KR20020062028A - Double Coating Tablet - Google Patents

Double Coating Tablet Download PDF

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KR20020062028A
KR20020062028A KR1020010003233A KR20010003233A KR20020062028A KR 20020062028 A KR20020062028 A KR 20020062028A KR 1020010003233 A KR1020010003233 A KR 1020010003233A KR 20010003233 A KR20010003233 A KR 20010003233A KR 20020062028 A KR20020062028 A KR 20020062028A
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gastric
enteric
component
coating
tablet
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KR1020010003233A
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KR100404657B1 (en
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구창휘
이희상
홍재국
김현조
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부광약품 주식회사
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    • 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
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/01—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/695—Silicon compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46—Hydrolases (3)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medicinal Preparation (AREA)

Abstract

PURPOSE: A process of preparing a double-layer tablet containing creosote and dimethicone as a gastric-soluble component and pancreatin as an enteric component by controlling a film coating layer of the gastric-soluble part to be 7 to 10% by weight of the total weight is provided which exhibits a desirable digestive function improving effect. CONSTITUTION: A gastric-soluble component such as creosote and dimethicone is directly dissolved in a gastric-soluble film coating liquid and coated on the surface of a film forming agent of an enteric part containing pancreatin as an enteric component. The film coating liquid is hydroxy propyl methylcellulose phthalate and isopropanol and the film forming agent is glycerin fatty acid ester, phthalic acid hydroxy propyl methylcellulose, shellac.

Description

이중코팅정 및 그 제조방법{Double Coating Tablet}Double coated tablet and its manufacturing method {Double Coating Tablet}

본 발명은 소화효소인 판크레아틴을 포함한 장용부 성분을 먼저 타정한후 장용성 코팅을 실시하고 그위에 가스제거 효과가 있는 시메치콘과 방부 살균력이 우수한 크레오소오트를 포함한 위용부 성분들을 위용부 필름 코팅 액에 용해시킨 후 장용성 코팅 위에 다시 이중코팅을 함으로써 종래의 장용핵정 제조공정, 장용제피공정, 위용부정 제조공정, 위용부의 외용피공정의 4단계 공정을 2단계로 단순화시키고 각각의 코팅층을 조절함으로써 위용성분과 장용성분의 연속적인 방출을 가능하게 한 것이다.In the present invention, the enteric component including the digestive enzyme pancreatin is first tableted, and then enteric coating is applied to the stomach coating for gastric component including the gastric effect and the creosote having excellent antiseptic bactericidal effect. By dissolving in liquid and then double-coating on the enteric coating, the four-step process of the conventional enteric core manufacturing process, enteric coating process, gastric irregularity manufacturing process, and external coating process of the gastric part in two steps is simplified and each coating layer is adjusted. It enables the continuous release of gastric and enteric ingredients.

한국등록특허공보 등록번호 제 217308호에는 위용 외부 층과 장용핵정으로 분리 구성되어 있는 이중핵정이 공지되어 있으나 장용부를 먼저 중앙핵정으로 타정하고 장용 코팅 후 다시 그 위에 위용부를 외부 코팅핵정으로 타정한 다음에 통상의 외피를 코팅하여 이중핵정으로 제조해야 하는 공정상 번거러움이 있다. 또한 위용부와 장용부를 핵정으로 만들어 코팅을 하기 때문에 위용성분과 장용성분의 연속적인 방출에 어려움이 있다. 한국등록특허공보 등록번호 제165920호에는 상층과 하층에 제산제를 함유하고 중간층에 소화효소를 함유하는 삼중정이 기재되어 있으나 제산제를 함유하는 상층과 하층의 바깥층이 먼저 용해되어 위내 pH를 조절함으로써 소화효소의 생리활성을 증진시키고자 단순히 삼중정 으로 제조한 것으로 약효성분의 방출을 조절하는 기능은 갖지 못한다.Korean Patent Application Publication No. 217308 discloses a double core tablet which is composed of an outer layer and an enteric core tablet, but enters the enteric core first into a central core tablet, and then enters the enteric coating into an outer coated core tablet. There is a hassle in the process of manufacturing a double core tablet by coating a conventional outer shell. In addition, there is a difficulty in the continuous release of gastric components and enteric components because the coating to make the stomach and enteric part nuclear tablets. Korean Patent Publication No. 165920 discloses a triplet containing an antacid in the upper and lower layers and a digestive enzyme in the middle layer, but the outer layer of the upper and lower layers containing the antacid is dissolved first to adjust the pH in the stomach. In order to enhance the physiological activity of the prepared by simply triple tablets do not have the function to control the release of the active ingredient.

