JP6122667B2 - Eggshell membrane-containing fine powder, tablet, method for producing eggshell membrane-containing fine powder, and method for producing tablet - Google Patents
Eggshell membrane-containing fine powder, tablet, method for producing eggshell membrane-containing fine powder, and method for producing tablet Download PDFInfo
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- JP6122667B2 JP6122667B2 JP2013048943A JP2013048943A JP6122667B2 JP 6122667 B2 JP6122667 B2 JP 6122667B2 JP 2013048943 A JP2013048943 A JP 2013048943A JP 2013048943 A JP2013048943 A JP 2013048943A JP 6122667 B2 JP6122667 B2 JP 6122667B2
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- eggshell membrane
- eggshell
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- 239000011735 vitamin B7 Substances 0.000 description 1
- 235000019166 vitamin D Nutrition 0.000 description 1
- 239000011710 vitamin D Substances 0.000 description 1
- 150000003710 vitamin D derivatives Chemical class 0.000 description 1
- 235000019168 vitamin K Nutrition 0.000 description 1
- 239000011712 vitamin K Substances 0.000 description 1
- 150000003721 vitamin K derivatives Chemical class 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
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Landscapes
- General Preparation And Processing Of Foods (AREA)
- Meat, Egg Or Seafood Products (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Description
本発明は、卵殻膜含有微粉末、錠剤、卵殻膜含有微粉末の製造方法および錠剤の製造方法に関するものである。 The present invention relates to eggshell membrane-containing fine powder, tablets, a method for producing eggshell membrane-containing fine powder, and a method for producing tablets.
ヒトの皮膚は、表面にある上皮層と、その下の結合組織性の真皮層からなっている。上皮層を構成するタンパク質は主としてケラチンであり、ケラチンは皮膚の保護作用を有し、また上皮層に含まれるメラニン（色素）は紫外線に対する防護作用を有する。一方、真皮層を構成するタンパク質は主としてコラーゲンであり、他にエラスチン、アルブミン、グロブリン、ムチンよりなっている。 Human skin consists of an epithelial layer on the surface and a connective tissue dermis layer below it. The protein constituting the epithelial layer is mainly keratin, keratin has a protective action on the skin, and melanin (pigment) contained in the epithelial layer has a protective action against ultraviolet rays. On the other hand, the protein constituting the dermis layer is mainly collagen, and is composed of elastin, albumin, globulin, and mucin.
真皮層を構成するコラーゲンは、主としてα１（Ｉ）型コラーゲン［以下「（Ｉ）型コラーゲン」という］およびα１（ＩＩＩ）型コラーゲン［以下「（ＩＩＩ）型コラーゲン」という］である。（Ｉ）型コラーゲンは主として皮膚の構造維持、また（ＩＩＩ）型コラーゲンは主として皮膚への柔軟性の付与とそれぞれ異なった機能を果たしている。 Collagen constituting the dermis layer is mainly α1 (I) type collagen (hereinafter referred to as “(I) type collagen”) and α1 (III) type collagen (hereinafter referred to as “(III) type collagen”). Type (I) collagen mainly functions to maintain the structure of the skin, and type (III) collagen mainly functions differently from imparting flexibility to the skin.
皮膚における（Ｉ）型コラーゲンと（ＩＩＩ）型コラーゲンの割合は定常的ではなく、加齢に伴って変化する。（ＩＩＩ）型コラーゲンは胎児型コラーゲンとも呼ばれるように皮膚の老化と密接な関係があり、胎児のときに最も多く、１０代から減り始め、その後は減少の一途をたどる。例えば、１５週の胎児の皮膚では（ＩＩＩ）型コラーゲンの方が（Ｉ）型コラーゲンよりも多いが、成人では、（Ｉ）型コラーゲン／（ＩＩＩ）型コラーゲンの比率が約３になっているといわれている。 The proportion of type (I) collagen and type (III) collagen in the skin is not steady and changes with age. Type III collagen is closely related to skin aging, also called fetal collagen, most often in the fetus, and begins to decrease from the teenage, and then continues to decrease. For example, 15-week fetal skin has more type III collagen than type I collagen, but in adults the ratio of type I collagen / type III collagen is about 3. It is said that.
皮膚における（ＩＩＩ）型コラーゲンの割合を増すことができれば、加齢による皮膚の老化を止め、肌荒れを防止し、皮膚を滑らかで、柔らかく、シットリとした状態に保つことができる。かかる点から、コラーゲン、特に（ＩＩＩ）型コラーゲンの生成を促進することのできる化粧料や栄養剤（ビタミン剤など）の開発が色々試みられ、実用化されている。 If the proportion of type (III) collagen in the skin can be increased, skin aging due to aging can be stopped, rough skin can be prevented, and the skin can be kept smooth, soft and tight. From this point, various attempts have been made to develop cosmetics and nutrients (vitamins and the like) that can promote the production of collagen, particularly (III) type collagen, and have been put to practical use.
卵殻膜は、鶏卵などの鳥類の卵の卵殻の内側にある膜で、内外２枚からなり、外卵殻膜は卵殻内面に密着し、内卵殻膜は卵白を包んでいる。卵殻膜は、強靭な繊維性のタンパク質よりなりなり、オポケラチンとオポムシンを主成分とする。卵殻膜は、昔から相撲部屋で擦り傷などの手当にも使われていたように、皮膚の再生を促進する働きを有することが知られており、最近になって、特に胎児性コラーゲンとも称される（ＩＩＩ）型コラーゲンの生成を促進させる作用を有することが報告されている。 The eggshell membrane is a membrane inside the eggshell of avian eggs such as chicken eggs, and consists of two inside and outside. The outer eggshell membrane is in close contact with the inner surface of the eggshell, and the inner eggshell membrane wraps the egg white. The eggshell membrane is composed of tough fibrous protein, and is composed mainly of pokekeratin and opomsin. Egg shell membrane is known to have a function to promote skin regeneration, as it has been used for medical treatments such as scratches in the sumo room for a long time. Recently, it is also called fetal collagen. It has been reported to have an action of promoting the production of (III) type collagen.
このような卵殻膜を用いた技術としては、たとえば、本願出願人により、粉末状に粉砕した卵殻膜を含む錠剤や菓子類などが提案されている（特許文献１、２）。たとえば、特許文献１記載の錠剤には、キューピー株式会社が市販する卵殻膜粉末が用いられている。この卵殻膜粉末は７０メッシュで９０％以上通過した粒度を有するものである（非特許文献１）。なお、７０メッシュは、メッシュの規格にもよるが目開きで約２１３μｍ前後に相当する。また、特許文献２記載の菓子類では、１５０メッシュ（目開き１０４μｍ）の標準篩を通過する粒子の含有割合が７０質量％以上である卵殻膜粉末が用いられている。 As a technique using such an eggshell membrane, for example, the applicant of the present application has proposed tablets or confectionery containing an eggshell membrane pulverized into a powder (Patent Documents 1 and 2). For example, eggshell membrane powder marketed by Kewpie Co., Ltd. is used for the tablet described in Patent Document 1. This eggshell membrane powder has a particle size of passing 90% or more at 70 mesh (Non-Patent Document 1). Incidentally, 70 mesh corresponds to about 213 μm in terms of mesh opening although it depends on the mesh standard. Moreover, in the confectionery described in Patent Document 2, eggshell membrane powder in which the content ratio of particles passing through a 150-mesh (mesh 104 μm) standard sieve is 70% by mass or more is used.
一方、卵殻膜は、繊維状の蛋白質を主成分とし、網目状の構造を有している。そして、この蛋白質は酸、アルカリ、プロテアーゼに対し比較的安定で水に不溶である（非特許文献１）。すなわち、卵殻膜を構成する材料自体は上述したように網目構造の繊維質を主成分として構成され、水等に溶解し難いため、本来的に、人体に消化吸収され難い。このため、更なる消化吸収効率の改善が求められている。 On the other hand, eggshell membranes are mainly composed of fibrous proteins and have a network structure. This protein is relatively stable to acids, alkalis and proteases and is insoluble in water (Non-patent Document 1). That is, the material constituting the eggshell membrane itself is composed mainly of a network-structured fiber as described above and hardly dissolves in water or the like, so that it is inherently difficult to be digested and absorbed by the human body. For this reason, the further improvement of digestion absorption efficiency is calculated | required.
消化吸収効率を改善するためには、たとえば、（１）卵殻膜を酸、アルカリ等により加水分解処理したり、あるいは、（２）より細かく粉砕して卵殻膜粒子の単位体積当たりの表面積を大きくすることで、単位時間当たりの卵殻膜の成分を溶解・溶出させる効率を上げる方法なども挙げられる。しかしながら、加水分解処理では、化学反応を利用するため、加水分解の過程において卵殻膜中に含まれる各種の有効成分が劣化・変性するというデメリットも生じやすい。この点を考慮すると、卵殻膜を機械的に粉砕する方が有利であると考えられる。 In order to improve the digestion and absorption efficiency, for example, (1) the eggshell membrane is hydrolyzed with acid, alkali, etc., or (2) the surface area per unit volume of the eggshell membrane particles is increased by finer grinding. Thus, a method of increasing the efficiency of dissolving and eluting the components of the eggshell membrane per unit time can also be mentioned. However, since the hydrolysis treatment uses a chemical reaction, a demerit that various active ingredients contained in the eggshell membrane deteriorate or denature easily during the hydrolysis process. Considering this point, it is considered advantageous to mechanically grind the eggshell membrane.
一方、卵殻膜をより細かく粉砕した場合の効果を調査すべく、本願出願人は、卵殻膜の消化吸収効率を向上させるために、７０メッシュで分級処理して得られた卵殻膜と、１５０メッシュで分級処理して得られた卵殻膜とについて比較調査した。しかしながら、両者の間には有意な差異は全く見られなかった。すなわち、卵殻膜の消化吸収効率は、粒径に対して単純に比例して増加しない。このため、特許文献１，２に例示されたレベルで、粒径を変化させて卵殻膜を粉砕しても、更なる消化吸収効率の向上は望めない。 On the other hand, in order to investigate the effect when the eggshell membrane is pulverized more finely, the applicant of the present application, in order to improve the digestion and absorption efficiency of the eggshell membrane, And compared with eggshell membranes obtained by classification. However, there was no significant difference between the two. That is, the digestion and absorption efficiency of the eggshell membrane does not increase simply in proportion to the particle size. For this reason, even if the particle size is changed and the eggshell membrane is pulverized at the level exemplified in Patent Documents 1 and 2, further improvement in digestion and absorption efficiency cannot be expected.
本発明は上記事情に鑑みてなされたものであり、従来よりも更に消化吸収効率が改善された卵殻膜含有微粉末およびこれを用いた錠剤、ならびに、当該卵殻膜含有微粉末の製造方法およびこれを用いた錠剤の製造方法を提供することを課題とする。 The present invention has been made in view of the above circumstances, and eggshell membrane-containing fine powder having further improved digestion and absorption efficiency than before, tablets using the same, and a method for producing the eggshell membrane-containing fine powder and the same It is an object of the present invention to provide a method for producing a tablet using.
