TWI528904B - Prenatal milk-derived composition for preventing the risk of low birthweight of newborns - Google Patents
Prenatal milk-derived composition for preventing the risk of low birthweight of newborns Download PDFInfo
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Description
本發明係關於健康食物之技術領域及更特定言之係關於用於預防新生兒出生體重低之風險的食物組合物之技術領域。The present invention relates to the technical field of healthy foods and more particularly to the technical field of food compositions for preventing the risk of low birth weight in newborns.
到1975為止,新生兒在出生時具有2500 g或更輕之低出生體重(亦即出生體重低嬰兒)之問題在日本已得到改善。然而,自1980以來,在所有新生兒中出生體重低嬰兒之比例卻在日本增加。出現此現象之原因如下。直到當時為止,仍然建議在妊娠期間充分攝取足夠的營養物,但自1975-1980,即使在日本的一般公眾中亦已開始指出能量攝入過多會引起肥胖或不同的新陳代謝問題。妊娠婦女被警告在妊娠期間過度攝取營養物會引起異常的分娩或妊娠併發症。此外,亦包括妊娠婦女對美容之要求。同樣,建議的其他理由為產科藥劑的哲理變化、在妊娠期間提早出生之新生兒數量增加、婦女在20歲或更年輕的時候吸煙的發生率增加、多胎妊娠增加的影響、及類似理由(非專利文獻1)。By 1975, the problem of newborns having a low birth weight of 2,500 g or less (ie, low birth weight infants) at birth has improved in Japan. However, since 1980, the proportion of low birth weight infants in all newborns has increased in Japan. The reason for this phenomenon is as follows. Until then, it was still recommended to get enough nutrients during pregnancy, but since 1975-1980, even in the general public in Japan, it has been pointed out that excessive energy intake can cause obesity or different metabolic problems. Pregnant women are warned that excessive intake of nutrients during pregnancy can cause abnormal childbirth or pregnancy complications. In addition, it also includes the beauty requirements of pregnant women. Similarly, other suggested reasons are philosophical changes in obstetric agents, increased number of newborns born early during pregnancy, increased incidence of smoking in women at 20 years of age or younger, increased effects of multiple pregnancies, and similar reasons (non- Patent Document 1).
據稱新生兒在出生時出生體重低係與諸如糖尿病、高血壓、及冠狀動脈疾病之疾病相關(非專利文獻2)及亦據稱與代謝綜合症相關。同樣,出生體重低嬰兒之呼吸功能通常不成熟,諸如約25%的該等嬰兒發展成早產兒原發性呼吸暫停。其已提出腦中或其他器官中發生疾病之風險。It is said that a newborn born with a low birth weight is associated with diseases such as diabetes, hypertension, and coronary artery disease (Non-Patent Document 2) and is also said to be associated with metabolic syndrome. Similarly, the respiratory function of a low birth weight infant is usually immature, such as about 25% of these infants develop into a primary apnea in preterm infants. It has raised the risk of developing disease in the brain or other organs.
如上所述,在出生時出生體重低會對新生兒造成不同的負擔、疾病或風險,因此預防出生時的出生體重低相當重要。為了努力避免該等問題,認為具有良好的飲食習慣(依規律時間表吃早飯及類似習慣)比較重要(非專利文獻3)。同樣,例如一種預測及診斷在出生時出生體重低新生兒之方法係報告於專利文獻1中。As mentioned above, low birth weight at birth can cause different burdens, diseases or risks to newborns, so it is important to prevent low birth weight at birth. In order to avoid such problems, it is considered to be important to have good eating habits (to eat breakfast and similar habits according to a regular schedule) (Non-Patent Document 3). Also, for example, a method for predicting and diagnosing a newborn born at a low birth rate is reported in Patent Document 1.
此外,40多年來,在營養必需品中,諸如妊娠期對維生素的需求,已特別建議在妊娠期需要攝取葉酸。已經建議葉酸不足與抑制中樞神經系統形成之間的關係。建議在懷孕之前開始服用葉酸,因為此可降低神經管缺陷(NTD)之風險(非專利文獻4)。此外,亦已建議妊娠婦女中維生素B12或葉酸不足與新生兒出生時出生體重低之間的關係(非專利文獻5)。In addition, for more than 40 years, in the nutritional necessities, such as the demand for vitamins during pregnancy, it has been specifically recommended to take folic acid during pregnancy. The relationship between folate deficiency and inhibition of central nervous system formation has been suggested. It is recommended to start taking folic acid before pregnancy because it reduces the risk of neural tube defects (NTD) (Non-Patent Document 4). In addition, the relationship between vitamin B12 or folic acid deficiency in pregnant women and low birth weight at birth is also suggested (Non-Patent Document 5).
