KR20030095958A - Preparation method of liquid agent for increasing immunity - Google Patents
Preparation method of liquid agent for increasing immunity Download PDFInfo
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Abstract
Description
하기 식의 다당체 물질은 식물 조직 원료를 배지 원료로 하여 바시디오마이세테스(BASIDIOMYCETES, 담자균류)를 액체배양한 배양액 및 균사체 혼합물부터 추출, 분리, 정제되는 것으로서 면역증강 등의 효능이 있어 항암제의 보조제로서 사용되고 있는 건강보조식품으로서, AHCC라는 상품명으로 널리 판매되고 있는 실정이다. 그러나, 분말 형태로 제조되어 있어 복용하기가 불편하고 맛 또한 복용에 거부감을 일으키게 하는 점이 단점으로 지적되어 왔다.The polysaccharide substance of the following formula is extracted, separated and purified from the culture medium and mycelium mixture in which BASDIOMYCETES is liquid cultured using the raw material of plant tissue as a medium raw material, and has an effect such as immunopotentiation. As a dietary supplement used as a supplement, it is widely marketed under the trade name AHCC. However, it has been pointed out that it is inconvenient to take because it is prepared in powder form, and taste and rejection of taking.
(식중, R은 수소원자 또는 아세틸기를 나타내고, 2,3 위의 수산기가 약 30% 아세틸화되어 있으며, 분자량 500 내지 1000임)(Wherein R represents a hydrogen atom or an acetyl group, the hydroxyl group on the 2,3 position is about 30% acetylated and has a molecular weight of 500 to 1000)
종래의 액상 생약제제의 제조방법에서는 추출용매로 물 또는 에틸알콜을 사용하였으며, 국립보건원 예규에 있어서도 표준탕액 방법으로서 원료 약품 총량의 물 10배량을 넣고 80 ~ 100℃에서 2 ~ 3시간 추출하여 추출액량이 1/2이 되었을 때까지 추출하는 것을 규정하고 있다.In the conventional liquid herbal preparation, water or ethyl alcohol was used as the extraction solvent.In the National Institutes of Health regulations, the standard liquid solution was added with 10 times the amount of the total amount of the drug substance and extracted for 2 hours at 80 to 100 ° C. It is prescribed to extract until the amount reaches 1/2.
상기 다당체의 경우 이러한 방법으로 액상 제제를 만들 경우 얼마 지나지 않아 침전물이 생기는 등 완전한 용액상태가 되지 않아 복용이 간편한 액상으로 제조하는 데 많은 어려움이 있었다.In the case of the polysaccharide, a liquid formulation is prepared in such a manner, and there is a lot of difficulty in preparing a liquid that is easy to take because it does not become a complete solution state such as a precipitate.
따라서, 본 발명의 목적은 상기 다당체를 장기간 보관 후에도 침전물이 생기지 않는 완전한 용액 형태로 제조하는 방법에 관한 것이다.Accordingly, an object of the present invention relates to a process for preparing the polysaccharide in the form of a complete solution which does not form a precipitate even after long term storage.
상기 본 발명의 목적은 하기 식의 다당체를 매실 액기스 및 물의 혼합 용매에 용해시킨 다음 감미제 등의 첨가제를 첨가하는 것으로 구성된 액상 면역증강 조성물의 제조 방법에 의해 달성된다.The object of the present invention is achieved by a method for producing a liquid immuno-enhancing composition consisting of dissolving a polysaccharide of the following formula in a mixed solvent of plum extract and water and then adding an additive such as a sweetener.
(식중, R은 수소원자 또는 아세틸기를 나타내고, 2,3 위의 수산기가 약 30% 아세틸화되어 있으며, 분자량 500 내지 1000임)(Wherein R represents a hydrogen atom or an acetyl group, the hydroxyl group on the 2,3 position is about 30% acetylated and has a molecular weight of 500 to 1000)
본 발명의 조성물에 첨가되는 매실 엑기스는 본 발명의 조성물의 pH를 3-5 범위로 조절하는 양으로 첨가된다. 또, 첨가되는 감미제의 양은 당도가 15-25%가 되는 양으로 첨가된다. 또한, 비타민 B군 등 각종 비타민 제제 등의 첨가제를 더 첨가할 수 있다.Plum extract added to the composition of the present invention is added in an amount to adjust the pH of the composition of the present invention in the range of 3-5. In addition, the sweetener is added in an amount such that the sugar content is 15-25%. Moreover, additives, such as various vitamin preparations, such as a vitamin B group, can be further added.