上記課題は以下の本発明により達成される。すなわち、
本発明の四塩化炭素誘発性肝障害改善用卵殻膜含有微粉末添加食は、体積最大粒子径が２０μｍ以下であり、体積平均粒子径が６μｍ以下である卵殻膜含有微粉末を、標準食に対し１％含有させた添加食であり、これを摂取することにより、血液及び肝臓中のチォバルビツール酸反応性物質濃度を低下させ、四塩化炭素により誘発される過酸化脂質の生成を抑制し、四塩化炭素誘発性の肝臓の炎症及び障害を抑制するものであることを特徴とする。
The above-mentioned subject is achieved by the following present invention. That is,
The eggshell membrane-containing fine powder-added diet for improving carbon tetrachloride-induced liver injury according to the present invention uses an eggshell membrane-containing fine powder having a volume maximum particle size of 20 μm or less and a volume average particle size of 6 μm or less as a standard diet. against a 1% supplemented diet which contains, by ingesting this reduces the Chio barbituric acid reactive substances concentration in the blood and liver, to suppress the formation of lipid peroxides induced by carbon tetrachloride It is characterized by suppressing carbon tetrachloride-induced liver inflammation and damage .
本発明の卵殻膜含有微粉末の一実施形態は、卵殻膜成分のみを含むことが好ましい。 One embodiment of the eggshell membrane-containing fine powder of the present invention preferably contains only the eggshell membrane component.
本発明の卵殻膜含有微粉末の他の実施形態は、卵殻膜成分と卵殻カルシウム成分のみを含むことが好ましい。 It is preferable that other embodiment of the eggshell membrane containing fine powder of this invention contains only an eggshell membrane component and eggshell calcium component.
本発明の卵殻膜含有微粉末の他の実施形態は、食品添加用から選択されることが好ましい。 Another embodiment of the eggshell membrane-containing fine powder of the present invention is preferably selected from those for food addition.
本発明の四塩化炭素誘発性肝障害改善用卵殻膜含有微粉末添加食の製造方法において、第一の方法は、 卵殻の内面から剥離して取り出された卵殻膜を少なくとも含む卵殻膜含有原料をガス中で相互に衝突させて微粉砕し、この微粉砕により作製された卵殻膜含有微粉末を、目開き２０μｍ以下の篩で分級して粗大粒子を除去して体積最大粒子径が２０μｍ以下であり、体積平均粒子径が６μｍ以下である卵殻膜含有微粉末を製造し、この製造された卵殻膜含有微粉末を標準食に少なくとも１％含有率で添加して製造され、これは摂取されることにより、血液及び肝臓中のチォバルビツール酸反応性物質濃度を低下させ、四塩化炭素により誘発される過酸化脂質の生成を抑制し、四塩化炭素誘発性の肝臓の炎症及び障害を抑制するものであることを特徴とする。 In the method for producing an egg shell membrane-containing fine powder-added food for improving carbon tetrachloride-induced liver injury according to the present invention, the first method is to include an eggshell membrane-containing raw material containing at least an eggshell membrane peeled off from the inner surface of the eggshell. Finely pulverize by colliding with each other in gas, the eggshell membrane-containing fine powder produced by this pulverization is classified with a sieve having an opening of 20 μm or less to remove coarse particles, and the maximum volume particle diameter is 20 μm or less. There was prepared the eggshell membrane-containing fine powder volume average particle size of 6μm or less, is prepared by adding at least 1% content of the eggshell membrane-containing fine powder is the production standard diet, which is ingested Reduce the concentration of thiobarbituric acid-reactive substances in the blood and liver, suppress carbon tetrachloride-induced lipid peroxide formation, and suppress carbon tetrachloride-induced liver inflammation and damage To be things It is characterized by.
本発明の四塩化炭素誘発性肝障害改善用卵殻膜含有微粉末添加食の製造方法において、第二の方法は、卵殻の内面に卵殻膜が付着した状態の卵殻及び卵殻膜を少なくとも含む卵殻膜含有原料をガス中で相互に衝突させて微粉砕し、この微粉砕により作製された卵殻膜含有微粉末を、目開き２０μｍ以下の篩で分級して粗大粒子を除去して体積最大粒子径が２０μｍ以下であり、体積平均粒子径が６μｍ以下である卵殻膜含有微粉末を製造し、この製造された卵殻膜含有微粉末を標準食に少なくとも１％含有率で添加して製造され、これは摂取されることにより、血液及び肝臓中のチォバルビツール酸反応性物質濃度を低下させ、四塩化炭素により誘発される過酸化脂質の生成を抑制し、四塩化炭素誘発性の肝臓の炎症及び障害を抑制するものであることを特徴とする。 In the method for producing an egg shell membrane-containing fine powder-added food for improving carbon tetrachloride-induced liver injury according to the present invention, the second method is an eggshell membrane in which the eggshell membrane is attached to the inner surface of the eggshell and the eggshell membrane including at least the eggshell membrane The contained raw materials collide with each other in a gas and finely pulverized. The eggshell membrane-containing fine powder produced by this fine pulverization is classified with a sieve having an opening of 20 μm or less to remove coarse particles, and the volume maximum particle size is increased. and at 20μm or less, to produce a eggshell membrane-containing fine powder volume average particle size of 6μm or less, is prepared by adding at least 1% content of the eggshell membrane-containing fine powder is the production standard diet, which Ingestion reduces the concentration of thiobarbituric acid-reactive substance in blood and liver, suppresses carbon tetrachloride-induced lipid peroxide formation, carbon tetrachloride-induced liver inflammation and damage To suppress And wherein the Rukoto.
本発明の錠剤の一実施形態は、賦形剤を含有することが好ましい。 One embodiment of the tablet of the present invention preferably contains an excipient.
本発明の錠剤の他の実施形態は、卵殻膜成分を１０〜４０質量％の割合で含有することが好ましい。 It is preferable that other embodiment of the tablet of this invention contains eggshell membrane component in the ratio of 10-40 mass%.
本発明の錠剤の他の実施形態は、皮膚の老化、肌荒れ、皮膚疾病から選択される少なくとも１種の症状の予防剤あるいは治療剤であることが好ましい。 Another embodiment of the tablet of the present invention is preferably a prophylactic or therapeutic agent for at least one symptom selected from skin aging, rough skin, and skin disease.
本発明の錠剤の他の実施形態は、育毛、発毛促進および脱毛防止から選択される少なくとも１種の剤であることが好ましい。 Another embodiment of the tablet of the present invention is preferably at least one agent selected from hair growth, hair growth promotion and hair loss prevention.
第一の本発明の卵殻膜含有微粉末の製造方法は、卵殻の内面から剥離して取り出された卵殻膜を少なくとも含む卵殻膜含有原料をガス中で相互に衝突させて微粉砕する微粉砕工程を、少なくとも経て作製されることを特徴とする。 The method for producing the eggshell membrane-containing fine powder of the first aspect of the present invention is a fine pulverization step in which the eggshell membrane-containing raw materials containing at least the eggshell membrane peeled off from the inner surface of the eggshell are collided with each other in a gas and pulverized. It is produced through at least the above.
第二の本発明の卵殻膜含有微粉末の製造方法は、卵殻の内面に卵殻膜が付着した状態の卵殻および卵殻膜を少なくとも含む卵殻膜含有原料をガス中で相互に衝突させて微粉砕する微粉砕工程を、少なくとも経て作製されることを特徴とする。 In the method for producing the eggshell membrane-containing fine powder of the second aspect of the present invention, the eggshell membrane with the eggshell membrane attached to the inner surface of the eggshell and the eggshell membrane-containing raw material containing at least the eggshell membrane are collided with each other in the gas and pulverized. It is produced through at least a pulverization step.
第一および第二の本発明の卵殻膜含有微粉末の製造方法の一実施形態は、微粉砕工程を経た後に、目開き２０μｍ以下の篩で分級して粗大粒子を除去する分級工程を実施することが好ましい。 In one embodiment of the method for producing the eggshell membrane-containing fine powder of the first and second inventions, after the fine pulverization step, classification is performed with a sieve having an opening of 20 μm or less to remove coarse particles. It is preferable.
第一および第二の本発明の卵殻膜含有微粉末の製造方法の他の実施形態は、微粉砕工程が、第一の微粉砕処理と、第二の微粉砕処理とを含み、第一の微粉砕処理を終えた後の原料粉末を高圧蒸気で滅菌処理した後、第二の微粉砕処理を行うことが好ましい。 In another embodiment of the method for producing the eggshell membrane-containing fine powder of the first and second present inventions, the fine pulverization step includes a first fine pulverization treatment and a second fine pulverization treatment, It is preferable to perform a second pulverization process after the raw powder after the pulverization process is sterilized with high-pressure steam.
本発明の錠剤の製造方法は、本発明の卵殻膜含有微粉末を少なくとも含む打錠用原料を用いて、打錠することで裸錠を形成する裸錠形成工程を少なくとも経て錠剤を製造することが好ましい。 The method for producing a tablet of the present invention comprises producing a tablet through at least a tablet forming step of forming a tablet by tableting using a tableting raw material containing at least the eggshell membrane-containing fine powder of the present invention. Is preferred.
本発明の錠剤の製造方法の一実施形態は、裸錠に対して保護コーティング処理を行う保護コーティング工程をさらに実施することが好ましい。 In one embodiment of the method for producing a tablet of the present invention, it is preferable to further carry out a protective coating step of performing a protective coating treatment on the plain tablet.
本発明の錠剤の製造方法の一実施形態は、打錠用原料が、卵殻膜含有微粉末と、賦形剤とを含むことが好ましい。 In one embodiment of the tablet production method of the present invention, the tableting raw material preferably contains eggshell membrane-containing fine powder and an excipient.
本発明によれば、従来よりも更に消化吸収効率が改善された卵殻膜含有微粉末およびこれを用いた錠剤、ならびに、当該卵殻膜含有微粉末の製造方法およびこれを用いた錠剤の製造方法を提供することができる。 According to the present invention, there are provided an eggshell membrane-containing fine powder having improved digestion and absorption efficiency further than before, a tablet using the same, a method for producing the eggshell membrane-containing fine powder, and a method for producing a tablet using the same. Can be provided.
（卵殻膜含有微粉末）
第一の本実施形態の卵殻膜含有微粉末は、体積平均粒子径が６μｍ以下であることを特徴とする。また、第二の本実施形態の卵殻膜含有微粉末は、体積最大粒子径が２０μｍ以下であることを特徴とする。なお、本願明細書において、卵殻膜含有微粉末の「体積平均粒子径」および「体積最大粒子径」は、レーザー回折式粒度分布測定機（ＬＭＳ−３０、株式会社セイシン企業製）を用いて測定した値を意味する。ここで、「体積平均粒子径」は、粒度分布における小粒径側からの累積値が５０％における粒子径を意味する。また、卵殻膜含有微粉末の粒子径の測定に際しては、卵殻膜含有微粉末を界面活性剤を用いて水に分散させた測定試料を用いた。
(Fine powder containing eggshell membranes)
The eggshell membrane-containing fine powder according to the first embodiment has a volume average particle size of 6 μm or less. In addition, the eggshell membrane-containing fine powder of the second embodiment has a volume maximum particle size of 20 μm or less. In the present specification, the “volume average particle size” and “volume maximum particle size” of the eggshell membrane-containing fine powder are measured using a laser diffraction particle size distribution analyzer (LMS-30, manufactured by Seishin Enterprise Co., Ltd.). Means the value. Here, the “volume average particle diameter” means the particle diameter when the cumulative value from the small particle diameter side in the particle size distribution is 50%. In measuring the particle diameter of the eggshell membrane-containing fine powder, a measurement sample in which the eggshell membrane-containing fine powder was dispersed in water using a surfactant was used.
卵殻膜含有微粉末の体積平均粒子径が６μｍ以下、または、体積最大粒子径が２０μｍ以下となるように、卵殻膜含有微粉末の粒度分布を制御することにより、７０メッシュあるいは１５０メッシュで分級処理して得られた従来の卵殻膜粉末（最大粒子径で１００〜２００μｍの卵殻膜粉末）よりも更に消化吸収効率を改善することができる。 By controlling the particle size distribution of the eggshell membrane-containing fine powder so that the volume average particle size of the eggshell membrane-containing fine powder is 6 μm or less, or the volume maximum particle size is 20 μm or less, classification is performed at 70 mesh or 150 mesh. The digestion and absorption efficiency can be further improved compared to the conventional eggshell membrane powder obtained in this manner (eggshell membrane powder having a maximum particle size of 100 to 200 μm).
