KR102163637B1 - Method for producing functional health food - Google Patents
Method for producing functional health food Download PDFInfo
- Publication number
- KR102163637B1 KR102163637B1 KR1020200041404A KR20200041404A KR102163637B1 KR 102163637 B1 KR102163637 B1 KR 102163637B1 KR 1020200041404 A KR1020200041404 A KR 1020200041404A KR 20200041404 A KR20200041404 A KR 20200041404A KR 102163637 B1 KR102163637 B1 KR 102163637B1
- Authority
- KR
- South Korea
- Prior art keywords
- coating
- functional food
- health functional
- hpmc
- tablet
- Prior art date
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Images
Classifications
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- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/20—Agglomerating; Granulating; Tabletting
- A23P10/25—Agglomeration or granulation by extrusion or by pressing, e.g. through small holes, through sieves or between surfaces
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- 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
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
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- 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
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- A23P20/10—Coating with edible coatings, e.g. with oils or fats
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- 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
- A23P20/15—Apparatus or processes for coating with liquid or semi-liquid products
- A23P20/18—Apparatus or processes for coating with liquid or semi-liquid products by spray-coating, fluidised-bed coating or coating by casting
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- 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
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23V2200/30—Foods, ingredients or supplements having a functional effect on health
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Food Science & Technology (AREA)
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- Oil, Petroleum & Natural Gas (AREA)
- Mycology (AREA)
- Health & Medical Sciences (AREA)
- Nutrition Science (AREA)
- Medicinal Preparation (AREA)
- Coloring Foods And Improving Nutritive Qualities (AREA)
Abstract
Description
본 발명은 건강기능식품에 관한 것으로, 보다 상세하게는 장기능 개선 효과를 위해 주로 장(intestine)에서 원료나 성분을 방출하도록 이루어지는 건강기능식품의 제조방법에 관한 것이다.The present invention relates to a health functional food, and more particularly, to a method of manufacturing a health functional food made to release raw materials or ingredients mainly from the intestine for the effect of improving intestinal function.
건강기능식품이라 함은 인체에 유용한 기능을 가진 원료나 성분을 사용하여 정제(tablet), 캡슐(capsule), 환(pill), 과립(granule), 분말(powder), 액상(lipid), 편상(flake), 페이스트상(paste), 시럽(syrup), 겔(gel), 젤리(jelly), 바(bar), 필름(film) 등의 형태로 제조(가공을 포함한다)한 식품을 말한다. 여기서 원료는 건강기능식품 제조에 사용되는 물질로 최종 제품 내에 들어 있는 것을 말하고, 성분은 분리된 단일 물질 또는 원료에 함유되어 있는 단일 물질로 최종 제품내에 들어 있는 것을 말한다.Health functional food refers to a tablet, capsule, pill, granule, powder, liquid, or flake (tablet), capsule, pill, granule, powder, using raw materials or ingredients that have useful functions for the human body. It refers to food manufactured (including processed) in the form of flake, paste, syrup, gel, jelly, bar, film, etc. Here, raw materials are substances used in the manufacture of health functional foods and are contained in the final product, and ingredients are separate single substances or single substances contained in raw materials that are contained in the final product.
건강기능식품은 영양소 기능, 생리활성 기능, 및 질병발생위험감소 기능의 기능성 등급을 가진다. 영양소 기능은 비타민 C 등을 사용하여 인체의 성장 증진 및 정상적인 기능에 대한 영양소의 생리적인 작용과 관련된 것을 지칭하고, 생리활성 기능은 루테인이나 코엔자임Q10 등을 사용하여 인체의 정상기능이나 생물학적 활동에 특별한 효과가 있어 건강상의 기여나 기능향상 또는 건강유지, 개선을 나타내는 기능을 말하며, 질병발생위험감소 기능은 칼슘이나 비타민 D 등을 사용하여 질병의 발생 또는 건강상태의 위험감소와 관련된 기능을 말한다.The health functional food has a functional grade of nutrient function, physiological activity function, and disease risk reduction function. The nutrient function is related to the physiological action of nutrients for the growth and normal function of the human body by using vitamin C, etc., and the physiological activity function is special for normal function or biological activity of the human body by using lutein or coenzyme Q10. It is effective and refers to a function that indicates health contribution or function improvement or health maintenance or improvement. The disease occurrence risk reduction function refers to a function related to the occurrence of diseases or reducing the risk of a health condition by using calcium or vitamin D.
대표적인 건강기능식품 중 하나인 프로바이오틱스는 장관(腸管)에서 서식하며 건강에 도움을 주는 유익균들을 총칭하며 대표적으로 요거트 발효에 사용되는 유산균(lactic acid bacteria)을 말한다. 이들은 구강 충치균 저해, 체내 면역체계 조절(항염증반응 촉진, 알러지성 증상 경감 등), 과민성대장증후군 완화, 정장작용 등 다양한 생리활성 효과를 나타내는 것으로 알려져 있다.Probiotics, one of the representative health functional foods, is a generic term for beneficial bacteria that live in the intestine and help health, and typically refers to lactic acid bacteria used in yogurt fermentation. They are known to exhibit various physiological effects such as inhibiting oral caries bacteria, regulating the body's immune system (promoting anti-inflammatory reactions, reducing allergic symptoms, etc.), alleviating irritable bowel syndrome, and intestinal action.
최근 프로바이오틱스를 분말화하여 건강기능식품으로 제조하려고 하는 연구개발이 많이 진행되고 있다. 프로바이오틱스 분말은 빵, 과자, 초콜릿, 크림, 소스, 껌, 음료 등 다양한 식품에 적용이 용이하여 식품의 건강기능성을 증진시킬 수 있는 소재로 유용하며, 액상에 비하여 보관 및 취급이 용이하고 그 자체로 상품화가 가능하다는 장점을 갖고 있다. 따라서 분말 제조공정의 효율성을 높이고, 분말의 특성을 조절하고, 제조 및 저장 중이나 섭취 시에 프로바이오틱스의 생존율과 효능을 향상시키기 위한 다양한 연구개발이 진행되고 있다.In recent years, a lot of research and development is being conducted to make probiotics into powdered health functional foods. Probiotics powder is easy to apply to various foods such as bread, confectionery, chocolate, cream, sauce, gum, beverage, etc., so it is useful as a material that can improve the health function of food. It is easy to store and handle compared to liquid. It has the advantage of being commercialized. Therefore, various research and development are being conducted to increase the efficiency of the powder manufacturing process, control the properties of the powder, and improve the survival rate and efficacy of probiotics during manufacture and storage or during ingestion.
