CN105770815A - 一种含有艾叶的治疗产后虚脱的中药组合物及其制备方法 - Google Patents
一种含有艾叶的治疗产后虚脱的中药组合物及其制备方法 Download PDFInfo
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Abstract
本发明属于中药技术领域,具体涉及一种含有艾叶的治疗产后虚脱的中药组合物及其制备方法。该中药组合物包括以下重量份数的制备原料:艾叶25‑35份、五味子20‑33份、黄芪18‑30份、当归19‑25份、丹参18‑20份、益母草15‑18份、女贞子12‑18份、桂枝10‑15份、茯苓9‑13份、干姜5‑13份和甘草6‑16份。本发明中药组方由纯天然中草药组成,配伍合理、主次分明、调治结合,具有理气顺血、益气生精、清心除烦和温中散寒的疗效,临床试验证明能够有效缓解产妇产后出现的面色苍白、周身出汗、四肢发冷、头晕、乏力等症状,同时具有成本低廉、药效稳定、携带和服用方便、疗效好、治愈率高、无副作用的优点。
Description
技术领域
本发明属于中药技术领域,涉及一种含有艾叶的治疗产后虚脱的中药组合物及其制备方法。
背景技术
产后虚脱是指产妇产后出现面色苍白、周身出汗、四肢发冷的体征,主要为头晕、乏力,有的出现恶心呕吐,甚者晕厥。产后虚脱常常见于产妇产后第1次下床活动或上厕所时。体格检查发现:血压偏低、脉搏细数。根据病史、临床表现及体征即可确诊。
其发病机制为:胎盘排出后,由于胎盘子宫血液循环的停止、子宫缩复导致多量血液从子宫血窦涌入血循环,又由于静脉压下降使组织间液回入血循环,故全身循环量大增,心率变快,心排血量较产前增加10%~20%;再加上在整个分娩过程中,产妇能量及氧的消耗量大大增加,产后大量出汗,可能导致有轻度的酸碱平衡失调或轻度的电解质紊乱,但有些虚脱者并未出现电解质的变化。
产后虚脱常常伴随着电解质紊乱等多种并发症,严重者出现头晕、心慌、虚脱、四肢发冷等症状,对于哺乳期的妇女生活带来了很大的困扰。因此,及时对孕妇产后虚脱进行恢复治疗是很有必要的。
中医治疗具有丰富的用药经验和坚实的中医药理论基础,具有辩证不辨病的特点,中医用药讲求君、臣、佐、使,诸药协调相和、相辅相成,具有成本低、疗效好、见效快、毒副作用小等优势,在治疗产后虚脱方面往往会有奇效。
目前公开的治疗产后虚脱的发明专利尚少。中国专利申请201510063815.9公开了一种用于治疗产后虚脱的中药制剂,其有效成分的原料组成为:山药、党参、一点血、鸡肉、三月花、叶上珠、莲子、百合、淡菜、石耳、补血草、川芎、桑叶、山茱萸、槐花和飞廉。该发明中药虽然具有一定的有祛风清热、活血行气、补益肝肾的疗效,能够减轻患者的产后虚脱病症,但是,该发明药物组方复杂,配伍欠缺合理,用药量大,以缓补为主则药疗效缓、见效慢、治疗时间长、使用不便。
发明内容
本发明克服了现有技术的不足,本发明提供了一种含有艾叶的治疗产后虚脱的中药组合物及其制备方法。本发明中药组合物通过选择合适的药材及调节配伍,标本兼治,能够有效地理气顺血、益气生精、清心除烦、温中散寒、回阳通络、活血止痛、平冲降气,具有成本低廉、配伍合理、药效稳定、针对性强、治愈率高、无副作用等优势。
为实现本发明的目的,发明人依据中医理论的研究及临床反复的试验和验证,其技术方案如下:
一种含有艾叶的治疗产后虚脱的中药组合物,包括以下重量份数的制备原料:
艾叶25-35份、五味子20-33份、黄芪18-30份、当归19-25份、丹参18-20份、益母草15-18份、女贞子12-18份、桂枝10-15份、茯苓9-13份、干姜5-13份和甘草6-16份。
在该重量份数的范围内,优选了3个疗效较为显著的配方:
配方1:艾叶25份、五味子20份、黄芪18份、当归19份、丹参18份、益母草15份、女贞子12份、桂枝10份、茯苓9份、干姜5份和甘草6份。
