JP2011032256A - Pharmaceutical composition and health food, produced by prevention of mengen reaction occurring at the time of taking saponin-containing galenical such as medicinal carrot and by process for increasing absorptivity of crude drug (method for causing chicken egg protein to absorb active constituent of galenical) - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a pharmaceutical composition and a health food, produced by the prevention of Mengen reaction occurring at the time of taking a saponin-containing galenical such as medicinal carrot and by a process for increasing the absorptivity of a crude drug (a method for causing a chicken egg protein to absorb an active constituent of the galenical). <P>SOLUTION: The effect of saponin, being an effective component of a galenical, against many clinical states (tumor prevention, physiology, etc.) is confirmed and reported. While this invention enhances the systemic absorption of an active element and suppresses adverse effects, it is intended that the vital function is heightened more quickly to further heighten the beneficial effect of galenical saponin and so that the efficacy which has been seeked for a long time and the prevention and treatment of cancer tumor, etc., can be anticipated. The pharmaceutical composition and the health food are characterized so that a living body affinity component is selected and adsorbed by a chicken egg protein near to a human protein composition and so that the protein is easily and conveniently taken in. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

薬用ニンジン等のサポニン高含有生薬は古くからその薬効が認められ広く漢方薬に用いられている。また、万病の妙薬とも言われ、これを裏付ける数多くの研究が発表されている。しかしながらより高い効果を得ようと大量の生薬を服用することでメンゲン反応（生体防御作用である一種の副作用）が発現することがある。
本発明はヒトのタンパク組成に最も近い鶏卵タンパクを使用することで、ヒトに親和性が高い成分と低抗する成分とを選択することができると考えた。さらに鶏卵タンパクに吸収された成分のみを選択的に服用することにより、副作用の発現を抑えつつ、有効成分のみをより効果的に摂取できる医薬組成物及び健康食品の提案に関するものである。Medicinal carrots and other saponin-rich herbal medicines have long been recognized for their medicinal properties and are widely used in traditional Chinese medicine. In addition, it is said to be a miracle drug for all diseases, and many studies have been published to support this. However, taking a large amount of herbal medicine to obtain a higher effect may cause a mengen reaction (a kind of side effect that is a biological defense action).
In the present invention, it was considered that a component having high affinity for humans and a component having low resistance can be selected by using the egg egg protein closest to the human protein composition. Further, the present invention relates to a proposal of a pharmaceutical composition and a health food that can take only an active ingredient more effectively while suppressing the occurrence of side effects by selectively taking only the ingredient absorbed in chicken egg protein.

薬用ニンジンは中国では漢方薬、日本では和漢薬として、東洋医学では古くから用いられているが、西洋薬と比較すると効果が緩慢である場合が多い。しかしながら、より高い効果を期待して大量の生薬を服用すると、メンゲン反応（副作用）が発現することがある。これらのことから歴史的に古くから用いられているにも係らず生薬が期待される程には使用されていない。  Medicinal carrots have been used for a long time in oriental medicine as a Chinese herbal medicine in China, as a Japanese herbal medicine in Japan, but are often less effective than Western medicine. However, if a large amount of herbal medicine is taken in anticipation of a higher effect, mengen reaction (side effects) may occur. In spite of these facts, herbal medicines have not been used as much as expected even though they have been used historically.

このような状況を鑑み、本発明は生薬の副作用を抑えつつ、その効果を最大限発揮できるよう有効な医薬組成物及び健康食品を希求すべく研究を行ったところ、ヒト組成に近いタンパクを用いることで生薬の有効成分のうち生体親和成分と生体抵抗成分を選択することで、その生体親和性成分吸収タンパクをヒトが服用した場合、体内への吸収が増大し副作用が少ないことを発見した。  In view of such circumstances, the present invention has been studied to seek an effective pharmaceutical composition and health food so as to maximize the effects while suppressing the side effects of crude drugs, and uses proteins close to human compositions. Thus, by selecting the biocompatible component and the bioresistance component among the active ingredients of the crude drug, it was discovered that when humans take the biocompatible component absorption protein, the absorption into the body is increased and there are few side effects.