본 발명은 프로바이오틱스 균주를 함유한 원료로 이루어진 건강기능식품이 사람의 장(intestine)에서 원료를 방출하도록 하여 건강기능식품의 기능을 극대화할 수 있는 건강기능식품의 제조방법에 관한 것이다.The present invention relates to a method for manufacturing a health functional food capable of maximizing the function of a health functional food by allowing a health functional food made of a raw material containing a probiotic strain to release the raw material from a human intestine.
상기 기술적 과제를 해결하기 위한 본 발명의 일 측면에 따른 건강기능식품의 제조방법은, 측량된 건강기능식품의 원료를 배합 공정 및 조립 공정 중 어느 공정으로 진행할지를 판단하는 단계; 상기 판단 단계에서 상기 배합 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 배합하거나, 상기 판단 단계에서 상기 조립 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 혼합한 분말 혼합물에 물이나 유기 용매를 첨가하여 조립하는 단계; 배합한 재료나 조립한 재료를 호퍼(hopper)로부터 타정기의 회전반 위에 정량적으로 공급하고 상기 회전반에 형성되어 있는 구멍인 유발(mortar)에 투입되는 재료를 상하 2조의 강철봉으로 압축하여 타정하는 단계; 및 타정된 과립 또는 정제를 코팅하는 단계를 포함한다.A method of manufacturing a health functional food according to an aspect of the present invention for solving the above technical problem includes the steps of determining which process of a blending process and an assembly process to proceed with the measured raw material of the health functional food; When the progress to the blending process is determined in the determination step, the measured raw materials of the health functional food are mixed, or when the progress to the assembling process is determined in the determination step, the measured raw materials of the health functional food are mixed Assembling by adding water or an organic solvent to the mixture; Quantitatively supplying the blended or assembled material from the hopper to the rotating plate of the tablet press, and compressing the material input into the mortar, which is a hole formed in the rotating plate, with two sets of upper and lower steel bars and tableting. ; And coating the tableted granules or tablets.
일실시예에서, 상기 배합하는 단계는, 상대습도 65% 이하, 온도 20℃ 내지 24℃의 분위기에서 30분 내지 50분간 배합하고, 배합 공정의 마지막 10분 동안에는 스테아린산 마그네슘, 이산화규소 및 히드록시프로필메틸셀룰로오스(HPMC)에서 선택되는 어느 하나의 부형제를 첨가하여 배합한다.In one embodiment, the blending step is blended for 30 to 50 minutes in an atmosphere with a relative humidity of 65% or less and a temperature of 20° C. to 24° C., and magnesium stearate, silicon dioxide and hydroxypropyl for the last 10 minutes of the blending process. It is formulated by adding any one of excipients selected from methylcellulose (HPMC).
일실시예에서, 상기 타정하는 단계는, 상기 건강기능식품의 정제 크기로서의 소정 크기와 수분함량 5% 이하를 갖도록 성형되고, 부형제로써 포도당 또는 유당을 사용한다.In one embodiment, the tableting step is molded to have a predetermined size as a tablet size of the health functional food and a moisture content of 5% or less, and uses glucose or lactose as an excipient.
일실시예에서, 상기 코팅 물질은 지방, 지방산, 왁스, 쉘락, 초산프탈산셀룰로오스, 프탈산히드록시메틸셀룰로오스(hydroxypropyl methylcellulose, HPMC)로 이루어진 그룹에서 선택되는 어느 하나 이상을 포함한다.In one embodiment, the coating material includes any one or more selected from the group consisting of fat, fatty acid, wax, shellac, phthalate acetate, and hydroxypropyl methylcellulose (HPMC).
일실시예에서, 상기 코팅하는 단계는, 트리아세틴, 트리에틸 시트레이트 또는 디에틸 타르트레이트의 첨가제를 함유한 상기 HPMC의 미세입자 분산액을 사용한다. 상기 미세입자 분산액은 전체 용액 대비 HPMC 6중량% 내지 10중량%, 가소제 10중량%, 및 코팅용매로 구성된다.In one embodiment, the coating step uses a microparticle dispersion of the HPMC containing an additive of triacetin, triethyl citrate or diethyl tartrate. The microparticle dispersion is composed of 6% by weight to 10% by weight of HPMC, 10% by weight of a plasticizer, and a coating solvent based on the total solution.
일실시예에서, 상기 코팅 물질은 HPMC를 포함하고, 상기 코팅하는 단계에서는, HPMC 농도 6~10%, 코팅액 분사량 7.5~15.0g/min 및 흡기 온도 28℃ 내지 40℃의 코팅 조건에서 상기 코팅 물질을 함유한 코팅액을 분무하여 정제나 과립의 표면에 부착시키면서 분사되는 즉시 정제나 과립의 표면에 부착되어 가루형태로 건조되도록 에어 스프레이를 사용하는 공정으로서, 상기 코팅액이 분사될 때까지 그리고 정제나 과립의 표면에 부착될 때까지 균일한 코팅액이 정제나 과립의 표면에 균일하게 붙어 건조되도록 코팅 환경을 유지하는 것을 특징으로 한다.In one embodiment, the coating material includes HPMC, and in the coating step, the coating material under the coating condition of 6-10% HPMC concentration, 7.5-15.0 g/min of coating liquid injection amount, and 28℃-40℃ intake air temperature It is a process of using an air spray so that the coating solution containing is sprayed and adhered to the surface of tablets or granules and immediately adheres to the surface of tablets or granules and is dried in powder form, until the coating solution is sprayed and tablets or granules It is characterized in that the coating environment is maintained so that a uniform coating solution adheres evenly to the surface of tablets or granules and is dried until adhered to the surface of.
