CN116650609A - 一种固肾育胎药剂及其制备方法 - Google Patents
一种固肾育胎药剂及其制备方法 Download PDFInfo
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Abstract
本发明涉及一种改善人体体质的中药制剂,具体公开了一种改善体质固肾育胎的中药制剂及其制备方法,该中药制剂包括以下组分:菟丝子,续断,桑寄生,附子,桂枝,归尾,川芎,蒲黄炭,红花,白芷,透骨草,艾叶,败酱草,千年健,三棱,莪术,石菖蒲,苍术,元胡,徐长卿,青皮,干姜和三七。本发明中药制剂对由于肾虚血瘀、寒凝气滞、痰湿瘀结所致的盆腔炎性疾病后遗症(SPID)有显著疗效。
Description
技术领域
本发明涉及一种改善人体体质的中药制剂,特别是涉及一种改善体质固肾育胎的中药制剂。本发明还涉及该药物的制备方法。
背景技术
目前,不孕不育在是现代生活中困扰育龄夫妇的问题之一,现代男性女性不孕不育的程度大幅上升已经到了一种前所未有的地步,显然已经成为了一种现代病,它属于中医妇科学的疑难杂病之一,发病率为10%-15%;古称“全不产”、“断绪”。不孕症虽不属一种严重疾病,但它却关系到家庭和睦和社会安定。WHO预测,不孕不育症将成为21世纪继心脑血管病、肿瘤之后,威胁人类健康的第三大疾病。不孕症的病因病机有虚实之分,虚证多因肾阴阳气血不足,实证多责之于肝气郁结或痰瘀为患。
固肾育胎生态疗法(SYT-E-T)是指在医疗过程中运用生态学原理,使医疗达到最佳效果的方法。固肾育胎生态疗法针对人体体质与生态环境的关系,在运用固肾育胎外敷的基础上综合四季四时的变化,选取平和体质的中药服用、敷贴经络穴位,结合现代医学检查(如内分泌激素、血常规分析、心电图检查等),调整体质平衡(通过纠正偏颇体质,调控机体内外环境至平衡状态),使人体脏腑、气血与阴阳平和,达到“阴平阳秘”,如愿得子的一种疗法,临床上主要用于生育有关的临床治疗与研究(包括不孕夫妇平衡调理,备孕夫妇孕前保健与优生调护以及妊娠妇女固肾安胎等),采用固肾育胎生态疗法,能有效地提高妊娠率。
发明内容
本发明的目的是提供一种改善体质固肾育胎的中药制剂,本外敷贴对盆腔炎性疾病后遗症有相当的疗效。
为了实现上述目的,本发明提供了一种具有“固肾调冲、养血通脉、温经散寒、消癥止痛”功效,主治由于肾虚血瘀、寒凝气滞、痰湿瘀结所致的盆腔炎性疾病后遗症。
一种固肾育胎药剂,该药剂为外敷药贴,由以下重量份比的组分组成:
菟丝子45-55份,续断20-30份,桑寄生20-30份,附子5-12份,桂枝18-25份,归尾10-20份,川芎10-20份,蒲黄炭20-30份,红花12-20份,白芷15-17份,透骨草45-55份,艾叶145-155份,败酱草115-125份,千年健95-105份,三棱18-25份,莪术24-27份,石菖蒲15-25份,苍术15-25份,元胡15-25份,徐长卿28-33份,青皮10-20份,干姜8-12份,三七10-18份。
本发明的最优配方为:菟丝子50份,续断25份,桑寄生25份,附子10份,桂枝20份,归尾15份,川芎15份,蒲黄炭25份,红花15份,白芷15份,透骨草50份,艾叶150份,败酱草120份,千年健100份,三棱20份,莪术25份,石菖蒲20份,苍术20份,元胡20份,徐长卿30份,青皮15份,干姜10份,三七15份,各组分的组成为重量份。
