CN105456924A - 含有艾叶的具有活血化瘀功能的中药制剂及其制备方法 - Google Patents
含有艾叶的具有活血化瘀功能的中药制剂及其制备方法 Download PDFInfo
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- CN105456924A CN105456924A CN201510941652.XA CN201510941652A CN105456924A CN 105456924 A CN105456924 A CN 105456924A CN 201510941652 A CN201510941652 A CN 201510941652A CN 105456924 A CN105456924 A CN 105456924A
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Abstract
本发明属于中药领域，涉及含有艾叶的具有活血化瘀功能的中药制剂及其制备方法。该中药制剂由以下重量份的药材制备而成：艾叶10-18份、鸡血藤12-20份、远志10-18份、川芎12-22份、三七10-16份、当归8-16份、桂枝6-14份、毛冬青8-14份、丹参6-16份、莪术6-12份、肉桂4-8份和甘草4-8份。该中药制剂具有活血舒筋，消肿定痛，温通经脉，清心除烦的功效，能显著地改善血瘀症状，此外还具有疗效好，副作用低，服用方便等优点。
Description
技术领域
本发明属于中药领域，具体涉及含有艾叶的具有活血化瘀功能的中药制剂及其制备方法。
背景技术
血瘀是指中医辨证中的一种证型。血瘀即血液运行不畅，有瘀血。血瘀证可见于很多种疾病。一般而论，凡离开经脉之血不能及时消散和瘀滞于某一处，或血流不畅，运行受阻，郁积于经脉或器官之内呈凝滞状态，都叫血瘀。引起血瘀的原因有三种：一是外伤而没有伤口仅在局部造成瘀块肿痛；二是血液运行不畅或无力；三是受寒气或热气影响，导致血液滞留。血瘀证以刺痛不移，拒按，肿块，出血，唇舌爪甲紫暗，脉涩等为辨证要点。血瘀症可见于很多种疾病，如胸痹心痛、冠心病、中风、脑血管病、肝病、肝纤维化和不孕症等疾病。
活血化瘀，是指用具有消散作用的、或能攻逐体内瘀血的药物治疗瘀血病证的方法，有通畅血脉，消散瘀滞，调经止痛的作用。适用范围包括瘀阻于肺所致的胸痛咳血；瘀阻于肝所致的胁痛痞块；瘀阻于胞宫所致的小腹疼、月经不调、痛经等；瘀阻于肢体所致的局部肿痛青紫和瘀阻于脉络所致的半身不遂等。
中医药为我国的传统瑰宝，其在治疗血瘀方面积累了丰富的临床经验和治疗理论。中国专利申请201310147074.3的发明专利公开了一种活血化瘀中药组合物，该中药组合物由以下原料组成：灯盏细辛、丹参、红花、没药、木通、独活和三七组成。该中药组合物成分简单，但是该药物治疗周期较长，疗效一般。
发明内容
本发明的目的在于提供含有艾叶的具有活血化瘀功能的中药制剂，该中药制剂具有活血化瘀功效，能有效治疗血瘀。
本发明所述含有艾叶的具有活血化瘀功能的中药制剂由以下重量份的药材制备而成：
艾叶10-18份、鸡血藤12-20份、远志10-18份、川芎12-22份、三七10-16份、当归8-16份、桂枝6-14份、毛冬青8-14份、丹参6-16份、莪术6-12份、肉桂4-8份和甘草4-8份。
在该重量份的药材范围内，优选了3个疗效较为显著的配方：
配方1：艾叶10份、鸡血藤12份、远志10份、川芎12份、三七10份、当归8份、桂枝6份、毛冬青8份、丹参6份、莪术6份、肉桂4份和甘草4份。
配方2：艾叶18份、鸡血藤20份、远志18份、川芎22份、三七16份、当归16份、桂枝14份、毛冬青14份、丹参16份、莪术12份、肉桂8份和甘草8份。
配方3：艾叶14份、鸡血藤16份、远志14份、川芎16份、三七12份、当归12份、桂枝10份、毛冬青10份、丹参10份、莪术9份、肉桂6份和甘草6份。
相应地，本发明还提供所述中药制剂的制备方法，包括下述步骤：