配方2:艾叶35份、五味子33份、黄芪30份、当归25份、丹参20份、益母草18份、女贞子18份、桂枝15份、茯苓13份、干姜13份和甘草16份。
配方3:艾叶30份、五味子26份、黄芪24份、当归22份、丹参19份、益母草17份、女贞子15份、桂枝13份、茯苓11份、干姜9份和甘草11份。
相应地,本发明还提供一种所述中药组合物的制备方法,包括以下步骤:
S1、称取各味原料药材,分别去杂质,洗净,烘干,切片后粉碎成粗粉;
S2、取艾叶粗粉,加入粗粉总重量8-10倍量体积分数为60-80%的乙醇,微波提取8-15分钟,微波功率为240-300W,提取温度为40-60℃,过滤并保留艾叶药渣,滤液减压浓缩至55-60℃下测相对密度为1.20-1.25的浸膏,制得艾叶提取物;
S3、将五味子、黄芪、当归、丹参和甘草粗粉混匀,按照粗粉总重量的5-10倍量加入体积浓度为75-95%的乙醇溶液,浸泡18-24h,再回流提取2-6次,每次3-6h,过滤并保留滤渣,合并滤液,滤液经碱化后冷藏静置12-24h,再过滤,所得滤液经减压浓缩和微波干燥得浸膏物I;
S4、将益母草、女贞子、桂枝、茯苓、干姜以及S2所述艾叶滤渣和S3所述的滤渣混匀,按照粗粉总重量的7-9倍量加入纯化水,煎煮2-3次,每次3-6小时,过滤,合并滤液,并浓缩至55-60℃相对密度为1.20-1.25的浸膏物II;
S5、将艾叶提取物、浸膏物I和II充分混合,离心喷雾干燥制得本发明中药组合物原料药细粉,其中,进风温度为120-130℃,出风温度为65-75℃。
进一步地,利用现代通用的中药组合物技术,本发明中药组合物可被制成片剂、胶囊剂、丸剂、颗粒剂或散剂等临床常用制剂,方便患者携带和服用。
本发明中药组方所用中药材的来源、性味、归经及功效:
艾叶:本品为菊科植物艾的干燥叶;味辛、苦,性温;归肝、脾、肾经;具有散寒止痛、理气顺血、逐寒祛湿的药效。
五味子:本品为木兰科植物五味子的干燥成熟果实;味酸、甘,性温;归肺、心、肾经;具有收敛固涩、益气生津、补肾宁心的药效。
黄芪:本品为豆科植物红花岩黄芪的根;味甘、性温;归心、肺、脾、肾经;具有补气固表、利尿、托毒排脓、生肌敛疮的药效。
当归:本品为伞形科植物当归的干燥根;味甘、辛,性温;归肝、心、脾经;具有补血活血、调经止痛、润肠通便的药效。
丹参:本品为唇形科植物丹参的干燥根及根茎;味苦,性微寒;归心、肝经;具有祛瘀止痛、活血通经、清心除烦的药效。
益母草:本品为唇形科植物益母草的新鲜或干燥地上部分;味苦、辛,性微寒;归肝、心包经;具有活血调经、利尿消肿的药效。
女贞子:本品为木犀科女贞属植物女贞的果实;味甘、苦,性凉;归肝、肾经;具有补肝肾、强腰膝的药效。
桂枝:本品为樟科植物肉桂的干燥嫩枝;味辛、甘,性温;归心、肺、膀胱经;具有发汗解肌、温通经脉、助阳化气、平冲降气的药效。
茯苓:本品为多孔菌科真菌茯苓的干燥菌核;味甘、淡,性平;归心、肺、脾、肾经;具有利水渗湿、健脾宁心的药效。
干姜:本品为姜科植物姜的干燥根茎;味辛、性热;归脾、胃、肾、心、肺经。具有温中散寒、回阳通脉、燥湿消痰的药效。
甘草:本品为豆科植物甘草干燥根;味甘,性平;归心、肺、脾、胃经;具有补脾益气、清热解毒、祛痰止咳、缓急止痛,缓解药物毒性、烈性,调和诸药的功效。
本发明中药组合物的配伍分析:
本发明中药组合物的组方依据中医药基础理论对产后虚脱的辨证认知,遵循中药的配伍理论,强化了药材的使用量。该组方是以艾叶和五味子为君药,理气顺血、逐寒祛湿、补气固表、散寒止痛;以黄芪、当归和丹参为臣药,补血活血、祛瘀止痛、清心除烦、活血通经;以益母草、女贞子、桂枝、茯苓和干姜为佐药,收敛固涩、益气生津、发汗解肌、助阳化气;以甘草为使药,补脾益气、缓急止痛、调和诸药药性。诸药配合,相辅相成,协同作用,共奏温中散寒、回阳通络、活血止痛、平冲降气的功效,对治疗产后虚脱具有十分显著的疗效。
与现有技术相比,本发明中药具有以下优势:
