CN104768558B - 基于磷脂酰丝氨酸的催乳组合物 - Google Patents

基于磷脂酰丝氨酸的催乳组合物 Download PDF

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CN104768558B
CN104768558B CN201380054804.3A CN201380054804A CN104768558B CN 104768558 B CN104768558 B CN 104768558B CN 201380054804 A CN201380054804 A CN 201380054804A CN 104768558 B CN104768558 B CN 104768558B
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皮耶罗 F·迪
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Abstract

本发明涉及用于治疗缺乳的基于磷脂酰丝氨酸的催乳组合物。

Description

基于磷脂酰丝氨酸的催乳组合物
本发明涉及基于磷脂酰丝氨酸的催乳组合物。
现有技术
母乳无论从质量上还是从能量供给方面均是完整的婴儿食品。每日的乳量分泌在不同时期会发生变化，并且在不同妇女之间有一定的个体差异：平均而言，从生产后第3天的200克逐渐增加至哺乳期第六个月的1200-1500ml，然后逐渐下降。
女性的哺乳期与乳房的功能性活动相对应：其在临出生前不久开始，并在断奶时结束。不考虑初始期(初乳产生阶段)，产乳阶段在出生后约48小时开始。该延迟是由于脑垂体在出生后的最初几天内仍然受怀孕期间所积累的胎盘激素的抑制影响，因此无法产生催乳素。直到出生后的第3到第4天才开始泌乳。
完全缺乏乳汁分泌(无乳)是个例外。但是，特别是在初产妇中，有时可能在出生后的第一周内观察到特别低的分泌(缺乳)。在出生后第5天，24小时内的泌乳量小于280克的妇女被归类为缺乳(原发性缺乳)。继发性缺乳在一段正常的乳汁分泌后出现。
原发性缺乳在20世纪50年代之前是非常罕见的，但最近已经变得越来越常见。缺乳可以由泌乳延迟或特定的生物学、神经体液或心理状况(尤其是在外出工作的妇女中)所引起的分泌缺陷所造成、由局部或全身性疾病所造成，或由分泌停滞(由吮吸不足或排空障碍引起)所造成。
在缺乳妇女中观察到了血液乳糖水平的下降：在乳汁分泌正常的妇女中，血液乳糖水平范围为千分之0.30至0.80克，而在缺乳妇女中，该值低于千分之0.20克。对缺乳的治疗主要是基于识别和去除致病因素。
一些目前提出的用于治疗缺乳的药物，如胃复安、舒必利、氯丙嗪、多潘立酮和生长激素会诱导副作用(锥体外系和神经安定作用、体重和血压升高),这限制了它们的功效。使用传统医学中已知的植物或其提取物(葫芦巴、毛金丝桃(stinking tutsan)、锦葵、八角、奶蓟草和山羊豆(goat’s rue))基本上没有副作用，但其药理学的原理尚不十分清楚。
磷脂酰丝氨酸(PS)属于磷脂类，即构成细胞膜的分子。除了磷脂酰丝氨酸(其在动物组织中的含量较低)外，磷脂还包括磷脂酸、磷脂酰胆碱、磷脂酰乙醇胺、磷脂酰甘油磷酸、二磷脂酰甘油和磷脂酰肌醇。
人们早已知道，磷脂酰丝氨酸对于记忆和认知能力有有利的影响。多项研究证实了磷脂酰丝氨酸在复原特别是与衰老有关的记忆容量方面的特性。磷脂酰丝氨酸还被用作运动机能增进助剂、用作神经病学的抗抑郁剂以及作为焦虑镇静剂。
发明描述
现已发现，磷脂酰丝氨酸(PS)可以产生很强的催乳作用，增加产乳量而不改变乳汁的质量。因此，本发明的主题是用于治疗缺乳的包含磷脂酰丝氨酸的组合物。
本发明的组合物可以包含其活性与所述目的互补或可用于所述目的的其他成分。所述成分的实例包括维生素(A、B族、C、D、E、F和K)、矿物质(钙、锌、铁、铜、镁、锰、硒和钾)和植物治疗药物如奶蓟草或其成分(水飞蓟素)、山羊豆、锦葵、毛金丝桃、胡芦巴和八角，优选水飞蓟素和/或山羊豆。磷脂酰丝氨酸也可以其与所述药用植物提取物的组成成分的复合物的形式使用。所述提取物的制备是已知的，并且公开于例如EP209038。水飞蓟素与磷脂酰丝氨酸的复合物是特别优选的。
磷脂酰丝氨酸通常以20至500毫克的每日剂量给药，优选20至250毫克，更优选20至100毫克，可任选地分成一天两次或三次给药。其他成分(如果有的话)的剂量也可以在很宽的范围内变化，对应于相同成分用于不同指征的剂量。例如，水飞蓟素的剂量可以在50至500毫克的范围内，特别是在100至200毫克之间。
用雌性Wistar大鼠(重量:300克±35)评估磷脂酰丝氨酸的效果：口服给药100毫克/公斤/天引起的血浆催乳素值增加比腹膜内给药2.2毫克/公斤/天剂量的胃复安所获得的增加值高25％。同样以100毫克/公斤/天的剂量口服给药磷脂酰丝氨酸，还抵销了由腹膜内施用1毫克/公斤/天的溴隐亭所获得的抗催乳效应。
磷脂酰丝氨酸的催乳作用也在用2组10名妇女进行的临床试验中得到证实，出于伦理方面的原因，这些妇女已经处于哺乳的第四个月。第一组用30毫克/天的磷脂酰丝氨酸连续治疗30天，第二组用安慰剂治疗。
在试验结束时，观察到磷脂酰丝氨酸治疗组的妇女产乳量比安慰剂组(其与t＝0相比增加了约15％)的高30％(在t＝30天时)。这种变化仅仅是量的变化：生化参数(水分、脂肪、碳水化合物和蛋白质)在两组中均保持不变。
本发明的组合物可以配制成适于口服的形式，并通过制药技术中公知的常规方法、例如“雷明顿医药手册(Remington’s Pharmaceutical Handbook)”(Mack PublishingCo.,N.Y.,USA)中所描述的方法，使用对其最终应用而言可接受的赋形剂、稀释剂、填充剂、防结块剂、矫味剂和甜味剂来制备。适宜的剂型包括胶囊、片剂、颗粒、粉末、溶液和混悬液。可任选地将磷脂酰丝氨酸引入适宜的功能性食品中。
以下给出单剂量小药袋中的制剂的实例:

