.000 claims abstract description 9
- 238000004519 manufacturing process Methods 0.000 claims abstract description 9
- 239000008107 starch Substances 0.000 claims abstract description 9
- 235000019698 starch Nutrition 0.000 claims abstract description 9
- 239000000454 talc Substances 0.000 claims abstract description 9
- 229910052623 talc Inorganic materials 0.000 claims abstract description 9
- 239000000049 pigment Substances 0.000 claims abstract description 7
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 14
- 239000000654 additive Substances 0.000 abstract description 4
- 230000000694 effects Effects 0.000 abstract description 2
- 210000003296 saliva Anatomy 0.000 abstract description 2
- -1 pigments Chemical compound 0.000 abstract 1
- 238000004321 preservation Methods 0.000 abstract 1
- 239000003826 tablet Substances 0.000 description 31
- 238000000576 coating method Methods 0.000 description 15
- 239000011248 coating agent Substances 0.000 description 13
- 239000007788 liquid Substances 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 230000001055 chewing effect Effects 0.000 description 4
- 230000000052 comparative effect Effects 0.000 description 4
- 239000003795 chemical substances by application Substances 0.000 description 3
- 239000007921 spray Substances 0.000 description 3
- 230000003746 surface roughness Effects 0.000 description 3
- 239000008199 coating composition Substances 0.000 description 2
- 239000008298 dragée Substances 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 235000013373 food additive Nutrition 0.000 description 2
- 239000002778 food additive Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 2
- 238000005507 spraying Methods 0.000 description 2
- 235000000346 sugar Nutrition 0.000 description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- UBVSIAHUTXHQTD-UHFFFAOYSA-N 2-n-(4-bromophenyl)-1,3,5-triazine-2,4-diamine Chemical compound NC1=NC=NC(NC=2C=CC(Br)=CC=2)=N1 UBVSIAHUTXHQTD-UHFFFAOYSA-N 0.000 description 1
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 description 1
- SGHZXLIDFTYFHQ-UHFFFAOYSA-L Brilliant Blue Chemical compound [Na+].[Na+].C=1C=C(C(=C2C=CC(C=C2)=[N+](CC)CC=2C=C(C=CC=2)S([O-])(=O)=O)C=2C(=CC=CC=2)S([O-])(=O)=O)C=CC=1N(CC)CC1=CC=CC(S([O-])(=O)=O)=C1 SGHZXLIDFTYFHQ-UHFFFAOYSA-L 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- 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 description 1
- 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 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 108010010803 Gelatin Proteins 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 229960005069 calcium Drugs 0.000 description 1
- 229920002301 cellulose acetate Polymers 0.000 description 1
- 229920006217 cellulose acetate butyrate Polymers 0.000 description 1
- 239000013522 chelant Substances 0.000 description 1
- 239000007910 chewable tablet Substances 0.000 description 1
- 229940068682 chewable tablet Drugs 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 229960005188 collagen Drugs 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 235000012732 erythrosine Nutrition 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000013376 functional food Nutrition 0.000 description 1
- 229920000159 gelatin Polymers 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 235000019322 gelatine Nutrition 0.000 description 1
- 235000011852 gelatine desserts Nutrition 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 230000000873 masking effect Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 150000005846 sugar alcohols Chemical class 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/28—Tabletting; Making food bars by compression of a dry powdered mixture
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
- A23P20/10—Coating with edible coatings, e.g. with oils or fats
- A23P20/105—Coating with compositions containing vegetable or microbial fermentation gums, e.g. cellulose or derivatives; Coating with edible polymers, e.g. polyvinyalcohol
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2893—Tablet coating processes
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2250/00—Food ingredients
- A23V2250/50—Polysaccharides, gums
- A23V2250/51—Polysaccharide
- A23V2250/5116—Other non-digestible fibres
Abstract
본 발명은 씹어먹는 필름 코팅제용 조성물 및 이를 이용한 정제의 제조방법에 관한 것으로, 좀 더 상세하게는 물 100중량부에 전분 1∼4중량부, 폴리덱스트로스(polydextrose) 20∼40중량부, TiO2 10∼15중량부, 락토오스(lactose) 2∼5중량부, 탈크(talc) 2∼5중량부, 백색 쉘락(shelac) 2∼5중량부 및 색소와 같은 기타 첨가제로 이루어진 씹어먹는 필름 코팅제용 조성물 및 이를 이용한 정제의 제조방법에 관한 것이다. 상기 조성물은 정제에 코팅시 표면이 매끄럽고 끈적거림이 없으며 내용물의 보존 효과가 뛰어나고, 씹어 먹을 때 입안에 필름의 잔류감이 없이 침에 의해서 쉽게 녹는다.The present invention relates to a chewable film coating composition and a method for producing a tablet using the same. More specifically, 100 parts by weight of water 1 to 4 parts by weight of starch, polydextrose (polydextrose) 20 to 40 parts by weight, TiO 2 10 A composition for a chewable film coating, comprising 15 parts by weight, 2 to 5 parts by weight of lactose, 2 to 5 parts by weight of talc, 2 to 5 parts by weight of white shellac, and other additives such as pigments, and It relates to a method for producing a tablet using the same. When the composition is coated on tablets, the surface is smooth and non-sticky, and the preservation effect of the contents is excellent, and when chewed, it is easily melted by saliva without any residue of the film in the mouth.
