KR100460282B1 - A mouth dosable medicine compound whose bitter taste is reduced - Google Patents
A mouth dosable medicine compound whose bitter taste is reduced Download PDFInfo
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- KR100460282B1 KR100460282B1 KR10-2001-0077882A KR20010077882A KR100460282B1 KR 100460282 B1 KR100460282 B1 KR 100460282B1 KR 20010077882 A KR20010077882 A KR 20010077882A KR 100460282 B1 KR100460282 B1 KR 100460282B1
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- methacrylate copolymer
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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Abstract
에그알렌나트륨에, 쓴 맛 경감제로서 아미노알킬메타크릴레이트 공중합체 및/또는 글루타민산 화합물을 배합하여 된 경구투여제제 조성물이다. 상기의 아미노알킬메타크릴레이트 공중합체는, 아미노알킬메타크릴레이트 공중합체 E 및/또는 아미노알킬메타크릴레이트 공중합체 RS가 바람직하다. 또한, 글루타민산 화합물은, L-글루타민, L-글루타민산 나트륨 및 L-글루타민산 칼륨으로부터 선택된 적어도 1종을 사용하는 것이 바람직하다. 쓴 맛이 대폭 경감되어, 복용감이 우수한 에그알렌나트륨 함유 경구투여제제 조성물이 얻어진다.It is an oral dosage composition which mix | blended the aminoalkyl methacrylate copolymer and / or glutamic acid compound with sodium egg allene as a bitter taste reducer. As for the said aminoalkyl methacrylate copolymer, aminoalkyl methacrylate copolymer E and / or aminoalkyl methacrylate copolymer RS are preferable. In addition, it is preferable to use at least 1 sort (s) chosen from the glutamic acid compound from L- glutamine, sodium L-glutamate, and L-glutamic acid potassium. The bitter taste is greatly reduced, and the egg allene-containing oral dosage composition excellent in the feeling of taking is obtained.
Description
본 발명은, 쓴 맛 경감제를 배합하여 쓴 맛을 경감한 에그알렌나트륨 함유 경구투여제제 조성물에 관한 것이다.TECHNICAL FIELD This invention relates to the egg allel sodium containing oral dosage agent composition which mix | blended the bitter taste alleviator and reduced bitter taste.
에그알렌나트륨[화학명:3-에틸-7-이소프로필-1-아즐렌설폰산 나트륨 ·1/3 수화물(sodium 3-ethyl-7-isopropyl-1-azulenesulfonate 1/3 hydrate)]은, 경구투여로 우수한 위점막 보호작용을 가져, 위궤양 등의 치료약으로서 우수한 약물이지만, 쓴 맛을 가지는 약물이다. 이와 같은 특이한 맛이 있는 약물을 포함하는 의약품제제의 맛을 감추기 위해서는, 정제의 경우 필름코팅이 유효하지만, 과립제, 세립제, 산제의 경우는, 표면적이 넓기 때문에 필름코팅에 의해 쓴 맛을 완전히 은폐하기 위해서는, 필름코팅을 두껍게 행할 필요가 있고, 그 때문에 소화관에 있어서의 용출이 나빠진다고 하는 결점을 갖게 된다.Sodium egg allene (chemical name: 3-ethyl-7-isopropyl-1-azlensulfonate sodium 1/3 hydrate) is oral administration It is an excellent drug for treating gastric ulcers and has excellent gastric mucosal protection, but has a bitter taste. In order to hide the taste of pharmaceutical preparations containing such unusually flavored drugs, film coating is effective in the case of tablets, but in the case of granules, fine granules, and powder, the surface area is large so that the bitter taste is completely hidden by film coating. In order to do this, it is necessary to perform film coating thickly, and therefore, it has the drawback that elution in a digestive tract worsens.