PTL 1:JP Patent Publication(Kohyo) No. 2002-512047 APTL 1: JP Patent Publication (Kohyo) No. 2002-512047 A
NPL 1:http://www.aiiku.or.jp/aiiku/jigyo/contents/kaisetsu/ks0207/ks0207.htmNPL 1:http://www.aiiku.or.jp/aiiku/jigyo/contents/kaisetsu/ks0207/ks0207.htm
NPL 2:Lancet 1999,Vol.353,No.9166,p.1789-1792NPL 2: Lancet 1999, Vol. 353, No. 9166, p. 1789-1792
NPL 3:http://www.asagumi.jp/asagohan/txt/1-6NPL 3: http://www.asagumi.jp/asagohan/txt/1-6
NPL 4:Report Concerning Reduction in the Risk of the Onset of Neural Tube Defects(December 2000) Conference concerning Risk of the Onset of Inborn Error NPL 4: Report Concerning Reduction in the Risk of the Onset of Neural Tube Defects (December 2000) Conference concerning Risk of the Onset of Inborn Error
NPL 5:Asia Pac Journal of Clinical Nutrition 2006,Vol. 15,p. 538-543NPL 5: Asia Pac Journal of Clinical Nutrition 2006, Vol. 15, p. 538-543
本發明之第一目標係發展一種用於改善新生兒出生體重低之醫藥組合物或食物組合物,以藉由改善妊娠期間營養來預防出生體重降低至新生兒之平均出生體重以下的水準(後文中亦稱為新生兒出生體重低)。A first object of the present invention is to develop a pharmaceutical composition or food composition for improving neonatal birth weight to prevent birth weight loss to below the average birth weight of a newborn by improving nutrition during pregnancy (post Also known as neonatal birth weight is low.
同樣,本發明之第二目標係發展一種用於預防新生兒出生體重低之醫藥或食物組合物,其係意欲用於因攝取零食作為主食及維生素缺乏引起的缺乏營養平衡(認為係最近出生體重低嬰兒之數量增加的背景條件)而增加出現出生體重低新生兒之風險的妊娠婦女。Similarly, a second object of the present invention is to develop a pharmaceutical or food composition for preventing neonatal birth weight, which is intended to be used for lack of nutritional balance due to snack intake as a staple food and vitamin deficiency (considered to be the recent birth weight) Pregnant women who are at increased risk of birth weight and low birth weight increase the background condition of the increase in the number of low infants.
葉酸,其已規定為妊娠婦女妊娠期間之營養素,係一種水溶性維生素,且已知為弱抗光、酸、鹼、熱及類似物。已知包含葉酸及類似物之飲料(諸如牛奶)之問題在於其在長期儲存下會觀察到葉酸濃度減少,例如(Nihon Chikusan Gakkaiho 2009,第80卷,第41-45頁)。因此,希望提供一種醫藥產物,一種用於特殊飲食用途之產前食物,或一種對妊娠提供安全及確保營養及易於保存之除葉酸外之產前營養補充食物。Folic acid, which has been defined as a nutrient for pregnant women during pregnancy, is a water-soluble vitamin and is known to be weakly resistant to light, acids, bases, heat and the like. A problem with beverages such as milk containing folic acid and the like is known to be that a decrease in folic acid concentration is observed under long-term storage, for example (Nihon Chikusan Gakkaiho 2009, Vol. 80, pp. 41-45). Therefore, it is desirable to provide a pharmaceutical product, a prenatal food for a particular dietary use, or a prenatal nutritional supplement other than folic acid that provides safety and ensures nutrition and is easy to preserve.
乳磷脂(乳磷脂或自乳汁衍生之磷脂)係安全食物成份,其具有優異的熱穩定性及保存品質。藉由攝入乳磷脂而成功地預防新生兒出生體重低,非常有助於妊娠婦女及新生兒之健康。Milk phospholipids (yeast phospholipids or phospholipids derived from milk) are safe food ingredients with excellent thermal stability and preservation qualities. Successful prevention of neonatal birth weight by ingesting lactophospholipids is very helpful for the health of pregnant women and newborns.
本發明者已經投與乳磷脂至維生素B-不足的妊娠期大鼠中,及隨後基於在出生之後立即測量之大鼠(嬰兒)體重、身長、及器官重量來評估維生素B群對妊娠大鼠之影響及維生素B群對胎兒期大鼠之影響。因此,本發明者已經發現,在妊娠大鼠缺乏維生素B的情況下會生出出生體重低大鼠嬰兒,然而可經由投與乳磷脂至維生素B不足之妊娠鼠(懷孕母畜)中,來預防出生體重較低的大鼠嬰兒。因此,本發明者已完成本發明。The present inventors have administered lecithin to vitamin B-deficient gestational rats, and subsequently evaluated the vitamin B group against pregnant rats based on the weight (length), body length, and organ weight of the rat (infant) measured immediately after birth. The effect and effects of vitamin B group on fetal rats. Therefore, the present inventors have found that a pregnant rat having a low birth weight can be born in the absence of vitamin B in a pregnant rat, but can be prevented from being born in a pregnant rat (pregnant female) which is administered with a lecithin to a vitamin B deficiency. Lower weight rat babies. Accordingly, the inventors have completed the present invention.