Description
본 발명은 씹어먹는 필름 코팅제용 조성물 및 이를 이용한 정제의 제조방법에 관한 것으로, 좀 더 상세하게는 표면이 매끄럽고 끈적거리지 않으며 씹을 때 입안에 잔류감이 없는 씹어먹는 필름 코팅제용 조성물 및 이를 이용한 정제의 제조방법에 관한 것이다.The present invention relates to a chewable film coating composition and a method for producing a tablet using the same, and more particularly, the surface of the chewable film coating composition and a tablet using the same having a smooth, non-sticky and no residue in the mouth when chewing It relates to a manufacturing method.
씹어먹는 제형으로는 당의정을 생각할 수 있으나, 이 경우는 당의에 의해서 정제가 단단해져서 씹어 먹기에 불편할 뿐만 아니라 제조 시간이 오래 걸리는 단점이 있다.The chewable formulation can be thought of as dragee, but in this case, the tablet is hardened by the dragee not only inconvenient to chew, but also takes a long time to manufacture.
본 발명에서는 필름 코팅으로 코팅된 씹어 먹는 정제를 제시하는 바, 이러한 필름 코팅제는 수분이나 공기에 의하여 변색 또는 부패되는 내용물을 보호하기 위해 의약품에 일반적으로 사용된다.In the present invention provides a chewable tablet coated with a film coating, such a film coating agent is generally used in medicines to protect the contents discolored or rotted by moisture or air.
헤일릭(Helig) 등의 미합중국 특허 제 4,252,786호에는 쉘락(shelac) 및 폴리 비닐피롤리돈으로 피복된 정제가 개시되어 있으며, 이 외에도 일반적으로 쉘락 단독 내지는 에틸 셀룰로오스 등을 사용한 예는 다수 보고되어 있다. 그러나, 이 경우는 물과 함께 삼키는 것이 보통이므로 저작 가능한 제형의 경우에는 입안의 필름 잔류감 등의 이유로 적용될 수 없다.US Patent No. 4,252,786 to Helig et al. Discloses tablets coated with shellac and polyvinylpyrrolidone, and many examples of shellac alone or ethyl cellulose have been reported. . However, in this case, it is usually swallowed with water, and in the case of chewable formulation, it cannot be applied for reasons such as film residue in the mouth.
한편, 대한민국 특허공고 제 97-7899호에는 셀룰로스 아세테이트 또는 셀룰로스 아세테이트 부티레이트 및 폴리비닐 피롤리돈의 혼합물로 된 씹을 수 있는 맛 차폐용 필름코팅용 조성물이 제시된 바 있다. 그러나, 상기 특허의 목적은 고미를 나타내는 성분을 피복하여 저작시 고미성분이 침에 의해서 녹지 않도록 하는 것이므로 본 발명의 목적과는 다르다.Meanwhile, Korean Patent Publication No. 97-7899 discloses a chewable taste masking film coating composition of cellulose acetate or a mixture of cellulose acetate butyrate and polyvinyl pyrrolidone. However, the purpose of the patent is different from the object of the present invention, because the purpose of the patent is to coat the components representing the taste and so that the taste component is not dissolved by saliva during chewing.