현재 행해지고 있는 제제에 있어서의 쓴 맛 경감화법으로서는, 예를 들면 아스파르탐(aspartame), 1-멘톨(1-menthol) 등의 교미제(矯味劑)를 배합하여 약물의 쓴 맛을 은폐하는 방법(일본 특개평2-56416호 공보, 일본 특개평2-76826호 공보등), 마이크로캡슐화, 위용성 코팅제에 의한 분말코팅화, 약물의 화학수식, 포접화합물을 첨가하는 방법(일본 특개평3-236316호), 또한 유지성분, 특히 레시틴(포스파티딜콜린) 또는 케팔린(cephalin)의 단독 또는 이들의 혼합물을 첨가하는 방법(일본 특공소55-8966호 공보, 일본 특개소62-265234호 공보), 더욱이, 인지질과 수용성 당류와의 복합체를 첨가하는 방법(일본 특개평7-300429호 공보) 등이 알려져 있다. 그러나, 에그알렌나트륨의 경우, 이러한 방법을 사용한 것 만으로는, 그 쓴 맛을 충분히 경감하는 것은 곤란했다.As a method for reducing the bitter taste in the present formulations, for example, a method of concealing the bitter taste of the drug by blending a mate agent such as aspartame, 1-menthol, etc. (Japanese Patent Laid-Open Publication No. 2-56416, Japanese Patent Laid-Open Publication No. 2-76826, etc.), microencapsulation, powder coating with a gas-soluble coating agent, chemical modification of a drug, and a method of adding a clathrate compound 236316), and also methods for adding fats and oils, in particular lecithin (phosphatidylcholine) or kephalin alone or mixtures thereof (Japanese Patent Application Laid-Open No. 55-8966, Japanese Patent Application Laid-Open No. 62-265234); And a method of adding a complex of phospholipid and water-soluble sugars (Japanese Patent Laid-Open No. 7-300429) and the like are known. However, in the case of egg allene, it was difficult to fully reduce the bitter taste only by using such a method.
본 발명은, 쓴 맛이 대폭 경감되어, 복용감이 우수한 에그알렌나트륨 함유 경구투여제제 조성물을 제공하는 것을 목적으로 한다.It is an object of the present invention to provide an egg allotropin-containing oral dosage composition that is significantly reduced in bitterness and excellent in taking.
본 발명자 등은 상기 목적을 달성하기 위해 예의 검토를 거듭한 결과, 아미노알킬메타크릴레이트 공중합체 및/또는 글루타민산 화합물을 배합함으로써 에그알렌나트륨의 쓴 맛을 대폭 경감할 수 있는 것을 발견하고, 본 발명을 완성하기에 이르렀다.MEANS TO SOLVE THE PROBLEM As a result of earnestly examining in order to achieve the said objective, this inventor discovered that the bitter taste of egg allen sodium can be reduced significantly by mix | blending an aminoalkyl methacrylate copolymer and / or a glutamic acid compound, and this invention Came to complete.
즉, 본 발명은, 에그알렌나트륨에 쓴 맛 경감제로서 아미노알킬메타크릴레이트 공중합체(copolymer)를 배합하여 된 경구투여제제 조성물이다. 또한 본 발명은, 에그알렌나트륨에 쓴 맛 경감제로서 글루타민산 화합물을 배합하여 된 경구투여제제 조성물이다. 더욱이 본 발명은, 에그알렌나트륨에 쓴 맛 경감제로서 아미노알킬메타크릴레이트 공중합체 및 글루타민산 화합물을 배합하여 된 경구투여제제 조성물이다. 상기의 아미노알킬메타크릴레이트 공중합체는, 아미노알킬메타크릴레이트 공중합체 E 및/또는 아미노알킬메타크릴레이트 공중합체 RS가 바람직하다. 또한, 글루타민산 화합물은, L-글루타민, L-글루타민산 나트륨 및 L-글루타민산 칼륨으로부터 선택된 적어도 1종을 사용하는 것이 바람직하다.That is, this invention is an oral dosage composition which mix | blended the amino alkyl methacrylate copolymer as a taste-reducing agent with sodium egg allene. Moreover, this invention is an oral dosage composition which mix | blended the glutamic acid compound as a taste reducing agent for sodium egg allene. Furthermore, this invention is an oral dosage composition which mix | blended an aminoalkyl methacrylate copolymer and a glutamic acid compound as a taste reducer for egg allene. As for the said aminoalkyl methacrylate copolymer, aminoalkyl methacrylate copolymer E and / or aminoalkyl methacrylate copolymer RS are preferable. In addition, it is preferable to use at least 1 sort (s) chosen from the glutamic acid compound from L- glutamine, sodium L-glutamate, and L-glutamic acid potassium.