1、本发明中药组合物完全符合《中药符合中华人民共和国药典》相关规定,由纯天然中草药组成,配伍合理、诸药协同、侧重调理,具有很好的理气顺血、益气生精、清心除烦、温中散寒之功效,对各种产后虚脱症状疗效显著。
2、本发明中药组合物的药材有效成分采用现代工艺充分提纯,从而提高了药材的生物利用度;成分简单,更有利于质量控制;药效稳定;生产工艺简单、环保且成本低,适合于工业化大生产。
3、临床试验证明本发明中药组合物能够有效缓解产妇产后出现的面色苍白、周身出汗、四肢发冷、头晕、乏力等体征,具有疗效好、治愈率高、无副作用的优点。
具体实施方式
以下将通过具体实施例对本发明进行进一步描述,但本发明不仅仅限于以下实施例。本领域技术人员应理解为,本发明除以下实施例外,在不脱离本发明的内容、精神和范围的条件下对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,均包含在本发明的范围之内。
实施例1
本发明实施例1中药组合物由以下重量份数的制备原料组成:
艾叶25份、五味子20份、黄芪18份、当归19份、丹参18份、益母草15份、女贞子12份、桂枝10份、茯苓9份、干姜5份和甘草6份。
制备方法如下:
S1、称取各味原料药材,分别去杂质,洗净,烘干,切片后粉碎成粗粉;
S2、取艾叶粗粉,加入粗粉总重量9倍量体积分数为70%的乙醇,微波提取10分钟,微波功率为250W,提取温度为50℃,过滤并保留艾叶药渣,滤液减压浓缩至60℃下测相对密度为1.20的浸膏,制得艾叶提取物;
S3、将五味子、黄芪、当归、丹参和甘草粗粉混匀,按照粗粉总重量的8倍量加入体积浓度为80%的乙醇溶液,浸泡24h,再回流提取3次,每次3h,过滤并保留滤渣,合并滤液,滤液经碱化后冷藏静置12h,再过滤,所得滤液经减压浓缩和微波干燥得浸膏物I;
S4、将益母草、女贞子、桂枝、茯苓、干姜以及S2所述艾叶滤渣和S3所述的滤渣混匀,按照粗粉总重量的8倍量加入纯化水,煎煮2次,每次3小时,过滤,合并滤液,并浓缩至60℃相对密度为1.20的浸膏物II;
S5、将艾叶提取物、浸膏物I和II充分混合,离心喷雾干燥制得本发明中药组合物原料药细粉,其中,进风温度为120℃,出风温度为65℃;
S5、利用现代通用药物制剂技术,向原料药细粉中添加相应的辅料,制备成胶囊剂。
实施例2
本发明实施例2中药组合物由以下重量份数的制备原料组成:
艾叶35份、五味子33份、黄芪30份、当归25份、丹参20份、益母草18份、女贞子18份、桂枝15份、茯苓13份、干姜13份和甘草16份。
制备方法同实施例1。
实施例3
本发明实施例3中药组合物由以下重量份数的制备原料组成:
艾叶30份、五味子26份、黄芪24份、当归22份、丹参19份、益母草17份、女贞子15份、桂枝13份、茯苓11份、干姜9份和甘草11份。
制备方法同实施例1。
本发明中药组合物对产后虚脱临床患者志愿者的疗效观察
1、一般资料
选取2013年7月-2015年3月在广州某医院分娩并出现产后虚脱症的临床志愿者100例。患者年龄为18-35岁,平均年龄为26岁。将所有临床志愿者随机分成对照组和治疗组两组,每组各50人,两组患者的年龄和产后虚脱严重程度等方面无显著差异(P>0.05),具有可对比性。
2、治疗方法
实验组:服用实施例3制备的中药组合物胶囊剂,餐后1-2小时口服,每日2次,一次2粒(含生药量250mg/粒),5天为一个疗程,治疗3个疗程。
对照组:服用芪芳气血颗粒(国药准字B20020825,恒拓集团广西圣康制药有限公司),开水冲服,每日3次,一次15g,5天为一个疗程,治疗3个疗程。
3、疗效评定标准
参照我国卫生部编写的《临床常见疾病诊治规范》。
治愈:面色苍白、全身出汗、四肢发凉、心慌头晕等症状消失,面色红润,体力逐渐恢复。
有效:上述症状有所缓解,面色好转,但体力仍感不足。
无效:病症无变化。
4、治疗效果
表1两组患者的临床疗效评价