본 발명은 종래의 단점을 개선하여 단시간에 쉽게 제조가 가능하며 씹어 먹기에 편하고 내용물 보호력이 뛰어난 필름코팅 조성물에 관한 것이다.The present invention relates to a film coating composition which can be easily manufactured in a short time by improving the disadvantages of the conventional art, is easy to chew, and has excellent contents protection.
따라서, 본 발명의 목적은 표면이 매끄럽고 끈적거림이 없으며 입안에 잔류감이 없을 뿐 아니라 내용물 보호력이 뛰어난 코팅제용 조성물을 제공하는데에 있다.Accordingly, an object of the present invention is to provide a coating composition having a smooth surface, no stickiness, no residual feeling in the mouth, and excellent contents protection.
본 발명의 다른 목적은 상기 조성물로 코팅된 정제의 제조방법을 제공하는데 있다.Another object of the present invention to provide a method for producing a tablet coated with the composition.
상기 목적을 달성하기 위한 본 발명의 코팅제용 조성물은 물 100중량부에 전분 1∼4중량부, 폴리덱스트로스(polydextrose) 20∼40중량부, TiO2 10∼15중량부, 락토오스(lactose) 2∼5중량부, 탈크(talc) 2∼5중량부, 백색 쉘락 2∼5중량부 및 색소와 같은 기타 첨가제로 이루어진다.The coating composition of the present invention for achieving the above object is 1 to 4 parts by weight of starch, 20 to 40 parts by weight of polydextrose, 10 to 15 parts by weight of TiO 2 , lactose 2 to 5 parts by weight of water It is composed of parts by weight, 2 to 5 parts by weight of talc, 2 to 5 parts by weight of white shellac and other additives such as pigments.
상기 다른 목적을 달성하기 위한 본 발명의 제조방법은 물 100중량부에 전분 1∼4중량부, 폴리덱스트로스 20∼40중량부, TiO2 10∼15중량부, 락토오스 2∼5중량부, 탈크 2∼5중량부를 차례로 용해시킨 뒤, 색소와 같은 기타첨가제를 첨가시켜 용해시킨 액으로 정제에 대하여 정제 중량 대비 0.01중량부에서 0.03중량부로 1차 코팅한 다음, 1차 코팅된 정제에 에탄올 20중량부에 백색 쉘락 5∼20중량부를 용해시킨 액을 물 100중량부에 대하여 상기 백색 쉘락이 2∼5중량부의 양으로 분사시키는 것으로 이루어진다.The production method of the present invention for achieving the other object is 1 to 4 parts by weight of starch, 20 to 40 parts by weight of polydextrose, 10 to 15 parts by weight of TiO 2 , 2 to 5 parts by weight of lactose, 2 to talc After dissolving 5 parts by weight in turn, the solution was dissolved by adding other additives such as pigments, and then first coated with tablets from 0.01 parts by weight to 0.03 parts by weight of the tablet, and then 20 parts by weight of ethanol in the first coated tablet. It consists of spraying the solution which melt | dissolved 5-20 weight part of white shellac in the quantity of 2-5 weight part of said white shellac with respect to 100 weight part of water.
이하 본 발명의 조성물을 좀 더 구체적으로 살펴보면 다음과 같다.Looking at the composition of the present invention in more detail as follows.
본 발명에 따르면, 물 100중량부에 전분 1∼4중량부, 폴리덱스트로스 20∼40중량부, TiO2 10∼15중량부, 락토오스 2∼5중량부, 탈크 2∼5중량부를 차례로 용해시킨 뒤 마지막으로 색소를 체로 걸러 넣어 용해시킨 액으로써 우선 정제를 정제 중량 대비 0.01중량부에서 0.03중량부에 해당하는 양으로 1차 코팅한다. 1차 코팅된 정제에 에탄올 20중량부에 백색 쉘락 5∼20중량부를 용해시킨 액을 분사시켜 상기 백색 쉘락이 물 100중량부에 대하여 2∼5중량부로 코팅된 정제를 제조한다.According to the present invention, 1 to 4 parts by weight of starch, 20 to 40 parts by weight of polydextrose, 10 to 15 parts by weight of TiO 2 , 2 to 5 parts by weight of lactose, and 2 to 5 parts by weight of talc are dissolved in order. First, the tablets were first coated in an amount corresponding to 0.03 parts by weight to 0.01 parts by weight based on the weight of the tablets. A solution in which 5 to 20 parts by weight of white shellac was dissolved in 20 parts by weight of ethanol was sprayed onto a primary coated tablet to prepare a tablet in which the white shellac was coated to 2 to 5 parts by weight with respect to 100 parts by weight of water.
