CN106236886A - 一种治疗癫痫的中药制剂及其制备方法及应用 - Google Patents
一种治疗癫痫的中药制剂及其制备方法及应用 Download PDFInfo
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Abstract
本发明公开了一种治疗癫痫的中药制剂及其制备方法及应用,所述中药制剂按照质量份数计,由以下原料制成:太阳针7~12g、厚朴花4~7g、桑椹子5~9g、地菍3~7g、桔梗2~5g和山刺梨2~5g;将山刺梨和地菍洗净、粉碎,醇浸泡处理,间断式微波提取、高压脉冲电场提取,过滤得滤液和滤渣,滤液浓缩为稠膏;将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与滤渣混合,醇浸泡处理,超声热提取,过滤得提取液,浓缩为浸膏;将稠膏与浸膏混合,制成胶囊剂,即得。本发明中药制剂对癫痫病的临床治愈率为93.33~98.33%,总有效率为100%,具有疗程短、见效快、药效确切、标本兼治、无不良及毒副作用、愈后复发率低的优势。
Description
技术领域
本发明涉及医学技术领域,具体是一种治疗癫痫的中药制剂及其制备方法及应用。
背景技术
癫痫(epilepsy)即俗称的“羊角风”或“羊癫风”,是大脑神经元突发性异常放电,导致短暂的大脑功能障碍的一种慢性疾病。据中国最新流行病学资料显示,国内癫痫的总体患病率为7.0‰,年发病率为28.8/10万,1年内有发作的活动性癫痫患病率为4.6‰。据此估计中国约有900万左右的癫痫患者,其中500~600万是活动性癫痫患者,同时每年新增加癫痫患者约40万,在中国癫痫已经成为神经科仅次于头痛的第二大常见病。
癫痫是一种反复发作性神志异常的病证患者会意识丧失,甚至扑倒,不省人事,强直抽搐,口吐涎沫,两目上视或口中怪叫,移时苏醒,是一种常见的神经系统慢性发作性疾病,治疗复杂且疗程长。目前临床上多使用西药治疗癫痫,但多数抗癫痫药物存在毒副作用,依从性较差,直接影响患者的生活质量,不便于被病人及家属所接受,而中药学作为我国的传统医学,具有作用强、见效快、药效持久等优点,且没有依赖性、耐药性以及毒副作用,因此选择一种中药制剂治疗癫痫,对于治疗癫痫具有十分重要的临床意义。
发明内容
本发明的目的在于提供一种疗程短、见效快、标本兼治、无不良及毒副作用的治疗癫痫的中药制剂及其制备方法及应用。
为实现上述目的,本发明提供如下技术方案:
一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针7~12g、厚朴花4~7g、桑椹子5~9g、地菍3~7g、桔梗2~5g和山刺梨2~5g。
作为本发明进一步的方案:按照质量份数计,由以下原料制成:太阳针8~10g、厚朴花5~6g、桑椹子6~8g、地菍5~6g、桔梗3~4g和山刺梨3~4g。
作为本发明进一步的方案:按照质量份数计,由以下原料制成:太阳针9g、厚朴花5g、桑椹子7g、地菍5g、桔梗4g和山刺梨3g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的8~10倍量的体积浓度为75~78%的乙醇溶液中浸泡2~3h后,在微波功率为320~360W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取6~8次;接着在电场强度为18~20kV/cm、脉冲时间为320~340μs、脉冲频率为360~380Hz的条件下进行高压脉冲电场提取6~8min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.18~1.20的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的5~6倍量的体积浓度为88~90%的乙醇溶液中浸泡3~4h,接着在温度为42~46℃、超声波功率为250~280W、超声波频率为40kHz的条件下进行超声热提取40~45min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.14~1.16的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
本发明所采用的各中药材的药性及药效如下:
太阳针
【来源】珠藓科平珠藓属植物平珠藓Plagiopus oederi(Gunn.)Limpr.,以全草入药。四季可采,挤出水后阴干。
【性味】淡,平。
【功能主治】镇静安惊。用于失眠心慌,癫痫。
厚朴花
【来源】本品为木兰科植物厚朴或凹叶厚朴的干燥花蕾。春季花未开放时采摘,稍蒸后,晒干或低温干燥。
【性味】苦,微温。
【归经】归脾、胃经。
【功能主治】理气,化湿。用于胸脘痞闷胀满,纳谷不香。
桑椹子
【别名】桑实、葚、乌椹、文武实、黑椹、桑枣、桑葚子、桑粒、桑果。
【来源】药材基源:为桑科植物桑的果穗。
拉丁植物动物矿物名:Morus alba L.