본 발명의 소화기능 개선제에 있어서는 소화기능 개선효과를 극대화하기 위하여 위용성 성분과 장용부 성분의 연속적인 방출이 필요하다. 페놀성의 크레오소오트는 위용부의 코팅액인 유기용매에 용해되어 용출이 가능하므로 위용부성분에 포함되어 먼저 방출되어야하고, 또 가스제거 성분인 시메치콘도 역시 그 약화학적인 성질상 위용부 코팅액에 추가되는 것이 바람직하며 그 이후에 장용부성분인 소화효소가 용출되어야 장에서 그 소화기능을 가지기 때문이다. 본 발명에 있어서는 위용부 성분인 크레오소오트와 시메치콘이 2시간내 위에서 전량 방출되고 장용부 성분이 장내에 도달하여(약 1시간 30분후) 30분내에 방출하는 것이 가장 바람직한 소화기능개선 효과를 갖는다.In the digestive function improving agent of the present invention, in order to maximize the digestive function improving effect, the continuous release of gastric soluble components and enteric components. Phenolic creosote is dissolved in an organic solvent, which is a coating solution for stomach preparations, so that it can be eluted. Therefore, phenolic creosote must be included in the stomach preparations and released first. This is because the intestinal component of the digestive enzymes must be eluted afterwards to have the digestive function in the intestine. In the present invention, it is most preferable to release the gasoline component components such as creosote and simethicone in the stomach within 2 hours, and enteric component components reach the intestine (after about 1 hour and 30 minutes) to release within 30 minutes. Have

본 발명자는 위와 같은 용출패턴을 얻고자 연구한 결과 위용부 필름 코팅층을 총 정제 중량의 7-10중량%가 되도록 조절함으로써 본 발명을 완성하였다.The present inventors have completed the present invention by adjusting the gastric coating film coating layer to 7-10% by weight of the total tablet weight as a result of the study to obtain the above dissolution pattern.

도 1은 본 발명의 이중코팅의 소화제성분중 크레오소오트, 시메치콘 및 판크레아틴의 용출그림을 나타낸 것이다.Figure 1 shows the elution of creosote, simethicone and pancreatin in the double-coating extinguishing agent of the present invention.

본 발명은 위용부성분으로는 크레오소오트, 시메치콘을 함유하고 장용부성분으로는 판크레아틴을 함유하는 이중 코팅 정 및 그 제조방법에 관한 것으로, 위용부성분을 위용부 필름 코팅 액에 직접 녹여서 장용부제피위에 바로 이중 코팅한 것으로 간단한 이중코팅으로 장용부와 위용부를 분리하고 코팅 층을 조절함으로써 위용부성분과 장용성분의 연속적인 방출이 가능하게 한 이중코팅정을 제공하는 데에 그 목적이 있다.The present invention relates to a double-coated tablet containing a creosote, simethicone as a gastrointestinal component and a pancreatin as an enteric component, and a method for manufacturing the same. It is an object of the present invention to provide a double coated tablet which enables continuous release of the gastrointestinal component and the enteric component by separating the enteric part and the gastrointestinal part by controlling the coating layer by a simple double coating.

본 발명의 목적에 부합되는 바람직한 위용부와 장용부의 조성성분 및 코팅층의 구성성분을 열거하면 아래와 같다.The composition of the preferred gastric and enteric parts and the components of the coating layer according to the object of the present invention are listed as follows.