한편, 본 발명에서는 기존에 의약품 및 식품용 코팅제 성분으로 사용된 바 없는 폴리덱스트로스를 20∼40중량부 사용한다. 상기 폴리덱스트로스는 수용성 섬유소로서 다이어트 식품에서 섬유소를 공급하기 위하여 주로 사용된다. 폴리덱스트로스는 물에 잘 녹고 끈적거리는 성질이 있으나 씹어먹는 코팅제로 사용할 때 입안에서 이질감이 없는 수용성 필름을 형성하는 특징이 있어 코팅제에 적합하다. 그 사용량이 20중량부 미만이면 코팅 피막 형성이 미흡하고 40중량부를 초과하면 분사하기가 어렵고 점도가 지나쳐 정제끼리 달라 붙을 수 있다.On the other hand, the present invention uses 20 to 40 parts by weight of a polydextrose that has not previously been used as a coating component for pharmaceuticals and foods. The polydextrose is mainly used to supply fiber in diet foods as water-soluble fiber. Polydextrose is well soluble and sticky in water, but when used as a chewable coating, it is suitable for coating because it forms a water-soluble film with no discomfort in the mouth. If the amount is less than 20 parts by weight, the coating film is insufficient to form and if it exceeds 40 parts by weight, it is difficult to spray and the viscosity may be excessive to stick the tablets together.
또한, 현탁용도로 사용되는 전분은 1∼4중량부가 바람직하며, 상기 범위를 초과하면 분사시키기 어렵고 1중량부보다 적으면 조제액중의 고형분이 가라앉는 단점이 있다.In addition, the starch used for suspension is preferably 1 to 4 parts by weight, and if it exceeds the above range, it is difficult to spray, and when less than 1 part by weight, the solid content in the preparation subsides.
차광제인 TiO2는 10∼15중량부 사용되며, 상기 범위를 초과하면 코팅 표면이 거칠어지고 10중량부보다 적으면 차광 효과가 떨어지는 단점이 있다. 락토오스는 2∼5중량부 사용되며 초과하면 코팅표면이 거칠고, 적으면 침전물이 발생하는 단점이 있다. 탈크는 2∼5중량부 사용되며 초과하면 분사시키기 힘들고, 2중량부보다 적으면 정제끼리 달라 붙는 단점이 있다.TiO 2, which is a light shielding agent, is used in an amount of 10 to 15 parts by weight, and the coating surface becomes rough when it exceeds the above range, and when it is less than 10 parts by weight, there is a disadvantage in that the light blocking effect is inferior. Lactose is used in 2 to 5 parts by weight and if the coating surface is rough, there is a disadvantage that a small amount of precipitate occurs. Talc is used in 2 to 5 parts by weight, it is difficult to spray when exceeded, if less than 2 parts by weight has a disadvantage that the tablets stick to each other.
백색 쉘락은 에탄올 20중량부에 백색 쉘락 5∼20중량부의 양으로 용해시켜 사용하며 이 범위보다 백색 쉘락의 양이 초과하면 씹을 때 이질감이 있고 미만이면 끈적거림을 방지하는 효과가 떨어진다. 쉘락은 본 발명에서 1차 코팅된 정제에 물 100중량부에 대하여 2∼5중량부의 양으로 분사시키는 형태로 사용된다. 이때, 함께 사용된 에탄올은 휘발되어 제거된다. 또한 본 발명에 따른 조성물은 착색 및 차광을 하기 위해 색소와 같은 기타 첨가제를 포함한다.White shellac is dissolved in 20 parts by weight of ethanol in an amount of 5 to 20 parts by weight of white shellac. When the amount of white shellac is exceeded, the chelate has a heterogeneity and less than the effect of preventing stickiness. Shellac is used in the present invention in the form of spraying the primary coated tablet in an amount of 2 to 5 parts by weight based on 100 parts by weight of water. At this time, ethanol used together is removed by volatilization. The composition according to the invention also comprises other additives such as pigments for coloring and shading.