本发明的制备工艺为:选用23味中药材,烘干、粉碎、搅拌均匀、分装;具体步骤如下:
a.烘干:采用晒干法或阴干法;
a1.晒干法:将药材薄铺在透气框上晒干或置于太阳下暴晒;
a2.阴干法:将药材放在通风的室内,避免阳光直射,利用空气流通使药材水分自然蒸发达到干燥目的;
b.切片:将洗净软化后的药材根据质地软硬或个体大小、厚薄的不同,用机器切割成片状;
c.粉碎:将大块中药固体物质碎成适当细度;
d.分装、缝合:根据药量进行分装,定量分装置布包后将药袋缝合成包。
与现有技术相比较,实施本发明,具有如下有益效果:
本发明选取平和体质的中药服用、敷贴经络穴位,调整体质平衡,使人体脏腑、气血与阴阳平和,达到“阴平阳秘”,能有效地提高妊娠率。本发明中药制剂对由于肾虚血瘀、寒凝气滞、痰湿瘀结所致的盆腔炎性疾病后遗症(SPID)有显著疗效。
附图说明
图1-a为实施例1治疗前子宫B超图;
图1-b为实施例1治疗后子宫B超图;
图2-a为实施例2治疗前子宫B超图;
图2-b为实施例2治疗后子宫B超图;
图3-a为实施例3治疗前子宫B超图;
图3-b为实施例3治疗后子宫B超图;
图4-a为实施例4治疗前子宫B超图;
图4-b为实施例4治疗后子宫B超图。
具体实施方式
下面对本发明的具体实施方式作进一步详细描述。以下实施例用于说明本发明,但不用来限制本发明的范围。
中医体质学是中医基础理论的重要组成部分,是一门新兴学科。王琦教授等研究人员,对中医体质学从基础理论、实验研究、临床运用等方面进行了全面、系统的研究,为中医体质学的创立和发展奠定了良好的基础。“王琦中医体质九分法”阐述人体体质包括平和质、气虚质、阳虚质、阴虚质、痰湿质、湿热质、瘀血质、气郁质、特禀质等9种基本类型,不同体质类型在形体特征、生理特征、心理特征、病理反应状态、发病倾向等方面各有特点。九种体质的特点包括:平和型较正常,气虚型常无力,阴虚型最怕热,阳虚型最怕冷,湿热型爱出油,气郁型爱失眠,痰湿型易肥胖,血瘀型易健忘,特禀型会过敏。
根据不孕症病因病机有虚实之分,虚证多因肾阴阳气血不足,实证多责之于肝气郁结或痰瘀为患致不能养精育胎或不能摄精成孕的中医机制,本固肾育胎外敷贴基于肝气郁结或痰瘀为患,主要针对虚实夹杂之不孕症患者而设计。
肾主生殖,B型固肾育胎外敷方以固肾为本,针对器质性病变,本方同时着重活血、化瘀、消癥,菟丝子补益肝肾、固精缩尿、安胎,续断补肝肾、强筋骨、续折伤、安胎元,三七滋补,活血、化瘀、通络,故选用补肝肾之菟丝子、续断,滋补、活血、化瘀之三七为君药。
三七功能通能补,有补血,去瘀损,止血衄之功,是方药中之最珍贵者;“三七生吃,祛瘀生新,消肿定痛,并有止血不留淤血,行血不伤新的优点;熟服可补益健体。”《中药大词典》(1997年版);《本草纲目新编》记载:三七根,止血之神药也。无论上、中、下之血,凡有外越者,一味独用亦效,加入于补气补血药中则更神。盖此药得补而无沸腾之患,补红得此而有安静之休也。《本草纲目拾遗》记载:人参补气第一,三七补血第一,味同而功亦等,故称人参三七,为中药之最珍贵者。因此,常有“北人参南三七”之说,人参是补气的第一药物,三七是补血的第一药物。
