KR900006831B1 - Process for preparing soft capsule contains royal jelly - Google Patents

Process for preparing soft capsule contains royal jelly Download PDF

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KR900006831B1
KR900006831B1 KR1019880001591A KR880001591A KR900006831B1 KR 900006831 B1 KR900006831 B1 KR 900006831B1 KR 1019880001591 A KR1019880001591 A KR 1019880001591A KR 880001591 A KR880001591 A KR 880001591A KR 900006831 B1 KR900006831 B1 KR 900006831B1
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royal jelly
soft capsule
preparing soft
mixture
capsule contains
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KR1019880001591A
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KR890012637A (en
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임성기
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한미약품공업 주식회사
임성기
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate

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Abstract

A process for preparing soft capsule containing royal jelly comprises (a) mixing 100mg of royal jelly (65.0% of water content), 5g of natural tocopherol and 1000mg of nice crystal cellulose (5% of water content), (b) drying the mixture at 40-50 deg.C for 4hrs, (c) mixing 268mg of the dried material, 110g of palm oil, 6g of soybean phospholipid and 216g of soybean oil and emulsifying and (d) preparing soft capsule containing 600mg of the mixture.

Description

로얄제리를 함유한 연질 캅셀의 제조법Preparation of soft capsules containing royal jelly

본 발명은 로얄제리를 함유한 연질캅셀의 제조방법에 관한 발명이다. 생로얄제리는 조단백(약 12.5%), 조지방(약 3.5%), 당질(약 16%), 수분(약 67%), 수용성 비타민류(약 1-200%)를 함유하고 있으며 지표물질로서 지방산 성분인 10-하이드록시-2-대세노인산(약 1.4%이상)을 함유한 유화성 점조액이다. 이를 복용 가능한 제형으로 제조하기 위해서는 함유성분의 변질을 방지하고 미생물 오염을 저지해야 되기 때문에 종래에는 주로 생로얄제리를 감압 냉동 건조법으로 처리할 경우에는 처리시간이 길게(약 72시간) 소요되고, 에너지 소비가 크며, 처리된 냉동 건조물 자체가 흡습성을 가지므로 보관내지는 다음 처리 공정에서 쉽게 흡습연화되기 때문에 사후관리에 난점이 많았다.The present invention relates to a method for producing a soft capsule containing royal jelly. Saint Royal Jelly contains crude protein (about 12.5%), crude fat (about 3.5%), sugar (about 16%), water (about 67%), and water-soluble vitamins (about 1-200%). It is an emulsified viscous liquid containing 10-hydroxy-2-decenophosphate (about 1.4% or more) as a component. In order to prepare the dosage form, it is necessary to prevent the deterioration of the ingredients and to prevent microbial contamination. Therefore, when the raw royal jelly is mainly processed by the freeze-drying method under reduced pressure, the processing time is long (about 72 hours), Consumption is high, and the treated freeze-dried itself has hygroscopicity, so storage and storage are easily hygroscopically softened in the next treatment process, so that the post-management was difficult.

본 발명자는 이러한 실정을 감안하여 공업적으로 대량 처리하기 위한 방법으로서 생로얄제리를 미결정 셀룰로이스에 흡착(흡착비 1 : 0.5∼2.5)시키고, 이 흡착물을 저온(40-50℃)에서 약 4시간 건조시켜 수분 함량이 5%이하인 건조물을 얻은 다음에 이 건조물을 유성기제와 혼합 유화시킨 후, 이 배합물을 대용물로 하여 충전한 로얄제리 연질 캅셀을 제조하였다. 이때 생로얄제리 흡착 건조물 및 로얄제리 연질 캅셀에 함유된 지표물질 10-하이드록시-2-데세노인산의 함량변화(표 1참조)는 거의 없었으며, 색상, 냄새 및 맛의 변절은 나타나지 않았다. 또한 생균수 시험을 한 결과 미생물 오염의 흔적은 없었다.In view of such a situation, the present inventors adsorb the raw royal jelly to microcrystalline cellulose (adsorption ratio 1: 0.5 to 2.5) as a method for industrially mass-processing, and the adsorbate is about low temperature (40-50 ° C.). After drying for 4 hours to obtain a dried product having a moisture content of 5% or less, the dried product was emulsified by mixing with an oily base, and then a royal jelly soft capsule filled with the blend as a substitute was prepared. At this time, there was little change in the content of the indicator substance 10-hydroxy-2-decenophosphate contained in the raw royal jelly adsorption dried material and the royal jelly soft capsule (see Table 1), and there was no change in color, smell and taste. The bioburden test showed no signs of microbial contamination.

[표 1]TABLE 1

Figure kpo00001
Figure kpo00001

본 발명으로 제조된 연질캅셀은 장기간 보존(4개월)에서도 변질, 미생물 오염이 일어나지 않았고 지표물질의 함량 저하도 일어나지 않았다.In the soft capsule prepared according to the present invention, no deterioration or microbial contamination occurred even in long-term storage (4 months), and no decrease in the content of the indicator substance occurred.

