JP2757937B2 - Hypoglycemic agent containing silkworm powder as active ingredient and method for producing the same - Google Patents

Hypoglycemic agent containing silkworm powder as active ingredient and method for producing the same

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Publication number
JP2757937B2
JP2757937B2 JP7194750A JP19475095A JP2757937B2 JP 2757937 B2 JP2757937 B2 JP 2757937B2 JP 7194750 A JP7194750 A JP 7194750A JP 19475095 A JP19475095 A JP 19475095A JP 2757937 B2 JP2757937 B2 JP 2757937B2
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Prior art keywords
silkworm
blood glucose
powder
instar
hypoglycemic agent
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JPH08337530A (en
Inventor
江善 柳
聖顯 鄭
起源 洪
相豊 李
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DAIKANMINKOKU
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DAIKANMINKOKU
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/63Arthropods
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Mycology (AREA)
  • Nutrition Science (AREA)
  • Insects & Arthropods (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【0001】[0001]

【発明の属する技術分野】本発明は蚕粉末を有効成分と
して含む血糖降下剤およびその製造方法に係り、より詳
しくは、蚕を窒素ガスで酸化防止処理し、凍結乾燥して
粉末化する工程を含む蚕粉末の製造方法とそれを有効成
分として含む血糖降下剤および健康補助食品に関する。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a hypoglycemic agent containing silkworm powder as an active ingredient and a method for producing the same. More specifically, the present invention relates to an antioxidant treatment of silkworm with nitrogen gas, followed by freeze-drying to powder. The present invention relates to a method for producing silkworm powder containing the same, a hypoglycemic agent and a health supplement containing the same as an active ingredient.

【0002】[0002]

【従来の技術】糖尿病は遺伝的あるいは環境的な要因に
よって発症する全身的な代謝疾患の一つであって、体内
にインシュリンというホルモンの絶対的あるいは相対的
な欠乏によって発生する疾病である。主要な症状として
は糖、脂肪および蛋白質代謝に異常をもたらすことによ
り、非正常的な高血糖と尿糖が出現し、特徴的な3多
症、すなわち多食、多渇および多尿などとともに激しい
疲労と倦怠が現われ、病勢がひどい場合は体が消耗する
病として知られている。
2. Description of the Related Art Diabetes is a systemic metabolic disease caused by genetic or environmental factors, and is a disease caused by an absolute or relative deficiency of a hormone called insulin in the body. The main symptoms are abnormalities in sugar, fat and protein metabolism, resulting in abnormal hyperglycemia and urinary glucose, which are severe with the characteristic polyplegia, such as polyphagia, polydipsia and polyuria When fatigue and malaise appear and the disease is severe, it is known as a wasting disease.

【0003】糖尿病は最近その発病率が大きく増加して
いるが、発病の初期にすぐれた血糖降下剤を投与して余
病を予防することが最も効果的な治療法であると考えら
れている。すなわち、薬物投与によって持続的に食後血
糖を調節すると、糖化ヘモグロビンの減少、平均血糖値
の降下および空腹時の血糖値の低下が生じ、その結果、
インシュリン抵抗性が好転することによりほぼ正常人の
ような生活が可能となる。
[0003] Although the incidence of diabetes has recently increased greatly, it is considered that administering an excellent hypoglycemic agent at the beginning of the onset of disease to prevent the remaining disease is the most effective treatment. . That is, continuous postprandial regulation of blood glucose by drug administration results in a decrease in glycated hemoglobin, a decrease in average blood glucose, and a decrease in fasting blood glucose.
The improvement in insulin resistance makes it possible to live almost like a normal person.

【0004】一方、現在糖尿病の治療薬として主に用い
られているインシュリン製剤や経口血糖降下剤(スルホ
ニル尿素類およびビグアニド類)を投与する場合、飲食
物の摂取後の血糖濃度は速く増加するのに比べ、投与し
た薬物によるインシュリンの血液内の出現が相対的に遅
くなることにより食後血糖量の上昇と血中インシュリン
の出現時間との不一致(mismatch)現象が現わ
れるようになる。特に、インシュリンを皮下注射で投与
する場合にはその吸収がさらに遅いため、不一致現象が
深刻となり、これによって食後高血糖症(postpr
andialhyperglycemia)、食間の高
インシュリン血症(hyperinsulinaemi
a)および低血糖症が現われるようになる。
[0004] On the other hand, when an insulin preparation or an oral hypoglycemic agent (sulfonylureas and biguanides), which is currently mainly used as a therapeutic agent for diabetes, is administered, the blood glucose concentration after ingestion of food and drink rapidly increases. As compared with the above, the appearance of insulin in the blood by the administered drug is relatively delayed, so that a mismatch phenomenon between the rise in postprandial blood glucose level and the appearance time of blood insulin comes to appear. In particular, when insulin is administered by subcutaneous injection, its absorption is even slower, and the discrepancy phenomenon becomes serious, which causes postprandial hyperglycemia (postprg).
and internal hyperglycemia, hyperinsulinemia between meals (hyperinsulinaemi)
a) and hypoglycemia appear.