이하, 본 발명에 대해 상세히 설명한다. 본 발명의 경구투여제제 조성물에 있어서, 에그알렌나트륨은 화학명으로는, 3-에틸-7-이소프로필-1-아즐렌설폰산 나트륨 ·1/3 수화물이다. 쓴 맛 경감제인 아미노알킬메타크릴레이트 공중합체는, 아미노알킬메타크릴레이트, 예를 들면 메타크릴산 디메틸아미노에틸이나 메타크릴산 염화트리메틸암모늄에틸을 구성모노머로서 포함하는 공중합체이다. 이 공중합체에는 아미노알킬메타크릴레이트 공중합체 E 및/또는 아미노알킬메타크릴레이트 공중합체 RS가 바람직하게 사용된다. 아미노알킬메타크릴레이트 공중합체 E는, 메타크릴산 메틸과 메타크릴산 부틸, 메타크릴산 디메틸아미노에틸과의 공중합체이고, 또한 아미노알킬메타크릴레이트 공중합체 RS는, 아크릴산 에틸과 메타크릴산 메틸, 메타크릴산 염화트리메틸암모늄에틸과의 공중합체이다. 또한, 글루타민산 화합물로서는 L-글루타민, L-글루타민산 나트륨, L-글루타민산 칼륨을 들 수 있다.Hereinafter, the present invention will be described in detail. In the oral dosage form composition of the present invention, the egg allene is chemically named 3-ethyl-7-isopropyl-1-azlensulfonate sodium 1/3 hydrate. The aminoalkyl methacrylate copolymer which is a bitter alleviator is a copolymer containing aminoalkyl methacrylate, for example, dimethylaminoethyl methacrylate or trimethylammonium ethyl methacrylate as a constituent monomer. As the copolymer, aminoalkyl methacrylate copolymer E and / or aminoalkyl methacrylate copolymer RS are preferably used. Aminoalkyl methacrylate copolymer E is a copolymer of methyl methacrylate, butyl methacrylate, and dimethylaminoethyl methacrylate, and aminoalkyl methacrylate copolymer RS is ethyl acrylate and methyl methacrylate. And a copolymer with trimethylammonium ethyl methacrylate. Examples of the glutamic acid compound include L-glutamine, L-glutamic acid sodium and L-glutamic acid potassium.
아미노알킬메타크릴레이트 공중합체나 글루타민산 화합물의 배합량은, 제제중 에그알렌나트륨의 함유량에 따라 적절히 선택할 수 있다. 선택하는 배합량은 에그알렌나트륨 함유 제제를 복용한 경우, 연하(deglutition)하기까지의 동안 제제중 에그알렌나트륨의 쓴 맛이 경감되는 정도의 양 이상이라면 특별히 한정되지 않지만, 제제중 에그알렌나트륨 1중량부에 대해 아미노알킬메타크릴레이트 공중합체는0.01~10중량부가 바람직하고, 보다 바람직하게는 0.1~3중량부이다. 또한, 글루타민산 화합물의 배합량은, 제제중 에그알렌나트륨 1중량부에 대해 0.01~10중량부가 바람직하고, 보다 바람직하게는 0.05~7중량부이다.The compounding quantity of an aminoalkyl methacrylate copolymer and a glutamic acid compound can be suitably selected according to content of sodium egg allene in a formulation. The compounding amount to be selected is not particularly limited as long as the amount of the egg allergic in the formulation is reduced when the egg allergen containing the egg is taken, until it is swallowed. The amount of the aminoalkyl methacrylate copolymer is preferably 0.01 to 10 parts by weight, more preferably 0.1 to 3 parts by weight with respect to the part. Moreover, 0.01-10 weight part is preferable with respect to 1 weight part of sodium allene in a formulation, and, as for the compounding quantity of a glutamic acid compound, More preferably, it is 0.05-7 weight part.