本說明書包括說明書中所揭示之部份或所有內容及/或日本專利申請案第2009-143615號之圖式,其係本申請案之優先權文件。The present specification includes some or all of the contents disclosed in the specification and/or the drawings of Japanese Patent Application No. 2009-143615, which is a priority file of the present application.
本發明具有極佳效果,因此可藉由使用一種作為食物而攝取的安全成份(乳磷脂)來預防新生兒出生體重低。此外,一般而言,脂溶性維生素比水溶性維生素更難分解。因此,應瞭解脂溶性乳磷脂具有相當優異之長期儲存品質(不會分解)。The present invention has an excellent effect, and thus it is possible to prevent a low birth weight of a newborn by using a safe ingredient (yeast phospholipid) which is ingested as a food. In addition, in general, fat-soluble vitamins are more difficult to decompose than water-soluble vitamins. Therefore, it should be understood that the fat-soluble milk phospholipid has a rather excellent long-term storage quality (will not decompose).
本發明包括一種用於預防出生體重低之製劑,其包含作為活性成份之乳磷脂,藉以預防新生兒出生體重低。本發明進一步包括一種用於減少新生兒出生體重低之風險之製劑,其包含作為活性成份之乳磷脂,藉以減少新生兒出生體重低之風險。本發明進一步包含一種用於預防出生體重低之製劑,其包含作為活性成份之乳磷脂,藉以預防歸因於妊娠婦女維生素B不足之新生兒出生體重低。同樣,本發明包括一種用於減少出生體重低的風險之製劑,其包含作為活性成份之乳磷脂,藉以減少歸因於妊娠婦女維生素B不足之新生兒出生體重低之風險。The present invention includes a preparation for preventing low birth weight, which comprises as an active ingredient a milk phospholipid, thereby preventing a low birth weight of a newborn. The present invention further includes a preparation for reducing the risk of low birth weight of a newborn comprising as an active ingredient a milk phospholipid to reduce the risk of low birth weight of the newborn. The present invention further comprises a preparation for preventing low birth weight, which comprises as an active ingredient a milk phospholipid, thereby preventing birth weight loss of a newborn due to vitamin B deficiency in a pregnant woman. Also, the present invention includes a preparation for reducing the risk of low birth weight, which comprises as an active ingredient a milk phospholipid, thereby reducing the risk of low birth weight due to a vitamin B deficiency in a pregnant woman.
同樣,本發明包括一種產前藥劑,其係藉由投與該藥劑給新生兒之母親,用於減少新生兒在成長之後罹患與新生兒出生體重低相關的糖尿病、高血壓、或冠狀動脈疾病之風險。Similarly, the present invention encompasses a prenatal agent which is administered to a mother of a newborn by administering the agent to reduce diabetes, hypertension, or coronary artery disease associated with a low birth weight of the newborn after growth. Risk.
1. 新生兒出生體重低之預防1. Prevention of low birth weight in newborns
在妊娠期間維生素B攝取不足(維生素B缺乏)很可能會造成相關妊娠婦女之新生兒出生體重低。令人驚訝的是,本發明者已發現經由投與乳磷脂至飲食攝取維生素B不足之該妊娠婦女,可明顯抑制或預防新生兒出生體重低。Insufficient intake of vitamin B during pregnancy (vitamin B deficiency) is likely to result in low birth weight in newborns of pregnant women. Surprisingly, the inventors have found that a pregnant woman who has been administered with milk phospholipids to a dietary intake of vitamin B is significantly inhibited or prevented from having a low birth weight.
本發明用於預防新生兒出生體重低之組合物包含作為活性成份之乳磷脂及包括:The composition for preventing neonatal birth weight of the present invention comprises as an active ingredient a milk phospholipid and comprises:
(1) 一種用於預防出生體重低之製劑,藉以預防新生兒出生體重低;(1) A preparation for preventing birth weight and low birth weight to prevent neonatal birth weight;
(2) 一種用於減少出生體重低之風險之製劑,藉以減少新生兒出生體重低之風險;(2) A preparation for reducing the risk of low birth weight to reduce the risk of low birth weight in newborns;
(3) 一種用於預防出生體重低之製劑,藉以預防歸因於維生素B不足之新生兒出生體重低;及(3) A preparation for preventing birth weight in order to prevent low birth weight of a newborn due to vitamin B deficiency;
(4) 一種用於減少出生體重低之風險之製劑,藉以減少歸因於維生素B不足之新生兒出生體重低之風險。(4) A preparation for reducing the risk of low birth weight to reduce the risk of low birth weight due to vitamin B deficiency.