【0005】従って、理想的な血糖降下剤はその薬効が
速く現われて食後血糖の上昇を防止し、短い時間内にそ
の効力が消失されて不必要な低血糖を起こさないばかり
でなく、糖尿病に特異に付随して起こる代謝異常を同時
に正常化できる安定な経口薬剤でなければならない。現
在、かかる血糖降下剤の開発が切実に求められており、
伝統的な薬物あるいは民間療法を用いた糖尿病の治療法
が大きく脚光を浴びている趨勢である。
[0005] Therefore, an ideal hypoglycemic agent has a rapid effect and prevents a rise in postprandial blood sugar, and its efficacy is lost within a short period of time, thus not only causing unnecessary hypoglycemia but also reducing diabetes. It must be a stable oral drug that can simultaneously normalize the metabolic abnormalities associated with specificities. Currently, the development of such hypoglycemic agents is urgently required,
Treatment of diabetes using traditional drugs or folk remedies is in the limelight.

【0006】一方、東医寳鑑をはじめとする東洋医学古
書においては蚕の蛹および繭が糖尿病に治療効果がある
と記録されており、最近では民間療法として蚕自体を血
糖降下を目的に用いる事例が増している。これは、蚕自
体が飲食物の吸収を遅延させるα−グルコシダーゼ阻害
剤(α−glucosidase inhibito
r)の効果を有するためであり、桑の葉に由来する物質
が蚕の体内において前記効果を有する物質に変換される
と推定されている。
[0006] On the other hand, in ancient books of Oriental medicine such as Higashi Ihokan, it is described that pupae and cocoons of silkworms have a therapeutic effect on diabetes. Recently, as a folk remedy, silkworms themselves are used for the purpose of lowering blood glucose. Cases are increasing. This is due to the fact that the silkworm itself delays the absorption of food and drink by an α-glucosidase inhibitor (α-glucosidase inhibitor).
It is presumed that the substance derived from mulberry leaves is converted into a substance having the above-mentioned effect in the body of the silkworm.

【0007】一般に、蚕は卵から孵化して4回の脱皮を
経て繭から蛹に変態した後、蛾になり卵を産み、ほぼ2
週間を経過すると死ぬという一生の完全変態昆虫の一つ
である。蚕の幼虫の成長段階に従う生理学的変化は非常
に大きく、脱皮前後の幼虫の体内酵素をはじめとする物
質水準の差異は著しいことが知られている。蚕の体内に
は主に桑の葉成分の蚕糞と各種酵素が入っている中腸消
化液と血液とがある。このうち、中腸消化液と血液はき
わめて酸化されやすく、空気と接するようになると容易
に酸化されて黒く変色されながら不活化される。
In general, silkworms hatch from eggs, undergo molting four times, transform from cocoons to pupae, then become moths and lay eggs.
It is one of the lifetime metamorphic insects that die after a week. It is known that the physiological changes according to the growth stages of silkworm larvae are extremely large, and the difference in the levels of substances including larval internal enzymes before and after molting is remarkable. In the body of the silkworm, there are mainly silkworm dung, which is a component of mulberry leaf, and mid-gut digestive juice and blood containing various enzymes. Among them, the midgut digestive juice and blood are very easily oxidized. When they come into contact with air, they are easily oxidized and inactivated while discoloring black.