Claims (1)

1.磷脂酰丝氨酸在制备用于治疗缺乳的药物中的用途。
CN201380054804.3A 2012-10-22 2013-09-19 基于磷脂酰丝氨酸的催乳组合物 Active CN104768558B (zh)

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CN105816705A (zh) * 2016-04-07 2016-08-03 赵卫军 一种包含玉米须和磷脂酰丝氨酸的药物及其制备方法
CN106072283A (zh) * 2016-06-08 2016-11-09 芜湖福民生物药业有限公司 含有磷脂酰丝氨酸的催乳材料组合物、催乳汤及其制备方法
CN108143976A (zh) * 2018-03-05 2018-06-12 徐少峰 一种中药催乳剂及其制备工艺
CN111685318A (zh) * 2020-06-24 2020-09-22 南京玉鹤鸣医学营养研究院有限公司 一种促进产后泌乳的配方食品

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101129763A (zh) * 2007-09-24 2008-02-27 北京艺信堂医药研究所 治疗产后缺乳的一种中成药
CN102160651A (zh) * 2003-09-25 2011-08-24 酶学技术有限公司 稳定的磷脂酰丝氨酸制剂

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1212900B (it) * 1983-11-17 1989-11-30 Valle Francesco Della Uso terapeutico della fosfatidilserina in malattie del sistema nervoso centrale senza effetti sulla coagulazione sanguigna
IT1215291B (it) 1985-07-17 1990-01-31 Inverni Della Beffa Spa Complessi di flavanolignani con fosfolipidi, loro preparazione e relative composizioni farmaceutiche.
EP0965597A4 (en) * 1996-12-27 2003-01-08 Mochida Pharm Co Ltd CELL MEMBRANE EFFECTIVE DRUGS
ITMI20051942A1 (it) * 2005-10-14 2007-04-15 S I I T S R L Servizio Interna Composizioni galattogeniche a base di silimarina
US8021659B2 (en) * 2006-04-28 2011-09-20 Naidu Lp Coenzyme Q10, lactoferrin and angiogenin compositions and uses thereof
US20090110674A1 (en) * 2007-10-24 2009-04-30 Loizou Nicos C Health supplement
FR2948537B1 (fr) * 2009-07-29 2011-09-09 France Bebe Nutrition Lab Composition nutritive pour femmes allaitant
CN102578436B (zh) * 2012-03-29 2013-05-08 常熟市润丰农业有限公司 一种母猪围产期饲料添加剂

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102160651A (zh) * 2003-09-25 2011-08-24 酶学技术有限公司 稳定的磷脂酰丝氨酸制剂
CN101129763A (zh) * 2007-09-24 2008-02-27 北京艺信堂医药研究所 治疗产后缺乳的一种中成药

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
葫芦巴何以风靡国际市场;徐铮奎;《医药经济报》;20080409;第003版 *

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