このような効果が得られる理由は定かではないが、本発明者は以下のように推定している。すなわち、最大粒子径で１００〜２００μｍ前後、平均粒子径で数十〜百数十μｍオーダの従来の卵殻膜粉末では、これらの粒径域レベルで最大粒子径あるいは平均粒子径を変化させて、より細かく粉砕しても消化吸収効率は殆ど改善しない。この理由は、卵殻膜は、繊維状の蛋白質を主成分とした強固な網目状の構造を有しており、これらの粒径域レベルで粉砕された卵殻膜粒子においては、未だに強固な網目構造が維持されているためであると考えられる。すなわち、強固な網目構造が維持されているため、卵殻膜が経口摂取された場合でも胃液や唾液等の各種の消化液によって分解・溶解が促進され難いためであると考えられる。 The reason why such an effect is obtained is not clear, but the present inventor estimates as follows. That is, in the conventional eggshell membrane powder having a maximum particle size of around 100 to 200 μm and an average particle size on the order of tens to hundreds of μm, the maximum particle size or the average particle size is changed at these particle size range levels, Even if it is pulverized more finely, the digestion and absorption efficiency is hardly improved. The reason for this is that eggshell membranes have a strong network structure mainly composed of fibrous proteins, and eggshell membrane particles pulverized at these particle size range levels still have a strong network structure. Is considered to be maintained. That is, it is considered that because a strong network structure is maintained, even when the eggshell membrane is orally ingested, it is difficult for decomposition and dissolution to be promoted by various digestive fluids such as gastric juice and saliva.
また、一般的に、粒径が小さくなるほど、粒子の単位体積当たりの表面積はより大きくなる。このため、粒子が消化液に対して可溶性または易溶性の物質のみから構成されるのであれば、粒径が小さくなるに従い消化吸収効率が改善されるものと期待される。しかしながら、上述した粒径域においては、粒径が変化しても消化吸収効率は殆ど改善されない。このことからは、卵殻膜が粉砕される過程で生成した破断面・粉砕面などの一部分が消化液に対して溶解し易くなったに過ぎず、強固な網目構造を維持した状態の卵殻膜粒子の本体部は相変わらず消化液に対して不溶状態または難溶状態を維持しているものと推測される。 In general, the smaller the particle size, the larger the surface area per unit volume of the particles. For this reason, if a particle | grain is comprised only from a substance soluble or easily soluble in a digestive liquid, it is anticipated that digestion absorption efficiency will improve as a particle size becomes small. However, in the above-mentioned particle size region, digestion absorption efficiency is hardly improved even if the particle size changes. From this, eggshell membrane particles in a state where only a part of the fracture surface, pulverized surface, etc. generated in the process of pulverizing the eggshell membrane is easily dissolved in the digestive fluid and a strong network structure is maintained. It is presumed that the main body part of the body remains insoluble or hardly soluble in the digestive juice as usual.
一方、本実施形態の卵殻膜含有微粉末では、従来の卵殻膜粉末と比べて、大幅に消化吸収効率が改善する。このような消化吸収効率の改善は、単純に粒径が小さくなったことに起因するものでは無く、卵殻膜を微粉化する過程において、卵殻膜微粒子全体において、卵殻膜が本来有する繊維状の強固な網目状の構造が破壊され、卵殻膜微粒子全体が消化液に対してより溶解し易くなったためであると推測される。 On the other hand, in the eggshell membrane-containing fine powder of this embodiment, the digestion and absorption efficiency is greatly improved as compared with the conventional eggshell membrane powder. Such improvement in digestion and absorption efficiency is not simply due to the reduction in particle size, but in the process of pulverizing the eggshell membrane, the whole eggshell membrane fine particles have a fibrous strong strength inherent in the eggshell membrane. It is presumed that this was because the net-like structure was destroyed and the whole eggshell membrane fine particles were more easily dissolved in the digestive fluid.
なお、消化吸収効率をより一層改善する観点からは、卵殻膜含有微粉末の体積平均粒子径が６μｍ以下、かつ、体積最大粒子径が２０μｍ以下であることがより好ましい。 From the viewpoint of further improving the digestion and absorption efficiency, the eggshell membrane-containing fine powder preferably has a volume average particle size of 6 μm or less and a volume maximum particle size of 20 μm or less.
本実施形態の卵殻膜含有微粉末には、微粉化された卵殻膜成分が少なくとも含まれるが、この他に微粉化された卵殻カルシウム成分が含まれていてもよい。この場合、本実施形態の卵殻膜含有微粉末は、卵殻膜成分のみを含む形態（第一形態）、あるいは、卵殻膜成分および卵殻カルシウムのみを含む形態（第二形態）のいずれかであることが特に好ましい。第一形態の卵殻膜含有微粉末の場合は、純粋に卵殻膜成分のみを含むため、錠剤、食品、化粧品等、各種の用途に幅広く本実施形態の卵殻膜含有微粉末を利用することができる。なお、第一形態の卵殻膜含有微粉末および第二形態の卵殻膜含有微粉末のいずれにおいても、製造過程等において混入する不純物成分が含まれることは許容される。 The eggshell membrane-containing fine powder of this embodiment contains at least a finely divided eggshell membrane component, but may also contain a finely divided eggshell calcium component. In this case, the eggshell membrane-containing fine powder of this embodiment is either in a form containing only the eggshell membrane component (first form) or in a form containing only the eggshell membrane component and eggshell calcium (second form). Is particularly preferred. Since the eggshell membrane-containing fine powder of the first form contains only eggshell membrane components purely, the eggshell membrane-containing fine powder of this embodiment can be widely used for various applications such as tablets, foods, and cosmetics. . It should be noted that both the eggshell membrane-containing fine powder of the first form and the eggshell membrane-containing fine powder of the second form are allowed to contain impurity components mixed in during the production process.
一方、卵殻膜は、卵殻の内側にある膜であり、卵殻膜は、卵殻カルシウムから構成される卵殻から隔離されて取り出される。また、卵殻膜成分を含有する錠剤を製造する場合、錠剤の硬度向上剤として卵殻カルシウムが利用できる。これに加えて、卵殻カルシウムは、人が摂取するカルシウム源としても好適である。これらの点を考慮すると、錠剤等の最終製品が、卵殻膜成分と卵殻カルシウム成分とを同時に含む場合、当該最終製品の製造には、第二形態の卵殻膜含有微粉末を用いることが特に好ましい。この場合、一連の製造過程において、卵殻膜を、卵殻カルシウムから隔離するプロセスを省くことができるため、製造工程の簡略化および低コスト化が図れる。 On the other hand, the eggshell membrane is a membrane inside the eggshell, and the eggshell membrane is isolated from the eggshell composed of eggshell calcium and taken out. Moreover, when manufacturing the tablet containing an eggshell membrane component, eggshell calcium can be used as a tablet hardness improver. In addition, eggshell calcium is also suitable as a calcium source for human consumption. In consideration of these points, when the final product such as a tablet contains an eggshell membrane component and an eggshell calcium component at the same time, it is particularly preferable to use the eggshell membrane-containing fine powder of the second form for the production of the final product. . In this case, since the process of isolating the eggshell membrane from the eggshell calcium can be omitted in a series of manufacturing processes, the manufacturing process can be simplified and the cost can be reduced.
本実施形態の卵殻膜含有微粉末を構成する卵殻膜は、鳥類の卵の卵殻の内側にある膜（外卵殻膜および／または内卵殻膜）であればいずれも使用できる。そのうちでも、鶏卵の卵殻膜が、入手の容易性、コストなどの点から好ましく用いられる。本実施形態の卵殻膜含有微粉末を製造する場合、市販の卵殻膜粉末、または、市販の卵殻膜粉末および卵殻カルシウムを利用し、これを、体積平均粒子径が６μｍ以下、および／または、体積最大粒子径が２０μｍ以下まで微粉砕すればよい。あるいは、卵殻に卵殻膜が付着した状態の原料を用いたり、当該原料と卵殻膜粉末とを併用することもできる。なお、卵殻膜粉末としては、たとえば、ＥＭパウダー３００（キューピー株式会社製）が利用できる。また、本実施形態の卵殻膜含有微粉末の製造方法の詳細については後述する。 Any eggshell membrane constituting the eggshell membrane-containing fine powder of this embodiment can be used as long as it is a membrane (outer eggshell membrane and / or inner eggshell membrane) inside the eggshell of avian eggs. Among them, eggshell membranes of chicken eggs are preferably used from the viewpoints of availability, cost, and the like. When producing the eggshell membrane-containing fine powder of this embodiment, commercially available eggshell membrane powder, or commercially available eggshell membrane powder and eggshell calcium are used, and the volume average particle diameter is 6 μm or less and / or the volume. What is necessary is just to pulverize until the maximum particle diameter is 20 micrometers or less. Alternatively, a raw material with an eggshell membrane attached to the eggshell can be used, or the raw material and eggshell membrane powder can be used in combination. As the eggshell membrane powder, for example, EM powder 300 (manufactured by Kewpie Co., Ltd.) can be used. Details of the method for producing the eggshell membrane-containing fine powder of this embodiment will be described later.
本実施形態の卵殻膜含有微粉末の用途としては特に限定されないが、経口摂取される用途、すなわち、錠剤、散剤、顆粒剤、カプセル剤、液剤などの経口剤用、あるいは、菓子類、健康食品、保存食品、加工食品などの食品添加用などに利用することが好ましい。また、必要に応じて、皮膚への塗布用、毛髪への塗布用、睫毛への塗布用および眉毛への塗布用などにも利用してもよい。 The use of the eggshell membrane-containing fine powder of the present embodiment is not particularly limited, but is orally ingested, that is, for oral preparations such as tablets, powders, granules, capsules, liquids, confectionery, and health foods. It is preferably used for food addition such as preserved food and processed food. Moreover, you may utilize for the application to skin, the application to hair, the application to eyelashes, the application to eyebrows, etc. as needed.
しかしながら、卵殻膜を高濃度で均一に含有し、保存時、流通時、服用時などに変形・崩壊が生じず、取扱い性に優れ、かつ、経口で簡単に服用できる観点からは、本実施形態の卵殻膜含有微粉末は、錠剤に用いられることが特に好ましい。 However, from the viewpoint of containing eggshell membranes uniformly at a high concentration, being free from deformation / disintegration during storage, distribution, and administration, excellent handleability, and can be easily taken orally, this embodiment The eggshell membrane-containing fine powder is particularly preferably used for tablets.
（錠剤）
以下に、本実施形態の卵殻膜含有微粉末を用いた錠剤について説明する。本実施形態の錠剤は、本実施形態の卵殻膜含有微粉末と、賦形剤とを含有する。
(tablet)
Below, the tablet using the eggshell membrane containing fine powder of this embodiment is demonstrated. The tablet of this embodiment contains the eggshell membrane-containing fine powder of this embodiment and an excipient.