전술한 건강기능식품의 제조방법을 사용하는 경우에는, 락토바실러스(lactobacillus), 락토코커스(lactococcus), 엔테로코커스(enterococcus), 스트렙토코커스(streptococcus) 및 비피도박테리움(bifidobacterium)으로 이루어진 그룹에서 선택되는 어느 하나 이상의 프로바이오틱스 균주를 함유한 정제 또는 과립으로서 위(stomach)에는 그대로 남아있고 소장에서 함유성분을 노출시키는 건강기능식품을 제공할 수 있다.In the case of using the above-described method for preparing a health functional food, it is selected from the group consisting of lactobacillus, lactococcus, enterococcus, streptococcus, and bifidobacterium. As a tablet or granule containing any one or more probiotic strains that remain as it is in the stomach (stomach), it is possible to provide a health functional food that exposes the components contained in the small intestine.
또한, 본 발명에 의하면, 장용성 코팅소재인 하이프로멜로스(hypromellose) 또는 하이드록시프로필 메틸셀룰로스(hydroxypropyl methylcellulose, HPMC)를 사용하여 미리 준비된 과립이나 정제를 효과적으로 코팅한 장용성 건강기능식품을 제공할 수 있다.In addition, according to the present invention, it is possible to provide an enteric health functional food in which granules or tablets prepared in advance are effectively coated using hypromellose or hydroxypropyl methylcellulose (HPMC) as an enteric coating material. have.
또한, 본 발명에 의하면, 코팅 공정을 최적화함으로써 장용성 건강기능식품의 효능과 그 신뢰성을 향상시킬 수 있다.In addition, according to the present invention, it is possible to improve the efficacy and reliability of an enteric health functional food by optimizing the coating process.
도 1 및 도 2는 본 발명의 일 실시예에 따른 건강기능식품의 제조방법에 대한 흐름도이다.1 and 2 are flow charts for a method of manufacturing a health functional food according to an embodiment of the present invention.
본 발명은 다양한 변형을 가할 수 있고 여러 가지 실시 예를 가질 수 있는 바, 특정 실시 예들을 도면에 예시하고 상세한 설명에 상세하게 설명하고자 한다. 그러나 이는 본 발명을 특정한 실시 형태에 대해 한정하려는 것이 아니며, 본 발명의 사상 및 기술 범위에 포함되는 모든 변환, 균등물 내지 대체물을 포함하는 것으로 이해되어야 한다. 본 발명을 설명함에 있어서 관련된 공지 기술에 대한 구체적인 설명이 본 발명의 요지를 흐릴 수 있다고 판단되는 경우 그 상세한 설명을 생략한다.In the present invention, various modifications may be made and various embodiments may be provided, and specific embodiments will be illustrated in the drawings and described in detail in the detailed description. However, this is not intended to limit the present invention to a specific embodiment, it should be understood to include all conversions, equivalents, or substitutes included in the spirit and scope of the present invention. In describing the present invention, when it is determined that a detailed description of a related known technology may obscure the subject matter of the present invention, a detailed description thereof will be omitted.
이하, 첨부된 도면을 참조하여 본 발명의 바람직한 실시예들을 상세하게 설명하면 다음과 같다.Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.
도 1 및 도 2는 본 발명의 일실시예에 따른 건강기능식품의 제조방법에 대한 흐름도이다.1 and 2 are flow charts for a method of manufacturing a health functional food according to an embodiment of the present invention.
도 1을 참조하면, 본 실시예에 따른 건강기능식품의 제조방법은 먼저 측량된 건강기능식품의 원료를 배합 공정 및 조립 공정 중 어느 공정으로 진행할지를 판단한다(S10).Referring to FIG. 1, in the method of manufacturing a health functional food according to the present embodiment, it is determined in which process of the mixing process and the assembly process the first measured raw material of the health functional food is performed (S10).
상기 단계(S10)에서의 판단 결과, 배합 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 배합한다. 배합 공정은 상대습도 65% 이하, 온도 20℃ 내지 24℃의 분위기에서 30분 내지 50분간 수행될 수 있다(S11).As a result of the determination in step S10, when the progress to the blending process is determined, the measured raw materials of the health functional food are blended. The blending process may be performed for 30 minutes to 50 minutes in an atmosphere with a relative humidity of 65% or less and a temperature of 20°C to 24°C (S11).
또한, 배합 공정의 마지막 10분 동안에는 스테아린산 마그네슘, 이산화규소 및 히드록시프로필메틸셀룰로오스(HPMC)에서 선택되는 어느 하나의 부형제를 첨가하여 배합하도록 이루어질 수 있다(S12). 이러한 부형제를 배합하면, 이후의 타정 공정에서 과립이나 정제의 형태로 효과적으로 성형할 수 있다.In addition, during the last 10 minutes of the blending process, any one excipient selected from magnesium stearate, silicon dioxide and hydroxypropylmethylcellulose (HPMC) may be added and blended (S12). When these excipients are blended, it can be effectively molded into granules or tablets in the subsequent tableting process.
다음, 배합한 재료나 조립한 재료를 호퍼(hopper)로부터 타정기의 회전반 위에 정량적으로 공급하고 회전반에 형성되어 있는 구멍인 유발(mortar)에 투입되는 재료를 상하 2조의 강철봉으로 압축하여 타정한다(S13). 타정하는 단계에서는 건강기능식품의 정제 크기로서의 소정 크기로 성형하면서 수분함량 5% 이하를 갖도록 성형할 수 있다. 타정 공정에서 부형제로써 포도당 또는 유당이 추가로 사용될 수 있다.Next, the mixed material or the assembled material is quantitatively supplied from the hopper to the rotary table of the tablet press, and the material injected into the mortar, the hole formed in the rotary plate, is compressed with two sets of upper and lower steel bars and tableted. (S13). In the tableting step, it may be molded to have a moisture content of 5% or less while molding to a predetermined size as a tablet size of a health functional food. In the tableting process, glucose or lactose may additionally be used as an excipient.