【0008】[0008]

【発明が解決しようとする課題】既存の民間療法におい
ては5齢3日蚕あるいは5齢末極大重蚕を熱風乾燥して
粉末をつくるが、これは蚕の体内に存在する各種酵素の
不活化をもたらすようになる。このため、蚕を用いてよ
りすぐれた血糖降下剤を製造するためには粉末化の過程
で酸化防止処理が必要であることがわかる。結局、蚕の
粉末を用いて血糖降下剤を開発するにあたって、蚕の幼
虫の成長段階のいずれの段階のものを、どんな製剤で、
どの程度の投薬量をどんな方法で投薬するかを解明する
ことが主要な課題である。
In the existing folk remedies, 5th instar silkworms or 5th instar silkworms are dried with hot air to produce powders, which inactivate various enzymes present in the body of the silkworms. Will bring. Therefore, it can be understood that an antioxidant treatment is required in the process of powdering in order to produce a better hypoglycemic agent using silkworms. After all, in developing a hypoglycemic agent using silkworm powder, at any stage of the growth stage of the silkworm larva, with any formulation,
The main challenge is to figure out what dosage and how to administer it.

【0009】前記課題を解決するための本発明の目的
は、4齢期蚕から5齢末極大重蚕を窒素ガスを用いて酸
化防止処理および凍結乾燥して粉末化する工程を含む蚕
粉末の製造方法を提供することである。
[0009] An object of the present invention for solving the above-mentioned problems is to provide an antioxidant treatment using nitrogen gas from a 4th instar silkworm to a 5th instar silkworm, and a step of freeze-drying and powdering the silkworm powder. It is to provide a manufacturing method.

【0010】さらに、本発明の目的は、有効成分として
の前記蚕粉末および薬学的に許容される担体を含む血糖
降下剤を提供することである。
It is a further object of the present invention to provide a hypoglycemic agent comprising the silkworm powder as an active ingredient and a pharmaceutically acceptable carrier.

【0011】さらに、本発明の目的は、前記蚕粉末を有
効成分として含む健康補助食品を提供することである。
It is a further object of the present invention to provide a health supplement containing the silkworm powder as an active ingredient.

【0012】[0012]

【課題を解決するための手段】本発明者らは、4齢期蚕
から5齢末極大重蚕を窒素ガスを用いて酸化防止処理
し、凍結乾燥して蚕粉末を製剤化し、ネズミを用いた臨
床試験を通じて血糖降下剤としてのすぐれた効能を確認
することにより本発明を完成するに至った。
Means for Solving the Problems The present inventors antioxidantly treat the 4th instar silkworm from the 5th instar silkworm with nitrogen gas, freeze-dry to form a silkworm powder, and use the rat. The present invention has been completed by confirming excellent efficacy as a hypoglycemic agent through clinical trials.

【0013】本発明においては、4齢期蚕から5齢末極
大重蚕の幼虫それぞれを窒素ガスを用いて酸化防止処理
し、超低温冷凍機(deep freezer)内に保
管しながら凍結乾燥した後粉末化して蚕粉末を製造し
た。その後、高血糖の予防方法として飲食物の吸収を遅
延させるα−グルコシダーゼ阻害剤の効果を検討するた
め、このような効果を有することが知られたアカルボー
ス(acarbose)を対照に用いて、前記蚕粉末を
有効成分として含有する血糖降下剤と民間療法に使用さ
れている蚕粉末との血糖上昇抑制効果を比較した。その
結果、正常のネズミが血糖値10.6±3.6であるの
に比べ、民間療法において主に用いられている5齢3日
蚕の熱風乾燥粉末の場合には血糖値78.8±8.2で
あり、血糖上昇抑制効果は55%で対照であるアカルボ
ースの84%に比べ非常に低い効果を示し、5齢末極大
重蚕の熱風乾燥粉末の血糖上昇抑制効果は49%で5齢
3日蚕の乾燥粉末よりも低い効果を示した。
In the present invention, each of the larvae of the 4th-instar silkworm to the 5th-instar extreme heavy silkworm is subjected to an antioxidant treatment using nitrogen gas, freeze-dried while being stored in a deep freezer, and then powdered. To produce silkworm powder. Then, in order to examine the effect of an α-glucosidase inhibitor that delays the absorption of food and drink as a method for preventing hyperglycemia, the above silkworm was used as a control, using acarbose known to have such an effect as a control. The antihyperglycemic effect of a hypoglycemic agent containing powder as an active ingredient and silkworm powder used in folk remedies were compared. As a result, the blood glucose level was 18.8 ± 3.6 in the normal rat, whereas the blood glucose level was 78.8 ± in the case of the hot-air dried powder of the 5th instar 3 day silkworm, which is mainly used in folk remedies. The inhibitory effect on blood sugar rise was 55%, which was much lower than that of the control, acarbose, which was 84%. The effect was lower than that of dry powder of 3 day old silkworm.