1-1. 用於預防新生兒出生體重低之組合物1-1. Composition for preventing neonatal birth weight
在本發明中,用於預防新生兒出生體重低之組合物的活性成份實例為乳磷脂。乳磷脂之實例係藉由使用乙醇或類似物自乳汁提取脂質成份,繼而使用丙酮提取乳磷脂而獲得。In the present invention, an example of an active ingredient for use in a composition for preventing neonatal birth weight is milk phospholipid. An example of a milk phospholipid is obtained by extracting a lipid component from milk using ethanol or the like, followed by extraction of milk phospholipid with acetone.
舉例而言,自乳汁衍生之磷脂可藉由日本專利公開案(Kokai)第2002-226394 A號中所揭示之已知方法來製備。特定言之,該自乳汁衍生之磷脂可根據已知方法{「Lipid Chemistry(Shishitsu no Kagaku)(Seikagaku Jikken Koza(Biochemical Experimental Lecture Series) 3)」,Ed.,The Japanese Biochemical Society,第23頁,TOKYO KAGAKU DOZIN CO.,LTD,1974;「lipid II phospholipid(New Seikagaku Jikken Koza(New Biochemical Experimental Lecture Series) 4)」,Ed.,The Japanese Biochemical Society,第7頁,TOKYO KAGAKU DOZIN CO.,LTD,1991},使用溶劑提取奶油乳(奶油製造之副產物);乳清(乳酪製造之副產物);或脫脂乳來製備。或者自乳衍生之磷脂可使用不同類型的層析法,分離提取物(藉由前述溶劑提取而獲得)而製備。例如,自乳衍生之磷脂亦可自乳脂或奶油,或奶油乳清(其係奶油製造之副產物)作為丙酮(溶劑)之不可溶部分獲得。奶油乳清亦可用於市售乳品之領域,因此可自其中獲得(例如新西蘭,Tatua)。奶油乳清具有高含量的MFGM,其中含有磷脂,因此適用作提取磷脂之原料。For example, a milk-derived phospholipid can be prepared by a known method disclosed in Japanese Patent Publication (Kokai) No. 2002-226394 A. Specifically, the milk-derived phospholipid can be obtained according to a known method {"Lipid Chemistry (Shishitsu no Kagaku) (Seikagaku Jikken Koza (Biochemical Experimental Lecture Series) 3)", Ed., The Japanese Biochemical Society, page 23, TOKYO KAGAKU DOZIN CO., LTD, 1974; "lipid II phospholipid (New Seikagaku Jikken Koza (New Biochemical Experimental Lecture Series) 4)", Ed., The Japanese Biochemical Society, p. 7, TOKYO KAGAKU DOZIN CO., LTD, 1991}, using solvent extraction cream (by-product of butter making); whey (by-product of cheese making); or skim milk to prepare. Alternatively, the phospholipid derived from milk can be prepared by using different types of chromatography, separating the extract (obtained by solvent extraction as described above). For example, phospholipids derived from milk may also be obtained from milk fat or cream, or butter whey, which is a by-product of the manufacture of butter, as an insoluble portion of acetone (solvent). Butter whey can also be used in the field of commercially available dairy products and is therefore available from (eg New Zealand, Tatua). Cream whey has a high content of MFGM, which contains phospholipids, and is therefore suitable as a raw material for extracting phospholipids.
自奶油乳清中分離磷脂時,應利用磷脂不溶於丙酮之特性。經由多次丙酮提取,移除包含中性脂質之可溶於丙酮之部分及隨後獲得包含濃縮磷脂之不溶於丙酮的部分。不溶於丙酮部分經過真空濃縮移除丙酮,及隨後將該濃縮物在滅菌之後進行冷凍乾燥。將乾燥產物磨粉,獲得自乳衍生之磷脂部分。舉例而言,藉此所獲得之磷脂部分之組成中包含85%(重量%)磷脂。在磷脂部分中,存在包含膽鹼(諸如磷脂醯膽鹼)之成份及鞘磷脂。When separating phospholipids from butter whey, the phospholipids should be utilized insoluble in acetone. The acetone-soluble fraction containing the neutral lipid is removed via multiple acetone extractions and the acetone-insoluble fraction containing the concentrated phospholipid is subsequently obtained. The acetone-insoluble portion was subjected to vacuum concentration to remove acetone, and then the concentrate was freeze-dried after sterilization. The dried product is milled to obtain a phospholipid fraction derived from milk. For example, the composition of the phospholipid fraction thus obtained contains 85% by weight of phospholipids. In the phospholipid fraction, a component comprising choline (such as phospholipid choline) and sphingomyelin are present.
此外,對於乳磷脂,亦可使用包含乳磷脂之乳製品:「乳磷脂濃縮物」(包含約5重量%膽鹼;85重量%脂質,10重量%灰分含量,4重量%碳水化合物,及1重量%水分)。In addition, for milk phospholipids, a dairy product containing lactophospholipid may also be used: "milk phospholipid concentrate" (containing about 5% by weight choline; 85% by weight lipid, 10% by weight ash content, 4% by weight carbohydrate, and 1 Weight % moisture).