위용부성분으로서는 크레오소오트 2~3중량부, 시메치콘 1~2중량부와 코팅액 성분으로 하이드록시 프로필 메칠셀루로오스 프탈레이트 8-10중량부를 이소프로판올에 녹여서 필름코팅하고 필요에 따라 Orpadry Green 21025으로 색소를 입힌다. 장용부 성분으로는 주성분으로써 판크레아틴 (프로테아제 6000 USP, 리파제 480 USP, 아밀라제 4000 USP 단위) 15~20중량부와 부형제로써 유당, 미결정 셀룰로오스, 젤라틴화 전분, 탈크와 마그네슘 스테아레이트이다.As a gastric ingredient, 2 to 3 parts by weight of creosote, 1 to 2 parts by weight of simethicone and 8 to 10 parts by weight of hydroxypropyl methylcellulose phthalate as a coating liquid component are dissolved in isopropanol and coated with a pigment as needed. Clothe. Enteric components include 15-20 parts by weight of pancreatin (protease 6000 USP, lipase 480 USP, amylase 4000 USP units) as the main component and lactose, microcrystalline cellulose, gelatinized starch, talc and magnesium stearate as excipients.

장용피제 용액의 성분은 글리세린 지방산 에스테르, 프탈산 히드록시 프로필 메칠셀룰로오스 200731, 정제쉘락으로 구성되며 장용부 정제 중량의 7~10중량% 코팅 되도록 조정한다. 그러고나서, 장용코팅된 정제가 완전히 건조된 이후에 위용부 성분과 하이드록시 프로필 메칠셀루로오스 프탈레이트가 용해되어 있는 위용코팅액으로 총정제 중량에 대하여 시메치콘과 크레오소트의 함량이 비례적으로 증가되도록 즉, 위용부 코팅층이 정제 총중량의 7~10중량% 범위가 되도록 코팅액을 더해나간다.The components of the enteric skin solution consist of glycerin fatty acid ester, phthalic acid hydroxypropyl methylcellulose 200731, tablet shellac and are adjusted to coat 7-10% by weight of the tablet weight of the enteric tablet. Then, after the enteric-coated tablet is completely dried, the gastric coating solution in which gastric component and hydroxy propyl methylcellulose phthalate are dissolved so that the content of simethicone and creosote increases proportionally to the total tablet weight. , The coating solution is added so that the gastric coating layer is in the range of 7 to 10% by weight of the total weight of the tablet.