【0014】しかしながら、本発明の方法により製造さ
れた5齢3日蚕の凍結乾燥粉末の場合、血糖値は58.
0±3.1であって正常値より48.6程度上昇し、血
糖上昇抑制効果は67%であって非常に高い効果を示し
た。従って、4齢期蚕から5齢末極大重、最も好ましく
は5齢3日蚕から血糖吸収を抑制できる物質が最も多く
産生されていることがわかった。また、利用効率をより
高めるためには窒素ガスで酸化防止処理をした後、凍結
乾燥させることが最も効果的であることがわかった。
However, in the case of the freeze-dried powder of the 5th instar 3 day silkworm produced by the method of the present invention, the blood sugar level is 58.
The value was 0 ± 3.1, which was about 48.6 higher than the normal value, and the blood glucose elevation inhibitory effect was 67%, which was a very high effect. Therefore, it was found that the substance capable of suppressing the absorption of blood sugar was most frequently produced from the 4th-instar silkworm to the 5th-instar maximum gravity, most preferably from the 5th-instar 3rd-day silkworm. Also, in order to further enhance the utilization efficiency, it was found that it is most effective to freeze-dry after performing antioxidant treatment with nitrogen gas.

【0015】一方、健康志願者を対象に本発明において
製造された蚕粉末を有効成分として含む血糖降下剤の投
与量に対する血糖降下効果を測定する臨床試験を実施し
た結果、食後45分の血糖降下効果は1,162mg投
薬グループにおいて100%、830mg投薬グループ
において72%、498mg投薬グループにおいて65
%であった。また、投薬グループ別の時間経過に伴う血
糖値の変化において、498mg投薬グループにおいて
は食後45分の血糖値が空腹時の血糖値よりは高いが非
投与時よりは低い血糖値を示してから徐々に高くなる現
象を示し、830mg投薬グループにおいては空腹時よ
り血糖値が若干高い水準に維持しながら徐々に血糖値が
減少するようになる、最も理想的な結果を示した。さら
に、1,162mg投薬グループにおいては食後45分
の血糖値が空腹時より低い血糖値の水準まで抑制活性を
示してから再び上昇する現象を示した。結局、1,16
2mg投薬グループの場合は過多な抑制活性が確認され
ることから、830mgを投薬することが最も適正な投
薬量であると確認された。また、食後血糖量を調節する
ための本発明の蚕粉末の製剤の投薬時期および方法は、
食後の経口投与によることが最も効果的であることが確
認された。
On the other hand, a clinical test was conducted on healthy volunteers to measure the hypoglycemic effect on the dose of a hypoglycemic agent containing the silkworm powder produced in the present invention as an active ingredient. The effect was 100% in the 1,162 mg dose group, 72% in the 830 mg dose group, and 65% in the 498 mg dose group.
%Met. In addition, in the change in blood glucose level with the lapse of time for each dosage group, in the 498 mg dosage group, the blood glucose level 45 minutes after the meal showed a blood glucose level higher than the fasting blood glucose level but lower than that in the non-administration, and then gradually. In the 830 mg dose group, the blood glucose level gradually decreased while maintaining the blood glucose level at a slightly higher level than in the fasting state, showing the most ideal result. Further, in the 1,162 mg dose group, the blood glucose level 45 minutes after the meal showed a suppressive activity to a blood glucose level lower than that at the time of fasting and then increased again. After all, 1,16
In the case of the 2 mg dose group, excessive inhibitory activity was confirmed, and thus it was confirmed that administering 830 mg was the most appropriate dosage. In addition, the dosage time and method of the preparation of the silkworm powder of the present invention for regulating postprandial blood glucose,
It was confirmed that oral administration after meals was the most effective.