2. 產前藥劑Prenatal medication
本發明之藥劑為:The agent of the present invention is:
(1) 一種用於預防新生兒出生體重低之產前藥劑(用於預防出生體重低之製劑)或(2)一種用於減少新生兒出生體重低之風險之產前藥劑(用於減少出生體重低之風險之製劑);或(1) A prenatal agent for preventing birth weight in newborns (for the prevention of low birth weight) or (2) a prenatal agent for reducing the risk of low birth weight in newborns (for reducing birth) a preparation for the risk of low weight); or
(3) 一種用於減少新生兒在成長之後罹患與新生兒出生體重低相關疾病之風險之產前藥劑,其係經由投與該產前藥劑至新生兒母親的妊娠婦女。(3) A prenatal agent for reducing the risk of a newborn suffering from a disease associated with a low birth weight of a newborn, which is a pregnant woman who is administered the prenatal agent to a newborn mother.
本發明之包含乳磷脂作為活性成份之藥劑實例包括(1)一種用於預防新生兒出生體重低之產前藥劑(用於預防出生體重低之製劑),(2)一種用於減少新生兒出生體重低之風險之產前藥劑(用於減少出生體重低之風險之製劑),及(3)一種用於減少新生兒在成長之後患有與新生兒出生體重低相關疾病之風險之產前藥劑,其係經由投與該產前藥劑至新生兒母親的妊娠婦女。Examples of the agent of the present invention comprising a milk phospholipid as an active ingredient include (1) a prenatal agent for preventing birth weight of a newborn (a preparation for preventing birth weight), and (2) a method for reducing birth of a newborn a prenatal agent at a low risk of weight (a preparation for reducing the risk of low birth weight), and (3) a prenatal agent for reducing the risk of a newborn having a low birth weight-related disease after growth It is a pregnant woman who is administered the prenatal medication to the newborn mother.
本發明之藥劑可經調配成適宜的劑型,諸如粉末、顆粒、錠劑、膠囊及溶液。一旦調配好,則添加一般用於調配物之佐劑,諸如賦形劑、黏著劑、崩解劑及潤滑劑。賦形劑之實例包括澱粉、乳糖、蔗糖、甲基纖維素、羧甲基纖維素、藻酸鈉、磷酸氫鈣、合成矽酸鋁、微晶纖維素、聚乙烯吡咯啶酮(PVP)及羥基丙基澱粉(HPS)。同樣,黏著劑之實例包括澱粉、微晶纖維素、羧基甲基纖維素鈉、聚乙烯吡咯烷酮(PVP)、粉狀阿拉伯樹膠、凝膠、右旋糖及蔗糖之水溶液或類似物,或其水溶液或乙醇溶液。崩解劑之實例包括澱粉、羧基甲基纖維素、羧基甲基纖維素鈣、微晶纖維素、羥基丙基澱粉及磷酸鈣。此外,潤滑劑之實例包括巴西棕櫚蠟(carnauba wax)、輕質無水矽酸、合成矽酸鋁、天然矽酸鋁、合成矽酸鎂、硬化油、氫化植物油(Sterotex HM)之衍生物、芝麻油、白蜂蠟、氧化鈦、乾燥氫氧化鋁-凝膠硬脂酸、硬脂酸鈣、硬脂酸鎂、滑石、磷酸氫鈣及月桂基硫酸鈉。The agents of the invention may be formulated into suitable dosage forms such as powders, granules, lozenges, capsules and solutions. Once formulated, adjuvants such as excipients, adhesives, disintegrants, and lubricants, which are typically used in the formulation, are added. Examples of excipients include starch, lactose, sucrose, methylcellulose, carboxymethylcellulose, sodium alginate, calcium hydrogen phosphate, synthetic aluminum citrate, microcrystalline cellulose, polyvinylpyrrolidone (PVP), and Hydroxypropyl starch (HPS). Also, examples of the adhesive include starch, microcrystalline cellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone (PVP), powdered gum arabic, gel, aqueous solution of dextrose and sucrose, or the like, or an aqueous solution thereof Or ethanol solution. Examples of the disintegrant include starch, carboxymethylcellulose, carboxymethylcellulose calcium, microcrystalline cellulose, hydroxypropyl starch, and calcium phosphate. Further, examples of the lubricant include carnauba wax, light anhydrous citric acid, synthetic aluminum silicate, natural aluminum citrate, synthetic magnesium citrate, hardened oil, derivative of hydrogenated vegetable oil (Sterotex HM), sesame oil , white beeswax, titanium oxide, dried aluminum hydroxide-gel stearic acid, calcium stearate, magnesium stearate, talc, calcium hydrogen phosphate and sodium lauryl sulfate.