1912年版《中国医药大辞典》记载:(1)三七功用补血,去瘀损,止血衄,能通能补,功效最良,是方药中之最珍贵者。三七生吃,去瘀生新,消肿定痛,并有止血不留瘀血,行血不伤新的优点;熟服可补益健体。(2)扩张血管的作用;(3)有较强的镇痛作用,具有抗疲劳、提高学习和记忆能力的作用;(4)抗炎症作用;(5)具有免疫调节剂的作用,能使过高或过低的免疫反应恢复到正常,但不干扰机体正常的免疫反应;(6)抗肿瘤作用;抑制疤痕增生。(7)抗衰老、抗氧化作用;(8)降低血脂及胆固醇作用;(9)保护肝脏。
桑寄生助菟丝子、续断补肝肾、安胎元;三药均入肝肾,均有补肝肾、强筋骨、壮腰膝、固冲任、通血脉之功;红花、蒲黄炭活血化瘀;温热之附子、干姜、艾叶温阳散寒;归尾、川芎、元胡行气活血;以上诸药合用,一则温阳行气,气血同治,一则寓通于补,补而不滞,共为臣药。
佐以三棱、莪术加强破血消癥;败酱草祛瘀止痛;石菖蒲、白芷、苍术、徐长卿、透骨草、千年健祛风胜湿止痛。
使药桂枝、青皮为引经药,引药力直达病所。23味药共奏固肾调冲、养血通脉、温经散寒、消癥止痛之功。
本发明中药配方中菟丝子具有补肾益精的功效,可以治疗肾虚、阳痿、遗精、尿有余沥、遗尿、尿频,腰膝酸软以及白带过多;同时具有安胎的功效,可治胎动不安;菟丝子还可增强性功能,有温脾止泻之功效,治疗脾虚,脾肾虚泻,食少便溏。
续断:补肝肾,强筋骨,定经络,续折伤,止经中(筋骨)酸痛,安胎元,治妇人白带,生新血,破瘀血,落死胎,止咳嗽咳血,治赤白便浊。《滇南本草》:“补肝,强筋骨,定经络,止经中(筋骨)酸痛,安胎,生新血,破瘀血,止咳嗽咳血。”
桑寄生:可以养血、益肝肾、祛风湿、强筋骨,还有益精血,安胎的效果,可用于治疗妊娠期的相关疾病如胎漏血崩,以及产后乳汁少等。
附子:补益阳气,主要适用于肾阳不足、畏寒的患者,附子可疏通机体经络,尤其对于补益肾阳有显著的疗效。
归尾:补血活血,调经止痛,润肠通便;用于血虚萎黄、眩晕心悸、月经不调、经闭痛经、虚寒腹痛、肠燥便秘、风湿痹痛、跌扑损伤、痈疽疮疡。
盆腔炎性疾病后遗症临床主要表现是组织破坏,广泛的粘连、增生,以及瘢痕的形成,从而导致了临床上常见的输卵管阻塞,形成包块,以及输卵管伞端的闭锁,造成了输卵管的积水。
中医认为盆腔炎性后遗症,一般表现为不孕,输卵管粘连阻塞可导致不孕。急性盆腔炎性疾病后遗症不孕发生率在20%到30%。盆腔炎性疾病后遗症异位妊娠发生率是正常女性的八到十倍,还有就是慢性的盆腔痛,炎症形成粘连、瘢痕时,就会引起盆腔部位疼痛。
本发明外敷药贴对盆腔炎性疾病后遗症所致的盆腔痛以及轻度输卵管积水、病理性盆腔积液有明显疗效,从而达到固肾育胎的效果。
本发明的使用方法为:
1、先用水浸湿药包。
2、水滚烫后转文火蒸煮二十分钟。
3、蒸煮后浇上适量白酒。
4、待药包冷却至适温时(42°)外敷关元穴。
5、于药包上覆盖热毛巾,使药味渗透直达经络脏腑,并防止药效挥发。
6、每日1包,每包用3-5次,每次30分钟以上。
进行临床治疗试验,使用发明药物贴于关元穴,每天贴敷一次,以21次为一疗程,一疗程后重新评价体质。疗效判定标准:通过观察固肾育胎生态疗法九种体质的疗效评价指标(疗程≤6),针对就诊的不孕症患者,其中,诊断为盆腔炎性疾病后遗症不孕236例,进行固肾育胎生态疗效临床研究,找出盆腔炎性疾病后遗症不孕的最佳治疗方案:采用本发明的固肾育胎生态外敷+生态疗法+常规疗法。