组别 | 例数 | 治愈例(率) | 有效例(率) | 无效例(率) | 总有效率 |
实验组 | 50 | 38(76.0%) | 8(16.0%) | 4(8.0%) | 92.0% |
对照组 | 50 | 16(32.0%) | 22(44.0%) | 12(24.0%) | 76.0% |
由表1可以看出,口服本发明中药组合物的50例产后虚脱症临床志愿者,超过一半的产妇(38例,治愈率为76.0%)达到治愈的效果,明显优于阳性对照药芪芳气血颗粒的治愈效果(治愈率为32.0%)。此外,口服本发明中药组合物治疗的总有效率高达92.0%,亦优于阳性对照药物。
5、不良反应
通过观察诊断和产妇反馈,所有临床患者志愿者在口服本发明中药组合物后血压稳定,身心愉悦、身体状态佳,未出现任何不良症状。
可见,本发明中药组合物临床疗效好,无毒副作用,安全有效。
Claims (6)
1.一种含有艾叶的治疗产后虚脱的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:
艾叶25-35份、五味子20-33份、黄芪18-30份、当归19-25份、丹参18-20份、益母草15-18份、女贞子12-18份、桂枝10-15份、茯苓9-13份、干姜5-13份和甘草6-16份。
2.根据权利要求1所述的含有艾叶的治疗产后虚脱的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:
艾叶25份、五味子20份、黄芪18份、当归19份、丹参18份、益母草15份、女贞子12份、桂枝10份、茯苓9份、干姜5份和甘草6份。
3.根据权利要求1所述的含有艾叶的治疗产后虚脱的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:
艾叶35份、五味子33份、黄芪30份、当归25份、丹参20份、益母草18份、女贞子18份、桂枝15份、茯苓13份、干姜13份和甘草16份。
4.根据权利要求1所述的含有艾叶的治疗产后虚脱的中药组合物,其特征在于,所述中药组合物包括以下重量份数的制备原料:
艾叶30份、五味子26份、黄芪24份、当归22份、丹参19份、益母草17份、女贞子15份、桂枝13份、茯苓11份、干姜9份和甘草11份。
5.根据权利要求1-4任一所述的含有艾叶的治疗产后虚脱的中药组合物,其特征在于,所述中药组合物制成片剂、胶囊剂、丸剂、颗粒剂或散剂。
6.根据权利要求1-4任一所述的含有艾叶的治疗产后虚脱的中药组合物的制备方法,其特征在于,所述中药组合物的制备方法包括以下步骤:
S1、称取各味原料药材,分别去杂质,洗净,烘干,切片后粉碎成粗粉;
S2、取艾叶粗粉,加入粗粉总重量8-10倍量体积分数为60-80%的乙醇,微波提取8-15分钟,微波功率为240-300W,提取温度为40-60℃,过滤并保留艾叶药渣,滤液减压浓缩至55-60℃下测相对密度为1.20-1.25的浸膏,制得艾叶提取物;
S3、将五味子、黄芪、当归、丹参和甘草粗粉混匀,按照粗粉总重量的5-10倍量加入体积浓度为75-95%的乙醇溶液,浸泡18-24h,再回流提取2-6次,每次3-6h,过滤并保留滤渣,合并滤液,滤液经碱化后冷藏静置12-24h,再过滤,所得滤液经减压浓缩和微波干燥得浸膏物I;
S4、将益母草、女贞子、桂枝、茯苓、干姜以及S2所述艾叶滤渣和S3所述的滤渣混匀,按照粗粉总重量的7-9倍量加入纯化水,煎煮2-3次,每次3-6小时,过滤,合并滤液,并浓缩至55-60℃相对密度为1.20-1.25的浸膏物II;
S5、将艾叶提取物、浸膏物I和II充分混合,离心喷雾干燥制得本发明中药组合物原料药细粉,其中,进风温度为120-130℃,出风温度为65-75℃。
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