KR920010254B1 - Process for preparing soft gelatin capsule containing egg shells - Google Patents
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본 발명은 난각을 이용한 연질캅셀의 피막을 제조하는 방법에 관한 것이다. 더자세히말하면 연질캅셀이 위액내에서 쉽게 붕해되어 캅셀내용물이 체내로의 흡수를 용이하게 하며, 장기간의 보존 및 고온 다습시 캅셀간의 부착을 방지할 수 있고 생체 조절기능을 갖는 칼슘을 섭취할 수 있으며, 식품 부산물로 처리되는 난각을 이용함으로서 폐자원의 활용에도 기여하도록 함을 목적으로 하는 난각을 이용한 연질캅셀피막의 제조방법에 관한 것이다.The present invention relates to a method for producing a soft capsule film using eggshell. More specifically, soft capsules disintegrate easily in gastric juice, facilitating the absorption of capsule contents into the body, preventing the adhesion between capsules during long-term preservation and high temperature and high humidity, and ingesting calcium having bioregulatory function. The present invention relates to a method for producing a soft capsule film using egg shells for the purpose of contributing to the utilization of waste resources by using egg shells treated with food by-products.
일반적으로, 연질캅셀은 의약품, 건강식품 분야에서 사용되는 제품형태로서 내용물의 안정성이 높고 소화관내에서의 흡수가 용이하여 복용이 간편한 장점이 있다. 그리고 연질캅셀의 피막은 일반적으로 젤라틴 100에 대한 글리세린 20부에서 40부 그리고 미량의 색소 및 향기성분으로 이루어져 있으나 가소제로 사용되는 글리세린의 영향으로 붕해성이 떨어지는 단점이 있다.In general, soft capsule is a product form used in the field of medicines, health foods has the advantages of high stability of the contents and easy absorption in the digestive tract. And the film of the soft capsule is generally composed of 20 parts to 40 parts of glycerin for the gelatin 100 and a small amount of pigments and fragrance components, but has a disadvantage of poor disintegration due to the effect of glycerin used as a plasticizer.
따라서, 연질캅셀의 붕해성 및 안정성을 개선시키기 위한 시도가 종래에 행하여 졌는데 그 예를 들면 미합중국 특허 제4,708,834호(발명자 Jonathan M.Cohen, 1986.5.1. 출원 1987.11.24. 특허취득; Prepatation of gelatin-encapsulated controlled Releare composition)에서는 폴리사카라이드검 및 금속염을 첨가하였으며 미합중국 특허 제4,631,765호(발명자 Paul C.Guley; 1984.9.13. 출원 1987.7.21. 특허취득; "Rapid Releasing Triamterene containing gelatin capsule dosage forms for once daily antihypertensive use")에서는 메틸셀룰로오스 및 금속염을 첨가하여 연질캅셀 피막의 붕해도를 조절하였다. 그 밖에 일본국특공소 61-115,019호〔발명자 佐野莊仁의 1인; 1984.11.9. 출원; 일본국특개소 61-115019(1986.6.2. 공개); "젤라틴캅셀 피막")〕에서는 인산칼슘을 첨가하여 붕해도를 높게하였다.Thus, attempts have been made to improve the disintegration and stability of soft capsules, for example, in U.S. Patent No. 4,708,834 (inventor Jonathan M. Cohen, filed on Nov. 24, 1987, Nov. 1, 1987; Prepatation of gelatin). In the -encapsulated controlled releare composition, polysaccharide gum and metal salts were added and US Patent No. 4,631,765 (inventor Paul C. Guley; patent application issued on September 1, 1984. In once daily antihypertensive use, the disintegration of the soft capsule film was controlled by adding methyl cellulose and metal salts. In addition, JP 61-115,019 [One person of the inventor 佐野 莊 仁; 1984.11.9. Application; Japanese Patent Application Laid-Open No. 61-115019 (published on June 1, 1986); In gelatin capsule film IX), calcium phosphate was added to increase disintegration.
위 인용특허에서는 상기 본 발명의 목적에 따르는 연질캅셀피막의 제조방법에 대하여 암시한바도 없고 이와 같은 목적달성을 위하여 처리한 기술적 수단도 발견할 수 없다.In the above-cited patents, there is no suggestion regarding the manufacturing method of the soft capsule film according to the object of the present invention, and no technical means treated for achieving the above object can be found.