다음, 타정된 과립 또는 정제를 코팅한다(S14). 코팅 단계에서 코팅 물질은 HPMC를 함유한 액상의 코팅액이다. 코팅하는 단계에서는, HPMC 농도 6~10%, 코팅액 분사량 7.5~15.0g/min 및 흡기 온도 28℃ 내지 40℃의 코팅 조건에서 상기 코팅 물질을 함유한 코팅액을 분무하여 정제나 과립의 표면에 부착시키면서 분사되는 즉시 정제나 과립의 표면에 부착되어 가루형태로 건조되도록 에어 스프레이를 사용하는 공정으로서, 코팅액 용기에 저장된 코팅액이 분사될 때까지 그리고 코팅액이 정제나 과립의 표면에 부착될 때까지 균일한 코팅액이 균일하게 붙어 건조되도록 코팅 환경을 유지할 수 있다.Next, the tableted granules or tablets are coated (S14). In the coating step, the coating material is a liquid coating liquid containing HPMC. In the coating step, the coating solution containing the coating material is sprayed under the coating conditions of 6-10% HPMC concentration, 7.5-15.0 g/min of coating solution injection amount, and 28°C to 40°C intake air temperature, and adhered to the surface of tablets or granules. A process that uses air spray to adhere to the surface of tablets or granules as soon as they are sprayed and dry in powder form.Uniform coating liquid until the coating liquid stored in the coating liquid container is sprayed and the coating liquid adheres to the surface of the tablet or granule. The coating environment can be maintained so that it is evenly attached and dried.
코팅 물질은 지방, 지방산, 왁스, 쉘락, 초산프탈산셀룰로오스, 프탈산히드록시메틸셀룰로오스(hydroxypropyl methylcellulose, HPMC)로 이루어진 그룹에서 선택되는 어느 하나 이상을 포함한다. 코팅 물질은 HPMC인 것이 바람직하다.The coating material includes any one or more selected from the group consisting of fat, fatty acid, wax, shellac, phthalate cellulose acetate, and hydroxypropyl methylcellulose phthalate (HPMC). It is preferred that the coating material is HPMC.
또한 전술한 코팅 공정을 조금 변형할 수 있다. 그 경우, 코팅하는 단계에서는, 트리아세틴, 트리에틸 시트레이트 또는 디에틸 타르트레이트의 첨가제를 함유한 HPMC의 미세입자 분산액을 사용할 수 있다. 미세입자 분산액은 전체 용액 대비 HPMC 6중량% 내지 10중량%, 가소제 10중량%, 및 코팅용매로 구성될 수 있다.It is also possible to slightly modify the above-described coating process. In that case, in the step of coating, a fine particle dispersion of HPMC containing an additive of triacetin, triethyl citrate or diethyl tartrate may be used. The fine particle dispersion may be composed of 6% by weight to 10% by weight of HPMC, 10% by weight of a plasticizer, and a coating solvent based on the total solution.
코팅된 정제나 과립은 스틱 형태 등의 소정 모양의 포장 용기에 담겨 포장될 수 있다.The coated tablets or granules may be packaged in a packaging container having a predetermined shape such as a stick shape.
또 한편으로, 상기의 단계(S10)에서의 판단 결과, 조립 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 조립할 수 있다. 조립 공정에서는 측량된 건강기능식품의 원료를 혼합한 분말 혼합물에 물이나 유기 용매를 첨가하여 조립할 수 있다(S21).On the other hand, as a result of the determination in step S10, if the progress to the assembling process is determined, the measured raw materials of the health functional food may be assembled. In the assembling process, water or an organic solvent may be added to a powder mixture in which the measured raw materials of the health functional food are mixed to be assembled (S21).
또한, 조립 공정의 마지막 10분 동안에는 스테아린산 마그네슘, 이산화규소 및 히드록시프로필메틸셀룰로오스(HPMC)에서 선택되는 어느 하나의 부형제를 첨가하여 조립하도록 이루어질 수 있다(S22). 그 경우, 이후의 타정 공정에서 조립된 과립이나 정제의 성형 과정이 좀더 효과적으로 진행될 수 있다.In addition, during the last 10 minutes of the assembling process, it may be made to assemble by adding any one of excipients selected from magnesium stearate, silicon dioxide, and hydroxypropylmethylcellulose (HPMC) (S22). In that case, the process of molding granules or tablets assembled in a subsequent tableting process may be more effectively performed.
다음, 조립한 재료를 호퍼(hopper)로부터 타정기의 회전반 위에 정량적으로 공급하고 회전반에 형성되어 있는 구멍인 유발(mortar)에 투입되는 재료를 상하 2조의 강철봉으로 압축하여 타정할 수 있다(S23).Next, the assembled material is quantitatively supplied from the hopper to the turntable of the tablet press, and the material injected into the mortar, which is a hole formed in the turntable, can be compressed into two sets of upper and lower steel bars and tableted (S23). ).
그리고, 타정된 과립 또는 정제를 액상의 코팅 물질을 분무하여 코팅한다(S24).Then, the tableted granules or tablets are coated by spraying a liquid coating material (S24).
전술한 단계들 중 일부 주요 단계들과 이들 단계들 사이에 부가할 수 있는 추가 공정에 대하여 좀더 상세히 설명하면 다음과 같다.Some of the major steps of the aforementioned steps and additional processes that may be added between these steps will be described in more detail as follows.