1、研究对象
收集2020年01月~2021年07月就诊于汕头市中心医院和汕头市中心医院康复分院中医妇科的盆腔炎性疾病后遗症不孕患者236例,随机分2组,各118例,全部病例均取得患者的同意且符合纳入和排除标准。
2、诊断标准
参照2018年人民卫生出版社第九版《妇产科学》中输卵管炎性不孕的诊断标准,规定输卵管炎性不孕的诊断标准为:有未避孕1年及以上未孕病史;临床表现为少腹、腰骶部不同程度酸痛,下坠感,白带多,且在经期、劳累、性生活后症状加重,伴有月经不调;妇科检查子宫单侧或双侧可触及囊性长圆性肿物,活动受限,有压痛;B超检查可见单侧或双侧呈长条形无回声暗区或盆腔积液(深度>2cm的病理性盆腔积液);输卵管造影显示单侧或双侧输卵管伞端闭锁积液。
3、纳入标准
A.符合输卵管炎性不孕的诊断标准;
B.年龄在21~45岁的妇女;
C.配偶精液常规检查未见异常(按WHO第5版标准);
D.知情同意、自愿接受治疗,并可追踪观察者。
4、排除标准
A.依从性差,因各种原因不愿或不能参加调查者;
B.合并心脑血管、肝脏、肾脏、血液系统的严重疾病以及恶性肿瘤、精神疾病者;
C.严重皮肤感染、溃疡、瘢痕者;
5、脱落、剔除或中止标准
A.填写资料不全、无法计算、统计者;
B.研究未结束因各种原因退出或失访者;
C.未按规定用药或检查者;
D.治疗中发生严重的并发症或不良反应者。
6、分组与治疗
将纳入研究的患者按照初诊的时间顺序从1~236进行编号,用IBM SPSS 26.0统计软件将编号随机分为a、b两组,编号对应的患者即进入不同组别采用不同治疗方法。a组采用固肾育胎本发明生态外敷贴+生态疗法+常规疗法,b组单纯采用生态疗法+常规疗法,进行临床观察研究。
7、疗程
1个月经周期为1个疗程,共治疗并观察6个疗程。
8、疗效标准:疗效评定分为三个等级,治愈、有效和无效。
A.治愈:顺利妊娠,或腹痛、腰骶部酸痛、月经失调等症状及体征均完全消失,超声检查显示输卵管通畅,输卵管积液消失;
B.有效:腹痛症状偶然发生,妇科检查体征减少,月经恢复正常,超声检查提示输卵管有少量积液,积液暗区缩小2/3以上;
C.无效:未达到上述标准,仍小腹隐痛,且经B超显示输卵管积液无明显改变。
9、统计学方法
所有资料录入Excel数据表,同时采用Excel软件系统和IBM SPSS 26.0统计软件进行分类统计。计数资料采用均数±标准差,使用Pearson卡方检验和秩和检验对数据进行各观察因素多组间频率或构成比的比较。
表一两组患者临床疗效比较(例)(%)
注:与治疗组比较,▲P<0.05。
a组总有效率为93.22%,b组总有效率为72.03%,两组相比有统计学意义(P<0.05)。
a组妊娠率为27.12%,b组妊娠率为6.78%,两组相比有统计学意义(P<0.05)。
具体实际例子
实施例1
郭某,23岁,因未避孕1年余未孕来诊。平素腰骶部时感酸痛及下坠感,月经多推迟。妇科检查发现子宫大小正常,活动差,左侧附件触及囊性包块。查B超,如图1-a所示:左侧附件区索形液性暗区(输卵管积水可能)。治疗上予外敷本发明固肾育胎生态外敷、口服中药汤剂以及生态疗法,经治5个疗程后左侧输卵管积水消失,如图1-b所示。
汤剂具体药物如下:
少腹逐瘀汤加减,选用当归18g、川芎12g、赤芍12g、官桂3g、小茴香(炒)5g、干姜6克、延胡索10克、没药12克、生蒲黄18克、五灵脂(炒)12克、大腹皮15g、茯苓皮15g、甘草6g,巴戟天10g、续断12g;党参12g、黄芪15g。
本实施例采用的外敷贴的配方为:菟丝子45份,续断25份,桑寄生25份,附子10份,桂枝20份,归尾15份,川芎15份,蒲黄炭25份,红花15份,白芷15份,透骨草50份,艾叶150份,败酱草120份,千年健100份,三棱20份,莪术25份,石菖蒲20份,苍术20份,元胡20份,徐长卿30份,青皮15份,干姜10份,三七18份。
制备:将上述中药烘干、粉碎、搅拌混匀、分装。
(1)烘干:阴干法:通常将药材放在通风的室内,避免阳光直射,利用空气流通,使药材水分自然蒸发达到干燥的目的。
(2)切片:将洗净软化后的药材,根据质地软硬或个体大小、厚薄等不同,用机器切制成片状的过程。
(3)粉碎:是借助机械力将大块中药固体物质碎成适当细度的操作过程。
(4)分装、缝合。
①分装:根据药量的多少选择相应的量杯进行分装。
②缝合:将药材定量分装置布包后,将药袋缝合成包。
实施例2
邹某,28岁,婚后3年不孕,伴下腹坠痛,每于经期症状加重来诊。B超提示右侧输卵管积液,直径约5.4mm。输卵管造影提示右侧输卵管通而不畅,如图2-a所示。予局部外敷固肾育胎生态外敷B贴,口服中药汤剂行积祛瘀、通经止痛以及固肾育胎生态疗法,患者经6个疗程治疗后B超复查右侧输卵管积液消失,如图2-b所示。停药后3个月因停经36天来诊,行尿妊娠实验检查为阳性,B超证实为宫内早孕。
汤剂具体药物如下:
选用当归18g、川芎12g、赤芍12g、小茴香(炒)5g、干姜6克、延胡索15克、没药15克、生蒲黄18克、五灵脂(炒)12克、桃仁10g、厚朴10g、桂枝10g、大腹皮15g、茯苓皮15g、甘草6g中药。
本实施例采用的外敷贴的配方为:菟丝子45份,续断20份,桑寄生20份,附子6份,桂枝20份,归尾10份,川芎11份,蒲黄炭20份,红花12份,白芷15份,透骨草45份,艾叶150份,败酱草115份,千年健95份,三棱18份,莪术25份,石菖蒲15份,苍术15份,元胡18份,徐长卿30份,青皮10份,干姜10份,三七12份。
制备方法与实施例1相同。
实施例3
胡某,女,28岁,出现下腹坠痛、腰骶部酸痛2个月,常在劳累、性交后及月经期加重,伴有白带增多色黄,患者常感乏力、情绪不安、睡眠障碍等。B超,如图3-a所示:盆腔可见液性暗区深约26mm。西医诊断:病理性盆腔积液;中医诊断:妇人腹痛(肾虚血瘀证)。
予中药汤剂补肾活血、通络止痛,同时使用固肾育胎生态外敷B贴进行外敷关元穴,每次30分钟,每日2次,以21次为一疗程。治疗6个疗程后复查B超,如图3-b所示,盆腔积液消失、妇检示双附件压痛(-),腹痛、腰酸症状消失,白带正常。
本实施例采用的外敷贴的配方为:菟丝子50份,续断25份,桑寄生25份,附子10份,桂枝20份,归尾15份,川芎15份,蒲黄炭25份,红花15份,白芷15份,透骨草50份,艾叶150份,败酱草120份,千年健100份,三棱20份,莪术25份,石菖蒲20份,苍术20份,元胡20份,徐长卿30份,青皮15份,干姜10份,三七15份。
制备方法与实施例1相同。