본 발명은 난각을 첨가하여 연질캅셀 피막을 제조하여 연질캅셀의 붕해성향상, 접착방지에 효과가 있고 생체조절물질인 칼슘을 체내에 흡수시켜줌으로써 영양성이 매우 좋을 뿐만 아니라 식품부산물로 처리되는 난각을 이용함으로써 폐자원의 활용에도 기여하게 된다. 난각은 93.7%의 탄산칼슘과 1.3%의 탄산마그네슘등으로 이루어져 있어 위액과 같은 산성조건에서 탄산가스가 발생하면서 통상의 연질캅셀보다 붕해가 신속하여 캡셀내용물이 체내에서 흡수가 용이하다. 또한 용해된 난각칼슘 및 마그네슘이 체내로 흡수되어 생체조절기능 뿐만 아니라 골다공증, 위암, 고혈압을 방지하여 주는 효과도 있다. 이러한 성질을 이용하여 난각막을 제거한 난각을 미분쇄하여 연질캅셀피막액에 첨가한 후 성형시켜 인공위액에서의 붕해도를 실험한 결과 난각을 첨가하지 않은 대조품은 1시간이 지나도 분해되지 않은 반면 난각분말을 첨가한 피막은 40분안에 붕해되었고 접착성실험에서도 매우 우수하였다.The present invention is to produce a soft capsule film by adding egg shell to improve the disintegration property of the soft capsule, to prevent adhesion, and to absorb calcium, which is a bioregulator, into the body, which is very nutritious as well as an egg shell processed as a food by-product. It also contributes to the utilization of waste resources. Eggshell is composed of 93.7% calcium carbonate and 1.3% magnesium carbonate, so that carbonic acid gas is generated under acidic conditions such as gastric juice, so that disintegration is faster than ordinary soft capsules. In addition, dissolved eggshell calcium and magnesium are absorbed into the body to prevent osteoporosis, stomach cancer, hypertension as well as bioregulatory function. Using this property, the egg shells from which egg shells were removed were pulverized, added to soft capsule coating solution, and then molded and tested for disintegration in artificial gastric juice. The control products without egg shells did not decompose after 1 hour, whereas egg shell powder The added film disintegrated in 40 minutes and was excellent in the adhesion test.
본 발명에 사용한 난각분말은 할난된 난각을 물로 수세한 후 알칼리 용액에 침지하여 난각막을 제거한 후 물로 다시 수세하고 건조하여 사용하였다. 건조처리한 난각의 분말로는 실험결과 70메쉬이상 325메쉬 이하가 가장 적당하다. 70메쉬 이상에서는 난각이 위액에서 분해되는 시간이 거의 같다.The egg shell powder used in the present invention was washed with water and then immersed in an alkaline solution to remove the egg shell membrane, and then washed again with water and dried. As a dry eggshell powder, more than 70 mesh and less than 325 mesh are most suitable. Above 70 meshes, eggshells break down in gastric juice at about the same time.
본 발명에 의한 난각분말은 젤라틴에 대하여 1 내지 30wt%가 바람직하다. 1wt% 이하에서는 난각첨가효과가 거의 없고 과량첨가를 할 때에는 (30wt% 이상) 내용물이 유출되고 캅셀 피막형성에 문제가 있다.Eggshell powder according to the present invention is preferably 1 to 30wt% based on gelatin. At 1wt% or less, there is almost no eggshell addition effect, and when it is added (more than 30wt%), the contents leak out and there is a problem in capsule film formation.
본 발명에 의한 난각분말은 다음 실시예 1에서와 같이 젤라틴, 글리세린, 정제수를 혼합시킨 후 팽윤시켜 60∼70℃온도 범위에서 용해시킨 다음에 본 발명에 의한 난각분말을 필요한 범위로 첨가한다.The eggshell powder according to the present invention is mixed with gelatin, glycerin, and purified water as in Example 1, followed by swelling to dissolve in the temperature range of 60 to 70 ° C., and then the eggshell powder according to the present invention is added to the required range.
위에서 설명한 바와 같이, 본 발명의 제조방법을 젤라틴, 글리세린 및 정제수를 혼합, 팽윤, 용해시키는 공정(step)과, 본 발명의 처리에 의한 난각분말의 바람직한 첨가량을 첨가시키는 공정과, 교반후 갑압탈기시키는 공정 및 성형시키는 공정의 결합으로 구성함을 특징으로 한다.As described above, the production method of the present invention is a step of mixing, swelling and dissolving gelatin, glycerin and purified water, adding a preferred amount of egg shell powder by the treatment of the present invention, and depressurization after stirring. It is characterized by consisting of a combination of the process to make and forming process.