S1：分别按比例称取各味药材，去杂质，洗净，烘干，切片后粉碎成粗粉，备用；
S2：取鸡血藤粗粉，加入药材总重量8-10倍量体积分数为60-80％的乙醇，再加入药材总量0.8-1.2％的纤维素酶，在35-45℃下浸提1-2小时，然后在80-95℃回流提取3-5小时，过滤并保留鸡血藤滤渣，滤液减压浓缩至60℃下相对密度为1.05-1.15的浸膏，制得鸡血藤提取物；
S3：取艾叶、远志、川芎、三七、当归、桂枝、毛冬青、丹参、莪术、肉桂和甘草粗粉，合并S2所述的鸡血藤残渣，加入粗粉总量8-10倍量的水浸泡2-4小时，然后煎煮3次，每次2-4小时，过滤并保留滤渣，合并滤液，滤液进行真空减压浓缩，得水提浓缩液；
S4：往S3所述的滤渣中加入药材总量8-10倍量体积分数为75-85％的乙醇，回流提取2-3次，每次3-5小时，过滤，合并滤液，滤液进行真空减压浓缩，得醇提浓缩液；
S5：将所述的鸡血藤提取物、水提浓缩液和醇提浓缩液合并混匀，真空干燥后将干浸膏粉碎，过100-200目筛，即得。
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；散寒止痛，温经止血。
鸡血藤：本品为豆科崖豆藤属的植物，味苦、甘，性温；归肝、肾经；补血，活血，通络；活血舒筋，养血调经。
远志：本品为远志科植物远志或卵叶远志的干燥根；味苦、辛，性温；归心、肾、肺经；安神益智，祛痰，消肿。
川芎：本品为伞形科草本植物川芎的根茎；味辛，性温；归肝、胆经；行气开郁，祛风燥湿，活血止痛。
三七：本品为五加科植物三七的干燥根；味甘、微苦，性温；归肝、胃经；散瘀止血，消肿定痛。
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；补气活血，调经止痛，润肠通便。
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；发汗解肌，温通经脉，助阳化气，平冲降气。
毛冬青：为冬青科植物毛冬青的根。味微苦甘，性平；归肺、肝、大肠经；清热解毒，活血通脉。
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；祛瘀止痛，活血通经，清心除烦。
莪术：本品为姜科植物蓬莪术、广西莪术或温郁金的干燥根茎；味辛、苦，性温；归肝、脾经；行气破血，消积止痛。
肉桂：本品为樟科植物肉桂的干燥树皮；味辛、甘，性大热；归肾、脾、心、肝经；补火助阳，引火归源，散寒止痛，活血通经。
甘草：本品为豆科植物甘草、胀果甘草或光果甘草的干燥根；味甘，性平；归脾、胃、肺经；补脾益气，清热解毒，祛痰止咳，缓急止痛，调和诸药。
本发明中药组方的组方分析：
本发明中药组方是以艾叶、鸡血藤为君药，散寒止痛，活血舒筋；以远志、川芎、三七和当归为臣药，活血止痛，安神益智，消肿定痛；以桂枝、毛冬青、丹参、莪术和肉桂为佐药，温通经脉，活血通脉，祛瘀止痛，清心除烦；以甘草为使药，调和诸药性，使诸药协同配合，相辅相成，具有活血舒筋，消肿定痛，温通经脉，清心除烦的功效，能显著地改善血瘀症状。
与现有技术相比，本发明具有如下技术优势：
(1)本发明的中药制剂为天然纯中药制剂，毒副作用小，具有显著的活血化瘀功效，同时，本发明中药制剂中药组方简单，成本低。
(2)药效学试验表明，本发明中药制剂对血瘀证大鼠的血小板聚集具有显著的抑制效果，同时对其凝血四项指标的水平也有显著的改善作用，说明本发明中药制剂具有显著的活血化瘀效果；临床数据表明，本发明中药制剂对血瘀患者具有较高的治愈率和总有效率。
具体实施方式
以下通过具体实施方式进一步描述本发明，但本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内，对本发明所述的中药制剂进行适当改进、替换功效相同的组分，对于本领域技术人员来说是显而易见的，它们都被视为包括在本发明的范围之内。
实施例1
本发明实施例1含有艾叶的具有活血化瘀功能的中药制剂由以下重量份的药材制备而成：