먼저, 원료의 배합이나 조립하기 전에, 원료를 측량하여 준비하는 공정에서는, 장 내 세균의 일종인 유익균을 소정량 준비할 수 있다. 유익균은 락토바실러스(lactobacillus), 락토코커스(lactococcus), 엔테로코커스(enterococcus), 스트렙토코커스(streptococcus) 및 비피도박테리움(bifidobacterium)으로 이루어진 그룹에서 선택되는 어느 하나 이상의 프로바이오틱스 균주를 포함한다.First, in the step of measuring and preparing the raw materials before mixing or granulating the raw materials, a predetermined amount of beneficial bacteria, which is a kind of intestinal bacteria, can be prepared. Beneficial bacteria include any one or more probiotic strains selected from the group consisting of lactobacillus, lactococcus, enterococcus, streptococcus, and bifidobacterium.
본 실시예에서는 상술한 프로바이오틱스 균주로 이루어진 미생물 또는 이를 혼합한 균과 균 또는 배양체를 배양시키기 위한 배지 및 보호제를 원료로 사용할 수 있다.In the present embodiment, a medium and a protective agent for culturing a microorganism composed of the above-described probiotic strain or a microorganism and a microorganism or a culture mixture thereof may be used as a raw material.
가령 프로바이오틱스는 적정량을 섭취했을 때 숙주의 건강에 도움이 되는 살아있는 미생물로 정의되며, 독성이 없이 비교적 안전하다. 프로바이오틱스 유산균은 만성 위염의 원인균인 헬리코박터를 사멸하거나 억제하는 효과도 뛰어나다. 또한 락토라실러스 플랜타럼 HY7714는 자외선에 의한 피부 손상과 피부 보습과 관련해 인정을 받았다.Probiotics, for example, are defined as living microorganisms that benefit the health of the host when ingested in an appropriate amount, and are relatively safe without toxicity. Probiotics lactic acid bacteria are also excellent in killing or inhibiting Helicobacter, the causative agent of chronic gastritis. In addition, Lactoracillus Plantarum HY7714 has been recognized for skin damage and skin moisturization caused by UV rays.
또한, 락토라실러스는 과채유래 유산규인 락토바실러스 플랜타럼 CJLP133(L.plantarum CJLP133)을 포함하며, 이는 락토바실러스 속, 플랜타럼 종의 CJLP133이라는 이름의 균을 뜻한다. 프로바이오틱스는 균주에 따라 콜레스트롤 수치 개선, 면역 질환 개선, 장 질환 및 변비나 설사 개선, 아토피 질환 개선, 유당 불내증 개선 등의 효능을 가진다.In addition, Lactoracillus includes Lactobacillus plantarum CJLP133 (L. plantarum CJLP133), a lactic acid derived from fruit and vegetable, which means a fungus named CJLP133 of the genus Lactobacillus and plantarum species. Depending on the strain, probiotics have efficacy in improving cholesterol levels, improving immune diseases, improving intestinal diseases and constipation or diarrhea, improving atopic diseases, and improving lactose intolerance.
측량된 원료를 배합하는 공정에서는, 준비된 다수의 유산균들을 미리 설정된 일정 비율로 배합한다. 배합 공정에서는 유산균 외에 말토덱스트린, 사이클로 덱스트린, 자일리톨, 비타민 B 중에서 선택되는 적어도 어느 하나를 일정 비율로 배합하여 균질화할 수 있다. 배합 공정은, 상대습도 65% 이하, 온도 약 24℃의 분위기에서 약 30분 내지 약 50분간, 바람직하게는 약 40분간 수행된다. 배합 과정에서는 부용제가 추가되어 약 10분간 배합이 수행될 수 있다.In the process of blending the measured raw materials, a plurality of prepared lactic acid bacteria are blended at a predetermined ratio set in advance. In the blending process, in addition to lactic acid bacteria, at least one selected from maltodextrin, cyclodextrin, xylitol, and vitamin B may be blended in a predetermined ratio and homogenized. The blending process is carried out for about 30 minutes to about 50 minutes, preferably about 40 minutes, in an atmosphere with a relative humidity of 65% or less and a temperature of about 24°C. In the blending process, a sub-solvent is added and blending may be performed for about 10 minutes.
부용제로는 스테아린산 마그네슘, 이산화규소 및 히드록시프로필메틸셀룰로오스(hydroxypropyl methylcellulose, HPMC)로 이루어진 그룹에서 선택되는 적어도 어느 하나 이상의 재료가 사용될 수 있다. 부용제를 사용하면, 후속 타정 공정에서 우수한 타정 효과를 얻을 수 있다. 즉, 원료를 적절하게 배합하지 않는다면, 이후의 타정 공정에서 함량 균일성과 경도 균일성과 같은 좋은 물성을 지닌 정제나 과립을 얻기 어렵다.As the sub-solvent, at least one or more materials selected from the group consisting of magnesium stearate, silicon dioxide, and hydroxypropyl methylcellulose (HPMC) may be used. If a sub-solvent is used, an excellent tableting effect can be obtained in a subsequent tableting process. That is, if the raw materials are not properly blended, it is difficult to obtain tablets or granules having good physical properties such as content uniformity and hardness uniformity in the subsequent tableting process.
다음, 배합한 재료를 타정하는 공정에서는, 실온 내지 약 40℃의 온도 분위기에서 미세입자로 양호한 정제를 만들기 위해 장시간에 걸쳐 매우 느린 속도로 타정한다. 타정 공정에서는 프로바이오틱스 유산균이 배합된 재료를 과립 혹은 정제 형태로 성형한다.Next, in the step of tableting the compounded material, tableting is performed at a very slow speed over a long period of time in order to make good tablets with fine particles in an atmosphere of room temperature to about 40°C. In the tableting process, a material containing probiotic lactic acid bacteria is molded into granules or tablets.
