CN106039091A - 一种固肾保胎乳膏及其制备方法 - Google Patents
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Abstract
本发明涉及一种固肾保胎乳膏及其制备方法,属医药保健技术领域。按重量份,由龟板胶6‑9份,枸杞子3‑6份,熟地4‑6份,巴戟天2‑5份,当归5‑7份,白术4‑6份,甘草3‑5份,菟丝子2‑4份,杜仲1‑3份,肉苁蓉2‑4份,续断3‑5份,狗脊4‑6份,苏梗3‑5份,党参5‑7份,陈皮1‑3份,南瓜蒂1‑3份,苎麻根4‑6份,莲子2‑4份,山药2‑4份,竹茹2‑4份,油性原料5‑15份,本发明的有益效果:乳膏具有阴阳互补,对孕妇因肾阳和肾阴造成的五心烦热、潮热盗汗,寒肢冷,心悸咳嗽等孕期伴发症具有双向调节功效,具有疗效温和、药效持久,使用方便,安全性高,也可起到补气养颜、调理胎气、调整身体机能的作用。
Description
技术领域
本发明涉及一种固肾保胎乳膏及其制备方法,属医药保健技术领域。
背景技术
肾为先天之本,女性孕育生命时,益补肾气对于胎气紊乱,妊娠不正常的现象有良好的改善作用,孕期女性肾脏的健康与胎儿的生长,发育,以及生命活力紧密相关。为了避免流产现象以及胎儿早产畸形的现象,孕期女性做好补肾工作是必要的和重要的。
首先,孕妇肾阴虚时,容易引起五心烦热,潮热盗汗,腰酸腿软,耳鸣头晕,并伴有易怒,烦躁,焦虑,抑郁等症状;孕妇肾阳虚时,腰膝酸软,头目眩晕,宫寒不孕,大便久泄不止,腰以下浮肿, 腹部胀痛,心悸咳喘,畏寒肢冷等疾病相继而来,在这些并发症状的困扰下不仅使孕妇内伤劳损,而且容易使孕妇产生情绪波动,常难以自控。总之,在孕期内,肾虚会导致孕妇长期处于身心俱疲的状态。
其次,孕妇肾气充盛,胎有所系,是孕育胎儿的先决条件。胎儿的健康发育,从胚发育期至胎儿期,整个过程与母体的肾脏活力息息相关,特别是在怀孕早期,胎儿尚未形成,母体肾气不足,妊娠子宫平滑肌收缩紊乱,极易造成胎动而坠,导致流产,给孕妇身心带来极大创伤,所以,补肾安胎对怀孕早期的产妇尤为重要。
另外,现在高龄产妇逐渐增多,越来越多的35岁以上的中年妇女加入了孕育二胎的行列。这些高龄孕妇由于年龄较大,肾功能活力明显低于年轻孕妇,肾虚气虚的现象颇多,从而影响胎气,导致流产更易发生,而且容易影响胎儿的生长发育,甚至智力发育。
目前,市售养肾保胎药种类不少,其中,采用中药补肾保胎逐渐受到更多人们欢迎。由于肾气不足,相当多孕妇出现先兆性流产或心力交瘁等症状而选用一些养肾保胎的中药来益补肾气,但是,补肾类中药多为内服型,当其进入孕妇机体,由于快速吸收扩散,短时间内在机体形成较高的药物浓度,其毒性代谢产物也在短期内大量生成,从而对孕妇机体健康及胎儿发育造成不良影响。
发明内容
本发明的目的是提供一种使用方便、安全有效、用药过程温和持久的固肾保胎乳膏及其制备方法。
一种固肾保胎乳膏,由以下重量份的原料组成:龟板胶6-9份,枸杞子3-6份,熟地4-6份,巴戟天2-5份,当归5-7份,白术4-6份,甘草3-5份,菟丝子2-4份,杜仲1-3份,肉苁蓉2-4份,续断3-5份,狗脊4-6份,苏梗3-5份,党参5-7份,陈皮1-3份,南瓜蒂1-3份,苎麻根4-6份,莲子2-4份,山药2-4份,竹茹2-4份,油性原料5-15份。