본 발명의 액상 조성물의 제조방법으로 제조된 액상 제제는 장기간 침전 생성이 억제되며 분산계의 물리적 안정성도 장기간 유지되어 상품성이 높고 효능의 균일성을 확보할 수 있는 효과가 있을 뿐아니라 간단한 조작만으로도 안정성을 확보할 수 있으므로 제조시간이 단축되고 고속원심분리 장치 등의 고가설비가 필요없이 제조공정이 단순화되는 우수한 효과가 있다.The liquid formulation prepared by the method for preparing the liquid composition of the present invention is suppressed the formation of prolonged precipitation and the physical stability of the dispersion system is also maintained for a long time has the effect of ensuring high commerciality and uniformity of efficacy as well as a simple operation. Since it can ensure the manufacturing time is shortened and there is an excellent effect that the manufacturing process is simplified without the need for expensive equipment such as a high speed centrifugal separator.
이하 실시예에서는 본 발명을 좀더 상세히 설명하지만 이들 실시예가 본 발명의 범위를 제한하는 것은 아니다.The following examples illustrate the invention in more detail, but these examples do not limit the scope of the invention.
[실시예 1]Example 1
AHCC-SS(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스(54Brix) 2g, 정제수 155g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-SS (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract (54 Brix), and 155 g of purified water were mixed for 30 minutes, sterilized by heating to 100 ° C, and then 30 minutes at 70-80 ° C. Sterilize and fill each container with 20ml using a three-sided packaging machine.
[비교예 1]Comparative Example 1
AHCC-S(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 정제수 155을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-S (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, and 155 purified water were mixed for 30 minutes, then sterilized by heating to 100 ° C and sterilized for 30 minutes at 70-80 ° C. Fill the container with 20 ml each.
[실시예 2]Example 2
AHCC-SS(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2g 정제수 153g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-SS (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract, and 2 g of inositol 2 g of purified water were mixed for 30 minutes, sterilized by heating to 100 ° C, and then sterilized for 30 minutes at 70-80 ° C. Fill the container with 20 ml each by using a three-side packing machine.
[실시예 3]Example 3
AHCC-SS(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2g, 구연산 1g, 정제수 152g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-SS (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract, 2 g of inositol, 1 g of citric acid, and 152 g of purified water were mixed for 30 minutes, and then sterilized by heating to 100 ° C., followed by 70-80 ° C. Sterilize for 30 minutes in a three-sided packaging machine to 20mL each container.
[실시예 4]Example 4
AHCC-SS(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2.2g, 구연산 1g, 비타민 B1 0.002g, 미타민 B2 0.008g, 비타민B6 0.002g 정제수 151.738g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23g of AHCC-SS (manufactured by Amino Up Kagaku, Japan), 20g of oligosaccharides, 2g of plum extract, 2.2g of inositol, 1g of citric acid, 1g of vitamin B1, 0.002g of vitamin B2, 0.008g of vitamin B6, and 151.738g of vitamin B6 After mixing for 10 minutes, sterilize by heating to 100 ℃ and sterilization for 30 minutes at 70-80 ℃ to fill the container 20ml each by using a three-side packaging machine.
[실시예 5]Example 5
AHCC-S(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 정제수 155g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-S (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract, and 155 g of purified water were mixed for 30 minutes, then sterilized by heating to 100 ° C and sterilized for 30 minutes at 70-80 ° C. Fill the container with 20 ml each using a packaging machine.
[실시예 6]Example 6
AHCC-S(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2g 정제수 153g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-S (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract, and 2 g of inositol 2 g of purified water were mixed for 30 minutes, sterilized by heating to 100 ° C., and then sterilized for 30 minutes at 70-80 ° C. Fill the container with 20 ml each by using a three-side packing machine.
[실시예 7]Example 7
AHCC-S(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2g, 구연산 1g, 정제수 152g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23 g of AHCC-S (manufactured by Amino Up Kagaku, Japan), 20 g of oligosaccharide, 2 g of plum extract, 2 g of inositol, 1 g of citric acid, and 152 g of purified water were mixed for 30 minutes, and then sterilized by heating to 100 ° C., followed by 70-80 ° C. Sterilize for 30 minutes in a three-sided packaging machine to 20mL each container.
[실시예 8]Example 8
AHCC-S(일본 가부시키가이샤 아미노 업 가가쿠 제품) 23g, 올리고당 20g, 매실엑기스 2g, 이노시톨 2.2g, 구연산 1g, 비타민 B1 0.002g, 미타민 B2 0.008g, 비타민B6 0.002g 정제수 151.738g을 30분간 혼합한 다음, 100℃로 가열하여 살균한 다음 70-80℃에서 30분간 살균하여 삼면 포장기를 이용하여 용기에 20㎖씩 충전한다.23g of AHCC-S (manufactured by Amino Up Kagaku, Japan), 20g of oligosaccharide, 2g of plum extract, 2.2g of inositol, 1g of citric acid, 1g of vitamin B1, 0.002g of vitamin B2, 0.008g of vitamin B6, 151.738g of vitamin B6 After mixing for 10 minutes, sterilize by heating to 100 ℃ and sterilization for 30 minutes at 70-80 ℃ to fill the container 20ml each by using a three-side packaging machine.