[실시예 1]Example 1

생로얄제리 100mg(수분함량 65.0%)에 천연토코페로 5g가하여 혼합하고 미결정 셀룰로오스 1000mg(수분함량 5%)을 소량씩 가하면서 전질 균등하게 혼합시킨 다음에 이 혼합물을 45℃에서 4시간 건조시켜 건조물1340(수분함량 1.3%, 수득율 98.0%)을 얻었다. 이 건조올 268mg(생로얄제리 200mg해당량)을 취하고 여기에 정제야자유 110g, 대두 인지질 6g, 정제대두유 216g을 가하여 호모믹서로 혼합유화시켜 연질 캅셀 내용물을 조제한다. 이 배합물을 연질캅셀 제조기에서 1캅셀당 대용물 600mg(생로얄 제리 200mg해당량)이 함유된 연질캅셀을 제조하였다.5 g of natural royal tocope is added to 100 mg of fresh royal jelly (65.0% of water), mixed with a small amount of 1000 mg of microcrystalline cellulose (5% of water), and the mixture is mixed evenly for 4 hours. 1340 (1.3% moisture content, 98.0% yield) was obtained. Take 268 mg (200 mg equivalent of fresh royal jelly) of this driedol, add 110 g of refined palm oil, 6 g of soybean phospholipid, and 216 g of refined soybean oil to mix-emulsify it with a homomixer to prepare a soft capsule. This blend was prepared in a soft capsule maker containing a soft capsule containing 600 mg of substitute (200 mg equivalent of raw royal jelly) per capsule.

[실시예 2]Example 2

생로얄제리 1000(수분함량 66.5%)에 디-알파-토코페로 4g을 가하여 혼합하고 미결정 셀룰로오스 500g(수분함량 4%)을 소량씩 가하면서 전질균등하게 혼합시킨 다음에 이 혼합물을 45℃에서 4시간 건조시켜 건조물 810g(수분함량 1.8%, 수득율 97.5%)을 얻었다. 이 건조물 234g(생로얄제리 300해당량)을 취하고 여기에 정제 야자유 250g, 대두 인지질 9g, 정제 대두유 407g을 가하여 호모믹서로 혼합 유화시켜 연집캅셀 내용물을 제조한다. 이 배합물을 연질 캅셀 제조기에서 1캅셀망 내용물 900g(생로얄제리 300mg해당량)이 함유된 연질캅셀을 제조하였다.4 g of Saint Royal Jelly 1000 (moisture content 66.5%) was added with di-alpha-tocophere and mixed, and 500 g of microcrystalline cellulose (4% moisture content) were added in small portions and mixed in a homogeneous mixture. It dried over time and obtained 810g of dried materials (water content 1.8%, yield 97.5%). Take 234 g of this dried product (300 equivalent of raw royal jelly), add 250 g of refined palm oil, 9 g of soybean phospholipid, and 407 g of refined soybean oil, and mix and emulsify it with a homomixer to prepare a soft capsule content. This blend was prepared in a soft capsule maker containing a soft capsule containing 900 g (300 mg equivalent of fresh royal jelly) of one capsule network contents.

[실시예 3]Example 3

생로얄제러 1000g(수분함량 67%)에 디-알파-초산토코페롤 4g을 가하여 혼합하고 미결정 셀룰보오스1500(수분함량 4%)을 소량씩 가하면서 전질 균등하게 혼합시킨 다음에 이 혼합물을 45°에서 4시간 건조시켜 건조물 1780(수분함량 1.5%, 수득율 99.0%)을 얻었다. 이 건조물 178(생로얄제리 100mg해당량)을 취하고 여기에 정제야자유 87g, 대두인지질 5g, 정제 대두유 180g을 가하여 호모믹서로 혼합 유화시켜 연질캅셀 내용물을 조제한다. 이 배합물을 연질캅셀 제조기에서 1캅셀당 내용물 450mg(생로얄제리 100mg해당량)이 함유된 연질캅셀을 제조하였다.4 g of di-alpha-tocopherol dihydrate was added to 1000 g of fresh royal geranium (67% water content), and the mixture was uniformly mixed with a small amount of microcrystalline cellulose 1500 (water content 4%), and the mixture was 45 °. It dried for 4 hours, and obtained the dried material 1780 (water content 1.5%, yield 99.0%). Take the dried product 178 (100 mg equivalent of fresh royal jelly), add 87 g of refined palm oil, 5 g of soybean phospholipid, and 180 g of refined soybean oil, and mix and emulsify it with a homomixer to prepare a soft capsule. This blend was prepared in a soft capsule maker containing a soft capsule containing 450 mg of content (100 mg equivalent of raw royal jelly) per capsule.

Claims (1)

생로얄제리를 미결정 셀룰로오스에 흡착(흡착비 1 : 0.5-2.5)시킨후 저온(40-50°) 건조한 건조물을 유성기재와 혼합 유화시킨 배합물을 내용 충진물로 하는 연질캅셀 제조법.A method for producing a soft capsule comprising a formulation of a raw royal jelly adsorbed to microcrystalline cellulose (adsorption ratio 1: 0.5-2.5) and then a mixture of a low temperature (40-50 °) dried product mixed with an oily base to be emulsified.
KR1019880001591A 1988-02-15 1988-02-15 Process for preparing soft capsule contains royal jelly KR900006831B1 (en)

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