艾叶10份、鸡血藤12份、远志10份、川芎12份、三七10份、当归8份、桂枝6份、毛冬青8份、丹参6份、莪术6份、肉桂4份和甘草4份。
制备方法：
S1：分别按比例称取各味药材，去杂质，洗净，烘干，切片后粉碎成粗粉，备用；
S2：取鸡血藤粗粉，加入药材总重量10倍量体积分数为75％的乙醇，再加入药材总量1.0％的纤维素酶，在45℃下浸提2小时，然后在90℃回流提取4小时，过滤并保留鸡血藤滤渣，滤液减压浓缩至60℃下相对密度为1.05的浸膏，制得鸡血藤提取物；
S3：取艾叶、远志、川芎、三七、当归、桂枝、毛冬青、丹参、莪术、肉桂和甘草粗粉，合并S2所述的鸡血藤残渣，加入粗粉总量10倍量的水浸泡3小时，然后煎煮3次，每次3小时，过滤并保留滤渣，合并滤液，滤液进行真空减压浓缩，得水提浓缩液；
S4：往S3所述的滤渣中加入药材总量9倍量体积分数为75％的乙醇，回流提取3次，每次4小时，过滤，合并滤液，滤液进行真空减压浓缩，得醇提浓缩液；
S5：将所述的鸡血藤提取物、水提浓缩液和醇提浓缩液合并混匀，真空干燥后将干浸膏粉碎，过100目筛，即得中药粉末；
S6：取S5所得的中药粉末加入适当的辅料，利用现代中药制剂技术制成胶囊剂。
实施例2
本发明实施例2含有艾叶的具有活血化瘀功能的中药制剂由以下重量份的药材制备而成：
艾叶18份、鸡血藤20份、远志18份、川芎22份、三七16份、当归16份、桂枝14份、毛冬青14份、丹参16份、莪术12份、肉桂8份和甘草8份。
制备方法同实施例1。
实施例3
本发明实施例3含有艾叶的具有活血化瘀功能的中药制剂由以下重量份的药材制备而成：
艾叶14份、鸡血藤16份、远志14份、川芎16份、三七12份、当归12份、桂枝10份、毛冬青10份、丹参10份、莪术9份、肉桂6份和甘草6份。
制备方法同实施例1。
本发明中药制剂的药效实验
一、实验方法：
取SPF级Wistar大鼠60只，雌雄各半，体重220-280g，按体重分层随机分为6组，即空白对照组、模型对照组、阳性对照组(4.8g/kg)、本发明实施例1制得的中药胶囊高剂量组(4.8g/kg)、中剂量组(2.4g/kg)、低剂量组(1.2g/kg)，其中阳性对照组给药为复方血栓通胶囊。各组动物按上述剂量灌胃给药，每天灌胃1次，连续7d，空白对照组和模型对照组分别灌胃给予等体积生理盐水。除空白对照组以外的各组动物于第6天灌胃给药1h后皮下注射肾上腺素0.8mg/kg，注射肾上腺素2h后，将动物放入冰水中浸泡5min，2h后再次皮下注射肾上腺素0.8mg/kg进行血瘀证模型造模。第7天末次给药1h后，各组动物以戊巴比妥钠按40mg/kg的剂量腹腔注射进行麻醉，固定于解剖板上，行颈总动脉插管采血。测定大鼠的血小板聚集率、凝血酶原时间(PT)、活化部分凝血酶原时间(APTT)、凝血酶时间(TT)和纤维蛋白原(FIB)含量。
二、实验结果：见表1和表2。
从表1可以看出，本发明实施例1制得的中药胶囊和复方血栓通胶囊对血瘀证大鼠的血小板聚集均具有极显著的抑制作用(P＜0.01)，其中，本发明实施例1中药胶囊的高、中剂量组抑制血瘀证大鼠血小板聚集的效果要显著优于复方血栓通胶囊组(P＜0.05)。从表2可以看出，本发明本发明实施例1中药胶囊和复方血栓通胶囊均可显著改善血瘀证大鼠凝血四项指标的水平(P＜0.05)，具有延长血瘀证大鼠凝血酶原时间、活化部分凝血酶原时间、凝血酶时间和减少纤维蛋白原含量的作用，其中，中药胶囊高剂量组的效果要显著优于复方血栓通胶囊组(P＜0.05)。
表1本发明中药制剂对血瘀证大鼠血小板聚集的影响
注：与空白对照组相比，ΔΔΔP＜0.001；与模型组相比，**P＜0.01，***P＜0.001；与阳性对照组相比，#P＜0.05，##P＜0.01。
表2本发明中药制剂对血瘀证大鼠凝血四项指标的影响
| 组别 | 剂量(g/kg) | PT(s) | APTT(s) | TT(s) | FIB(mg/dl) |
| 空白对照组 | - | 15.6±1.5 | 19.7±2.1 | 25.7±2.6 | 2.4±1.1 |