作为本发明的优选方案,一种固肾保胎乳膏,由以下重量份的原料组成:龟板胶8份,枸杞子5份,熟地5份,巴戟天4份,当归6份,白术5份,甘草4份,菟丝子3份,杜仲2份,肉苁蓉3份,续断4份,狗脊5份,苏梗4份,党参6份,陈皮2份,南瓜蒂2份,苎麻根5份,莲子3份,山药3份,竹茹3份,油性原料10份。
本发明一种固肾保胎乳膏配方中,所述的油性原料由橄榄油、单硬脂酸甘油酯依次按重量份数99.5:0.5组合经乳化制备而成
本发明还提供了一种固肾保胎乳膏的制备方法,由原料称取、药材浸泡、药材煎煮、油性原料制备、乳膏制备五个步骤制备而成:
(1)原料称取:按所述重量份数分别称取龟板胶,枸杞子,熟地,巴戟天,当归,白术,甘草,菟丝子,杜仲,肉苁蓉,续断,狗脊,苏梗,党参,陈皮,南瓜蒂,苎麻根,莲子,山药,竹茹,橄榄油,单硬脂酸甘油酯备用;
(2)药材浸泡:将称量好的药材混合均匀,加入药材总重量约5倍的去离子水,浸泡60分钟;
(3)药材煎煮:将浸泡好的药材加热至沸腾,文火煎煮90分钟后,过滤得一次药液与一次药渣;向一次药渣中加入药材总重量约3倍的去离子水加热至沸腾,文火煎煮45分钟后,过滤得二次药液;将一次药液与二次药液合并,得到混合药液;
(4)油性原料制备:将称量好的橄榄油、单硬脂酸甘油酯倒入容器内,再加入相对于橄榄油重量比10-20%的去离子水,搅拌混合,加热至80-95℃,强烈搅拌至完全乳化,保持油性原料在80-95℃;
(5)乳膏制备:将混合药液加热至80-95℃,然后将乳化后的油性原料加入到混合药液中,搅拌均匀,然后在小火上慢慢煎熬浓缩,得到60℃时相对密度为1.15-1.25的浓缩药膏,制得固肾保胎乳膏。
本发明乳膏为外用乳膏,用药次数及用量可根据需要调整,使用时取适量乳膏均匀涂抹于孕妇腹部以及后腰两侧的皮肤表面,并轻柔舒缓按摩至完全吸收。以每天2-3次,每次乳膏用量5-10g,每次按摩时间不少于30分钟为佳。
本发明采取以上技术方案,具有以下优益效果:
(1)本发明以龟板胶、熟地、枸杞子等合理搭配补肾阴,辅以巴戟天、当归、肉苁蓉等予以调和,阴阳合理搭配,协同作用,对孕妇因肾阴虚引起的五心烦热,潮热盗汗,耳鸣头晕等病症,焦虑抑郁等孕期伴发病症具有良好的缓解、治愈作用;也可弥补因肾阳虚亏引起的宫寒不孕,腹泻腹痛,畏寒肢冷,心悸咳嗽等症状,实现阴阳互补,达到良好的固肾保胎作用。
(2)治疗方法独特,药物疗效温和、持久,使用方便,安全性高。本发明打破常规,开发了安胎保胎内病外治疗法,可避免常规内服药物因快速吸收扩散,短时间内体内积聚的药物浓度过高,激发机体药物反应,造成胃肠道或心血管等机体严重不良反应的发生;本发明乳膏作用于腹部以及后腰两侧特定部位,通过轻缓按摩,经皮肤组织渗透吸收,乳膏中的药物成分可缓慢持续进入肌体,特别是子宫周围及肾脏周边组织,逐渐被子宫和肾脏组织吸纳,药效更加温和且持久,用药部位更加集中,有针对性,可显著增强固肾安胎作用,同时降低对身体其它系统的影响。
(3)在使用本发明乳膏对腹部以及后腰两侧部位进行舒缓按摩的过程中,通过局部穴位刺激,也可起到补气养颜、调理胎气、调整身体机能的作用,能够有效缓解并治愈五心烦乱、腰酸膝软、潮热盗汗、腹痛腹胀等症状,为胚胎发育,及胎儿健康生长提供有利环境。