2-1. 本發明之藥劑之劑型2-1. Formulation of the medicament of the present invention
本發明之藥劑Agent of the invention
本發明之藥劑,其尤其係(1)一種用於預防新生兒出生體重低之產前藥劑,(2)一種用於減少新生兒出生體重低之風險之產前藥劑,或(3)一種用於減少新生兒在成長之後罹患與新生兒出生體重低相關疾病之風險之產前藥劑,其係經由投與該產前藥劑至新生兒母親的妊娠婦女且可經口服或非經腸投與,較佳係經口服投與。The agent of the present invention is, in particular, (1) a prenatal agent for preventing low birth weight of a newborn, (2) a prenatal agent for reducing the risk of low birth weight of a newborn, or (3) a use A prenatal agent for reducing the risk of a neonatal growth-related disease associated with a low birth weight of a newborn, which is administered to a pregnant woman who is administered the neonatal mother to the newborn mother and may be administered orally or parenterally. Preferably, it is administered orally.
同樣,就本發明之藥劑之口服劑型而言,例如,膽鹼之劑量希望在60 mg/天至3.5 g/天的範圍內,較佳在100 mg/天至3.5 g/天的範圍內,更佳在200 mg/天至3.5 g/天的範圍內,亦較佳係在350 mg/天至3.5 g/天的範圍內。「乳磷脂濃縮物」之劑量(包含約5重量%膽鹼;85重量%脂質,10重量%灰分含量,4重量%碳水化合物,及1重量%水分)希望在1.4 g/天至75 g/天的範圍內,較佳在2.4 g/天至75 g/天的範圍內,更佳在4.8 g/天至75 g/天的範圍內,及亦較佳在7.5 g/天至75 g/天的範圍內(例如,American Journal of Clinical Nutrition 2005,82,第111-117頁;American Journal of Clinical Nutrition 2006,第83卷,第905-911頁;European Journal of Nutrition,2007,第46卷,第300-306頁,Dietary Reference Intakes,第411頁)。Similarly, with regard to the oral dosage form of the agent of the present invention, for example, the dose of choline is desirably in the range of 60 mg/day to 3.5 g/day, preferably in the range of 100 mg/day to 3.5 g/day. More preferably, it is in the range of 200 mg/day to 3.5 g/day, and more preferably in the range of 350 mg/day to 3.5 g/day. The dose of "breast phospholipid concentrate" (containing about 5% by weight choline; 85% by weight lipid, 10% by weight ash content, 4% by weight carbohydrate, and 1% by weight moisture) is desirably from 1.4 g/day to 75 g/ Within the range of days, preferably in the range of 2.4 g/day to 75 g/day, more preferably in the range of 4.8 g/day to 75 g/day, and also preferably in the range of 7.5 g/day to 75 g/ Within the scope of the day (for example, American Journal of Clinical Nutrition 2005, 82, pp. 111-117; American Journal of Clinical Nutrition 2006, vol. 83, pp. 905-911; European Journal of Nutrition, 2007, Vol. 46, Pages 300-306, Dietary Reference Intakes, p. 411).
在本發明中,希望在妊娠之前開始攝取用於預防新生兒出生體重低之產前藥劑。希望在整個妊娠期間攝取該產前藥劑至少一次,及較佳在整個妊娠期間連續如此攝取(例如,每天)。In the present invention, it is desirable to start ingesting a prenatal agent for preventing birth weight of a newborn before pregnancy. It is desirable to ingest the prenatal agent at least once throughout the pregnancy, and preferably such ingestion throughout the pregnancy (eg, daily).
2-2. 投與本發明之藥劑之主題2-2. Subject to the agent of the present invention
本發明之藥劑,其明確言之係(1)一種用於預防新生兒出生體重低之產前藥劑(用於預防出生體重低之製劑),(2)一種用於減少新生兒出生體重低之風險之產前藥劑(用於減少出生體重低之風險之製劑),或(3)一種用於減少新生兒在成長之後罹患與新生兒出生體重低相關疾病之風險之產前藥劑,其係經由投與該產前藥劑至新生兒母親的妊娠婦女且可投與至所有的妊娠婦女。可將本發明之藥劑特別投與至營養攝取不平衡的妊娠婦女。該等妊娠婦女之特殊實例包括維生素不足的妊娠婦女及其進一步明確實例包括素食妊娠婦女及維生素B不足的妊娠婦女。在此,術語「維生素B不足」係指葉酸不足、維生素B2不足、維生素B6不足、及維生素B12不足。The agent of the present invention, which is specifically described as (1) a prenatal agent for preventing birth weight of a newborn (for preventing a low birth weight), and (2) a method for reducing the birth weight of a newborn a prenatal agent for risk (a preparation for reducing the risk of low birth weight), or (3) a prenatal agent for reducing the risk of a newborn having a low birth weight-related disease after growth, which is via A pregnant woman who is administered this prenatal medication to a newborn mother and can be administered to all pregnant women. The agent of the present invention can be specifically administered to pregnant women who have an imbalance in nutritional intake. Specific examples of such pregnant women include pregnant women with insufficient vitamins and further clear examples thereof include vegetarian pregnant women and pregnant women with insufficient vitamin B. Here, the term "deficiency of vitamin B" means insufficient folic acid, insufficient vitamin B2, insufficient vitamin B6, and insufficient vitamin B12.