【0016】[0016]

【発明の実施の形態】以下、本発明を実施例によってよ
り具体的に説明する。これら実施例は専ら本発明を説明
するためのものであり、本発明はこれに限られない。実施例1 −蚕粉末の製造− 4齢期蚕から5齢末極大重蚕の幼虫それぞれを窒素ガス
を用いて酸化防止処理し、超低温冷凍機内に保管しなが
ら凍結乾燥した後、粉砕方法で粉末化した。これは、食
品工業において広く用いられる冷凍方法の一つであり、
製造の後蚕粉末に窒素ガスが残存しないことによって人
体に害のない方法であると確認された。
DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described more specifically with reference to embodiments. These examples are only for describing the present invention, and the present invention is not limited thereto. Example 1- Production of silkworm powder-Each of the larvae of the 4th instar silkworm to the 5th instar extreme heavy silkworm was subjected to antioxidant treatment using nitrogen gas, freeze-dried while being stored in an ultra-low temperature refrigerator, and then powdered by a pulverization method. It has become. This is one of the widely used freezing methods in the food industry,
After the production, no nitrogen gas remained in the silkworm powder, and it was confirmed that the method was harmless to the human body.

【0017】実施例2 −本発明の血糖降下剤の血糖上昇抑制効果の確認− 高血糖の予防方法として飲食物の吸収を遅延させるα−
グルコシダーゼ阻害剤の効果を検討するため、このよう
な効果を有することが知られたアカルボースを対照に用
い、実施例1において製造された蚕粉末を有効成分とし
て含む血糖降下剤と民間療法で使用されている蚕粉末と
の血糖上昇抑制効果を比較した(表1参照)。下記表1
からわかるように、正常のネズミが血糖値10.6±
3.6であるのに比べ、民間療法において主に用いられ
ている5齢3日蚕の熱風乾燥粉末の場合には血糖値7
8.8±8.2であり、血糖上昇抑制効果は55%で対
照であるアカルボースの84%に比べ非常に低かった。
一方、5齢末極大重蚕の熱風乾燥粉末の血糖上昇抑制効
果は49%で5齢3日蚕の乾燥粉末よりも低く現われ
た。しかしながら、本発明において製造された5齢3日
蚕の凍結乾燥粉末の場合血糖値は58.0±3.1であ
って正常値より48.6程度上昇し、血糖上昇抑制効果
は67%であって非常に高い効果を示した。参考に提示
された4齢期蚕の熱風乾燥粉末の場合は5齢3日蚕より
は低いが5齢末極大重蚕の熱風乾燥のものと同様の効果
を示している。
Example 2- Confirmation of the effect of suppressing hypoglycemia of the hypoglycemic agent of the present invention-As a method for preventing hyperglycemia, α- which delays absorption of food and drink is used.
In order to examine the effect of the glucosidase inhibitor, acarbose known to have such an effect was used as a control, and the silkworm powder produced in Example 1 was used as a hypoglycemic agent containing an active ingredient and used in folk remedies. The effect of suppressing blood glucose elevation was compared with that of the silkworm powder (see Table 1). Table 1 below
As can be seen, normal rats had a blood glucose level of 10.6 ±
Compared to 3.6, the blood sugar level of hot-air dried powder of 5th instar 3 day silkworm, which is mainly used in folk remedies, is 7
It was 8.8 ± 8.2, and the blood glucose elevation inhibitory effect was 55%, which was much lower than that of the control, acarbose, which was 84%.
On the other hand, the hot-air-dried powder of the 5th-instar extremely heavy silkworm showed a 49% reduction in blood glucose elevation, which was lower than the dry powder of the 5th-instar 3rd-day silkworm. However, in the case of the freeze-dried powder of the 5th instar 3 day silkworm produced in the present invention, the blood glucose level is 58.0 ± 3.1, which is about 48.6 higher than the normal value, and the blood glucose elevation inhibitory effect is 67%. There was a very high effect. The hot-air-dried powder of the 4th-instar silkworm presented for reference shows the same effect as that of the hot-air-dried powder of the 5th-instar extreme heavy silkworm, though lower than that of the 5th-instar and 3rd-day silkworm.

【0018】[0018]