本发明所述的中药原料中,龟板胶:滋阴,补血,止血。主治阴虚血亏,劳热骨蒸,吐血,衄血,烦热惊悸,肾虚腰痛,脚膝痿弱,崩漏,带下。
枸杞子:滋肾,润肺,补肝,明目。主治肝肾阴亏,腰膝酸软,头晕,目眩,目昏多泪,虚劳咳嗽,消渴,遗精。
熟地:滋阴补血,益精填髓。主治肝肾阴虚,腰膝酸软,骨蒸潮热,盗汗遗精,内热消渴,血虚萎黄,心悸怔忡,月经不调,崩漏下血,眩晕,耳鸣,须发早白。
巴戟天:补肾阳,强筋骨,祛风湿。主治宫冷不孕,月经不调,少腹冷痛等。
当归:补血和血,调经止痛,润燥滑肠。主治月经不调、经闭腹痛、崩漏,血虚头痛、眩晕、痿痹。
白术:补脾,安胎。主治脾胃气弱,不思饮食,泄泻,水肿,黄疸,胎气不安,小便不利等。
甘草:补脾益气,清热解毒,缓急止痛,调和诸药。主治脾胃虚弱,倦怠乏力,脘腹,四肢挛急疼痛,痈肿疮毒,缓解药物毒性、烈性。
菟丝子:补肾益精,养肝明目,固胎止泄。主治腰痛耳鸣,消渴,不育,淋浊带下,头目昏暗,食少泄泻,胎动不安。
杜仲:补肝肾,安胎。主治肝肾亏虚,下元虚冷的妊娠下血,胎动不安或习惯性流产等。
肉苁蓉:补肾阳,益精血,润肠通便。主治不孕,腰膝酸软,筋骨无力,肠燥便秘。
续断:补肝,强筋骨,定经络,止经中(筋骨)酸痛,安胎。主治妇人白带,生新血,止咳嗽咳血,治赤白便浊。
狗脊:补肝肾,壮筋骨,祛风湿。主治肝肾不足,腰膝酸冷,腿软乏力,风湿痹痛。
苏梗:理气宽中,止痛,安胎。主治胸膈痞闷,胃脘疼痛,嗳气呕吐,胎动不安。
党参:补中益气,健脾益肺。主治脾肺虚弱,气短心悸,食少便溏,虚喘咳嗽,内热消渴,增强抵抗力,扩张周围血管而降低血压,又可抑制肾上腺素的升压作用。
陈皮:健脾,开胃。主治脾胃虚弱,消化不良,恶心呕吐,大便泄泻等症。
南瓜蒂:解毒,利水,安胎。主治烫伤,疮溃不敛,水肿腹水,胎动不安。
苎麻根:凉血止血,清热解毒,安胎。主治血热妄行之咯血,吐血,衄血,胎漏下血,及热毒痈肿,丹毒,蛇虫咬伤,跌打损伤等。
莲子:养心,益肾,补脾,涩肠。主治夜寐多梦,遗精,淋浊,久痢,虚泻,妇人崩漏带下。
山药:补脾,养肺,固肾,益精。主治脾虚久泻,慢性肠炎,肺虚咳喘,慢性胃炎,糖尿病,遗精,遗尿,带下等症。
竹茹:清热化痰,除烦止呕,安胎凉血。主治烦热惊悸,胃热呕呃,妊娠恶阻,胎动不安,吐血,衄血,尿血,崩漏。
油性原料:由橄榄油经单硬脂酸甘油酯乳化而成,有保护、润湿和柔软皮肤的作用,橄榄油含有丰富的单不饱和脂肪酸和多种维生素,具有防皲裂、防癌、防辐射、抗菌消炎、抗衰老、预防妊娠纹、促进血液循环,保护皮肤,改善消化和内分泌系统,提高免疫力的功效;单硬脂酸甘油酯是一种非离子型的表面活性剂,常在化妆品及医药膏剂中用作乳化剂,使膏体细腻,滑润。
具体实施方式:
下述结合具体实施例进一步阐明本发明,但这些实施例仅限于说明本发明而不是用于限制本发明的范围。
实施例1,一种固肾保胎乳膏,其原料组成按重量配比为:龟板胶6份,枸杞子3份,熟地4份,巴戟天2份,当归5份,白术4份,甘草3份,菟丝子2份,杜仲1份,肉苁蓉2份,续断3份,狗脊4份,苏梗3份,党参5份,陈皮1份,南瓜蒂1份,苎麻根4份,莲子2份,山药2份,竹茹2份,油性原料10份,其中油性原料由橄榄油、单硬脂酸甘油酯依次按重量份数99.5:0.5组合经乳化制备而成。
其制备方法为:
(1)原料称取:按所述重量份数分别称取龟板胶,枸杞子,熟地,巴戟天,当归,白术,甘草,菟丝子,杜仲,肉苁蓉,续断,狗脊,苏梗,党参,陈皮,南瓜蒂,苎麻根,莲子,山药,竹茹,橄榄油,单硬脂酸甘油酯,备用;
(2)药材浸泡:将称量好的药材混合均匀,加入药材总重量约5倍的去离子水,浸泡60分钟;
(3)药材煎煮:将浸泡好的药材加热至沸腾,文火煎煮90分钟后,过滤得一次药液与一次药渣;向一次药渣中加入药材总重量约3倍的去离子水加热至沸腾,文火煎煮45分钟后,过滤得二次药液;将一次药液与二次药液合并,得到混合药液;
(4)油性原料制备:将称量好的橄榄油、单硬脂酸甘油酯倒入容器内,再加入相对于橄榄油重量比10-20%的去离子水,搅拌混合,加热至80-95℃,强烈搅拌至完全乳化,保持油性原料在80-95℃;
(5)乳膏制备:将混合药液加热至80-95℃,然后将乳化后的油性原料加入到混合药液中,搅拌均匀,然后在小火上慢慢煎熬浓缩,得到60℃时相对密度为1.15-1.25的浓缩药膏,制得固肾保胎乳膏。
实施例2,一种固肾保胎乳膏,其原料组成按重量配比为:龟板胶8份,枸杞子5份,熟地5份,巴戟天4份,当归6份,白术5份,甘草4份,菟丝子3份,杜仲2份,肉苁蓉3份,续断4份,狗脊5份,苏梗4份,党参6份,陈皮2份,南瓜蒂2份,苎麻根5份,莲子3份,山药3份,竹茹3份,油性原料10份,其中油性原料由橄榄油、单硬脂酸甘油酯依次按重量份数99.5:0.5组合经乳化制备而成。其制备方法与实施例1相同。
实施例3,一种固肾保胎乳膏,其原料组成按重量配比为:龟板胶9份,枸杞子6份,熟地6份,巴戟天5份,当归7份,白术6份,甘草5份,菟丝子4份,杜仲3份,肉苁蓉4份,续断5份,狗脊6份,苏梗5份,党参7份,陈皮3份,南瓜蒂3份,苎麻根6份,莲子4份,山药4份,竹茹4份,油性原料10份,其中油性原料由橄榄油、单硬脂酸甘油酯依次按重量份数99.5:0.5组合经乳化制备而成。其制备方法与实施例1相同。
在2009年7月-2015年3月期间,从寿光市某家医院,选取怀孕早期确诊中医肾阴虚症的孕妇,随机分为实验组和对照组,每组累计各跟踪100例。实验组使用本发明的固肾保胎乳膏,每次取乳膏6—7g,均匀涂抹于孕妇腹部以及后腰两侧的皮肤表面,轻柔按摩不少于30分钟,一日三次,连续用药28天停用,用药1周症状未减缓计为无效人数;对照组使用北京广大制药厂生产的固肾安胎丸,口服,一次1袋,一日3次,连续服用28天,用药1周症状未减缓计为无效人数。统计各组使用产品两周后至分娩期间孕妇的身体状况,实验结果见下表。
本发明固肾保胎乳膏与固肾安胎丸的使用效果对比表
结果显示,本发明的固肾保胎乳膏与固肾安胎丸相比,无效人数有所减少,保胎养胎效果相对较好,特别是肾阴虚症孕妇在使用本发明的固肾保胎乳膏后烦热盗汗、腰酸腿软、焦虑、头晕等伴发症状显著降低,较固肾安胎丸治疗效果更加明显。
典型病例:
病例1:仉某,40岁,生育二胎,妊娠43天,阴道少量出血,并伴有腰膝酸软、烦热盗汗,轻微头晕耳鸣症状。使用本发明固肾保胎乳膏涂抹腹部以及后腰两侧,每日三次,每次5-7g,涂抹后按摩30分钟,用药3天后流血症状明显缓解,用药7天后阴道无流血症状,耳鸣头晕、腰膝酸软症状减轻,继续巩固用药30天后上述症状彻底消失,停止用药,孕后期未再有复发,顺利生产一健康男婴。