실시예Example

정제 1정당 미결정 셀룰로오스 10 mg, 유당 180 mg, 젤라틴화 전분 20 mg, 판크레아틴 70 mg 을 0.5 mm 체로 사과하여 스피드 믹서기에 차례대로 넣고 10분간 혼합한다. 이 후에 결합제는 따로 제조하여 즉, 100℃ 의 정제수 적량을 넣은 후 여기에 아라비아고무 32 mg을 서서히 가하여서 약 5분간 교반한 다음 스텐레스 용기에 옮겨 수욕상에서 35~40℃ 가 되도록 냉각한다. 스피드 믹서에 혼합한 분말을 넣고 결합제를 서서히 가하면서 믹서 100 rpm, 초파 1,500 rpm 으로 2분간 연합후 유출한다. 연합후 조립기 (mesh size : 210 mm)를 사용하여 적절하게 조립한다. 이 연합물을 건조기 바트에 골고루 펴서 60℃ 에서 16 시간 건조한다 (L.O.D : 1.5 ±0.3%). 건조한 과립을 10 mm 체를 이용하여 체질한 후 통과한 과립을 정립기 ( mesh size : 2.0 mm)로 정립한다. 통과하지 못한 과립은 휫츠밀을 사용하여 정립한다. 시험 완료된 과립을 다음 조건으로 타정한다. 정제기는 혼 (ERP-25E), 로타리식, 25~75 rpm, 25 station 을 사용했으며 정제의 조건들은 다음과 같다. 직경은 15.7- 0.1 mm, 두께는 5.80-0.3 mm, 곡률반경은 6.0 mm, 경도는 최소 30N 이어야 하며, 마손도는 최대 0.5%, 붕해도는 45분 이내, 중량편차는 5%이내, 장용부정제의 표준중량은 570 mg 이다. 이 후에 장용제피를 하기위해서 장용용액을 제조한다. 아세톤에 하이드록시 프로필 메칠셀룰로오스 프탈레이트를 용해한 후 이소프로필 알콜을 가한다. 이 용액에 쉘락을 가하여 교반한다. 이때 쉘락용액은 이소프로필 알콜에 정제쉐락을 완전중탕 용해한다. 정제를 Hi-Coater 에 옮기고 다음의 조건에 의해 장용코팅을 실시한다. 처음 20분간은 실온에서 분사속도 900ml/min.으로 펌프압력 0.8~1.3 kgt/cm2, 급기온도 35℃ , 4 rpm 에서 실시하며 그 이후에는 실온에서 1040 ml/min.으로 0.8~1.5 kgt/cm2, 35℃ , 4~5 rpm 에서 7~10% 장용피가 얻어질 때까지 이 공정을 실시한다. 장용공정이 끝난 정제는 35℃ 에서 건조기에서 12 시간 건조한다. 완성된 장용정을 위용부 성분이 녹여져 있는 위용코팅액으로 필름코팅을 실시한다. 위용부성분, 시메치콘과 크레오소오트를 하이드록시 프로필 메칠셀루로오스 프탈레이트와 함께 이소프로판올에 녹여서 총정제 무게당 7~10%가 되도록 필름코팅을 하고 이소프로판올에 녹인 Opardy Green 21025 색소로 색소층을 만듦으로써 제조공정을 마친다.10 mg of microcrystalline cellulose per tablet, 180 mg of lactose, 20 mg of gelatinized starch, and 70 mg of pancreatin are apples in a 0.5 mm sieve and placed in a speed mixer in order to mix for 10 minutes. After that, the binder is prepared separately, that is, a suitable amount of purified water at 100 ° C. is added thereto, and 32 mg of gum arabic is slowly added thereto, stirred for about 5 minutes, and then transferred to a stainless steel container, and cooled to 35-40 ° C. in a water bath. The mixed powder is added to the speed mixer, and the binder is slowly added, followed by 2 minutes of coalescence at 100 rpm of the mixer and 1,500 rpm of the mixer, followed by distillation. After assembling, assemble them properly using a granulator (mesh size: 210 mm). Spread this combination evenly on a dryer bart and dry at 60 ° C for 16 hours (LOD: 1.5 ± 0.3%). The dried granules are sieved using a 10 mm sieve, and the granules passed through are sized with a sizer (mesh size: 2.0 mm). Granules that failed to pass are sized using a nuts mill. The tested granules are compressed into the following conditions. The refiner used a horn (ERP-25E), rotary, 25-75 rpm, 25 stations. The diameter should be 15.7-0.1 mm, thickness 5.80-0.3 mm, radius of curvature 6.0 mm, hardness minimum 30N, wear and tear up to 0.5%, disintegration within 45 minutes, weight deviation within 5%, enteric negativity The standard weight of the agent is 570 mg. Thereafter, enteric solutions are prepared for enteric coating. Hydroxypropyl methylcellulose phthalate is dissolved in acetone and isopropyl alcohol is added. Shellac is added to this solution and stirred. At this time, the shellac solution is completely dissolved in purified chelac in isopropyl alcohol. The tablets are transferred to Hi-Coater and enteric-coated under the following conditions. The first 20 minutes are carried out at a spray pressure of 900 ml / min. At room temperature, at a pump pressure of 0.8 to 1.3 kgt / cm 2 , at an air supply temperature of 35 ° C. and at 4 rpm. Thereafter at 0.8 to 1.5 kgt / cm at room temperature to 1040 ml / min. This process is carried out at 2 , 35 ° C, 4-5 rpm until 7-10% enteric coating is obtained. After the enteric process, the tablet is dried in a drier at 35 ° C for 12 hours. The coated enteric tablet is coated with a gastric coating solution in which gastric component is dissolved. Gastric components, simethicone and creosoot are dissolved in isopropanol with hydroxypropyl methylcellulose phthalate and film-coated to 7-10% per total weight of the tablet. Finish the manufacturing process.