【表1】 *5HD:5齢3日蚕の熱風乾燥粉末 MHD:5齢末極大重蚕の熱風乾燥粉末 5CD:5齢3日蚕の凍結乾燥粉末 4HD:4齢期蚕の熱風乾燥粉末 4CD:4齢期蚕の凍結乾燥粉末 5A:5齢3日蚕の冷凍乾燥粉末+成虫蚕の粉砕液 MAC:5齢末極大重蚕の熱風乾燥粉末+アルカラーゼ
(alcalase) 以上の結果から、4齢期蚕から5齢末極大重、より好ま
しくは5齢3日蚕において血糖吸収を抑制できる物質が
最も多く産生されていることがわかり、利用効率をより
高めるためには窒素ガスで酸化防止処理をした後、凍結
乾燥することが最も効果的であることがわかった。
[Table 1] * 5HD: Hot-air dried powder of 5-year-old 3 day old silkworm MHD: Hot-air-dried powder of 5th-year-old extremely heavy silkworm 5CD: Freeze-dried powder of 5th-day 3-day silkworm 4HD: Hot-air dried powder of 4th-instar silkworm 4CD: 4th-instar Freeze-dried powder of silkworm 5A: Frozen-dried powder of 5th-instar 3rd-day silkworm + crushed liquid of adult silkworm MAC: Hot-air-dried powder of 5th-instar end-maximum heavy silkworm + alcalase (alcalase) It can be seen that the substance capable of suppressing blood glucose absorption is produced most in the end-of-life heavy weight, more preferably in the 5th instar 3 day silkworm, and in order to further increase the utilization efficiency, it is subjected to antioxidant treatment with nitrogen gas and then frozen. Drying has been found to be the most effective.

【0019】実施例3 −本発明の血糖降下剤の投与量、投与時期および方法の
確定− 体重65〜80kgである健康志願者30名を対象に実
施例1において製造された血糖降下剤(蚕粉末)の投与
量に対する血糖降下効果を測定する臨床試験を行った結
果を下記表2に示した。表2において、食後45分の血
糖降下効果は1,162mg投薬グループにおいて10
0%、830mg投薬グループにおいて72%、498
mg投薬グループにおいて65%であった。また、投薬
グループ別の時間経過に伴う血糖値の変化を図1,図2
および図3にそれぞれ示してある。図1の498mg投
薬グループにおいては食後45分の血糖値が空腹時の血
糖値よりは高いが非投与時よりは低い血糖値を示してか
ら徐々に高くなる現象を示している。一方、図2の83
0mg投薬グループにおいては空腹時より血糖値が若干
高い水準を維持しながら徐々に血糖値が減少するように
なる、最も理想的な結果を示した。さらに、図3の1,
162mg投薬グループにおいては食後45分の血糖値
が空腹時より低い血糖値の水準まで抑制活性を示してか
ら再び上昇する現象を示した。
Example 3- Determination of dosage, timing and method of administration of hypoglycemic agent of the present invention-Hypoglycemic agent (silkworm) produced in Example 1 for 30 healthy volunteers weighing 65 to 80 kg The results of a clinical test for measuring the hypoglycemic effect with respect to the dose of (powder) are shown in Table 2 below. In Table 2, the hypoglycemic effect at 45 minutes after meal was 10% in the 1,162 mg dose group.
0%, 72% in the 830 mg dose group, 498
65% in the mg dose group. FIGS. 1 and 2 show changes in blood glucose level over time for each medication group.
And FIG. 3 respectively. In the 498 mg dose group in FIG. 1, the phenomenon that the blood glucose level 45 minutes after a meal is higher than the fasting blood glucose level but lower than the non-administration blood glucose level and then gradually increases. On the other hand, 83 in FIG.
In the 0 mg dose group, the blood glucose level gradually decreased while maintaining a level slightly higher than that in the fasting state, indicating the most ideal result. Further, FIG.
The 162 mg dose group showed a phenomenon in which the blood glucose level 45 minutes after a meal showed inhibitory activity to a blood glucose level lower than that in the fasting state, and then rose again.

【0020】[0020]

【表2】 以上の結果から、1,162mg投薬グループの場合は
過多な抑制活性が確認されることから、830mgを投
薬することが最も適正な投与量であると確認された。ま
た、食後血糖量を調節するための本発明の蚕粉末の製剤
の投与時期および方法は食後の経口投与によることが最
も効果的であった。従って、本発明の血糖降下剤830
mgを食後経口投与する糖尿病の治療方法は、食後血糖
値が最高となる食後45分から1時間の間において既存
の製剤の不一致現象をほぼ補完し、90分以後にも血糖
量の緩慢な下降現象を示すことにより、食後高血糖と空
腹時の低血糖を防止できる最も理想的な血糖量調節方法
であることを確認することができた。
[Table 2] From the above results, excessive inhibitory activity was confirmed in the case of the 1,162 mg dosage group, and thus it was confirmed that administration of 830 mg was the most appropriate dose. In addition, the timing and method of administration of the silkworm powder preparation of the present invention for regulating the postprandial blood glucose level were most effective when administered orally after a meal. Therefore, the hypoglycemic agent 830 of the present invention
The method of treating diabetes, in which mg is orally administered after a meal, almost completely compensates for the inconsistency of the existing preparation between 45 minutes and 1 hour after the meal, when the blood glucose level after the meal is the highest, and a slow decrease in the blood glucose level even after 90 minutes. By confirming this, it could be confirmed that this is the most ideal blood glucose control method capable of preventing postprandial hyperglycemia and fasting hypoglycemia.