病例2:徐某,26岁,生育一胎,妊娠47天,腰酸腿沉,夜梦多盗汗,伴有轻微耳鸣,情绪暴躁。使用本发明固肾保胎乳膏涂抹腹部以及后腰两侧,每日三次,每次约7g,轻缓按摩30分钟,用药1周后症状明显减缓,用药4周后症状彻底消失,其后又继续巩固使用1周后停用,期间及孕后期未再有复发,顺利生产一名健康女婴。
病例3:魏某,31岁,有数次流产史,未曾生育,就诊时妊娠45天,阴道少量出血,面色苍白,手脚冰冷,腹部胀痛,便溏,易惊。使用本发明固肾保胎乳膏涂抹腹部以及后腰两侧,每日三次,每次7g左右,涂抹后按摩30分钟,用药3天后腹痛、流血症状明显缓解,气色好转,用药8天后流血症状消失,用药28天后畏寒、腹泻基本消失,期间未再发生先兆性流产症状,其后减为每日用药两次,继续巩固用药到妊娠14周停止,期间及孕后期身体健康状况良好,顺利生产一健康女婴。
Claims (5)
1.一种固肾保胎乳膏,其特征是:由以下重量份的原料组成:龟板胶6-9份,枸杞子3-6份,熟地4-6份,巴戟天2-5份,当归5-7份,白术4-6份,甘草3-5份,菟丝子2-4份,杜仲1-3份,肉苁蓉2-4份,续断3-5份,狗脊4-6份,苏梗3-5份,党参5-7份,陈皮1-3份,南瓜蒂1-3份,苎麻根4-6份,莲子2-4份,山药2-4份,竹茹2-4份,油性原料5-15份。
2.如权利要求1所述的一种固肾保胎乳膏,其特征是:由以下重量份的原料组成:龟板胶8份,枸杞子5份,熟地5份,巴戟天4份,当归6份,白术5份,甘草4份,菟丝子3份,杜仲2份,肉苁蓉3份,续断4份,狗脊5份,苏梗4份,党参6份,陈皮2份,南瓜蒂2份,苎麻根5份,莲子3份,山药3份,竹茹3份,油性原料10份。
3.如权利要求1或2所述的一种固肾保胎乳膏,其特征是:所述的油性原料由橄榄油、单硬脂酸甘油酯依次按重量份数99.5:0.5组合经乳化制备而成。
4.如权利要求1或2所述的一种固肾保胎乳膏,其特征在于:所述乳膏为外用乳膏。
5.一种固肾保胎乳膏的制备方法,其特征是:由原料称取、药材浸泡、药材煎煮、油性原料制备、乳膏制备五个步骤制备而成:
(1)原料称取:按所述重量份数分别称取龟板胶,枸杞子,熟地,巴戟天,当归,白术,甘草,菟丝子,杜仲,肉苁蓉,续断,狗脊,苏梗,党参,陈皮,南瓜蒂,苎麻根,莲子,山药,竹茹,橄榄油,单硬脂酸甘油酯备用;
(2)药材浸泡:将称量好的药材混合均匀,加入药材总重量约5倍的去离子水,浸泡60分钟;
(3)药材煎煮:将浸泡好的药材加热至沸腾,文火煎煮90分钟后,过滤得一次药液与一次药渣;向一次药渣中加入药材总重量约3倍的去离子水加热至沸腾,文火煎煮45分钟后,过滤得二次药液;将一次药液与二次药液合并,得到混合药液;
(4)油性原料制备:将称量好的橄榄油、单硬脂酸甘油酯倒入容器内,再加入相对于橄榄油重量比10-20%的去离子水,搅拌混合,加热至80-95℃,强烈搅拌至完全乳化,保持油性原料在80-95℃;
(5)乳膏制备:将混合药液加热至80-95℃,然后将乳化后的油性原料加入到混合药液中,搅拌均匀,然后在小火上慢慢煎熬浓缩,得到60℃时相对密度为1.15-1.25的浓缩药膏,制得固肾保胎乳膏。
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