本実施形態の錠剤に含まれる微粉末状の卵殻膜成分の含有量は特に制限されない。しかしながら、粒子への造粒および打錠が円滑に行われ、錠剤を経口で摂取（服用）した際のコラーゲン、特に（ＩＩＩ）型コラーゲンの生成促進作用が高くなって皮膚の老化や肌荒れ防止効果や皮膚疾病の予防および／または治療効果がより優れたものになり、育毛、発毛促進、脱毛防止効果が高くなり、生体内で生成した活性酸素の低減または消去能が高くなるなどの観点から、錠剤の全質量に対して、卵殻膜成分を１０〜４０質量％の割合で含有することが好ましく５〜２５質量％の割合で含有することがより好ましい。 The content of the fine powdered eggshell membrane component contained in the tablet of the present embodiment is not particularly limited. However, granulation and tableting into particles are performed smoothly, and the action of promoting the production of collagen, particularly (III) type collagen, is enhanced when the tablets are taken orally (ingestion), thereby preventing skin aging and rough skin. From the viewpoint of improving the effect of preventing and / or treating skin diseases, improving hair growth, promoting hair growth and preventing hair loss, and increasing the ability to reduce or eliminate active oxygen generated in vivo. The eggshell membrane component is preferably contained at a rate of 10 to 40% by mass and more preferably 5 to 25% by mass with respect to the total mass of the tablet.
卵殻膜成分の含有量を１０質量％以上とすることにより、コラーゲンの生成促進効果、育毛、発毛促進、脱毛防止効果、活性酸素の低減または消去能を得るために、多量の錠剤を摂取する必要がなくなる。一方、錠剤における卵殻膜の含有量が４０質量％以下とすることにより、粒子への造粒および打錠が容易となり、錠剤を製造しやすくなる。 By setting the content of the eggshell membrane component to 10% by mass or more, a large amount of tablets is taken in order to obtain collagen generation promoting effect, hair growth, hair growth promotion, hair loss preventing effect, active oxygen reduction or elimination ability. There is no need. On the other hand, when the content of the eggshell membrane in the tablet is 40% by mass or less, granulation and tableting into particles are facilitated, and the tablet is easily produced.
本実施形態の錠剤には、錠剤を形成するために各種の添加剤として、たとえば、賦形剤、結合剤、崩壊剤、滑沢剤等を適宜添加できる。 For example, an excipient, a binder, a disintegrant, a lubricant, and the like can be appropriately added to the tablet of this embodiment as various additives in order to form a tablet.
賦形剤は、有効成分が少ない場合に取扱うのに適当な量となるように添加される添加剤である。賦形剤としては、公知の賦形剤が適宜利用できるが、化工澱粉および乳糖の少なくとも１種が用いられることが好ましい。賦形剤の含有量は、賦形性の観点から卵殻膜成分の質量に対して０.５〜３質量倍であることが好ましく、１〜２.５質量倍であることがより好ましい。化工澱粉としては、焙焼デキストリン（白色デキストリン、黄色デキストリンなど）などのデキストリン類、酸化澱粉（次亜塩素酸酸化澱粉など）、低粘性変性澱粉（酸浸漬澱粉、酵素処理澱粉など）などを挙げることができ、これらの１種または２種以上を用いることができる。これらの中でも、化工澱粉としては、デキストリンが好ましく用いられ、具体例としては、日食株式会社製の「ワキシａ」、松谷化学株式会社製の「パインファイバー」などを挙げることができる。化工澱粉として、「ワキシａ」と「パインファイバー」を併用することが、打錠がより円滑に行われる点からより好ましい。「ワキシａ」と「パインファイバー」を併用する場合は、両者を、１：４〜４：１の質量比で用いることが好ましい。 Excipients are additives that are added in an amount suitable for handling when there are few active ingredients. As the excipient, known excipients can be used as appropriate, but at least one of modified starch and lactose is preferably used. The content of the excipient is preferably 0.5 to 3 times, more preferably 1 to 2.5 times the mass of the eggshell membrane component from the viewpoint of formability. Modified starches include dextrins such as roasted dextrin (white dextrin, yellow dextrin, etc.), oxidized starch (eg hypochlorous acid oxidized starch), low viscosity modified starch (acid soaked starch, enzyme treated starch, etc.), etc. 1 type, or 2 or more types of these can be used. Among these, as the modified starch, dextrin is preferably used, and specific examples include “Waxi a” manufactured by Solar Eclipse Co., Ltd. and “Pine Fiber” manufactured by Matsutani Chemical Co., Ltd. It is more preferable to use “waxy a” and “pine fiber” in combination as the modified starch from the viewpoint that tableting is performed more smoothly. In the case where “waxy a” and “pine fiber” are used in combination, it is preferable to use both in a mass ratio of 1: 4 to 4: 1.
また、賦形剤として、化工澱粉（特に「ワキシａ」および「パインファイバー」）と乳糖を併用する場合は、化工澱粉：乳糖の使用割合（質量比）が、１：５〜５：１であることが好ましく、１：３〜３：１であることがより好ましい。 In addition, when a modified starch (particularly “waxy a” and “pine fiber”) and lactose are used as excipients, the ratio (mass ratio) of modified starch: lactose is 1: 5 to 5: 1. It is preferable that the ratio is 1: 3 to 3: 1.
結合剤は、錠剤原料を構成する粉体同士を結着させる目的で用いられる添加剤である。結合剤としては、公知の結合剤が適宜利用できるが、たとえば、デンプン糊、アラビアゴム糊、ヒドロキシプロピルセルロースなどを挙げることができる。 The binder is an additive used for the purpose of binding powders constituting the tablet raw material. As the binder, known binders can be used as appropriate, and examples thereof include starch paste, gum arabic paste, and hydroxypropyl cellulose.
崩壊剤は、唾液などの水分を吸収することで膨張するなどして錠剤を崩壊させることで、卵殻膜成分等の有効成分の放出を容易にするために添加される添加剤である。崩壊剤としては、公知の崩壊剤が適宜利用できるが、たとえば、セルロース類などを用いることができる。なお、デンプンは崩壊剤としての機能も有する。 A disintegrant is an additive that is added to facilitate the release of an active ingredient such as an eggshell membrane component by disintegrating the tablet by absorbing water such as saliva to disintegrate the tablet. As the disintegrant, known disintegrants can be used as appropriate. For example, celluloses can be used. Note that starch also has a function as a disintegrant.
滑沢剤は、錠剤原料を構成する粉体の流動性を高めて、打錠時の圧縮成形を容易とする目的で用いられる添加剤である。滑沢剤としては、公知の滑沢剤が適宜利用できるが、たとえば、ステアリン酸マグネシウム、ショ糖脂肪酸エステルなどのワックス類やタルク、ビタミンＣなどを挙げることができる。 A lubricant is an additive used for the purpose of enhancing the fluidity of powder constituting the tablet raw material and facilitating compression molding at the time of tableting. As the lubricant, known lubricants can be used as appropriate, and examples thereof include waxes such as magnesium stearate and sucrose fatty acid ester, talc, vitamin C and the like.
さらに、本実施形態の錠剤は、錠剤の硬度を高くし、錠剤の変形や傷つきを防止して、包装時、保存時、流通時などにおける錠剤の取り扱い性を向上し、摂取性を良好なものにするために、硬度向上剤として卵殻カルシウムを含有することが特に好ましい。錠剤が卵殻カルシウムを含む場合、錠剤の製造に用いる原料としては、第一形態の卵殻膜含有微粉末および卵殻カルシウムを少なくとも用いるか、あるいは、第二形態の卵殻膜含有微粉末を少なくとも用いることができる。 Furthermore, the tablet of this embodiment increases the hardness of the tablet, prevents deformation and scratching of the tablet, improves the handleability of the tablet during packaging, storage, distribution, etc., and has good ingestion Therefore, it is particularly preferable to contain eggshell calcium as a hardness improver. When the tablet contains eggshell calcium, the raw materials used in the manufacture of the tablet should at least use the eggshell membrane-containing fine powder and eggshell calcium of the first form, or at least the eggshell membrane-containing fine powder of the second form. it can.
卵殻カルシウムは、鶏卵などの鳥類の卵の殻を粉砕・乾燥してなる微粉末であり、人が摂取可能な卵殻カルシウムであればいずれも使用できる。卵殻カルシウムとしては、例えば、従来から市販されているキューピー株式会社製「カルホープ」、太陽化学株式会社製の卵殻カルシウムなどをそのまま用いることができる。なお、第二態様の卵殻膜含有微粉末を用いて錠剤を製造する場合、これらの卵殻カルシウムの使用を省略してもよい。錠剤中に含まれる卵殻カルシウムの含有量は、錠剤の全質量に対して、５〜２０質量％であることが好ましく、８〜１５質量％であることがより好ましい。 Eggshell calcium is a fine powder obtained by pulverizing and drying the eggshells of birds such as chicken eggs, and any eggshell calcium that can be ingested by humans can be used. As eggshell calcium, for example, commercially available “Culhope” manufactured by Kewpie Co., Ltd., eggshell calcium manufactured by Taiyo Kagaku Co., Ltd., etc. can be used as they are. In addition, when manufacturing a tablet using the eggshell membrane containing fine powder of a 2nd aspect, you may abbreviate | omit use of these eggshell calcium. The content of eggshell calcium contained in the tablet is preferably 5 to 20% by mass and more preferably 8 to 15% by mass with respect to the total mass of the tablet.
本実施形態の錠剤は、卵殻膜の体内での吸収を速め、皮膚におけるコラーゲンの生成、特に（ＩＩＩ）型コラーゲンの生成を促進させて、皮膚の老化や肌荒れをより効果的に防止して皮膚を滑らかで、柔らかく、シットリとした状態にするために、湿疹、炎症、ヤケドなどの皮膚疾患の予防および／または治癒効果をより高めるために、また育毛、発毛促進、脱毛防止効果をより優れたものにするために、さらに生体内に生成した活性酸素の低減または消去能をより高くするために、卵殻膜成分と共に、β−カロチン、ビタミン類およびローヤルゼリーのうちの少なくも１種を含有することが好ましく、β−カロチン、ビタミン類およびローヤルゼリーの３者を含有することがより好ましい。 The tablet of this embodiment accelerates the absorption of the eggshell membrane in the body, promotes the production of collagen in the skin, particularly the production of type (III) collagen, and prevents skin aging and rough skin more effectively. In order to make the skin smooth, soft and crisp, in order to enhance the prevention and / or healing effect of skin diseases such as eczema, inflammation, burns, etc., and also have better hair growth, hair growth promotion and hair loss prevention effects In order to further increase the ability to reduce or eliminate the active oxygen produced in the living body, it contains at least one of β-carotene, vitamins and royal jelly along with eggshell membrane components. It is preferable to contain three of β-carotene, vitamins and royal jelly.
本実施形態の錠剤中に含有させるビタミンの種類は特に制限されず、人が摂取可能なビタミンであればいずれでもよく、ビタミンＡ、ビタミンＤ、ビタミンＥ、ビタミンＦ、ビタミンＫなどの脂溶性ビタミン類、ビタミンＢ、ビタミンＣ、ビタミンＨ、ビタミンＬなどの水溶性ビタミン類などを挙げることができ、これらのビタミン類の１種または２種以上を含有することができる。β−カロチンおよびビタミン類の含有量は、ヒトが摂取するのに適するそれぞれのビタミンの量に応じて適宜決めることができる。 The kind of vitamin contained in the tablet of the present embodiment is not particularly limited, and any vitamin that can be ingested by humans may be used. Fat-soluble vitamins such as vitamin A, vitamin D, vitamin E, vitamin F, vitamin K and the like And water-soluble vitamins such as vitamin B, vitamin C, vitamin H, and vitamin L, and one or more of these vitamins can be contained. The content of β-carotene and vitamins can be appropriately determined according to the amount of each vitamin suitable for human consumption.