【0021】一方、本発明において製造された蚕粉末は
薬剤学的に許容可能な担体を添加した組成物の形態で経
口投与できる。経口用の組成物としては、例えば、錠剤
およびゼラチンカプセルがあり、これらは活性成分以外
に希釈剤(例えば、ラクトース、デキストロース、スク
ロース、マンニトール、ソルビトール、セルロースおよ
び/またはグリシン)、滑沢剤(例えば、シリカ、タル
ク、ステアリン酸およびそのマグネシウムまたはカルシ
ウム塩および/またはポリエチレングリコール)を含有
し、錠剤はまた結合剤(例えば、マグネシウムアルミニ
ウムケイ酸塩、澱粉ペースト、ゼラチン、メチルセルロ
ース、ナトリウムカルボキシメチルセルロースおよび/
またはポリビニルピロリドン)を含有し、場合によって
は崩壊剤(例えば澱粉、寒天、アルギン酸またはそのナ
トリウム塩)および/または吸水剤、着色剤、香味剤お
よび甘味剤を含むことが好ましい。前記血糖降下剤の組
成物は通常的な混合、顆粒化あるいはコーティング方法
によって製造され、全組成物に対しほぼ70%〜85%
(w/w)、好ましくはほぼ80%〜83%(w/w)
の蚕粉末を活性成分として含有する。そして、ほぼ50
kg〜70kgの哺乳動物に対する単位容量剤型はほぼ
800mg〜830mgの活性成分を含有する。
On the other hand, the silkworm powder produced in the present invention can be orally administered in the form of a composition containing a pharmaceutically acceptable carrier. Oral compositions include, for example, tablets and gelatin capsules, which, in addition to the active ingredient, contain diluents (eg, lactose, dextrose, sucrose, mannitol, sorbitol, cellulose and / or glycine), lubricants (eg, , Silica, talc, stearic acid and its magnesium or calcium salts and / or polyethylene glycol), and the tablets may also contain binders such as magnesium aluminum silicate, starch paste, gelatin, methylcellulose, sodium carboxymethylcellulose and / or
Or polyvinylpyrrolidone), and if necessary, a disintegrating agent (eg, starch, agar, alginic acid or a sodium salt thereof) and / or a water absorbing agent, a coloring agent, a flavoring agent and a sweetening agent. The composition of the hypoglycemic agent is manufactured by a general mixing, granulating or coating method, and is about 70% to 85% of the total composition.
(W / w), preferably approximately 80% to 83% (w / w)
Silkworm powder as an active ingredient. And almost 50
A unit dosage form for a mammal weighing from 70 kg to 70 kg contains approximately 800 mg to 830 mg of active ingredient.

【0022】[0022]

【発明の効果】以上説明したように、本発明において製
造された血糖降下剤は従来の熱風乾燥させた蚕粉末より
血糖上昇抑制効果がすぐれ、それを用いた糖尿病の治療
方法は既存の薬剤の不一致現象を補完することにより、
食後の高血糖と空腹時の低血糖を防止できる理想的な血
糖降下効果がある。
As described above, the hypoglycemic agent produced in the present invention is more effective in suppressing blood glucose elevation than conventional hot-air-dried silkworm powder, and the method of treating diabetes using the same is effective for the treatment of existing drugs. By complementing the discrepancy phenomenon,
It has an ideal hypoglycemic effect that can prevent postprandial hyperglycemia and fasting hypoglycemia.

【図面の簡単な説明】[Brief description of the drawings]

【図1】本発明の血糖降下剤498mgを投薬したグル
ープの時間経過に伴う血糖量の変化を示すグラフであ
る。
FIG. 1 is a graph showing changes in blood glucose level over time of a group to which 498 mg of a hypoglycemic agent of the present invention was administered.