상기의 쓴 맛 경감제의 배합에 의해 에그알렌나트륨의 쓴 맛은 경감할 수 있지만, 더욱이 복용감의 향상을 목적으로서, 통상 사용되는 교미제를 가하더라도 전혀 지장이 없다. 이와 같은 교미제로서는, 백당, 아스파르탐, 글리시리딘(glycyrrhizin), 1-멘톨, 크실리톨, 에리스리톨, 만니톨, 과당 등을 들 수 있고, 아스파르탐, 1-멘톨이 특히 바람직하다. 이들 교미제의 배합량은, 통상 사용되는 방법에 따라 적절히 결정하면 좋고, 특별히, 제한은 없지만, 대략 제제중 에그알렌나트륨 1중량부에 대해, 0.00005~0.5중량부, 바람직하게는 0.0001~0.2중량부 정도이고, 구체적으로 나타내면, 아스파르탐의 경우에는, 제제중 에그알렌나트륨 1중량부에 대해 0.001~0.5중량부, 바람직하게는 0.05~0.2중량부, 1-멘톨의 경우에는 0.00005~0.1중량부, 바람직하게는 0.0001~0.01중량부이다.Although the bitter taste of egg allen sodium can be reduced by mix | blending said bitterness reducing agent, even if it adds the copulation agent normally used for the purpose of improving the feeling of taking it, it does not interfere at all. Examples of such a coagulant include sucrose, aspartame, glycyrrhizin, 1-menthol, xylitol, erythritol, mannitol, and fructose. Aspartame and 1-menthol are particularly preferred. What is necessary is just to determine suitably the compounding quantity of these mating agents suitably according to the method used normally, Although there is no restriction | limiting in particular, About 0.00005-0.5 weight part, Preferably it is 0.0001-0.2 weight part with respect to 1 weight part of sodium egg allene in a formulation. In the case of aspartame, it is 0.001-0.5 weight part with respect to 1 weight part of sodium allene in a formulation, Preferably it is 0.05-0.2 weight part, and in the case of 1-menthol, it is 0.00005-0.1 weight part Preferably it is 0.0001 to 0.01 weight part.
더욱이 본 발명의 경구투여제제 조성물에 있어서, 그 밖의 배합성분으로서는, 통상의 경구투여제제에 사용되는 첨가제를 사용할 수 있고, 특별히 한정되지 않지만, 예를 들면 부형제, 붕해제, 결합제, 활택제 등을 배합할 수 있다. 첨가제의 일례를 들면, 부형제로서는, 유당, 만니톨, 백당, 결정 셀룰로오스, 전분 등; 붕해제로서는 칼멜로오스칼슘, 저치환도 히드록시프로필셀룰로오스 등; 결합제로서는 폴리비닐피롤리돈, 메틸셀룰로오스, 히드록시프로필메틸셀룰로오스, 마크로골, 왁스, 파라핀 등; 활택제로서는 스테아르산 마그네슘, 스테아르산 칼슘, 탈크 등을들 수 있다. 또한, 착색제 등 그 밖의 첨가제, 예를 들면 β-카로틴, 타르색소, 레이크색소, 카라멜, 산화제, 동클로로필(copper chlorophyll) 등을 포함하더라도 좋다.Furthermore, in the oral dosage form composition of the present invention, as other compounding ingredients, additives used in conventional oral dosage forms can be used, and are not particularly limited, but examples include excipients, disintegrants, binders, lubricants, and the like. It can mix. As an example of an additive, excipients include lactose, mannitol, white sugar, crystalline cellulose, starch and the like; Examples of disintegrants include carmellose calcium, low-substituted hydroxypropyl cellulose, and the like; As the binder, polyvinylpyrrolidone, methyl cellulose, hydroxypropyl methyl cellulose, macrogol, wax, paraffin and the like; Examples of the lubricant include magnesium stearate, calcium stearate and talc. In addition, other additives such as colorants, such as β-carotene, tar pigment, lake pigment, caramel, oxidizing agent, copper chlorophyll, and the like may be included.