| 模型组 | - | 10.1±1.7ΔΔΔ | 13.1±2.3ΔΔΔ | 19.4±1.9ΔΔΔ | 4.7±1.3ΔΔ |
| 阳性对照组 | 4.8 | 12.2±1.5* | 17.2±3.1** | 22.1±2.8* | 3.7±1.4* |
| 高剂量组 | 4.8 | 14.2±0.9**# | 20.2±1.9***# | 25.4±1.9**# | 2.6±0.9**# |
| 中剂量组 | 2.4 | 13.1±1.1** | 17.8±2.5** | 23.1±2.7* | 3.0±1.1** |
| 低剂量组 | 1.2 | 12.1±1.4* | 16.2±1.7* | 21.8±1.5* | 3.6±1.5* |
注：与空白对照组相比，ΔΔP＜0.01，ΔΔΔP＜0.001；与模型相比，*P＜0.05，**P＜0.01；与阳性对照组相比，#P＜0.05。
本发明的中药制剂的临床实验
一、诊断依据：参照《中药新药临床研究指导原则》(2010版)中的诊断标准评定：
主症：刺痛、痛有定处、拒按、脉络瘀血(诸如口唇、齿龈、爪甲紫暗，肤表赤缕，或腹部青筋外露)，皮下瘀斑，癥积，离经之血，舌质紫暗或有瘀斑、瘀点，舌脉粗张，脉涩、无脉或沉弦、弦迟。
次症：肌肤甲错，肢体麻木或偏瘫。痴癫，狂躁，善忘，局部感觉异常，外伤史、手术史及人工流产史。
血瘀证主症2项，或主症1项、次症2项，即可诊断。
二、疗效评定标准：参照《中药新药临床研究指导原则》(2010版)中的诊断标准评定：
临床痊愈：血瘀的临床症状、体征消失或基本消失，证候积分减少≧95％；
显效：血瘀的临床症状、体征明显改善，证候积分减少≧70％；
有效：血瘀的临床症状、体征均有好转，证候积分减少≧30％；
无效：血瘀的临床症状、体征均无明显改善，甚或加重，证候积分减少不足30％。
三、实验方法：选取400例临床血瘀志愿者患者，随机分为治疗组A、B、C组和对照组4组，每组100人，治疗A-C组分别服用实施例1-3制得的中药胶囊，
每天3次，每次1粒，以7天为一疗程，4个疗程后评定效果；对照组服用复方血栓通胶囊(广东众生药业有限公司)，一次1粒，每天3次，以7天为一疗程，4个疗程后评定效果。
四、治疗结果：见表3。
表3本发明中药制剂临床疗效
| 组别 | 例数 | 痊愈(率) | 显效 | 有效 | 无效(率) | 总有效率 |
| 治疗A组 | 100 | 72(72％) | 13 | 10 | 5(5％) | 95％ |
| 治疗B组 | 100 | 70(70％) | 12 | 11 | 7(7％) | 93％ |
| 治疗C组 | 100 | 68(68％) | 11 | 11 | 10(10％) | 90％ |
| 对照组 | 100 | 55(55％) | 15 | 12 | 18(18％) | 82％ |
从表3的结果可知，临床血瘀证患者服用本发明实施例1-3制得的中药胶囊活血化瘀效果显著，总有效率达90％以上，痊愈率达68％以上，均明显优于对照组。由此可知，本发明中药制剂活血化瘀效果显著，用于治疗血瘀证疗效好，临床治愈率高。
由于已经通过以上较佳实施例描述了本发明，在本发明的精神和/或范围内，任何针对本发明的替换/或组合来实施本发明，对于本领域的技术人员来说都是显而易见的，且包含在本发明之中。
Claims (7)
1.含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂由以下重量份的药材制备而成：
艾叶10-18份、鸡血藤12-20份、远志10-18份、川芎12-22份、三七10-16份、当归8-16份、桂枝6-14份、毛冬青8-14份、丹参6-16份、莪术6-12份、肉桂4-8份和甘草4-8份。
2.如权利要求1所述含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂由以下重量份的药材制备而成：
艾叶10份、鸡血藤12份、远志10份、川芎12份、三七10份、当归8份、桂枝6份、毛冬青8份、丹参6份、莪术6份、肉桂4份和甘草4份。