위 공정에서, 난각은 통상의 원심분쇄기에 의해 70메쉬-325메쉬로 분해시켜 소요의 난각분말을 조제한 다음, 젤라틴 및 글리세린을 정제수와 소정량 혼합시킨다. 혼합시킨 다음 1-2시간 통상의 방법으로 팽윤시켜 용해온도 60-70℃로 용해시킨다. 그 결과 얻어진 용해된 젤라틴피막액에 소요량의 난각분말을 첨가시켜 고속교반기로 20-30분간 교반한다. 교반후 통상의 방법으로 가입탈기시킨다. 얻어진 용액을 스테인레스스틸제 플레이트(plate)상에 소요의 두께로(약 2mm) 성형한다. 성형후 열풍기건조기에 의해 통상 30℃에서 약 하루동안 건조시킨다. 그 다음 필요한 형상으로 절단시켜 연질캅셀 피막이 제조된다.In the above process, the egg shell is decomposed into 70 mesh-325 mesh by a conventional centrifugal mill to prepare a required egg shell powder, and then gelatin and glycerin are mixed with a predetermined amount of purified water. After mixing, the mixture was swollen in a conventional manner for 1-2 hours and dissolved at a dissolution temperature of 60-70 ° C. The required amount of eggshell powder is added to the resultant dissolved gelatine coating liquid and stirred for 20-30 minutes with a high speed stirrer. After stirring, it is degassed by the usual method. The obtained solution is molded to a required thickness (about 2 mm) on a stainless steel plate. After molding, it is dried for about one day at 30 DEG C by a hot air dryer. It is then cut into the required shape to produce a soft capsule film.
다음에 실시예에 의해 본 발명을 설명한다.Next, an Example demonstrates this invention.
〔실시예 1〕EXAMPLE 1
건조된 난각을 100메쉬 원시분쇄기로 분쇄하여 난각분말을 조제하였다. 다음 표1에서와 같이 젤라틴 200g, 글리세린 75g을 정제수 150g과 혼합시킨 다음 1 내지 2시간 팽윤시켜 60 내지 70℃에서 용해시킨다. 용해된 젤라틴피막액에 난각분말 20g을 첨가하여 고속교반기로 20 내지 30분간 교반한 후 감압탈기 시켰다. 그액을 스테인레스스틸제판에 2mm의 두께로 성형한 후 열풍건조기로 30℃에서 24시간 건조하여 직경 1cm사각형으로 절단하여 연질캅셀피막을 제조하였다.The dried eggshell was ground with a 100 mesh raw mill to prepare an eggshell powder. Next, as shown in Table 1, 200 g of gelatin and 75 g of glycerin were mixed with 150 g of purified water, followed by swelling for 1 to 2 hours to dissolve at 60 to 70 ° C. 20 g of eggshell powder was added to the dissolved gelatin coating liquid, which was stirred for 20 to 30 minutes with a high speed stirrer and degassed under reduced pressure. The liquid was molded into a stainless steel plate to a thickness of 2 mm, dried at 30 ° C. for 24 hours with a hot air dryer, and cut into 1 cm squares to prepare a soft capsule film.
〔실시예 2〕EXAMPLE 2
실시예 1의 방법에 따라 제조된 피막과 난각분말을 첨가하지 않은 피막을 각각 10개씩 40℃ 습도 75%에서 4주간 보존한 후 37℃ 0.1N 염산에 녹인 1% 펩신용액에 넣어 붕해시간을 측정한 결과 표 2와 같다.Ten films each prepared according to the method of Example 1 and no coating of eggshell powder were stored for 4 weeks at 75 ° C and 75% humidity for 4 weeks, and then dissolved in 1% pepsin solution dissolved in 37 ° C 0.1N hydrochloric acid to measure the disintegration time. One result is shown in Table 2.
[표 2]TABLE 2
20g의 난각분말을 첨가한 연질캅셀 피막은 40분 이내에 100% 붕해되는 반면 첨가하지 않은 캅셀피막은 90%가 60분을 초과하였다.The soft capsule film containing 20 g of eggshell powder was 100% disintegrated within 40 minutes, whereas the capsule capsule film not added was more than 90% in 60 minutes.
〔실시예 3〕EXAMPLE 3
실시예 1의 방법에 따라 제조된 피막과 난각분말을 첨가하지 않은 피막을 각각 10개씩 샘플병에 넣어 50℃ 습도 75%에서 4주간 보존하여 부착에 대한 안정성을 대비하여 보면 난각분말을 첨가한 연질캅셀 피막은 부착이 일어나지 않았으나 난각분말을 첨가하지 않은 제품은 용기 벽면 또는 피막끼리 부착이 일어났다.The film prepared according to the method of Example 1 and the film without the addition of eggshell powder were added to each of 10 samples in a sample bottle and preserved for 4 weeks at 75 ° C humidity of 75%. The capsule film did not adhere but the egg shell powder was not attached to the container wall or the film.
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