본 발명의 경구투여제제 조성물로부터 여러 제형의 제제를 제조할 수 있다. 제제로서는, 예를 들면, 산제, 과립제, 세립제, 정제, 드라이시럽 등을 들 수 있다. 이들 제제는, 분쇄, 분급, 혼합, 연합, 조립, 건조, 정립, 타정 등 이 기술분야에 있어서의 일반적인 방법에 의해 제조할 수 있다. 조립방법으로서는, 건식 조립법, 습식 조립법, 유동 조립법 등을 사용할 수 있다.The formulations of various formulations can be prepared from the oral dosage form compositions of the present invention. As a formulation, powder, a granule, a fine granule, a tablet, dry syrup, etc. are mentioned, for example. These formulations can be produced by general methods in the art, such as grinding, classifying, mixing, coalescing, granulating, drying, granulating, and tableting. As a granulation method, a dry granulation method, a wet granulation method, a fluid granulation method, etc. can be used.
상기와 같이 하여 얻어진 제제는, 필요에 따라 통상 사용되는 코팅제로 코팅하더라도 좋다. 이와 같은 코팅제의 예로서는, 히드록시프로필메틸셀룰로오스, 히드록시프로필셀룰로오스, 폴리비닐아세탈디메틸아미노아세테이트, 카르복시메틸에틸셀룰로오스, 에틸셀룰로오스, 폴리비닐알코올, 초산비닐 수지, 왁스 또는 이들을 2종 이상 조합시킨 것 또는 이것에 스테아르산 마그네슘, 탈크, 산화티탄 등의 코팅 보조제를 가한 것 등을 들 수 있다. 또한, 아스파르탐, 1-멘톨 등의 교미제를 코팅제에 첨가할 수 있다.The formulation obtained as mentioned above may be coated with the coating agent normally used as needed. Examples of such a coating agent include hydroxypropyl methyl cellulose, hydroxypropyl cellulose, polyvinyl acetal dimethylamino acetate, carboxymethyl ethyl cellulose, ethyl cellulose, polyvinyl alcohol, vinyl acetate resin, wax or a combination of two or more thereof, or Addition of coating aids, such as magnesium stearate, talc, and titanium oxide, to this is mentioned. In addition, a mating agent such as aspartame or 1-menthol may be added to the coating agent.
이하, 본 발명에 대해 실시예 및 비교예에 의해 더욱 상세히 설명하지만, 본 발명의 범위는 이들 실시예 및 비교예에 조금도 한정되지 않는다.Hereinafter, although an Example and a comparative example demonstrate this invention further in detail, the scope of the present invention is not limited to these Examples and a comparative example at all.
실시예 1Example 1
에그알렌나트륨 30 g, 결정 셀룰로오스 40 g, 옥수수전분 1070 g, 아미노알킬메타크릴레이트 공중합체 E 40 g, 히드록시프로필셀룰로오스 20 g을 습식 조립법으로 조립하여, 과립제로 했다.30 g of sodium allene, 40 g of crystalline cellulose, 1070 g of corn starch, 40 g of aminoalkyl methacrylate copolymer E, and 20 g of hydroxypropyl cellulose were granulated by wet granulation to obtain granules.