3. 用於特殊飲食用途之產前食物或產前營養補充食物3. Prenatal food or prenatal nutritional supplements for special dietary purposes
本發明之用於特殊飲食用途之食物或營養補充食物係(1)一種用於預防新生兒出生體重低之於特殊飲食用途上之產前食物或產前營養補充食物,(2)一種用於減少新生兒出生體重低之風險之於特殊飲食用途上的產前食物或產前營養補充食物,或(3)一種用於減少新生兒在成長之後罹患與新生兒出生體重低相關疾病之風險之於特殊飲食用途上的產前食物或產前營養補充食物,其係經由投與該產前藥劑至新生兒母親的妊娠婦女。The food or nutritional supplement food for special dietary use of the present invention (1) a prenatal food or a prenatal nutritional supplement for preventing a newborn having a low birth weight for a particular dietary use, and (2) one for Reduce the risk of low birth weight in newborns for prenatal or prenatal nutritional supplements for special dietary use, or (3) a risk of reducing the risk of neonatal growth-related diseases associated with low birth weight Prenatal food or prenatal nutritional supplements for special dietary use are administered to pregnant women who have given the prenatal medication to the newborn mother.
本發明用於特殊飲食用途之食物或營養補充食物包含乳磷脂作為活性成份,且可呈固體(例如粉末及顆粒)、糊狀、液體或懸浮液之任何形式。舉例而言,當該食物調配成可飲用配製劑時,則亦可添加添加劑,諸如甜味劑、酸化劑、維生素配製劑及其他常用於製造可飲用配製劑之添加劑。The food or nutritional supplement food for the special dietary use of the present invention comprises milk phospholipid as an active ingredient, and may be in any form of a solid (for example, a powder and a granule), a paste, a liquid or a suspension. For example, when the food is formulated into a drinkable formulation, additives such as sweeteners, acidulants, vitamin formulations, and other additives commonly used in the manufacture of drinkable formulations may also be added.
本發明用於特殊飲食用途之食物或營養補充食物可調配成呈適宜劑型(諸如粉末、顆粒、錠劑、膠囊或溶液)之補充劑。The food or nutritional supplement food of the present invention for special dietary use may be formulated as a supplement in a suitable dosage form such as a powder, granule, lozenge, capsule or solution.
此外,本發明用於特殊飲食用途之食物或營養補充食物可呈食物添加劑形式,其包含磷脂作為活性成份,用於製備於特殊飲食用途上之產前食物或產前營養補充食物。Further, the food or nutritional supplement food of the present invention for special dietary use may be in the form of a food additive comprising phospholipid as an active ingredient for preparing prenatal food or prenatal nutritional supplement food for special dietary use.
就攝取本發明之用於特殊飲食用途之食物或營養補充食物而言,希望攝取之膽鹼在60 mg/天至3.5 g/天的範圍內,較佳為100 mg/天至3.5 g/天的範圍內,更佳為200 mg/天至3.5 g/天的範圍內,及亦較佳為350 mg/天至3.5 g/天的範圍內,及希望攝取的「乳磷脂濃縮物」(包含約5重量%膽鹼、85重量%脂質、10重量%灰分含量、4重量%碳水化合物、及1重量%水分)係在1.4 g/天至75 g/天的範圍內,較佳在2.4 g/天至75 g/天的範圍內,更佳在4.8 g/天至75 g/天的範圍內,及亦較佳在7.5 g/天至75 g/天的範圍內(例如,American Journal of Clinical Nutrition 2005,82,第111-117頁;American Journal of Clinical Nutrition 2006,第83卷,第905-911頁;European Journal of Nutrition,2007,第46卷,第300-306頁,Dietary Reference Intakes,第411頁)。For the ingestion of the food or nutritional supplement for the special dietary use of the present invention, it is desirable to take choline in the range of 60 mg/day to 3.5 g/day, preferably 100 mg/day to 3.5 g/day. In the range of 200 mg/day to 3.5 g/day, and preferably in the range of 350 mg/day to 3.5 g/day, and the desired "milk phospholipid concentrate" (including About 5% by weight of choline, 85% by weight of lipid, 10% by weight of ash content, 4% by weight of carbohydrate, and 1% by weight of water) are in the range of 1.4 g/day to 75 g/day, preferably 2.4 g. /day to 75 g / day, more preferably in the range of 4.8 g / day to 75 g / day, and also preferably in the range of 7.5 g / day to 75 g / day (for example, American Journal of Clinical Nutrition 2005, 82, pp. 111-117; American Journal of Clinical Nutrition 2006, Vol. 83, pp. 905-911; European Journal of Nutrition, 2007, Vol. 46, pp. 300-306, Dietary Reference Intakes, Page 411).