3.如权利要求1所述含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂由以下重量份的药材制备而成：
艾叶18份、鸡血藤20份、远志18份、川芎22份、三七16份、当归16份、桂枝14份、毛冬青14份、丹参16份、莪术12份、肉桂8份和甘草8份。
4.如权利要求1所述含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂由以下重量份的药材制备而成：
艾叶14份、鸡血藤16份、远志14份、川芎16份、三七12份、当归12份、桂枝10份、毛冬青10份、丹参10份、莪术9份、肉桂6份和甘草6份。
5.如权利要求1-4任一所述含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂的制备方法包括下述步骤：
S1：分别按比例称取各味药材，去杂质，洗净，烘干，切片后粉碎成粗粉，备用；
S2：取鸡血藤粗粉，加入药材总重量8-10倍量体积分数为60-80％的乙醇，再加入药材总量0.8-1.2％的纤维素酶，在35-45℃下浸提1-2小时，然后在80-95℃回流提取3-5小时，过滤并保留鸡血藤滤渣，滤液减压浓缩至60℃下相对密度为1.05-1.15的浸膏，制得鸡血藤提取物；
S3：取艾叶、远志、川芎、三七、当归、桂枝、毛冬青、丹参、莪术、肉桂和甘草粗粉，合并S2所述的鸡血藤残渣，加入粗粉总量8-10倍量的水浸泡2-4小时，然后煎煮3次，每次2-4小时，过滤并保留滤渣，合并滤液，滤液进行真空减压浓缩，得水提浓缩液；
S4：往S3所述的滤渣中加入药材总量8-10倍量体积分数为75-85％的乙醇，回流提取2-3次，每次3-5小时，过滤，合并滤液，滤液进行真空减压浓缩，得醇提浓缩液；
S5：将所述的鸡血藤提取物、水提浓缩液和醇提浓缩液合并混匀，真空干燥后将干浸膏粉碎，过100-200目筛，即得。
6.如权利要求1-4任一所述含有艾叶的具有活血化瘀功能的中药制剂，其特征在于，所述中药制剂被制成片剂、丸剂、散剂、颗粒剂或胶囊剂。
7.如权利要求1-6任一所述所述含有艾叶的具有活血化瘀功能的中药制剂的制备方法，其特征在于，包括下述步骤：
S1：分别按比例称取各味药材，去杂质，洗净，烘干，切片后粉碎成粗粉，备用；
S2：取鸡血藤粗粉，加入药材总重量8-10倍量体积分数为60-80％的乙醇，再加入药材总量0.8-1.2％的纤维素酶，在35-45℃下浸提1-2小时，然后在80-95℃回流提取3-5小时，过滤并保留鸡血藤滤渣，滤液减压浓缩至60℃下相对密度为1.05-1.15的浸膏，制得鸡血藤提取物；
S3：取艾叶、远志、川芎、三七、当归、桂枝、毛冬青、丹参、莪术、肉桂和甘草粗粉，合并S2所述的鸡血藤残渣，加入粗粉总量8-10倍量的水浸泡2-4小时，然后煎煮3次，每次2-4小时，过滤并保留滤渣，合并滤液，滤液进行真空减压浓缩，得水提浓缩液；
S4：往S3所述的滤渣中加入药材总量8-10倍量体积分数为75-85％的乙醇，回流提取2-3次，每次3-5小时，过滤，合并滤液，滤液进行真空减压浓缩，得醇提浓缩液；
S5：将所述的鸡血藤提取物、水提浓缩液和醇提浓缩液合并混匀，真空干燥后将干浸膏粉碎，过100-200目筛，即得。
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| CN108379532A (zh) * | 2018-04-09 | 2018-08-10 | 汉寿县新运堂医药科技有限公司 | 艾叶、菊三七止疼制剂 |
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| CN108379532A (zh) * | 2018-04-09 | 2018-08-10 | 汉寿县新运堂医药科技有限公司 | 艾叶、菊三七止疼制剂 |
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