실시예 2Example 2
에그알렌나트륨 30 g, 결정 셀룰로오스 40 g, L-글루타민 160 g, 옥수수전분 970 g을 혼합하여, 산제로 했다.30 g of sodium allene, 40 g of crystalline cellulose, 160 g of L-glutamine, and 970 g of corn starch were mixed to prepare a powder.
실시예 3Example 3
에그알렌나트륨 30 g, 결정 셀룰로오스 60 g, L-글루타민산 나트륨 24 g, 옥수수전분 1066 g의 혼합물에, 메틸셀룰로오스 20 g의 수용액을 분무하여, 유동층 조립법으로 조립하여, 과립제로 했다.An aqueous solution of 20 g of methyl cellulose was sprayed onto a mixture of 30 g of sodium allene, 60 g of crystalline cellulose, 24 g of L-glutamate, and 1066 g of corn starch, and granulated by a fluidized bed granulation method to obtain granules.
실시예 4Example 4
에그알렌나트륨 30 g, 결정 셀룰로오스 40 g, L-글루타민 120 g, 옥수수전분 970 g, 아미노알킬메타크릴레이트 공중합체 E 20 g, 히드록시프로필셀룰로오스 20 g을 습식 조립법으로 조립하여 과립제로 했다.30 g of sodium allene, 40 g of crystalline cellulose, 120 g of L-glutamine, 970 g of corn starch, 20 g of aminoalkyl methacrylate copolymer E and 20 g of hydroxypropyl cellulose were granulated by wet granulation to obtain granules.
실시예 5Example 5
에그알렌나트륨 30 g, 결정 셀룰로오스 60 g, L-글루타민 160 g, 옥수수전분 882 g, 아스파르탐 6 g, 아미노알킬메타크릴레이트 RS 40 g, 히드록시프로필셀룰로오스 20 g을 습식 조립법으로 조립하여, 스테아르산 마그네슘 2 g을 가하여 혼합한 후, 타정기로 타정하여 정제로 했다.30 g of sodium allene, 60 g of crystalline cellulose, 160 g of L-glutamine, 882 g of corn starch, 6 g of aspartame, 40 g of aminoalkyl methacrylate RS, 20 g of hydroxypropyl cellulose were wet granulated, 2 g of magnesium stearate was added and mixed, followed by tableting with a tableting machine to obtain a tablet.
실시예 6Example 6
에그알렌나트륨 30 g, 결정 셀룰로오스 40 g, L-글루타민 120 g, L-글루타민산 나트륨 12 g, 옥수수전분 958 g, 아미노알킬메타크릴레이트 공중합체 E 20 g,히드록시프로필셀룰로오스 20 g을 습식 조립법으로 조립하여 과립제로 했다.30 g of sodium allene, 40 g of crystalline cellulose, 120 g of L-glutamine, 12 g of L-glutamate, corn starch 958 g, 20 g of aminoalkyl methacrylate copolymer E, 20 g of hydroxypropyl cellulose by wet granulation It was granulated to make granules.
실시예 7Example 7
에그알렌나트륨 30 g, 결정 셀룰로오스 40 g, L-글루타민 120 g, L-글루타민산 칼륨 12 g, 옥수수전분 951.7 g, 아스파르탐 6 g, 아미노알킬메타크릴레이트 공중합체 E 20 g, 히드록시프로필셀룰로오스 20 g을 습식 조립법으로 조립하여, 이것에 1-멘톨 0.3 g을 가하고 혼합하여 과립제로 했다.30 g of sodium allene, 40 g of crystalline cellulose, 120 g of L-glutamine, 12 g of L-glutamic acid potassium, 951.7 g of corn starch, 6 g of aspartame, 20 g of aminoalkyl methacrylate copolymer E, hydroxypropyl cellulose 20 g was granulated by the wet granulation method, 0.3 g of 1-menthol was added to this, and it mixed, and was made into granules.