また、ローヤルゼリーの含有量は、本実施形態の錠剤の上記した作用効果を十分に発揮させ得る点、コストなどの点から、卵殻膜成分の全質量に対して０．１〜１．５質量倍であることが好ましく、０．２〜１質量倍であることがより好ましく、０．５〜０．８質量倍であることが更に好ましい。 In addition, the content of the royal jelly is 0.1 to 1.5 times by mass with respect to the total mass of the eggshell membrane component from the viewpoint of sufficiently exerting the above-described effects of the tablet of the present embodiment and cost. It is preferable that it is 0.2-1 mass times, and it is still more preferable that it is 0.5-0.8 mass times.
本実施形態の錠剤は、錠剤中に含まれる成分の変質や分解を防止し、また錠剤表面の耐傷つき性の向上などの目的で、コーティング皮膜で覆われていることが好ましい。コーティング皮膜は、錠剤のコーティング皮膜として従来から用いられているのと同様の皮膜形成材料から形成することができる。皮膜形成材料としては、特に限定されるものではないが、例えば、岐阜セラック株式会社製の「セラック」（トラック３０）などが利用できる。 The tablet of the present embodiment is preferably covered with a coating film for the purpose of preventing deterioration and decomposition of components contained in the tablet and improving scratch resistance on the tablet surface. The coating film can be formed from a film-forming material similar to that conventionally used as a tablet coating film. The film forming material is not particularly limited, and for example, “Shellak” (Track 30) manufactured by Gifu Shellac Co., Ltd. can be used.
また、本実施形態の錠剤は、経口での摂取をし易くするために、糖衣で覆われていることが好ましい。その際の糖衣としては、錠剤に従来から用いられている糖衣であればいずれでもよい。本実施形態の錠剤は、商品価値を高めるために、必要に応じて、適当な色に着色してあってもよい。また、着色後に、艶だし処理を行ってもよい。 Moreover, it is preferable that the tablet of this embodiment is covered with the sugar coating in order to make it easy to take orally. Any sugar coating can be used as long as it is conventionally used for tablets. The tablet of this embodiment may be colored in an appropriate color as necessary in order to increase the commercial value. Moreover, you may perform a glossing process after coloring.
本実施形態の錠剤の大きさは特に制限されず、適宜決めることができるが、一般には、直径が約７〜１０ｍｍ程度の円形や楕円形の錠剤とするのが、取り扱い性、服用のし易さなどの点から好ましい。 The size of the tablet of this embodiment is not particularly limited and can be determined as appropriate. In general, a round or elliptical tablet having a diameter of about 7 to 10 mm is easy to handle and easy to take. It is preferable from the point of view.
さらに、本実施形態の錠剤は、例えば、錠剤１個の重さが約３５０〜４００ｍｇ程度であることが好ましく、このような錠剤１個中に卵殻膜成分が約３５〜４０ｍｇの量で含まれることが好ましい。 Furthermore, in the tablet of the present embodiment, for example, the weight of one tablet is preferably about 350 to 400 mg, and the eggshell membrane component is contained in such a tablet in an amount of about 35 to 40 mg. It is preferable.
例えば、本実施形態の錠剤１個当たり、卵殻膜成分が約３５〜４０ｍｇの割合で含有されると仮定する。この場合、成人では、当該錠剤を１日当たり１〜２個摂取すると（１日当たり卵殻膜成分を合計で３５〜７０ｍｇ摂取すると）、皮膚におけるコラーゲン、特に（ＩＩＩ）型コラーゲンの生成が促進されて、皮膚の老化や肌荒れが防止され、皮膚を滑らかで、柔らかく、シットリとした状態にすることができ、湿疹、炎症、サケドなどの皮膚疾患の予防や治癒が促進され、育毛、発毛促進、脱毛の防止、白髪の減少などがなされ、生体内に生成した活性酸素が消去または低減されて種々の疾病の予防や回復を促進することができる。 For example, it is assumed that the eggshell membrane component is contained in a ratio of about 35 to 40 mg per tablet of the present embodiment. In this case, in adults, taking 1-2 tablets per day (taking 35-70 mg of eggshell membrane components per day in total) promotes the production of collagen in the skin, particularly (III) type collagen, Prevents skin aging and rough skin, makes the skin smooth, soft and dry, promotes prevention and healing of skin diseases such as eczema, inflammation, and salmon, hair growth, hair growth promotion, hair loss Prevention, reduction of gray hair, and the like, and the active oxygen generated in the living body can be eliminated or reduced to promote prevention and recovery of various diseases.
（卵殻膜含有微粉末の製造方法）
本実施形態の卵殻膜含有微粉末は、卵殻膜含有原料をガス中で相互に衝突させて微粉砕する微粉砕工程を、少なくとも経て作製される。このような微粉砕工程では、ノズルから噴射される高圧の空気あるいは蒸気等のガスを超高速ジェットとして粒子に衝突させ、粒子どうしの衝撃によって数ミクロンのレベルの微粒子にまで粉砕する粉砕装置、いわゆるジェットミルが用いられる。このような粉砕方法は、従来の回転刃などの硬質の破砕部材を原料と衝突させて粉砕する粉砕方法と比べて、粉砕時に、破砕部材と原料との接触・衝突などに起因する摩擦熱が殆ど発生しない。このため、卵殻膜中に含まれるアミノ酸や蛋白質などの熱により変性・劣化・分解しやすい成分へのダメージが少ない。すなわち、製造過程で、卵殻膜中の有効成分が失われにくくなる。これに加えて、原料を粉砕するために、破砕部材ではなく高圧ガスを使うため、粉砕装置由来の不純物が卵殻膜含有微粉末に混入することも無い。
(Production method of eggshell membrane-containing fine powder)
The eggshell membrane-containing fine powder of the present embodiment is produced through at least a pulverization step in which the eggshell membrane-containing raw materials collide with each other in a gas and are finely pulverized. In such a fine pulverization process, a high-pressure air or gas such as steam jetted from a nozzle is collided with particles as an ultra-high speed jet, and is pulverized to a level of several microns by impact between particles, so-called A jet mill is used. Compared with the conventional grinding method in which a hard crushing member such as a rotary blade collides with the raw material, this crushing method generates frictional heat caused by contact / collision between the crushing member and the raw material at the time of crushing. It hardly occurs. For this reason, there is little damage to the components which are easily denatured, deteriorated and decomposed by heat such as amino acids and proteins contained in the eggshell membrane. That is, the active ingredient in the eggshell membrane is not easily lost during the manufacturing process. In addition, since a high-pressure gas is used instead of a crushing member to crush the raw material, impurities derived from the crushing device are not mixed into the eggshell membrane-containing fine powder.
一方、破砕部材を原料と衝突させて粉砕する粉砕方法では、３０μｍレベルよりも小さく粉砕することは困難である。このような粉砕方法で原料を粉砕した場合の粉砕限界粒径は、たとえば、カッターミルでは５００μｍ前後、解砕機では１５０μｍ前後、アトマイザーでは５０μｍ前後、インペラーミルでは７０μｍ前後、コントラプレックスミル、ボールミルおよびＡＣＭパルペライザーミルでは３０μｍ前後である。このため、仮に、目開き２０μｍ程度の篩を用いて分級処理しても、本実施形態の卵殻膜含有微粉末を殆ど得ることができず、収率も極めて低い。また、上述した粉砕方法では、粉砕時に加熱された粉末が、粉砕後に冷却される段階で、空気中の水分を吸湿しやすくなる。その結果、雑菌・カビが繁殖しやすくなり易いというデメリットもある。 On the other hand, in the pulverization method in which the crushing member collides with the raw material and pulverization, it is difficult to pulverize smaller than the 30 μm level. The pulverization limit particle size when the raw material is pulverized by such a pulverization method is, for example, about 500 μm for a cutter mill, about 150 μm for a crusher, about 50 μm for an atomizer, about 70 μm for an impeller mill, a contraplex mill, a ball mill and an ACM. In the pulverizer mill, it is around 30 μm. For this reason, even if it classifies using a sieve with about 20 micrometers of openings, the eggshell membrane containing fine powder of this embodiment can hardly be obtained, and the yield is also very low. In the pulverization method described above, the powder heated at the time of pulverization easily absorbs moisture in the air when it is cooled after pulverization. As a result, there is a demerit that germs and molds are easy to propagate.
なお、微粉砕工程に用いる卵殻膜含有原料としては、（１）卵殻の内面から剥離して取り出された卵殻膜を少なくとも含む原料（第一形態の卵殻膜含有原料）、および／または、（２）卵殻の内面に卵殻膜が付着した状態の卵殻および卵殻膜を少なくとも含む原料（第二形態の卵殻膜含有原料）のいずれかを用いることができる。ここで、卵殻の内面から剥離して取り出された卵殻膜を少なくとも含む卵殻膜含有原料としては、たとえば、ＥＭパウダー３００（キューピー株式会社製）を用いることができる。また、後述する錠剤の製造等のように、後工程において、卵殻カルシウムと卵殻膜とを同時に使用する場合、生産性の観点から、第二形態の卵殻膜含有原料を用いることが好ましい。 The eggshell membrane-containing raw material used in the fine pulverization step includes (1) a raw material containing at least the eggshell membrane peeled off from the inner surface of the eggshell (first-shell eggshell membrane-containing raw material) and / or (2 ) Either the eggshell with the eggshell membrane attached to the inner surface of the eggshell or a raw material containing at least the eggshell membrane (the eggshell membrane-containing material of the second form) can be used. Here, for example, EM powder 300 (manufactured by Kewpie Co., Ltd.) can be used as the eggshell membrane-containing material including at least the eggshell membrane peeled off from the inner surface of the eggshell. Further, when eggshell calcium and eggshell membranes are used simultaneously in the subsequent steps, such as the manufacture of tablets described later, it is preferable to use the eggshell membrane-containing raw material of the second form from the viewpoint of productivity.
微粉砕工程では、ジェットミルにより、卵殻膜含有原料の体積平均粒子径が４０μｍ以下となるまで粉砕することが好ましく、２０μｍ以下となるまで粉砕することがより好ましく、１０μｍ以下となるまで粉砕することがさらに好ましい。また、この場合、体積最大粒子径は２０μｍ以下となるまで粉砕することが好ましい。一方、ジェットミルにより粉砕された卵殻膜含有原料の体積平均粒子径の下限は特に限定されないが、生産性等の実用上の観点からは４μｍ以上が好ましく、５μｍ以上がより好ましい。 In the fine pulverization step, it is preferable that the eggshell membrane-containing raw material is pulverized by a jet mill until the volume average particle diameter is 40 μm or less, more preferably 20 μm or less, and more preferably 10 μm or less. Is more preferable. In this case, it is preferable to grind until the volume maximum particle size is 20 μm or less. On the other hand, the lower limit of the volume average particle diameter of the eggshell membrane-containing raw material pulverized by the jet mill is not particularly limited, but is preferably 4 μm or more, more preferably 5 μm or more from the practical viewpoint such as productivity.
ジェットミルにより粉砕された後の卵殻膜含有原料については、体積最大粒子径が２０μｍ以下、および／または、体積平均粒子径が６μｍ以下であれば、これをそのまま本実施形態の卵殻膜含有微粉末として利用できる。一方、粒度分布において粒径２０μｍを超える粗大粒子を含む場合、微粉砕工程を経た後に、目開き２０μｍ以下の篩で分級して粗大粒子を除去する分級工程をさらに実施してもよい。 Regarding the eggshell membrane-containing raw material after being pulverized by a jet mill, if the volume maximum particle size is 20 μm or less and / or the volume average particle size is 6 μm or less, this is used as it is in the eggshell membrane-containing fine powder of this embodiment. Available as On the other hand, in the case where coarse particles having a particle size exceeding 20 μm are included in the particle size distribution, after the fine pulverization step, classification may be further performed by removing the coarse particles by classification with a sieve having an opening of 20 μm or less.