타정 공정은 건강기능식품의 과립 또는 정제 크기로서의 소정 크기와 수분함량 5% 이하, 경도 7㎏/㎡ 내지 15㎏/㎡, 깨짐 정도 0.2 내지 0.3로 성형되고, 부형제로써 포도당 또는 유당을 사용할 수 있다. 타정 공정에서 성형된 과립이나 정제의 경도는 경도 측정기(tablet tester 6D, Dr. Schleuniger, Thun, Switzerland)를 사용하여 측정하는 것이 가능하다.The tableting process is molded into a predetermined size as a granule or tablet size of a health functional food and a moisture content of 5% or less, a hardness of 7 kg/m 2 to 15 kg/m 2 and a degree of cracking of 0.2 to 0.3, and glucose or lactose can be used as an excipient. . The hardness of granules or tablets molded in the tableting process can be measured using a hardness tester (tablet tester 6D, Dr. Schleuniger, Thun, Switzerland).
타정 공정 후의 과립 또는 정제는 건조실에서 일정 시간 동안 건조될 수 있다. 이때, 과립 또는 정제는 이후의 코팅 공정에 적합한 표면 상태를 갖도록 이루어진다.The granules or tablets after the tableting process may be dried for a certain time in a drying room. At this time, the granules or tablets are made to have a surface condition suitable for a subsequent coating process.
다음, 타정된 과립 또는 정제를 코팅하는 공정에서는, 과립 또는 정제를 코팅기에 투입하고 코팅 소재를 함유한 액상 물질을 분무하여 과립 또는 정제를 코팅한다. 코팅 공정은 온도 55℃ 내지 65℃에서 1시간 내지 2시간 동안 액상의 코팅 물질을 분무하여 정제 500㎎ 당 2㎎의 용량의 코팅층이 형성하도록 이루어질 수 있다. 코팅 물질은 지방, 지방산, 왁스, 쉘락, 초산프탈산셀룰로오스, 프탈산히드록시메틸셀룰로오스(hydroxypropyl methylcellulose, HPMC)로 이루어진 그룹에서 선택되는 어느 하나 이상을 포함할 수 있다.Next, in the process of coating the tableted granules or tablets, the granules or tablets are put into a coater and a liquid substance containing a coating material is sprayed to coat the granules or tablets. The coating process may be performed to form a coating layer of 2 mg per 500 mg tablet by spraying a liquid coating material at a temperature of 55°C to 65°C for 1 hour to 2 hours. The coating material may include any one or more selected from the group consisting of fat, fatty acid, wax, shellac, phthalate cellulose acetate, and hydroxypropyl methylcellulose (HPMC).
또한, 코팅층은 장용 코팅층으로서, 코팅층의 재료는 상대적으로 저비용이나 제조 용이성을 위해 고밀도인 것이 바람직하고, 고밀도의 구성을 위해 코팅층을 구성하는 고분자의 함량을 적절하게 조정할 수 있다.In addition, the coating layer is an enteric coating layer, and the material of the coating layer is preferably of high density for relatively low cost and ease of manufacture, and the content of the polymer constituting the coating layer can be appropriately adjusted for high density configuration.
전술한 히드록시프로필메틸셀룰로오스(HPMC)는 수분을 머금게 되면 팽윤하는 특성을 가진 대표적인 고분자이다. HPMC는 그 분말입자 크기와 점도에 따라 용해도가 달라지는데, HPMC의 입자크기가 클수록 팽윤 속도 및 겔층 형성 속도가 느려지게 된다. 또한, HPMC의 점도가 높아질수록 겔의 강도를 상승시켜 수분의 침투를 어렵게 하며, 이는 수화되는 속도를 감소시키므로 약물의 방출을 늦어지게 한다. 따라서, HPMC를 이용한 정제시 약물방출속도를 조절하는데 가장 편리한 방법은 HPMC의 점도 등급을 적절히 조절하여 선택하는 것이다.The aforementioned hydroxypropylmethylcellulose (HPMC) is a representative polymer that has a property of swelling when it contains moisture. The solubility of HPMC varies depending on the powder particle size and viscosity, and the larger the particle size of HPMC, the slower the swelling rate and the gel layer formation rate. In addition, as the viscosity of HPMC increases, the strength of the gel increases, making it difficult for moisture to penetrate, which decreases the rate of hydration, thereby slowing the release of the drug. Therefore, the most convenient way to control the drug release rate during purification using HPMC is to select the HPMC by appropriately adjusting the viscosity grade.
실시예 1Example 1
프로바이오틱스 균주를 함유한 정제의 코팅제로는 장용성 기제인 히드록시메틸셀룰로오스(HPMC)를 사용하고, 필름 코팅의 유연성을 높이기 위한 가소제로는 AMG(acethylated monoglyceride)를 사용하였다. 그리고 코팅용매로는 발효주정(95%)과 정제수를 혼합하여 사용하였다.As a coating agent for tablets containing the probiotic strain, hydroxymethylcellulose (HPMC), an enteric base, was used, and as a plasticizer for increasing the flexibility of the film coating, AMG (acethylated monoglyceride) was used. And as a coating solvent, fermented alcohol (95%) and purified water were mixed and used.
코팅액은 총 중량 500g으로 제조하고, 그 중 고형분이 HPMC의 사용량을 전체 용액의 중량대비 6%, 8%, 10%로 각각 변화시켜 코팅층을 형성하였다. 용매로는 발효주정과 정제수를 85:15 중량비로 혼합한 것을 사용하였다.The coating solution was prepared with a total weight of 500 g, of which the amount of HPMC was changed to 6%, 8%, and 10% based on the weight of the total solution to form a coating layer. As a solvent, a mixture of fermented alcohol and purified water at an 85:15 weight ratio was used.
코팅액의 제조는 발효주정과 정제수 혼합 용매를 균질기(homogenizer)로 교반하면서 HPMC와 AMG를 투입하여 2500rpm에서 한 시간 정도 더 교반하여 균질한 코팅액을 제조하였다.In the preparation of the coating solution, a mixture of fermented alcohol and purified water was stirred with a homogenizer, HPMC and AMG were added, followed by stirring at 2500 rpm for about an hour to prepare a homogeneous coating solution.
그리고 준비된 코팅액을 정제의 표면에 분무하여 정제 상에 코팅층을 형성하였다. 코팅층을 위한 코팅액은 500㎎ 용량의 정제 당 2㎎이 사용되었다.Then, the prepared coating solution was sprayed on the surface of the tablet to form a coating layer on the tablet. The coating solution for the coating layer was 2 mg per 500 mg tablet.