薬用ニンジンの有効成分サポニン等は多くの病態に対する効果が確認され公表されている。本発明は有効成分の体内吸収を高める一方、副作用を抑えることで、より早く有益な効果が期待できるよう検討した。ヒトタンパク組成に近い鶏卵タンパクに生体親和性成分を選択吸収させ、そのタンパクを簡便に摂取できるよう開発した。  The effective ingredient saponin of medicinal carrots has been confirmed and published for many pathological conditions. The present invention has been studied so that a beneficial effect can be expected more quickly by increasing the absorption of the active ingredient in the body while suppressing side effects. It has been developed so that a biocompatible component can be selectively absorbed into chicken egg protein close to the human protein composition and the protein can be easily ingested.

生薬の毒性及び副作用についてAbout toxicity and side effects of crude drugs

生薬水溶性エキス剤（Ａ）と生薬吸収卵Ｂ）のラットに対する経口投与における毒性比較テスト
（Ａ） 生薬水溶性エキス剤：
ラット６匹（平均体重１９９ｇ）に経口１日量として生薬水溶性エキス剤（生薬４ｇ含有）を与えたところ、１日目〜３日目で全匹死亡した。
（Ｂ） 生薬吸収卵（＝生薬の卵吸収物）：
ラット１０匹（平均体重２３７ｇ）に経口１日量として生薬吸収卵（生薬１０ｇ含有）を与え２７日間コントロール群と比較観察したところ、全匹が生存していた。また、体重、体温はコントロール群とほとんど差がなく、臓器重量及び血液検査結果も特に異状はなかった。
以上のことから（Ｂ）の生薬吸収卵、つまり鶏卵タンパクを介して生薬を摂取することで生薬に含まれる毒性を排除でき、なおかつ副作用の発現を抑制できるものと評価する。Toxicity comparison test for oral administration of herbal medicine water-soluble extract (A) and herbal medicine-absorbed egg B) to rats (A) Herbal medicine water-soluble extract:
When 6 rats (average body weight 199 g) were given a crude drug water-soluble extract (containing 4 g of crude drug) as an oral daily dose, all animals died on the first day to the third day.
(B) Herbal medicine absorption egg (= Herbal medicine egg absorption material):
When 10 rats (average body weight 237 g) were given a herbal medicine-absorbed egg (containing 10 g of herbal medicine) as an oral daily dose and compared with the control group for 27 days, all the animals were alive. Body weight and body temperature were almost the same as those of the control group, and organ weights and blood test results were not particularly abnormal.
Based on the above, it is evaluated that the herbal medicine can be eliminated by ingesting the herbal medicine through the herbal medicine-absorbing egg (B), that is, chicken egg protein, and the occurrence of side effects can be suppressed.

生薬の効果についてAbout the effect of crude drugs

薬用ニンジンサポニンに関して発表されている効能のうち、特に癌及び女性特有の生理調整作用ついて実施例及び実験例に基づき検討したところ、以下の効果が認められた。
（１）女性に対する生理調整作用について 〔実験例Ｉ〕
（２）抗癌作用について 〔実験例ＩＩ〕〔実験例ＩＩＩ〕Among the effects announced regarding medicinal carrot saponins, the physiological effects of cancer and women in particular were examined based on examples and experimental examples. The following effects were observed.
(1) Physiological adjustment effect on women [Experimental example I]
(2) Anticancer activity [Experimental example II] [Experimental example III]

以下に実施例及び実験例を挙げて本発明の詳細を説明するが、本発明の使用はこれらに限定されるものではない。
本発明で用いる生薬には、サポニン高含有生薬以外の生薬も補助生薬として混合した。
鶏卵は市販品を使用した。
〔図１〕に示す