また、本実施形態の卵殻膜含有微粉末の製造方法では、必要に応じてその他の工程・プロセスを実施してもよい。たとえば、微粉砕工程が、第一の微粉砕処理と、第二の微粉砕処理とを含み、第一の微粉砕処理を終えた後の原料粉末を高圧蒸気で滅菌処理した後、第二の微粉砕処理を行ってもよい。卵殻膜含有原料がジェットミルにより粉砕されて微細化される過程においては、卵殻膜の抗菌性が低下しやすくなるが、上述したように滅菌処理を行うことで本実施形態の卵殻膜含有微粉末にカビや細菌の繁殖を防ぐのが容易となる。 Moreover, in the manufacturing method of the eggshell membrane containing fine powder of this embodiment, you may implement another process and process as needed. For example, the fine pulverization step includes a first fine pulverization process and a second fine pulverization process. After the first fine pulverization process is finished, the raw material powder is sterilized with high-pressure steam, and then the second pulverization process is performed. A fine grinding treatment may be performed. In the process in which the eggshell membrane-containing raw material is pulverized and refined by a jet mill, the antibacterial properties of the eggshell membrane are likely to decrease, but the eggshell membrane-containing fine powder of the present embodiment can be obtained by performing sterilization as described above. It is easy to prevent the growth of mold and bacteria.
以上に説明したプロセスを経て作製された本実施形態の卵殻膜含有微粉末は、後述する経口用の錠剤・散剤・顆粒剤・液剤の製造、各種の加工食品の製造、疾病予防・治療・美容等の目的で皮膚に塗布するための液剤・乳液・クリームの製造、マスカラやトリートメント液などのように毛髪・眉毛・睫毛等に塗布するための液剤・乳液・クリームの製造に用いることができる。 The eggshell membrane-containing fine powder of this embodiment produced through the process described above is used for the manufacture of oral tablets, powders, granules, and liquids described later, the manufacture of various processed foods, disease prevention, treatment, and beauty. It can be used for the production of liquids, emulsions and creams to be applied to the skin for the purpose of the above, and the production of liquids, emulsions and creams to be applied to hair, eyebrows, eyelashes and the like like mascara and treatment liquids.
（錠剤の製造方法）
本実施形態の錠剤は、本実施形態の卵殻膜含有微粉末を少なくとも含む打錠用原料を用いて、公知の錠剤製造方法を適宜利用して製造することができる。具体的には、打錠用原料を用いて、打錠することで裸錠を形成する裸錠形成工程（打錠工程）を少なくとも経て本実施形態の錠剤を製造することができる。
(Tablet production method)
The tablet of this embodiment can be manufactured using the tableting raw material containing at least the eggshell membrane-containing fine powder of this embodiment and appropriately using known tablet manufacturing methods. Specifically, the tablet of the present embodiment can be produced through at least a naked tablet forming step (tablet step) in which a raw material for tableting is used to form a naked tablet by tableting.
なお、打錠用原料には、本実施形態の卵殻膜含有微粉末の他に、卵殻膜成分以外の有効成分、たとえば、β−カロチン、ビタミン類およびローヤルゼリーが含まれていてもよい。これに加えて、通常、賦形剤、結合剤、崩壊剤等から選択される少なくとも１種の添加剤が含まれるが、賦形剤が少なくとも含まれることが好ましい。また、硬度向上剤として、卵殻カルシウムがさらに含まれていてもよい。 In addition to the eggshell membrane-containing fine powder of the present embodiment, the tableting raw material may contain active ingredients other than the eggshell membrane component, for example, β-carotene, vitamins, and royal jelly. In addition to this, usually at least one additive selected from excipients, binders, disintegrants and the like is included, but it is preferable that at least an excipient is included. Moreover, eggshell calcium may further be contained as a hardness improver.
裸錠形成工程では、公知の打錠法が利用でき、たとえば、所定の原料を秤量・混合して得られた打錠用原料をそのまま打錠する直接打錠法で実施してもよく、打錠用原料を顆粒に造粒する造粒工程を経てから打錠する顆粒打錠法で実施してもよい。 In the uncoated tablet forming step, a known tableting method can be used. For example, a direct tableting method in which a tableting raw material obtained by weighing and mixing a predetermined raw material is directly compressed may be used. You may implement by the granule tableting method of tableting after passing through the granulation process which granulates the raw material for tablets into a granule.
造粒工程では、たとえば、以下の手順で、打錠用原料を顆粒化することができる。まず、打錠用原料１００質量部に対してアルコール（エタノール）を約１０質量部〜２０質量部の割合で添加してアルコール含有混合物を作製する。次に、このアルコール含有混合物を用いて従来既知の造粒法、例えば、撹拌造粒法、転動造粒法、噴霧造粒法などの造粒方法を採用して造粒を行う。そして、得られた粒子を、たとえば、４０℃〜７０℃程度の温度で加熱する乾燥工程を行うことで打錠用の顆粒を得ることができる。なお、得られた打錠用の顆粒は、篩を用いて分級して粒度を揃えてから打錠することが好ましい。 In the granulation step, for example, the raw material for tableting can be granulated by the following procedure. First, alcohol (ethanol) is added at a ratio of about 10 to 20 parts by mass with respect to 100 parts by mass of the raw material for tableting to produce an alcohol-containing mixture. Next, granulation is carried out using this alcohol-containing mixture by employing a conventionally known granulation method such as agitation granulation method, rolling granulation method, spray granulation method or the like. And the granule for tableting can be obtained by performing the drying process which heats the obtained particle | grains at the temperature of about 40 to 70 degreeC, for example. The obtained granules for tableting are preferably classified using a sieve and then tableted after uniforming the particle size.
裸錠形成工程で用いる打錠装置は、医薬などの分野で錠剤を製造するのに従来から用いられているのと同様の打錠装置を採用して行うことができる。なお、打錠に際して造粒工程および乾燥工程を経て得られた打錠用の顆粒にビタミンＣおよびショ糖脂肪酸エステルなどの滑沢剤を添加して打錠を行うことが好ましい。この場合、粒子の流動性および滑艶性が高まり、打錠をより円滑に行うことができる。ここで、滑沢剤としてビタミンＣおよびショ糖脂肪酸エステルを用いる場合、その添加量は以下の通りとすることが好ましい。すなわち、打錠時におけるビタミンＣの添加量は、乾燥状態の打錠用の顆粒１００質量部に対して８〜１０質量部であることが好ましい。また、ショ糖脂肪酸エステルの添加量は、乾燥状態の打錠用の顆粒１００質量部に対して０．１〜３．０質量部であることが好ましい。 The tableting device used in the bare tablet forming step can be performed by adopting the same tableting device as conventionally used for producing tablets in the field of medicine and the like. It is preferable to perform tableting by adding a lubricant such as vitamin C and sucrose fatty acid ester to the granules for tableting obtained through the granulation step and the drying step. In this case, the fluidity and smoothness of the particles are improved, and tableting can be performed more smoothly. Here, when vitamin C and sucrose fatty acid ester are used as the lubricant, the addition amount is preferably as follows. That is, it is preferable that the addition amount of vitamin C at the time of tableting is 8 to 10 parts by mass with respect to 100 parts by mass of the granules for tableting in a dry state. Moreover, it is preferable that the addition amount of sucrose fatty acid ester is 0.1-3.0 mass parts with respect to 100 mass parts of granules for tableting in a dry state.
裸錠形成工程を経て得られた裸錠は、これをそのまま本実施形態の錠剤としてもよいが、裸錠に対して保護コーティング処理を行う保護コーティング工程をさらに実施してもよい。保護コーティング工程に用いるコーティング剤の種類は、上記したように特に制限されず、例えば岐阜セラック株式会社製の「セラック」などが用いられる。保護コーティング層のコーティング量は特に制限されないが、一般に、錠剤１個に対し、１〜５ｍｇ程度であることが好ましい。 The uncoated tablet obtained through the uncoated tablet forming step may be used as it is as the tablet of this embodiment, but a protective coating step of performing a protective coating process on the uncoated tablet may be further performed. The kind of the coating agent used in the protective coating process is not particularly limited as described above, and for example, “Shellak” manufactured by Gifu Shellac Co., Ltd. is used. The coating amount of the protective coating layer is not particularly limited, but generally it is preferably about 1 to 5 mg per tablet.
なお、保護コーティングされた錠剤は、そのままで製品として流通、販売してもよいが、錠剤を服用し易くするために糖衣を施すことが好ましい。糖衣を施す糖衣コーティング工程は、１段で行ってもよいが、表面の仕上がりを綺麗にするためには、錠剤を粘度の高い糖分含有ペースト状物で被覆した後、乾燥し、さらに粘度の低い糖分含有ペースト状物や糖分含有液で再度被覆する多段による方法が好ましく採用される。 In addition, although the tablet with protective coating may be distributed and sold as a product as it is, it is preferable to apply sugar coating to make it easy to take the tablet. The sugar coating process for applying sugar coating may be carried out in one step, but in order to clean the surface finish, the tablet is coated with a high-viscosity sugar-containing paste and then dried, and further the viscosity is low. A multistage method of re-coating with a sugar-containing paste or a sugar-containing liquid is preferably employed.
糖衣材料の種類は特に制限されず、錠剤への糖衣処理に従来から用いられている糖衣材料などのいずれもが使用でき、例えば、グラニュー糖、アラビアガムやゼラチンなどの増粘剤、卵殻カルシウム、焼成牛骨粉などを含有する糖衣材料を用いることができる。 The type of sugar coating material is not particularly limited, and any sugar coating material conventionally used for sugar coating processing on tablets can be used, such as granulated sugar, thickeners such as gum arabic and gelatin, eggshell calcium, A sugar-coating material containing calcined beef bone meal can be used.
糖衣を施した錠剤は、そのまま流通、販売してもよいが、さらに着色を施すことにより、より綺麗で商品価値の高いものとすることができる。その際の着色方法は特に制限されず、錠剤の表面に着色を施す従来既知の方法と同様にして行うことができる。また、着色後に艶だし処理を行うことによって、錠剤の外観を一層良好なものにすることができる。艶だしは、例えばカルナウバロウなどのような艶だし剤を用いて行うことができる。これにより得られる本実施形態の錠剤は、選別、計量、包装などを行うことによって出荷される。 Sugar-coated tablets may be distributed and sold as they are, but can be made more beautiful and have higher commercial value by further coloring. The coloring method in that case is not particularly limited, and can be performed in the same manner as a conventionally known method of coloring the surface of the tablet. Further, the appearance of the tablet can be further improved by performing a glazing treatment after coloring. The glossing can be performed using a glossing agent such as carnauba wax. The tablet of this embodiment obtained by this is shipped by performing selection, measurement, packaging, and the like.
以下に、本発明を実施例を挙げて説明するが、本発明は以下の実施例にのみ限定されるものではない。 Hereinafter, the present invention will be described with reference to examples. However, the present invention is not limited to the following examples.
＜＜消化実験＞＞
（１）卵殻膜含有粉末サンプルＡの準備
卵殻膜含有粉末サンプルＡとして、キューピー株式会社のＥＭパウダー３００を用いた。このサンプルは、７０メッシュ（目開きで約２１３μｍ前後）で９０％以上通過した粒度を有するものである。なお、粒径を測定したところ体積最大粒子径は２１３μｍ、体積平均粒子径は３５μｍであった。
<< Digestion experiment >>
(1) Preparation of eggshell membrane-containing powder sample A As eggshell membrane-containing powder sample A, EM powder 300 manufactured by Kewpie Corporation was used. This sample has a particle size that passed 90% or more at 70 mesh (about 213 μm in mesh). When the particle diameter was measured, the maximum volume particle diameter was 213 μm, and the volume average particle diameter was 35 μm.