본 발명은 정제 코팅용 조성물의 적용 대상이 되는 정제의 제조 과정은 하기 예시하는 공지의 방법에 의한다.The present invention is a process for producing a tablet to be applied to the composition for coating coating by a known method illustrated below.
정제의 제조Manufacture of tablets
일반적으로 정제는 공지의 방법에 의해 제조가능한데, 포도당, 유당, 설탕 등의 당류 또는 솔비톨, 만니톨 등의 당알콜과 칼슘, 레시틴, 콜라겐, 비타민 등의 기능성 식품을 적당한 비율로 혼합하고 전분풀, 젤라틴액 등의 결합액을 사용하여 과립을 제조한 뒤 40∼60℃의 온도에서 수분의 4%미만이 될 때까지 건조시켜 체를 통과시켜서 알맞은 크기의 입자로 정립시킨 뒤 스테아린산 마그네슘 등의 활제를 0.5∼1.0% 혼합하고 타정하여 정제를 제조한다.Generally, tablets can be prepared by a known method, and sugars such as glucose, lactose and sugar or sugar alcohols such as sorbitol and mannitol and functional foods such as calcium, lecithin, collagen and vitamins are mixed in a suitable ratio, and starch paste and gelatin solution are used. The granules are prepared using a binder solution, and the like are dried at a temperature of 40 to 60 ° C. until they are less than 4% of water, passed through a sieve, and then granulated into particles of a suitable size. Tablets are prepared by mixing and tableting 1.0%.
이하 실시예를 통하여 본 발명을 좀 더 구체적으로 살펴보지만, 하기 예에 본 발명의 범주가 한정되는 것은 아니다. 이하 단위 "부"는 별도의 언급이 없는한, "중량부"를 의미한다.Hereinafter, the present invention will be described in more detail with reference to the following examples, but the scope of the present invention is not limited to the following examples. Hereinafter, the unit "parts" means "parts by weight" unless otherwise stated.
실시예 1Example 1
물 300g에 전분 6g, 폴리덱스트로스 100g, TiO2 35g, 락토오스 10g, 탈크, 10g를 차례로 용해시키고, 여기에 색소로 블루 1호(보라색소, 식품첨가물 규격품) 30mg과 레드 3호(보라색소, 식품첨가물 규격품) 50mg을 체로 걸러넣고 용해시킨다. 이렇게 제조된 액으로 정제를 코팅한다. 코팅하는 방법은 공지의 방법으로서 정제 5kg을 코팅팬에 넣고 10rpm의 속도로 운전시킨다. 정제 상층부에 75℃의 열풍을 가하면서 코팅액을 1.2l/hr의 양으로 분사시켜 정제중량 대비 0.01부에서 0.03부에 해당하는 양으로 코팅한다. 그 다음, 에탄올 20중량부에 백색 쉘락(Nippon Shelac(일본)) 10중량부를 용해시킨 다음, 상기 1차 코팅된 정제에 분사시켜 최종 백색 쉘락의 양은 물 100중량부에 대하여 약 3중량부이었다.In 300 g of water, 6 g of starch, 100 g of polydextrose, 35 g of TiO 2 , 10 g of lactose, talc, and 10 g were dissolved in this order. 50 mg of the standard product is sieved and dissolved. The tablet is coated with the liquid thus prepared. The coating method is a known method, in which 5 kg of tablets are put in a coating pan and operated at a speed of 10 rpm. The coating liquid is sprayed in an amount of 1.2 l / hr while applying hot air at 75 ° C. to the upper layer of the tablet, and the coating liquid is coated in an amount corresponding to 0.01 to 0.03 parts relative to the tablet weight. Then, 10 parts by weight of white shellac (Nippon Shelac (Japan)) was dissolved in 20 parts by weight of ethanol, and then sprayed onto the primary coated tablet, and the amount of the final white shellac was about 3 parts by weight based on 100 parts by weight of water.