实施例4
林某,女,36岁,反复下腹坠胀疼痛1年余,未予规范治疗。2020年10月因症状加重,持续不已来诊。平素腰酸如折,带下量多,色白质稠,面色晦暗,两颧黯斑,口干不思饮,纳呆,神疲乏力,二便自调,舌紫黯边有瘀斑,苔薄白,脉沉弦。B超如图4-a所示,盆腔可见液性不规则暗区,深约31mm。西医诊断:病理性盆腔积液;中医诊断:妇人腹痛(气虚血瘀证)。
予中药汤剂补气活血、通络止痛,同时使用固肾育胎生态外敷B贴进行外敷关元穴,每次30分钟,每日2次,以21次为一疗程。治疗5个疗程后复查B超如图4-b所示,盆腔积液消失、妇检示双附件压痛(-),腹痛、腰酸症状消失,白带正常。
外敷贴具体配方为:菟丝子55份,续断30份,桑寄生28份,附子12份,桂枝25份,归尾20份,川芎20份,蒲黄炭30份,红花20份,白芷17份,透骨草55份,艾叶155份,败酱草125份,千年健105份,三棱25份,莪术25份,石菖蒲25份,苍术25份,元胡25份,徐长卿30份,青皮20份,干姜10份,三七18份。
制备方法与实施例1相同。
综上,本发明的目的是提供一种改善体质固肾育胎的中药制剂,能治疗由于肾虚血瘀、寒凝气滞、痰湿瘀结所致的盆腔炎性疾病后遗症,从而达到固肾育胎的效果。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员来说,在不脱离本发明技术原理的前提下,还可以做出若干改进和替换,这些改进和替换也应视为本发明的保护范围。
Claims (3)
1.一种固肾育胎药剂,其特征在于,该药剂为外敷药贴,由以下重量份比的组分组成:
菟丝子45-55份,续断20-30份,桑寄生20-30份,附子5-12份,桂枝18-25份,归尾10-20份,川芎10-20份,蒲黄炭20-30份,红花12-20份,白芷15-17份,透骨草45-55份,艾叶145-155份,败酱草115-125份,千年健95-105份,三棱18-25份,莪术24-27份,石菖蒲15-25份,苍术15-25份,元胡15-25份,徐长卿28-33份,青皮10-20份,干姜8-12份,三七10-18份。
2.根据权利要求1所述的药剂,其特征在于,由以下重量份比的组分组成:
菟丝子50份,续断25份,桑寄生25份,附子10份,桂枝20份,归尾15份,川芎15份,蒲黄炭25份,红花15份,白芷15份,透骨草50份,艾叶150份,败酱草120份,千年健100份,三棱20份,莪术25份,石菖蒲20份,苍术20份,元胡20份,徐长卿30份,青皮15份,干姜10份,三七15份。
3.一种权利要求1所述药剂的制备方法,其特征在于制备工艺为:选用23味中药材,烘干、粉碎、搅拌均匀、分装;具体步骤如下:
a.烘干:采用晒干法或阴干法;
a1.晒干法:将药材薄铺在透气框上晒干或置于太阳下暴晒;
a2.阴干法:将药材放在通风的室内,避免阳光直射,利用空气流通使药材水分自然蒸发达到干燥目的;
b.切片:将洗净软化后的药材根据质地软硬或个体大小、厚薄的不同,用机器切割成片状;
c.粉碎:借助机械力将大块中药固体物质碎成适当细度;
d.分装、缝合:根据药量进行分装,定量分装置布包后将药袋缝合成包。
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