（２）卵殻膜含有粉末サンプルＢの準備
卵殻膜含有粉末サンプルＢとして、ＥＭパウダー３００をジェットミルで粉砕したものを用いた。なお、ジェットミルとしてはシングルトラックジェットミル（株式会社セイシン企業製、ＦＳ−４）を用いて、風量：１．２ｍ３／ｍｉｎ、動力：１１ｋｗにて、体積最大粒子径が３２５メッシュ（目開きで約４５μｍ）程度となるまで粉砕を実施した。
(2) Preparation of eggshell membrane-containing powder sample B As eggshell membrane-containing powder sample B, EM powder 300 crushed by a jet mill was used. As the jet mill Single Track Jet Mill (Seishin Enterprise Co., FS-4) with air volume: 1.2 m 3 / min, power: at 11kW, volume maximum particle diameter of 325 mesh (sieve opening The pulverization was carried out until about 45 μm).
（３）卵殻膜含有粉末サンプルＣの準備
卵殻膜含有粉末サンプルＣを以下として、ＥＭパウダー３００をジェットミルで粉砕したものを用いた。なお、ジェットミルとしてはシングルトラックジェットミル（株式会社セイシン企業製、ＦＳ−４）を用いて、風量：１．２ｍ３／ｍｉｎ、動力：１１ｋｗにて、体積最大粒子径が８００メッシュ（目開きで約２０μｍ）程度となるまで粉砕を実施した。なお、粉砕後の粒径を測定したところ体積最大粒子径は１９．６μｍ、体積平均粒子径は５．８μｍであった。
(3) Preparation of Eggshell Membrane-Containing Powder Sample C The eggshell membrane-containing powder sample C was as follows, and EM powder 300 pulverized with a jet mill was used. In addition, as a jet mill, a single track jet mill (manufactured by Seishin Enterprise Co., Ltd., FS-4) was used, and the maximum volume particle diameter was 800 mesh (opening) at an air volume of 1.2 m 3 / min and a power of 11 kW. The pulverization was carried out until it became about 20 μm). When the particle diameter after pulverization was measured, the volume maximum particle diameter was 19.6 μm, and the volume average particle diameter was 5.8 μm.
（４）消化テスト
２００倍に希釈した卵殻膜含有粉末サンプルＡの懸濁液０．８ｍｌを入れた試験管４本を準備した。次に、各々の試験管に消化酵素（豚膵臓由来のパクレアチン）を加えて３７℃でそれぞれ０分、３０分、６０分および１８０分加温した。その後、１００℃で５分間加熱し、反応停止後、１５００ｒｐｍで１０分間遠心分離処理を行った後、上澄の可溶性タンパク質をＢｒａｄｆｏｒｄ法により測定した。測定結果は、牛血清アルブミンを標準にして換算した。なお、ブランクとして、懸濁液の代わりに０．１Ｍのリン酸緩衝液を用いた。また、同様のテストを、卵殻膜含有粉末サンプルＢ、Ｃについても実施した。
(4) Digestion Test Four test tubes containing 0.8 ml of suspension of eggshell membrane-containing powder sample A diluted 200 times were prepared. Next, a digestive enzyme (pacreatin derived from porcine pancreas) was added to each test tube and heated at 37 ° C. for 0 minutes, 30 minutes, 60 minutes and 180 minutes, respectively. Thereafter, the mixture was heated at 100 ° C. for 5 minutes. After the reaction was stopped, centrifugation was performed at 1500 rpm for 10 minutes, and then the soluble protein in the supernatant was measured by the Bradford method. The measurement results were converted using bovine serum albumin as a standard. As a blank, a 0.1 M phosphate buffer was used instead of the suspension. A similar test was also performed on eggshell membrane-containing powder samples B and C.
（５）評価結果
各卵殻膜含有粉末サンプルの懸濁液に消化酵素を加えて３７℃で加温した際に、検出された可溶性タンパク質を加温時間に対して整理した結果を表１に示す。表１から明らかなように卵殻膜含有粉末サンプルＣを分散させた懸濁液に消化酵素を加えた場合、卵殻膜含有粉末サンプルＡ，Ｂを分散させた懸濁液に消化酵素を加えた場合と比べて、約２０％前後も可溶性タンパク質の検出量が大きいことが分かった。これに対して、卵殻膜含有粉末サンプルＡを分散させた懸濁液に消化酵素を加えた場合と、卵殻膜含有粉末サンプルＢを分散させた懸濁液に消化酵素を加えた場合とでは、可溶性タンパク質の検出量に差異は見られなかった。
(5) Evaluation results Table 1 shows the results of arranging the soluble proteins detected with respect to the heating time when digestive enzymes were added to the suspension of each eggshell membrane-containing powder sample and heated at 37 ° C. . As is apparent from Table 1, when digestive enzyme is added to the suspension in which eggshell membrane-containing powder sample C is dispersed, digestive enzyme is added to the suspension in which eggshell membrane-containing powder samples A and B are dispersed It was found that the amount of soluble protein detected was about 20% greater than that of. On the other hand, when the digestive enzyme is added to the suspension in which the eggshell membrane-containing powder sample A is dispersed and when the digestive enzyme is added to the suspension in which the eggshell membrane-containing powder sample B is dispersed, There was no difference in the amount of soluble protein detected.
＜＜錠剤の作製＞＞
（１）打錠用の顆粒の製造：
卵殻膜含有粉末サンプルＣ：２０．０
質量部、日食株式会社製「ワキシａ 」：１０．０質量部、松谷化学株式会社製「パインファイバー」：２０．０質量部、乳糖（メグレ社製）：２５．９質量部、卵殻カルシウム（キューピー株式会社製「カルホープ」）：１０質量部、β
− カロチン：５．０質量部、ビタミンＢ：２０．０５質量部、ビタミンＥ：０．０５質量部およびナイアシン：２．０質量部をＶ型混合機を用いて混合して原料混合物を調製した。次いで、その原料混合物９３．０質量部に対して、エチルアルコール１５質量部を混合し、これにより得られた混合物を、湿式造粒装置を用いて造粒し、次いで温度５０℃
で約１６時間乾燥して、打錠用の顆粒を製造した。
<< Preparation of tablets >>
(1) Manufacture of granules for tableting:
Eggshell membrane-containing powder sample C: 20.0
Mass parts, “Waxa” manufactured by Solar Eclipse Co., Ltd .: 10.0 parts by mass, “Pine Fiber” manufactured by Matsutani Chemical Co., Ltd .: 20.0 parts by mass, lactose (manufactured by Megre): 25.9 parts by mass, eggshell calcium ("Cal Hope" manufactured by Kewpie Corporation): 10 parts by mass, β
-Carotene: 5.0 parts by mass, vitamin B: 20.05 parts by mass, vitamin E: 0.05 parts by mass and niacin: 2.0 parts by mass were mixed using a V-type mixer to prepare a raw material mixture. . Next, 15 parts by mass of ethyl alcohol is mixed with 93.0 parts by mass of the raw material mixture, and the resulting mixture is granulated using a wet granulator, and then the temperature is 50 ° C.
And dried for about 16 hours to produce granules for tableting.
（２）打錠：
次に、打錠用の顆粒１００質量部に対して、ビタミンＣを９質量部およびショ糖脂肪酸エステルを１質量部の割合で混合し、それにより得られた混合物を、打錠装置を使用して、１粒が２００ｍｇの裸錠を製造した。
(2) Tableting:
Next, 9 parts by mass of vitamin C and 1 part by mass of sucrose fatty acid ester are mixed with 100 parts by mass of granules for tableting, and the resulting mixture is mixed using a tableting device. 1 tablet of 200 mg was produced.
（３）保護コーティング：
次に、裸錠の表面に、コーティング装置を使用して、岐阜セラック株式会社製「セラック」の水溶液を塗布し、温度４０℃
で２時間乾燥して、保護コーティングされた錠剤（保護コーティング錠）を得た。
(3) Protective coating:
Next, an aqueous solution of “shellac” manufactured by Gifu Shellac Co., Ltd. was applied to the surface of the bare tablet using a coating apparatus, and the temperature was 40 ° C.
And dried for 2 hours to obtain a protective-coated tablet (protective-coated tablet).
（４）糖衣被覆：
十分に乾燥させた保護コーティング錠の表面に、糖衣被覆装置を使用して、糖衣用ペーストＡ（グラニュー糖７０質量部、アラビアガム３質量部、ゼラチン４質量部、卵殻カルシウム３質量部および水６５質量部を混合したペースト）を被覆した後、温度約４０℃で約４
時間乾燥した。その後、糖衣用ペーストＡに水を加えて希釈した糖衣用ペーストＢを調製した。さらに、糖衣用ペーストＡでコーティング処理および乾燥処理された錠剤の表面に、糖衣被覆装置を使用して、糖衣用ペーストＢを、被覆した後、温度約４０℃で約４
時間乾燥した。これにより糖衣用ペーストでコーティングされた錠剤（糖衣コーティング錠）を得た。
(4) Sugar coating:
On the surface of the sufficiently dried protective coating tablet, a sugar coating apparatus is used to prepare a sugar coating paste A (70 parts by weight of granulated sugar, 3 parts by weight of gum arabic, 4 parts by weight of gelatin, 3 parts by weight of eggshell calcium and 65% of water). 4 parts at a temperature of about 40 ° C.
Dry for hours. Then, the sugar-coating paste B which diluted the sugar-coating paste A by adding water was prepared. Further, after the sugar-coated paste B is coated on the surface of the tablet coated and dried with the sugar-coated paste A using a sugar coating apparatus, the temperature is about 4 ° C.
Dry for hours. As a result, a tablet coated with a sugar coating paste (sugar coated tablet) was obtained.
（５）色付け：
糖衣コーティング錠の表面に、三栄源社製「ＳＲレッドＫ３」を含む着色液を塗布した後、４０〜５０℃で４時間乾燥して、赤色に着色した錠剤（着色錠）を製造した。
(5) Coloring:
A colored liquid containing “SR Red K3” manufactured by San-Ei Gen Co., Ltd. was applied to the surface of the sugar-coated tablet, and then dried at 40 to 50 ° C. for 4 hours to produce a tablet colored in red (colored tablet).
（６）艶だし：
着色錠の表面に、カルナウバロウを用いて、艶だしを行った。これにより得られた錠剤１個の質量は４００ｍｇであり、錠剤１個当たり卵殻膜成分を約４０ｍｇの割合で含有していた。
(6) Glossy:
The surface of the colored tablet was glazed using Carnauba wax. The mass of one tablet obtained in this manner was 400 mg, and the eggshell membrane component was contained at a ratio of about 40 mg per tablet.
（７）選別−計量−包装：
艶出し処理を行った錠剤を選別して不良品を除き、製品検査後に計量し、乾燥剤を同封
した二重袋で包装した。なお、錠剤は、十分な硬度および形状保持性を有しており、選別
、検査、包装時に変形したり、崩壊したりすることがなく、取り扱い性に優れていた。
(7) Sorting-Weighing-Packaging:
The polished tablets were selected to remove defective products, weighed after product inspection, and packaged in a double bag containing a desiccant. The tablet had sufficient hardness and shape retention, and was excellent in handleability without being deformed or disintegrated during sorting, inspection, and packaging.