비교예 1Comparative Example 1
에탄올 300g에 백색쉘락 100g, TiO2 35g, 락토오스 10g, 탈크 10g을 용해시키고 여기에 색소로 블루 1호(보라색소, 식품첨가물 규격품) 30mg과 레드 3호(보라색소, 식품첨가물 규격품) 50mg을 체로 걸러 넣고 용해시킨다. 이렇게 제조된 액으로 정제를 코팅한다. 코팅하는 방법은 공지의 방법으로서 정제 5kg을 코팅팬에 넣고 10rpm의 속도로 운전시킨다. 정제 상층부에 60℃의 열풍을 가하면서 코팅액을 1.2l/hr의 양으로 분사하여 정제 중량 대비 0.01부에서 0.03부에 해당하는 양으로 코팅한다.Dissolve 100g of white shellac, 35g of TiO 2 , 10g of lactose, and 10g of talc in 300g of ethanol and sift 30 g of Blue No. 1 (purple color, food additive standard) and 50mg of Red No. 3 (purple color, food additive standard) as a pigment. Filter and dissolve. The tablet is coated with the liquid thus prepared. The coating method is a known method, in which 5 kg of tablets are put in a coating pan and operated at a speed of 10 rpm. The coating liquid is sprayed in an amount of 1.2 l / hr while applying hot air at 60 ° C. to the upper layer of the tablet to coat an amount corresponding to 0.01 to 0.03 parts by weight of the tablet.
상기 실시예 및 비교예에 의해 제조된 정제에 대한 필름잔류감 및 표면거칠기를 훈련된 관능검사요원 30이 측정하였다. 그 결과는 하기 표 1에 기재하였다.The film residue and surface roughness of the tablets prepared by Examples and Comparative Examples were measured by the trained sensory agent 30. The results are shown in Table 1 below.
[표 1]TABLE 1
표면거칠기 및 필름잔류감은 하기의 기준으로 평가한 평균치임.Surface roughness and film residue are average values evaluated based on the following criteria.
1: 매우거침 2: 거침 3: 보통 4: 매끄러움 5: 매우 매끄러움1: very rough 2: rough 3: moderate 4: smooth 5: very smooth
1: 매우 많음 2: 많음 3: 보통 4: 약간 5: 잔류하지 않음1: Very much 2: Many 3: Normal 4: Slight 5: No residue
상기 표 1에서 알 수 있는 바와 같이, 본 발명에 따른 조성물은 표면이 매끄럽고 끈적거림이 없다. 특히, 실시예 1의 정제는 씹을 때 필름 잔류감이 없는데 반해, 비교예 1의 정제는 씹을 때 필름 잔류감이 많음을 확인할 수 있다.As can be seen in Table 1, the composition according to the present invention has a smooth surface and no stickiness. In particular, while the tablet of Example 1 does not have a film residual feeling when chewing, it can be confirmed that the tablet of Comparative Example 1 has a large film residual feeling when chewing.
Claims (2)
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| US4808411A (en) * | 1987-06-05 | 1989-02-28 | Abbott Laboratories | Antibiotic-polymer compositions |
| JPH04228030A (en) * | 1990-04-09 | 1992-08-18 | Warner Lambert Co | Low calory compression tablet with improved taste |
| WO1996000509A1 (en) * | 1994-06-29 | 1996-01-11 | Cultor Ltd. | Polydextrose and food additive mixture |
| KR970005278A (en) * | 1995-07-18 | 1997-02-19 | 장민수 | Chewable dragee and its manufacturing method |
| KR970025608A (en) * | 1995-11-08 | 1997-06-24 | 장민수 | Soft sugar dragee and manufacturing method |
| KR19990000223A (en) * | 1997-06-03 | 1999-01-15 | 김재철 | Acetaminophen formulation with excellent bitterness concealment |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4808411A (en) * | 1987-06-05 | 1989-02-28 | Abbott Laboratories | Antibiotic-polymer compositions |
| JPH04228030A (en) * | 1990-04-09 | 1992-08-18 | Warner Lambert Co | Low calory compression tablet with improved taste |
| WO1996000509A1 (en) * | 1994-06-29 | 1996-01-11 | Cultor Ltd. | Polydextrose and food additive mixture |
| KR970005278A (en) * | 1995-07-18 | 1997-02-19 | 장민수 | Chewable dragee and its manufacturing method |
| KR970025608A (en) * | 1995-11-08 | 1997-06-24 | 장민수 | Soft sugar dragee and manufacturing method |
| KR19990000223A (en) * | 1997-06-03 | 1999-01-15 | 김재철 | Acetaminophen formulation with excellent bitterness concealment |
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