【図2】本発明の血糖降下剤830mgを投薬したグル
ープの時間経過に伴う血糖量の変化を示すグラフであ
る。
FIG. 2 is a graph showing a change in blood glucose level over time of a group to which 830 mg of a hypoglycemic agent of the present invention was administered.

【図3】本発明の血糖降下剤1,162mgを投薬した
グループの時間経過に伴う血糖量の変化を示すグラフで
ある。
FIG. 3 is a graph showing a change in blood glucose level over time of a group to which 1,162 mg of the hypoglycemic agent of the present invention was administered.

フロントページの続き (72)発明者 李 相豊 大韓民国京畿道安養市東安區虎溪洞 木 漣エイピーティー803棟1502号 (56)参考文献 特開 昭51−82742(JP,A) 特表 平6−505479(JP,A) (58)調査した分野(Int.Cl.6,DB名) A61K 35/64 A23L 1/30 A23L 3/34 A23L 3/40Continuation of the front page (72) Inventor Li Seofeng No. 1502, No. 803 Building No. 803, Jugyeon-dong, Dong'an-gu, Anyang-si, Gyeonggi-do, Republic of Korea (56) Reference JP-A-51-82742 (JP, A) 6-505479 (JP, A) (58) Fields investigated (Int. Cl. 6 , DB name) A61K 35/64 A23L 1/30 A23L 3/34 A23L 3/40

Claims (3)

(57)【特許請求の範囲】(57) [Claims] 【請求項1】 4齢期蚕から5齢末極大重蚕を窒素ガス
を用いて酸化防止処理をした後、次いで凍結乾燥して粉
末化する工程を含む蚕粉末の製造方法。
1. A method for producing silkworm powder comprising the steps of subjecting a 4th-instar silkworm to a 5th-instar extreme heavy silkworm to an antioxidant treatment using nitrogen gas , and then freeze-drying to powder.
【請求項2】 有効成分としての請求項1の方法で製造
された蚕粉末および薬学的に許容される担体を含む血糖
降下剤。
2. A hypoglycemic agent comprising the silkworm powder produced by the method of claim 1 as an active ingredient and a pharmaceutically acceptable carrier.
【請求項3】 有効成分として請求項1の方法で製造さ
れた蚕粉末を含む健康補助食品。
3. A health supplement comprising, as an active ingredient, silkworm powder produced by the method of claim 1.
JP7194750A 1995-01-23 1995-07-31 Hypoglycemic agent containing silkworm powder as active ingredient and method for producing the same Expired - Lifetime JP2757937B2 (en)

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KR95-1068 1995-01-23
KR1019950001068A KR0151731B1 (en) 1995-01-23 1995-01-23 Agent for reducing blood sugar containing powder of silkworm as effective ingredient and method for making the same

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KR20010044759A (en) * 2001-03-23 2001-06-05 김애정 A process for preparing functional fortification Dasik derives from sericultural products and herbs
KR20030079237A (en) * 2002-04-02 2003-10-10 최진호 Composition of anti-diabetes patient food using silkworm extract
KR20040036992A (en) * 2002-10-25 2004-05-04 (주)네오날 Extracting method of extract from Protaetia brevitarsis grub and pharmaceutical composition for diabetes treatment containing the extract
KR100712659B1 (en) * 2005-08-31 2007-05-02 정두수 Herbal composition for treatment and prevention of diabetes and diabetic complications
CN100548315C (en) * 2006-03-15 2009-10-14 中国农业科学院上海家畜寄生虫病研究所 Silkworm health-care product and preparation method thereof
CN100431554C (en) * 2006-05-30 2008-11-12 江苏科技大学 A method for preparing silkworm powder
CN102318819A (en) * 2011-08-12 2012-01-18 辽宁柞蚕丝绸科学研究院有限责任公司 Method for preparing Antheraea Pernyi powder and Antheraea Pernyi powder thereof
KR101376437B1 (en) * 2012-08-14 2014-03-19 장기운 The method for producing dietary supplement using extracts from silkworm
WO2019083057A1 (en) * 2017-10-24 2019-05-02 주식회사 비엠바이오 Functional pet feed composition using microalgae having anti-obesity and anti-diabetic functions
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US20220312818A1 (en) * 2019-07-25 2022-10-06 Korea University Research And Business Foundation Preparation method for two-spotted cricket powder or extract thereof, food composition comprising same, and uses of same
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KR960028911A (en) 1996-08-17

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