코팅층의 HPMC 농도, 흡기 온도, 코팅분사 액량이 정제의 코팅 표면에 미치는 영향을 알아보기 위하여 필름 코팅기(Hi-coater, Freund Corporate)를 사용하였다. HPMC 농도 6, 8, 10%로 각각에 대하여 흡기 온도는 32, 35, 38℃로 각각 조절하고, 코팅분사 액량은 펌프로 7.5, 11.25, 15.0g/min으로 각각 조절하여 코팅층의 품질을 평가하였다.A film coater (Hi-coater, Freund Corporate) was used to investigate the effect of the HPMC concentration of the coating layer, the intake air temperature, and the amount of coating spray liquid on the coating surface of the tablet. For each HPMC concentration of 6, 8, and 10%, the intake air temperature was adjusted to 32, 35, and 38°C, respectively, and the amount of coating sprayed liquid was adjusted to 7.5, 11.25, and 15.0 g/min with a pump to evaluate the quality of the coating layer. .
코팅층의 균일한 상태를 확인하기 위해 이온 스퍼터 코팅기(ion suptter coater)로 금이온(gold-ion)을 코팅한 다음 단면을 주사전자현미경을 이용하여 100배율에서 관찰하였다. 그 결과, 코팅액의 분사 액량이 코팅 품질을 저하시키는 백색현상을 일으키는데 상당한 영향을 주고 있음을 확인하였다.In order to check the uniform state of the coating layer, gold-ion was coated with an ion sputter coater, and the cross-section was observed at 100 magnification using a scanning electron microscope. As a result, it was confirmed that the sprayed liquid amount of the coating liquid had a significant influence on causing a white phenomenon that deteriorates the coating quality.
붕해시험은 건강기능식품공전에 기술되어 있는 붕해시험법으로 측정하였다. 즉, 제조된 정제를 인공위액과 인공장액에 6개씩 넣은 다음, 인공위액은 120분, 인공장액은 60분간 상하운동을 한 다음 관찰하여 정제의 용해를 관찰하였다. 사용한 인공위액은 염화나트륨 2.0g에 염산 7.0㎖과 물을 넣어 녹여 1L로 제조하였고(pH 1.2), 인공장액은 0.2mol/L 인산이수소칼륨시액 250㎖에 0.2mol/L과 물을 넣어 1L로 제조하였다(pH 6.8).The disintegration test was measured by the disintegration test method described in the Health Functional Food Code. That is, the prepared tablets were placed in each of the artificial gastric juice and the artificial intestinal juice by six, followed by up-and-down motion for 120 minutes for the artificial gastric juice and 60 minutes for the artificial intestinal juice, and the dissolution of the tablets was observed. The used artificial gastric juice was prepared by dissolving 7.0 ml of hydrochloric acid and water in 2.0 g of sodium chloride to make 1 L (pH 1.2), and 0.2 mol/L and water were added to 250 ml of 0.2 mol/L potassium dihydrogen phosphate TS to make 1 L. Was prepared (pH 6.8).
실험 결과, 백색현상이 발생하는 것을 방지하기 위해 즉, 정제의 표면 코팅 시 표면의 투명도를 증가시키기 위해, 발효주정과 정제수 혼합 용매를 균질기(homogenizer)로 교반하면서 HPMC와 AMG를 투입하여 2500rpm에서 한 시간 정도 더 교반하여 균질한 코팅액을 제조한 후, 코팅액 분사량 7.5~15.0g/min, 흡기 온도 실온(28℃) 내지 40℃(바람직하게는 32~38℃), HPMC 농도 6~10%(바람직하게는 6~8%)의 코팅 조건에서 코팅액을 분무하여 정제의 표면에 부착시키면서 분사되는 즉시 가루형태로 건조되어 정제 표면에 부착되도록 에어 스프레이(air spray)를 사용하는 공정에서, 코팅액이 분사될 때까지 혹은 정제 표면에 부착될 때까지 균일한 코팅액이 정제 표면에 균일하게 붙어 건조되도록 하는 것이 중요한 것으로 확인되었다.As a result of the experiment, in order to prevent the occurrence of whitening, that is, to increase the transparency of the surface when coating the surface of the tablet, HPMC and AMG were added while stirring the fermented alcohol and purified water mixed solvent with a homogenizer at 2500 rpm. After stirring for an additional hour to prepare a homogeneous coating solution, the coating solution injection amount 7.5-15.0 g/min, the intake air temperature room temperature (28°C) to 40°C (preferably 32-38°C), HPMC concentration 6-10% ( Preferably, in the process of using air spray to adhere to the tablet surface by spraying the coating solution under the coating condition of 6 to 8%) and attaching it to the surface of the tablet, the coating solution is sprayed in the process of using air spray so that it is dried in powder form and adhered to the tablet surface. It was confirmed that it is important to ensure that a uniform coating solution adheres evenly to the tablet surface and is dried until it is adhered to the tablet surface.
전술한 실시예에 의하면, 건강기능식품 조성물인 과립 또는 정제가 위에서는 형태를 거의 그대로 유지하고 소장에서 녹아 함유성분을 노출시키는 건강기능식품을 생산할 수 있다. 또한, 전술한 건강기능식품 조성물은 일정 용량의 스틱 용기로 포장되어 건강기능식품 스틱 용기로서 사용자가 1일 적정량을 사용하는데 용이하도록 제조될 수 있다.According to the above-described embodiment, it is possible to produce a health functional food in which granules or tablets, which are health functional food compositions, maintain their shape almost intact in the stomach and melt in the small intestine to expose the contained components. In addition, the above-described health functional food composition may be packaged in a stick container of a predetermined capacity and prepared as a health functional food stick container so that the user can easily use an appropriate amount per day.