實例1:在妊娠期間攝取乳磷脂之影響Example 1: Effect of ingesting lactose during pregnancy
試驗方法experiment method
將大鼠分成4組進行實驗,每組使用8隻大鼠分別進行飼養實例,共進行4種飼養實例。在試驗開始時大鼠體重係在155 g至165 g的範圍內,在完成試驗時(妊娠期間)在240 g至290 g的範圍內。此時,每組體重之間沒有出現顯著差異。The rats were divided into 4 groups for experiments, and 8 rats in each group were used for feeding examples, and a total of 4 feeding examples were performed. The rat body weight ranged from 155 g to 165 g at the start of the experiment and ranged from 240 g to 290 g at the completion of the test (during pregnancy). At this time, there was no significant difference between the weights of each group.
(1) 用低維生素飲食(低維生素飲食:自AIN93G維生素混合物中去除維生素B2、葉酸、維生素B12、及膽鹼酒石酸氫鹽而製備)或對照飲食(對照組:AIN93G)飼養9周齡雌Wistar大鼠,自由取食一周。(表1)(1) Feeding a 9-week-old female Wistar with a low-vitamin diet (low-vitamin diet: prepared by removing vitamin B2, folic acid, vitamin B12, and choline bitartrate from the AIN93G vitamin mixture) or a control diet (control group: AIN93G) Rats were given a free week of feeding. (Table 1)
(2) 使10周齡雌Wistar大鼠交配。(2) Female Wistar rats of 10 weeks old were mated.
(3) 確定交配(交配栓)的那天記為懷孕的第0天。用測試飲食(AIN93G,低維生素飲食,低維生素飲食+乳磷脂(2.6重量%;膽鹼含量為約40 mg/g),低維生素飲食+膽鹼酒石酸氫鹽(0.25重量%))飼養各組(自由取食)。用測試飲食飼養(自由取食)直至懷孕的第20天。此外,低維生素飲食+乳磷脂、低維生素飲食+膽鹼酒石酸氫鹽及AIN93G中之膽鹼濃度為0.1重量%。(3) The day on which the mating (mating plug) is determined is recorded as day 0 of pregnancy. Feed the groups with a test diet (AIN93G, low-vitamin diet, low-vitamin diet + lactose (2.6% by weight; choline content of about 40 mg/g), low-vitamin diet + choline bitartrate (0.25% by weight) (free access to food). Feed on a test diet (free access) until the 20th day of pregnancy. In addition, the low-vitamin diet + lactose, low-vitamin diet + choline bitartrate and choline in AIN93G had a concentration of 0.1% by weight.
(4) 在懷孕的第20天,經靜脈收集約0.3 ml的血液,進行剖腹手術,取出胎兒,及隨後測量其體重。此外,同胞胎數一般定為12+/-3(超過該數量的大鼠則不計)及隨後將該等組相互比較。進行統計分析時,使用Statview差異單向分析(SAS)進行多重比較法(Post-hoc: Scheffe)試驗。(4) On the 20th day of pregnancy, about 0.3 ml of blood was collected intravenously, laparotomy was performed, the fetus was taken out, and then the body weight was measured. In addition, the number of siblings is generally set at 12 +/- 3 (excluding the number of rats) and the groups are then compared to each other. For statistical analysis, the Statview differential one-way analysis (SAS) was used to perform the multiple comparison (Post-hoc: Scheffe) test.
試驗結果test results
由於攝入低維生素飲食,胎兒體重降低(圖1)。然而,由於攝入含乳磷脂之低維生素補充劑,胎兒體重得到改善,因此增加(圖1及表2)。Fetal weight is reduced due to low vitamin intake (Figure 1). However, due to the intake of low vitamin supplements containing milk phospholipids, fetal weight is improved and therefore increased (Figure 1 and Table 2).
已經藉由此試驗證實攝取維生素係嬰兒成長所必需。其進一步證實,攝取乳磷脂可改善歸因於維生素不足而未充份發展的嬰兒。It has been confirmed by this test that the intake of vitamin-based infants is necessary. It further confirms that the intake of milk phospholipids can improve infants that are not fully developed due to vitamin deficiency.
本發明之產前藥劑、用於特殊飲食用途之食物、或營養補充食物對預防新生兒出生體重低具有極佳的效果。因此,產前藥劑、用於特殊飲食用途之食物、或營養補充食物可用於醫藥或食物製造工業。The prenatal agent of the present invention, food for special dietary use, or nutritional supplement food has an excellent effect on preventing neonatal birth weight. Therefore, prenatal medications, foods for special dietary uses, or nutritional supplements can be used in the pharmaceutical or food manufacturing industries.
文中所引用之所有公開案、專利及專利申請案係以引用的方式併入本文中。All publications, patents and patent applications cited herein are hereby incorporated by reference.
圖1顯示在妊娠第20天打開腹腔、提取胎兒及隨後測量其數量及體重之結果。Figure 1 shows the results of opening the abdominal cavity on the 20th day of pregnancy, extracting the fetus and subsequently measuring its quantity and body weight.
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