＜＜卵殻膜粉末の摂取による肝障害に対する効果＞＞
（１）実験目的
鶏卵卵殻膜は、食品産業における副産物としてほとんどが廃棄されており、その有効利用が望まれている。この実験以前に、正常ラット肝臓におけるトランスクリプトーム（transcriptome）解析において、卵殻膜摂取が肝線維化に関わる遺伝子の発現に影響を与えることを見いだした。そこで、今回は、四塩化炭素誘発性肝障害ラットを用い、卵殻膜成分の長期摂取が肝障害の進行に対して効果があるかどうかを、他の研究者と共に検討した。
<< Effects of ingestion of eggshell membrane powder on liver damage >>
(1) Experimental purpose Most of the eggshell membrane is discarded as a by-product in the food industry, and its effective use is desired. Prior to this experiment, we found that ingestion of eggshell membranes affects the expression of genes involved in liver fibrosis in transcriptome analysis in normal rat liver. Therefore, in this study, we investigated whether long-term intake of eggshell membrane components has an effect on the progression of liver injury using rats with carbon tetrachloride-induced liver injury.
（２）実験方法
３週齢Ｗｉｓｔａｒ系雄性ラットを1週間予備飼育後、無作為に３群（Ｎ＝６）に分け、標準食（Ａ、Ｂ群）および卵殻膜粉末１％添加食（Ｃ群）で１３週間飼育した。Ｂ、Ｃ群には５０％四塩化炭素を１ｋｇにつき１ミリリットル（＝１ｍｌ／ｋｇ）の割合で、その体重に合わせ、週２回連続皮下投与し、肝障害を誘導した。Ａ群にはオリーブ油（１ｍｌ／ｋｇ）
をその体重に合わせ、同様に投与した。実験終了時に１２時間絶食後、頸動脈から採血し、肝臓等を摘出した。肝機能や脂質代謝に関わる血漿指標を測定した。肝臓から抽出したＲＮＡを実験群毎にプールした後、ＤＮＡマイクロアレイ解析（Rat Genome 230 v2.0, Affymetrix）に供し、炎症、線維化、酸化ストレス、脂質代謝関連の遺伝子の発現に注目して解析を行った。
(2) Experimental method Three weeks old Wistar male rats were preliminarily raised for one week, then randomly divided into 3 groups (N = 6), and the standard diet (groups A and B) and the diet supplemented with 1% eggshell membrane powder (C Group) for 13 weeks. In groups B and C, 50% carbon tetrachloride was administered subcutaneously twice a week according to the body weight at a rate of 1 milliliter per kilogram (= 1 ml / kg) to induce liver damage. Group A has olive oil (1 ml / kg)
Was administered in the same manner according to its body weight. After fasting for 12 hours at the end of the experiment, blood was collected from the carotid artery and the liver and the like were removed. Plasma indicators related to liver function and lipid metabolism were measured. RNA extracted from the liver is pooled for each experimental group and then subjected to DNA microarray analysis (Rat Genome 230 v2.0, Affymetrix), focusing on the expression of genes related to inflammation, fibrosis, oxidative stress, and lipid metabolism Went.
（３）結果
Ｃ群では、四塩化炭素投与により生じた、ａ．体重減少、ｂ．肝臓および腎臓の腫大、ｃ．上昇したアスパラギン酸アミノトランスファーゼ（aspartate aminotransferase（ＡＳＴ））や上昇したアラニンアミノトランスファーゼ（alanine aminotransferase（ＡＬＴ））の各活性、のそれぞれについて改善効果が認められた。同様に血漿中脂質、血漿Fischer ratioおよび肝臓中脂質のいずれも回復傾向を示した。一方、Ｂ群と比べ、Ｃ群に７９個の遺伝子が発現増加し、３３個の遺伝子が発現減少していた。これらの遺伝子に対してネットワーク解析を行った結果、卵殻膜摂取による肝臓への脂質蓄積抑制は、SREBP-1c調節シグナルの調節因子であるＳＨＰを介した経路等複数の経路が関わっていることが示唆された。さらに、Ｃ群では、抗炎症、抗酸化酵素のHeme Oxygenase- 1、その上流の調節遺伝子ＡＰ−１、ＪＵＮの発現が上昇している事が明らかとなった。これは四塩化炭素により誘発された酸化ストレスから生体を保護するための応答であることが推察された。
(3) Results In group C, a. Weight loss, b. Enlargement of the liver and kidney, c. An improvement effect was observed for each activity of elevated aspartate aminotransferase (AST) and elevated alanine aminotransferase (ALT). Similarly, all of lipids in plasma, plasma Fischer ratio and liver lipid showed a recovery tendency. On the other hand, 79 genes had increased expression and 33 genes had decreased expression in group C compared to group B. As a result of network analysis of these genes, suppression of lipid accumulation in the liver by ingestion of eggshell membranes may involve multiple pathways such as the pathway via SHP, a regulator of SREBP-1c regulatory signals. It was suggested. Furthermore, in group C, it was revealed that the expression of anti-inflammatory and antioxidant enzymes Heme Oxygenase-1 and its upstream regulatory genes AP-1 and JUN were increased. This was presumed to be a response to protect the living body from oxidative stress induced by carbon tetrachloride.
＜＜８００メッシュの卵殻膜微粉末の摂取効果＞＞
（１）実験目的
これまでに、ラットにおいて鶏卵卵殻膜成分の長期摂取が四塩化炭素誘発性肝障害を改善することが報告されている。また、トランスクリプトーム解析によりその作用には酸化ストレス低減が関与している可能性が示されている。そこで、今回は、そのメカニズムを更に明瞭にするため、長期および短期の卵殻膜の摂取が生体内過酸化脂質生成に影響を及ぼすかを、他の研究者と共に検討した。
<< Intake effect of 800 mesh eggshell membrane fine powder >>
(1) Experimental purpose So far, long-term intake of chicken egg shell membrane components has been reported to improve carbon tetrachloride-induced liver injury in rats. In addition, transcriptome analysis indicates that the action may involve reduction of oxidative stress. Therefore, this time, in order to clarify the mechanism, we examined with other researchers whether long-term and short-term intake of eggshell membranes affects in vivo lipid peroxide production.
（２）実験方法
３週齢Ｗｉｓｔａｒ系雄性ラットを1週間予備飼育後、無作為に３群（Ｎ＝６）に分け、標準食（Ａ、Ｂ群）および卵殻膜微粉末添加食（Ｃ群）を長期（１３週間）および短期（７週間）の間、給餌した。Ｂ、Ｃ群には、オリーブ油に溶解した５０％四塩化炭素（１ｍｌ／ｋｇ）をその体重に合わせ、週２回連続皮下投与し、酸化ストレスおよび肝障害を誘導した。Ａ群にはオリーブ油（１ｍｌ／ｋｇ）
をその体重に合わせ、同様に投与した。
(2) Experimental method Three weeks old Wistar male rats were preliminarily raised for 1 week, then randomly divided into 3 groups (N = 6), and the standard diet (Groups A and B) and the diet supplemented with eggshell membranes (Group C) ) Was fed for a long period (13 weeks) and a short period (7 weeks). In groups B and C, 50% carbon tetrachloride (1 ml / kg) dissolved in olive oil was adjusted to its body weight and administered subcutaneously twice a week to induce oxidative stress and liver damage. Group A has olive oil (1 ml / kg)
Was administered in the same manner according to its body weight.
なお、長期の摂取実験では、Ｃ群に、７０メッシュ卵殻膜微粉末１％を含む食餌で１３週間飼育した。７０メッシュ卵殻膜微粉末とは、ＥＭパウダー３００をジェットミルで粉砕し、７０メッシュ（目開きで約２１３μｍ前後）で９０％以上通過した粒度を有するものであり、体積最大粒子径は２１３μｍ（ミクロン）、体積平均粒子径は３５μｍのものである。短期の摂取実験では、Ｃ群に、より微少な８００メッシュの卵殻膜微粉末２％を含む食餌で７週間飼育した。８００メッシュの卵殻膜微粉末とは、ＥＭパウダー３００をジェットミルで粉砕し、体積最大粒子径が８００メッシュ（目開きで約２０μｍ）程度となるまで粉砕を実施したもので、粉砕後の体積最大粒子径は１９．６μｍ、体積平均粒子径は５．８μｍのものである。そして、実験終了時に１２時間絶食後、頸動脈から採血し、肝臓等を摘出した。肝機能指標や体内抗酸化酵素、およびチオバルビツール酸反応性物質（ＴＢＡＲＳ）値をそれぞれ測定した。 In a long-term ingestion experiment, group C was reared for 13 weeks on a diet containing 1% of 70 mesh eggshell membrane fine powder. The 70-mesh eggshell membrane fine powder is obtained by pulverizing EM powder 300 with a jet mill and having a particle size of 90% or more passing through a 70 mesh (approximately 213 μm opening), and the maximum volume particle size is 213 μm (micron) ), And the volume average particle diameter is 35 μm. In a short-term ingestion experiment, group C was reared for 7 weeks on a diet containing 2% of a finer 800 mesh eggshell membrane powder. The 800 mesh eggshell membrane fine powder is obtained by crushing EM powder 300 with a jet mill and crushing until the maximum volume particle diameter reaches about 800 mesh (about 20 μm with openings). The particle diameter is 19.6 μm, and the volume average particle diameter is 5.8 μm. Then, after fasting for 12 hours at the end of the experiment, blood was collected from the carotid artery and the liver and the like were removed. Liver function index, in-vivo antioxidant enzyme, and thiobarbituric acid reactive substance (TBARS) values were measured.
（３）結果
いずれの飼育期間においても、Ｃ群では、四塩化炭素投与により生じた、ａ．体重減少、ｂ．肝臓および腎臓の腫大、ｃ．上昇したアスパラギン酸アミノトランスファーゼ（aspartate aminotransferase（ＡＳＴ））や上昇したアラニンアミノトランスファーゼ（alanine aminotransferase（ＡＬＴ））の各活性、のそれぞれについて改善効果が認められた。一方、血漿中のスーパーオキサイドジスムターゼ（superoxide dismutase）やカタラーゼ（catalase）など抗酸化酵素の濃度は変化しなかったが、血漿および肝臓中のチオバルビツール酸反応性物質（ＴＢＡＲＳ（Thiobarbituric acid reactive substances））の濃度が、卵殻膜長期摂取と卵殻膜短期摂取の各実験では、それぞれ約１５から２５％低下した。以上の結果から、卵殻膜は、四塩化炭素により誘発した過酸化脂質の生成を抑えることで、結果的に肝臓の炎症拡大、さらには、進行する肝障害を抑制している可能性が推察された。また、粒子径は小さい方、特に上述の８００メッシュの卵殻膜微粉末、が効果的であることが明らかになった。すなわち、体積平均粒子径が６μｍ以下または／および体積最大粒子径が２０μｍ以下の卵殻膜含有微粉末は、酸化ストレス抑制作用が大きく、肝臓の炎症、障害を大きく抑制する。
(3) Results In any breeding period, in group C, a. Weight loss, b. Enlargement of the liver and kidney, c. An improvement effect was observed for each activity of elevated aspartate aminotransferase (AST) and elevated alanine aminotransferase (ALT). On the other hand, the concentration of antioxidant enzymes such as superoxide dismutase and catalase in plasma did not change, but thiobarbituric acid reactive substances (TBARS) in plasma and liver ) Decreased by about 15 to 25% in each experiment of long-term intake of eggshell membranes and short-term intake of eggshell membranes. From the above results, it is inferred that the eggshell membrane may suppress the increase of liver inflammation and further the progressive liver damage by suppressing the formation of lipid peroxide induced by carbon tetrachloride. It was. Further, it has been found that the smaller particle diameter, particularly the above-mentioned 800 mesh eggshell membrane fine powder, is effective. That is, eggshell membrane-containing fine powder having a volume average particle size of 6 μm or less and / or a volume maximum particle size of 20 μm or less has a large oxidative stress-inhibiting effect and greatly suppresses inflammation and damage of the liver.
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