釜に精製水２０００ｍｌを入れ加熱沸騰したら混合生薬７０ｇを添加し加熱する。次に弱火にした釜に予め準備していた半茹での鶏卵を入れ、そのまま２時間３０分加熱し鶏卵タンパクに生薬成分を吸収させる。出来上がった鶏卵の殻を剥き服用検体とする。
〔実験例Ｉ〕 ヒトに対する生理不順改善テスト
服用期間 ： １〜３ヵ月
服用量 ： 本発明鶏卵１個〜３個／日

〔服用後の声〕 〔図２〕に示す
・生理不順の方は冷え性や肩こりを訴えていたが、生理機能が順調になるとともにこれらの症状も改善された。
・生理不順の自覚症状が順調に改善し、中には精力も高まり不妊症の方が懐妊した。
・生理機能の改善効果も認められ、体調もよくなり、リュウマチの方が改善した。
したがって、本発明品には生理機能の改善効果を有していると考えられた。
〔実験例ＩＩ〕
実施例に用いた生薬原料１ｇを水溶性抽出エキス３ｇに調製した検体を作成し、そのＴＮＦ活性を測定した。
生体内では常に癌のもとになる細胞が発生しているが、生体防御作用のあるマクロファージが腫瘍壊死因子（ＴＮＦ）を産生し細胞の癌化を防止していることで発癌しない。
しかしながら、免疫力の低下でマクロファージの作用が弱化すると、癌化が促進され発癌すると考えられている。一方、外部因子による刺激が生体内でマクロファージのＴＮＦ産生を促進し、細胞の癌化阻止能が高まると考えられることから、本発明品が生体内ＴＮＦの産生誘導活性を有するのかを下記の方法で測定した。
（マクロファージ培養し腫瘍細胞障害効果）
吸光度グラフ

測定検体
１、生薬エキス（検体）
２、市販抗癌剤（ポジテブコントロール）
３、コントロール（ネガテイブコントロール）
Ｙ軸は、５００ｎｍの吸光度で、低いものほど細胞の死滅を表している。つまり、ＴＮＡ活性による腫瘍細胞障害効果が高いことを表している。〔図３〕に示す
〔測定結果〕
検体１、の生薬エキスには２、の市販抗癌剤と同等以上のＴＮＦ産生誘導活性が認められた。したがって、本発明品には発癌抑制作用を有していると考えられる。
〔実験例ＩＩＩ〕
６０歳男性の癌患者を用いて本発明品の抗癌作用を検討した。服用量は本発明鶏卵１日１個〜３個であった。本患者は肝臓に巨大転移肝細胞癌（最大１２，２×１０ｃｍ）が数個認められた。原発巣は進行性胃癌であり、根治切除術不能と診断され、シメチジンを含む混合化学療法にて治療が行われた。しかしながら、副作用が強く食欲不振やそれに伴う体重減少などにより化学療法治療継続が困難であった。そこで本発明品を化学療法と併用したしたところ、食欲不振が改善し体重も次第に回復したことにより、社会生活を継続しながら化学療法治療が繰り返し継続して行えるようになった。さらに、本開発品服用後１〜３ヶ月で腫瘍マーカーは正常化し、１年後には巨大肝細胞の消失がＣＴで確認された。本患者はその後、再発なく７年間生存した。
（治療中の腫瘍マーカー値の推移）

（治療中の体重の推移）

発症前に７３ｋｇの体重が、治療開始６ヵ月でもとに戻っている。〔図６〕に示す
したがって、本発明品には抗癌作用を有していると考えられる。〔図４〕、〔図５〕に示す。The details of the present invention will be described below with reference to examples and experimental examples, but the use of the present invention is not limited thereto.
In the crude drug used in the present invention, a crude drug other than a saponin-rich crude drug was mixed as an auxiliary crude drug.
Commercial eggs were used as chicken eggs.
[Figure 1]