상기에서는 본 발명의 바람직한 실시예를 참조하여 설명하였지만, 해당 기술 분야의 숙련된 당업자는 청구범위에 기재된 본 발명의 사상 및 영역으로부터 벗어나지 않는 범위 내에서 본 발명을 다양하게 수정 및 변경시킬 수 있음을 이해할 수 있을 것이다.Although the above has been described with reference to the preferred embodiments of the present invention, those skilled in the art can variously modify and change the present invention without departing from the spirit and scope of the present invention described in the claims. You can understand.
Claims (5)
상기 판단 단계에서 상기 배합 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 배합하는 단계;
상기 판단 단계에서 상기 조립 공정으로의 진행이 결정되면, 측량된 건강기능식품의 원료를 혼합한 분말 혼합물에 물이나 유기 용매를 첨가하여 조립하는 단계;
배합한 과립이나 조립한 과립을 호퍼(hopper)로부터 타정기의 회전반 위에 정량적으로 공급하고 상기 회전반에 형성되어 있는 구멍인 유발(mortar)에 투입된 상기 과립을 상하 2조의 강철봉으로 압축하여 타정하는 단계; 및
타정된 과립 또는 정제를 건조하는 단계; 및
건조된 과립 또는 정제의 표면을 코팅하는 단계를 포함하고,
상기 배합하는 단계는, 상기 원료에 자일리톨과 비타민 B 중에서 선택되는 적어도 어느 하나를 추가하여, 상대습도 65% 이하, 온도 20℃ 내지 24℃의 분위기에서 30분 내지 50분간 배합하고, 배합 공정의 마지막 10분 동안에는 스테아린산 마그네슘, 이산화규소 및 히드록시프로필메틸셀룰로오스(HPMC)에서 선택되는 어느 하나의 부형제를 첨가하여 배합하고,
상기 타정하는 단계는, 상기 건강기능식품의 정제 크기로서의 소정 크기와 수분함량 5% 이하를 갖도록 성형되고, 부형제로써 포도당 또는 유당을 사용하며,
상기 코팅 물질은 HPMC를 포함하고, 상기 코팅하는 단계에서, HPMC 농도 6~8%, 코팅액 분사량 7.5~15.0g/min 및 흡기 온도 32℃ ~ 38℃의 코팅 조건에서 상기 코팅 물질을 함유한 코팅액을 분무하여 정제의 표면에 부착시키면서 분사되는 즉시 정제의 표면에 부착되어 가루형태로 건조되도록 에어 스프레이를 사용하는 공정에서, 상기 코팅액이 분사될 때까지 혹은 상기 정제의 표면에 부착될 때까지 균일한 코팅액이 상기 정제의 표면에 균일하게 붙어 건조되도록 코팅 환경을 유지하는 건강기능식품의 제조방법.Determining to which process the measured raw materials of the health functional food will proceed to the blending process and the assembly process;
Mixing the measured raw materials of the health functional food when it is determined to proceed to the blending process in the determination step;
When it is determined in the determination step that progress to the assembly process is determined, adding water or an organic solvent to a powder mixture in which the measured raw materials of the health functional food are mixed and assembling;
Quantitatively supplying the blended granules or granulated granules from a hopper to a turning table of a tablet press, and compressing the granules into a mortar, which is a hole formed in the turning plate, with two sets of upper and lower steel bars, and tableting them. ; And
Drying the tableted granules or tablets; And
Coating the surface of the dried granules or tablets,
In the blending step, at least one selected from xylitol and vitamin B is added to the raw material, blended for 30 to 50 minutes in an atmosphere having a relative humidity of 65% or less and a temperature of 20°C to 24°C, and the end of the blending process For 10 minutes, any one excipient selected from magnesium stearate, silicon dioxide and hydroxypropylmethylcellulose (HPMC) is added and blended,
The tableting step is molded to have a predetermined size as a tablet size of the health functional food and a moisture content of 5% or less, and uses glucose or lactose as an excipient,
The coating material includes HPMC, and in the coating step, a coating solution containing the coating material is applied under a coating condition of an HPMC concentration of 6 to 8%, a coating liquid injection amount of 7.5 to 15.0 g/min, and an intake air temperature of 32°C to 38°C. In the process of using air spray to adhere to the surface of the tablet and dry in powder form as soon as it is sprayed while attaching it to the surface of the tablet, a uniform coating solution is applied until the coating solution is sprayed or adheres to the surface of the tablet. A method of manufacturing a health functional food that maintains a coating environment so that it is evenly attached to the surface of the tablet and dried.
상기 코팅 물질은 지방, 지방산, 왁스, 쉘락, 초산프탈산셀룰로오스, 프탈산히드록시메틸셀룰로오스(hydroxypropyl methylcellulose, HPMC)로 이루어진 그룹에서 선택되는 어느 하나 이상을 포함하는 건강기능식품의 제조방법.The method according to claim 1,
The coating material is a method for producing a health functional food comprising at least one selected from the group consisting of fat, fatty acid, wax, shellac, phthalate cellulose acetate, and hydroxypropyl methylcellulose phthalate (HPMC).
상기 코팅하는 단계는, 트리아세틴, 트리에틸 시트레이트 또는 디에틸 타르트레이트의 첨가제를 함유한 상기 HPMC의 미세입자 분산액을 사용하는 건강기능식품의 제조방법.The method according to claim 2,
The coating step is a method for producing a health functional food using the fine particle dispersion of the HPMC containing an additive of triacetin, triethyl citrate or diethyl tartrate.
상기 미세입자 분산액은 전체 용액 대비 HPMC 6중량% 내지 10중량%, 가소제 10중량%, 및 코팅용매로 구성되는 건강기능식품의 제조방법.The method of claim 3,
The fine particle dispersion is a method for producing a health functional food consisting of 6% by weight to 10% by weight of HPMC, 10% by weight of a plasticizer, and a coating solvent based on the total solution.
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JP2019077705A (en) * | 2013-03-14 | 2019-05-23 | セラバイオーム,エルエルシー | Targeted gastrointestinal delivery of probiotic organisms and/or therapeutic agents |
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