비교예 1~3Comparative Examples 1 to 3
표1의 비교예 1~3에 나타내는 성분을 사용하여, 각각 제제를 제조했다. 비교예 1에서는 실시예 1과 동일하게 하여 과립제로 했다. 비교예 2에서는 실시예 5와 동일하게 하여 정제로 했다. 비교예 3에서는 실시예 7과 동일하게 하여 과립제로 했다.The formulations were produced using the components shown in Comparative Examples 1-3 of Table 1, respectively. In Comparative Example 1, a granule was prepared in the same manner as in Example 1. In Comparative Example 2, purification was carried out in the same manner as in Example 5. In Comparative Example 3, a granule was prepared in the same manner as in Example 7.
[관능시험][Sensory test]
본 발명의 제제인 실시예 1~7 및 대조제제인 비교예 1~3의 제제 각 1 g을 30초간 입에 머금은 후 뱉어 내어, 복용시의 쓴 맛을 조사했다. 그 결과를 표2에 나타낸다. 표중의 판정은, ◎: 대폭적인 쓴 맛 경감, △: 쓰다, ×: 매우 쓰다를 나타낸다.1 g of each of the formulations of Examples 1 to 7, which are the formulations of the present invention, and Comparative Examples 1 to 3, which are the control agents, were held in the mouth for 30 seconds, then spit out, and the bitter taste at the time of taking was examined. The results are shown in Table 2. Determination in a table | surface shows (circle): drastic reduction of bitterness, (triangle | delta): bitter, and x: bitter.
에그알렌나트륨에 아미노알킬메타크릴레이트 공중합체 및/또한 글루타민산 화합물을 배합함으로써, 에그알렌나트륨의 쓴 맛이 대폭 경감되어, 복용감이 우수한 경구투여제제 조성물을 얻을 수 있다.By blending an aminoalkyl methacrylate copolymer and / or a glutamic acid compound with sodium allene, the bitter taste of sodium allene is greatly reduced, and an oral dosage composition excellent in taking a feeling can be obtained.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US5972373A (en) * | 1995-05-02 | 1999-10-26 | Taisho Pharmaceutical Co., Ltd. | Taste masking pharmaceutical composition for oral administration |
| KR20000023713A (en) * | 1996-07-12 | 2000-04-25 | 스즈키 다다시 | Quickly disintegratable compression-molded materials and process for producing the same |
| JP2000204036A (en) * | 1998-11-11 | 2000-07-25 | Dainippon Pharmaceut Co Ltd | Glutamic salt-containing liquid preparation |
| JP2001069961A (en) * | 1999-09-02 | 2001-03-21 | Fuji Chem Ind Co Ltd | Bitterness masking composition |
| US6270807B1 (en) * | 1999-03-02 | 2001-08-07 | L. Perrigo Company | Taste-masked pharmaceutical composition |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US5972373A (en) * | 1995-05-02 | 1999-10-26 | Taisho Pharmaceutical Co., Ltd. | Taste masking pharmaceutical composition for oral administration |
| KR20000023713A (en) * | 1996-07-12 | 2000-04-25 | 스즈키 다다시 | Quickly disintegratable compression-molded materials and process for producing the same |
| JP2000204036A (en) * | 1998-11-11 | 2000-07-25 | Dainippon Pharmaceut Co Ltd | Glutamic salt-containing liquid preparation |
| US6270807B1 (en) * | 1999-03-02 | 2001-08-07 | L. Perrigo Company | Taste-masked pharmaceutical composition |
| JP2001069961A (en) * | 1999-09-02 | 2001-03-21 | Fuji Chem Ind Co Ltd | Bitterness masking composition |
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