제제예Formulation example

실시예에 의거 아래 처방조성으로 본원발명의 이중코팅정을 제조하였다. 위용부에 주성분으로써 크레오소오트 44.4 mg, 시메치콘 25.0 mg, Opadry Green 21025 16.0 mg, 하이드록시 프로필 메칠셀루로오스 프탈레이트 58.8mg, Isopropranol 638 mg 이며, 장용부 성분으로써는 주성분인 판크레아틴 70 mg, 이에는 프로테아제 6,000USP 단위, 리파제 480 USP단위와 아밀라제 4000 USP 단위가 포함되어 있다. 부형제로써는 유당 180 mg, 미결정 셀룰로오스 10 mg, 젤라틴화 전분 20 mg, 탈크 23.0 mg 와 마그네슘 스테아레이트 3.71 mg 등으로 구성되어져 있으며 장용피제에는 글리세린 지방산 에스테르 5 mg, 프탈산 히드록시 프로필 메칠 셀룰로오스 200731 40 mg, 정제쉘락 4 mg 으로 조성되어졌다.Double coated tablet of the present invention was prepared by the following formulation composition according to the embodiment. The main components of the stomach are creosote 44.4 mg, simethicone 25.0 mg, Opadry Green 21025 16.0 mg, hydroxypropyl methylcellulose phthalate 58.8 mg, Isopropranol 638 mg. This includes 6,000 USP units of protease, 480 USP units of lipase and 4000 USP units of amylase. The excipient consists of 180 mg of lactose, 10 mg of microcrystalline cellulose, 20 mg of gelatinized starch, 23.0 mg of talc and 3.71 mg of magnesium stearate. It was formulated with 4 mg of purified shellac.

상기 제제예를 가지고 용출실험은 미국 약전 제 3법 (Bio-Dis)에 따라서 실시하였으며 그 용출그림을 도 1에 나타내었다.With the above formulation example, the dissolution test was carried out according to the U.S. Pharmacopoeia 3 (Bio-Dis) method is shown in Figure 1 the dissolution.

도 1은 본 발명의 이중코팅제제를 인체소화관을 모의하여 미국약전 용출장치 제 3법 (Bio-Dis)에 따라 실험한 결과로써 위액 (pH 1.5)에서 2시간, 장액 (pH 5.0)에서 1시간동안 용출되는 약물의 양상을 도식화한것입니다. 보는 바와 같이 위액에서는 크레오소트(O)와 시메치콘(□) 가 2시간동안 98%, 95% 가 용출되며, 그 이후에 장용피에 의한 지연시간 ( 1.5~1.7 hrs)을 지난 다음에는 판크레아틴(△)이 30분내에 장액에서 모두 용출되어 나오는 것을 알수가 있다.Figure 1 is a double-coated preparation of the present invention simulated the human digestive tract as a result of the experiment according to the US Pharmacopeia Elution Method 3 (Bio-Dis) as a result of 2 hours in gastric juice (pH 1.5), 1 hour in serous (pH 5.0) This is a schematic of the behavior of the drug that is eluted. As you can see, in the gastric juice, creosote (O) and simethicone (□) elute 98% and 95% for 2 hours, and after that, enteric creatine (1.5 ~ 1.7 hrs) It can be seen that Δ) is eluted from the serous fluid within 30 minutes.

본 발명은 위용부 성분으로는 크레오소오트, 시메치콘을 함유하고 장용부성분으로는 판크레아틴을 함유하는 이중코팅정 및 그제조방법에 관한 것으로, 위용부성분을 위용부 필름코팅액에 직접 녹여서 장용부제피위에 바로 이중코팅한 것으로 간단한 이중코팅으로 장용부와 위용부를 분리하고 코팅층을 조절함으로써 위용부성분과 장용부성분의 연속적인 방출이 가능하여 바람직한 소화기능 개선효과를 나타낸다. The present invention relates to a double-coated tablet containing a creosote, simethicone as a gastric component and a pancreatin as an enteric component, and to a method for manufacturing the same. It is a double coating directly on the top by separating the enteric part and the gastric part by a simple double coating, and by controlling the coating layer, it is possible to continuously release the gastric ingredient and the enteric ingredient shows the desired digestive function improvement effect.