[실험예 1 : 용매별 가용성 고형분의 비교실험]Experimental Example 1 Comparative Experiment of Soluble Solids by Solvent
1) 시험액 : 실시예 1과 비교예 1의 액상 조성물을 3,000rpm에서 10분간 원심분리하여 얻은 상등액.1) Test solution: A supernatant obtained by centrifuging the liquid compositions of Example 1 and Comparative Example 1 at 3,000 rpm for 10 minutes.
2) 시험방법 : 각 시험액 10㎖를 취하여 105℃에서 항량이 될 때까지 건조하고 데시케이타에서 방냉한 후 무게를 측정하였다.2) Test method: Take 10 ml of each test solution, dry it to a constant quantity at 105 ° C, cool it in desiccator, and weigh.
3) 결과 : 각각 3회 실시하여 평균값을 얻었으며, 그 결과는 하기 표 1에 게재하였다. 가용 고형분이 비교예에 비해 실시예의 경우가 증가하였다.3) Results: Three times each, an average value was obtained, and the results are shown in Table 1 below. The available solids increased in the case of the example compared to the comparative example.
표 1Table 1
[실험예 2 : 용매별 안정성 비교]Experimental Example 2: Comparison of Stability by Solvent
실시예 1의 조성물과 비교예 1의 조성물을 각각 6개 10㎖씩을 무색투명한 바이알에 넣고 밀봉한 후, 실시예 1의 조성물과 비교예 1의 조성물 시료 각각 3개는 실온에서 12개월, 그리고 나머지 실시예 1의 조성물과 비교예 1의 조성물 시료 각각 3개는 50℃에서 30일 동안 침전개시 시기를 측정하였다.Example 6 and each of the compositions of Comparative Example 1 in each of 10 10 ml of a colorless transparent vial and sealed, each of the composition of Example 1 and three samples of Comparative Example 1 was 12 months at room temperature, and the rest Each of the compositions of Example 1 and three samples of the compositions of Comparative Example 1 measured the start time of precipitation for 30 days at 50 ° C.
50℃ 및 실온에서의 제품의 안정성 시험결과는 각각 표 2 및 표 3a에 기재된 바와 같다.The stability test results of the product at 50 ° C. and room temperature are as shown in Table 2 and Table 3a, respectively.
표 2TABLE 2
표 2에서 볼 수 있는 바와 같이 50℃의 가혹조건하에서의 침전안정성 실험에서 침전생성 여부를 매일 관찰한 결과 물을 용매로 사용한 비교예 1의 조성물은 1 ~ 3일 이내에 침전이 생성되는 반면, 메실엑기스와 물을 용매로 사용한 실시예 1의 조성물은 20일이 경과되기까지는 침전이 생성되지 않아 우수한 안정성을 보였다.As can be seen in Table 2, when the precipitation stability test was carried out daily in the precipitation stability test under 50 ° C harsh conditions, the composition of Comparative Example 1 using water as a solvent produced precipitate within 1 to 3 days, whereas mesyl extract The composition of Example 1 using water as a solvent showed excellent stability because no precipitation was formed until 20 days passed.
표 3TABLE 3
-침전생성 없음No sedimentation
+미량의 침전생성+ Generate small amount of precipitate
++다량의 침전생성++ Create a large amount of precipitation
실온에서의 장기 저장시의 안정성 시험결과, 물 용매를 사용한 비교예 1의 조성물에서는 1개월 이내에 소량의 침전이 생성되기 시작하였고, 6개월부터는 다량의 괴상 침전물이 시험관 하부에 침전되었다. 이에 비하여 본 발명의 조성물에서는 9개월 이내에는 침전생성이 전혀 없었고, 12개월 초기에 미량의 침전이 관측되어 안정성이 우수하였다.As a result of the stability test at a long time storage at room temperature, in the composition of Comparative Example 1 using a water solvent, a small amount of precipitation began to be produced within one month, and from 6 months, a large amount of mass precipitate precipitated in the lower part of the test tube. In contrast, in the composition of the present invention, there was no precipitation generation within 9 months, and a small amount of precipitation was observed at the beginning of 12 months, so the stability was excellent.
상기 실험예에서 알 수 있는 바와 같이, 본 발명의 제조방법에 의해 제조된 조성물은 안정성이 우수하여 침전물이 생성되지 않으며, 완전한 액상 제제로서 고형분의 용해도가 탁월하다.As can be seen in the experimental example, the composition prepared by the production method of the present invention is excellent in stability, no precipitate is produced, and the solubility of solids as a complete liquid formulation is excellent.
본 발명의 의해 고형분 형태로 판매되던 상기 식의 면역증강 조성물을 액상 제제로 제조하여 간편하게 복용이 가능하고, 감미제, 비타민 B 등을 첨가하여 맛과 면역 증강 등의 효과면에서 모두 우수한 제제를 제조할 수 있게 되었다.The immune enhancing composition of the above formula sold in solid form by the present invention can be prepared as a liquid preparation and can be easily taken. A sweetener, vitamin B, etc. can be added to prepare an excellent formulation in terms of effects such as taste and immune enhancement. It became possible.
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