Add 2,000 ml of purified water to the kettle and heat to boiling. Add 70 g of mixed herbal medicine and heat. Next, put the chicken eggs prepared in advance in a low-heated kettle and heat for 2 hours 30 minutes as it is so that the protein components are absorbed by the egg protein. The finished eggshell is peeled off and used as a sample for taking.
[Experimental Example I] Physiological irregularity improvement test for humans Period of intake: 1-3 months Dose: 1 to 3 eggs / day of the present invention

[Voice after taking] [Figure 2]-Those with poor menstruation complained of chilliness and stiff shoulders, but these symptoms improved as the physiological function went well.
・ The subjective symptoms of irregular menstruation steadily improved, and some of them became more energetic and became infertile.
・ Improved physiological function, improved physical condition, and improved rheumatism.
Therefore, it was considered that the product of the present invention has an effect of improving physiological function.
[Experimental Example II]
A specimen was prepared by preparing 1 g of the crude drug raw material used in the examples into 3 g of the water-soluble extract, and the TNF activity was measured.
Although cells that cause cancer always occur in the living body, macrophages having a biological defense action produce tumor necrosis factor (TNF) and prevent canceration of the cells, so that cancer does not occur.
However, when the action of macrophages is weakened due to a decrease in immunity, canceration is promoted and carcinogenesis is considered. On the other hand, since stimulation by an external factor promotes TNF production of macrophages in vivo and increases the ability to inhibit canceration of cells, whether the product of the present invention has in vivo TNF production-inducing activity or not is described below. Measured with
(Macrophage culture and tumor cell damage effect)
Absorbance graph

Measurement sample 1, herbal extract (specimen)
2. Commercially available anticancer drugs (positive control)
3. Control (negative control)
The Y axis shows absorbance at 500 nm, with lower values representing cell death. That is, it shows that the tumor cell damage effect by TNA activity is high. [Measurement results] shown in FIG.
The herbal medicine extract of Specimen 1 showed TNF production-inducing activity equivalent to or better than that of the commercially available anticancer drug of 2. Therefore, it is considered that the product of the present invention has a carcinogenic inhibitory action.
[Experimental Example III]
The anticancer activity of the product of the present invention was examined using a 60-year-old male cancer patient. The dose was 1 to 3 eggs per day of the present invention. In this patient, several large metastatic hepatocellular carcinomas (maximum 12, 2 × 10 cm) were found in the liver. The primary lesion was advanced gastric cancer, diagnosed as inoperable radical resection, and treated with mixed chemotherapy containing cimetidine. However, it was difficult to continue chemotherapy treatment due to strong side effects and loss of appetite and associated weight loss. Therefore, when the product of the present invention was used in combination with chemotherapy, anorexia improved and body weight gradually recovered, so that chemotherapy treatment could be repeated continuously while continuing social life. Furthermore, tumor markers were normalized 1 to 3 months after taking the developed product, and disappearance of giant hepatocytes was confirmed by CT one year later. The patient subsequently survived for 7 years without recurrence.
(Changes in tumor marker values during treatment)

(Changes in body weight during treatment)

Before the onset of the disease, the body weight of 73 kg had returned to 6 months after the start of treatment. Therefore, it is considered that the product of the present invention has an anticancer activity as shown in FIG. Shown in FIG. 4 and FIG.

Claims (2)

生薬に含まれる天然サポニン等の含有成分を鶏卵タンパクに選択吸収させた医薬組成物及び健康食品  Pharmaceutical composition and health food in which ingredients such as natural saponin contained in herbal medicine are selectively absorbed by egg protein 生薬（オタネニンジン、ソウキョウ）１０ｇ〜１８ｇ中に含まれる有効成分を鶏卵３０ｇ〜８０ｇに吸収させた〔請求項１〕の医薬組成物及び健康食品  The pharmaceutical composition and health food according to claim 1, wherein the active ingredient contained in 10 g to 18 g of crude drugs (Ginseng, Tokyo) is absorbed into 30 g to 80 g of chicken eggs.