Claims (4)

위용부 성분과 장용부 성분을 갖는 이중 코팅정에 있어서, 위용부 성분으로 크레오소오트, 시메치콘을 함유하고 장용부 성분으로는 판크레아틴을 함유하며 위용부 성분을 위용부 필름코팅액에 직접 녹여서 장용부 제피위에 바로 이중코팅하는 것을 특징으로 하는 위용부 성분과 장용부 성분의 연속적인 방출이 가능한 이중코팅정.In the double-coated tablet having the gastric component and the enteric component, the stomach component contains creosote and simethicone, the enteric component contains pancreatin, and the stomach component is directly dissolved in the gastric coating film. A double coated tablet capable of continuous release of gastric and enteric components, characterized by double coating directly on the subcoat. 제 1항에 있어서, 위용부 필름코팅액은 하이드록시 프로필 메칠셀루로오스 프탈레이트 및 이소프로판올이고 장용부 제피제는 글리세린 지방산 에스테르, 프탈산 히드록시 프로필 메칠셀룰로오스, 정제 쉘락(1~2:5~8:1~2)이며, 위용부 필름 코팅층이 정제 총중량의 7~10중량%임을 특징으로 하는 위용부 성분과 장용부 성분의 연속적인 방출이 가능한 이중코팅정.The gastric coating film according to claim 1, wherein the gastric coating film is hydroxy propyl methylcellulose phthalate and isopropanol and enteric coating agent is glycerin fatty acid ester, phthalic acid hydroxy propyl methyl cellulose, tablet shellac (1-2: 5-8: 1 2), wherein the stomach coating film coating layer is 7 to 10% by weight of the total weight of the tablet, characterized in that the continuous coating of the stomach component and the enteric component is possible. 위용부 성분과 장용부 성분을 갖는 이중코팅정의 제조방법에 있어서, 위용부 성분을 위용부 필름 코팅액에 직접 녹여서 장용부 제피위에 바로 이중코팅하는 것을 특징으로 하는 위용부 성분과 장용부 성분의 연속적인 방출이 가능한 이중코팅정의 제조방법.A method for producing a double coated tablet having a gastric component and an enteric component, wherein the gastric component is directly dissolved in the gastric coating film and double coated directly on the skin of the enteric coating to continuously coat the gastric component and the enteric component. Method for producing double coated tablets that can be released. 제 3항에 있어서, 위용부 필름코팅액은 하이드록시 프로필 메칠셀루로오스프탈레이트 및 이소프로판올이고 장용부 제피제는 글리세린 지방산 에스테르, 프탈산 히드록시 프로필 메칠셀룰로오스, 정제 쉘락(1~2:5~8:1~2)이며, 위용부 필름 코팅층이 정제 총중량의 7~10중량%임을 특징으로 하는 위용부 성분과 장용부 성분의 연속적인 방출이 가능한 이중코팅정의 제조방법.4. The gastric coating film coating liquid according to claim 3, wherein the gastric coating film is hydroxy propyl methylcellulose phthalate and isopropanol, and enteric coating agent is glycerin fatty acid ester, phthalic acid hydroxy propyl methylcellulose, tablet shellac (1-2: 5-8: 1). 2), wherein the stomach coating film coating layer is 7 to 10% by weight of the total weight of the tablet.
KR10-2001-0003233A 2001-01-19 2001-01-19 Double Coating Tablet KR100404657B1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100933183B1 (en) * 2007-09-20 2009-12-22 대원제약주식회사 Double coated tablet containing metoclopramide and pancreatin hydrochloride, and preparation method thereof
WO2014088181A1 (en) * 2012-12-04 2014-06-12 삼성정밀화학(주) Laminated film and method for laminating films
KR20180120634A (en) * 2011-10-14 2018-11-06 지엘팜텍주식회사 Delayed release enzyme preparations and the preparation method for the same

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100933183B1 (en) * 2007-09-20 2009-12-22 대원제약주식회사 Double coated tablet containing metoclopramide and pancreatin hydrochloride, and preparation method thereof
KR20180120634A (en) * 2011-10-14 2018-11-06 지엘팜텍주식회사 Delayed release enzyme preparations and the preparation method for the same
WO2014088181A1 (en) * 2012-12-04 2014-06-12 삼성정밀화학(주) Laminated film and method for laminating films
US9750686B2 (en) 2012-12-04 2017-09-05 Lotte Fine Chemical Co., Ltd. Laminated film and method for laminating films

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