采收和储藏:5~6月当桑的果穗变红色时采收,晒干或蒸后晒干。
【化学成分】果穗含糖,鞣酸(tannic acid),苹果酸(malicacid),维生素(vitamin)B1、B2和胡萝卜素(carotene);其脂类的脂肪酸主要为亚油酸(linoleic acid),油酸(oleic acid),软脂酸(palmitic acid),硬脂酸(stearic acid),尚有少量辛酸(caprylic acid),壬酸(pelargonic acid),癸酸(capric acid),肉豆蔻酸(myris-ticacid),亚麻酸(linolenic acid)等。精油中含桉叶素(cineole),牻儿醇(geraniol),芳樟醇乙酸酯(linalyl acetat),芳樟醇(linalool),樟脑(camphor),a-蒎烯(α-pinene)和柠檬烯(limonene)等;磷脂总含量0.41%,其中磷脂酸胆碱(phosphatidyl choline)32.15%,溶血磷脂酸胆碱(lysophosphatidy choline)19.30%,磷脂酸乙醇胺(phosphatidyl ethanolamine)15.91%,磷脂酸(phosphatidic acid)12.40%,磷脂酰肌醇(phosphatidyl inosi-tol)10.53%,双磷脂酰甘油(diphosphatidyl glycerol)6.59%。还含矢车菊素(cyanidin)和矢车菊甙(chrysanthemin)。
【药理作用】1.增强免疫功能:小鼠α-醋酸萘酯酯酶(ANAE)阳性的T淋巴细胞和脾脏B淋巴细胞(溶血空斑形成细胞数),随年龄增长逐渐减少。给LACA小鼠每日灌服桑椹水煎剂12.5g(生药)/kg,连续10天,可显着增加不同年龄组小鼠的T淋巴细胞;但同剂量的桑椹水煎剂,仅可增加幼龄小鼠B淋巴细胞数,对1年以上的老龄小鼠无明显影响。应用3H-TdR掺入淋巴细胞转化试验表明,桑椹水煎剂有中度激发淋巴细胞转化的作用。2.对Na+-K+-ATP酶活性的影响:给3~24月龄的BALb/c和LACA纯系小鼠每日灌服桑椹煎剂12.5g/kg,连续2星期。除24月龄老龄小鼠外,与同龄对照组比较均能显着降低红细胞膜Na+-K+-ATP酶活性。Na+-K+-ATP酶与机体释放能量、供Na+和K+的主动转运有关,桑椹子降低该酶的活性可能是其滋阴作用机制之一。
【性味】甘;酸;性寒
【归经】肝;肾经
【功能主治】滋阴养血;生津;润肠。主肝肾不足和血虚精亏的头晕目眩;腰酸耳鸣;须发早白;失眠多梦;津伤口渴;消渴;肠燥便秘
地菍
【别名】地茄子、地兰子、地石榴、铺地锦。
【来源】为野牡丹科野牡丹属植物地菍Melastoma dodecandrum Lour.,以全草或根入药。秋季采根或全草,洗净晒干。
【性味】甘、涩,平。
【功能主治】清热解毒,祛风利湿,补血止血。用于预防流行性脑脊髓寞炎,肠炎,痢疾,肺脓疡,盆腔炎,子宫出血,贫血,白带,腰腿痛,风湿骨痛,外伤出血,蛇咬伤。
桔梗
【别名】包袱花、铃当花、道拉基。
【来源】本品为桔梗科植物桔梗Platycodon grandiflorum(Jacq.)A.DC.的干燥根。春、秋二季采挖,洗净,除去须根,趁鲜剥去外皮或不去外皮,干燥。
【性味】苦、辛,平。
【归经】归肺经。
【功能主治】宣肺,利咽,祛痰,排脓。用于咳嗽痰多,胸闷不畅,咽痛,音哑,肺痈吐脓,疮疡脓成不溃。
山刺梨
【别名】刺梨根、绢毛蔷薇。
【来源】蔷薇科山刺梨Rosa sericea Lindl.,以根、果实入药。
【生境分部】四川、贵州、云南、西藏。
【性味】酸涩、甘,平。
【功能主治】消食健脾,止痢。主治积食腹胀,肠鸣腹泻。
所述的治疗癫痫的中药制剂的用法及用量为:口服,每日三次,分早、中、晚服用,饭后半小时温开水送服,每次服用相当于10g生药量的剂量。20天为一个疗程,2~3个疗程即可痊愈,病情严重者需遵医嘱酌增用量。
所述的中药制剂在制备治疗癫痫药物中的应用。
与现有技术相比,本发明的有益效果是:本发明配方科学合理,具有镇惊安神、祛痰解痉、消肿散结、理气、清热泻火、燥湿解毒、开窍提神、镇静止痛作用。在癫痫病的临床治疗试验中,本发明中药制剂的治愈率为93.33~98.33%,总有效率为100%,具有疗程短、见效快、药效确切、标本兼治、无不良及毒副作用、愈后复发率低的优势,可减少对大脑神经机能的损伤,不易产生耐药性,减轻药物依赖。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
本发明实施例中,一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针7g、厚朴花7g、桑椹子5g、地菍7g、桔梗2g和山刺梨5g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的8倍量的体积浓度为78%的乙醇溶液中浸泡2h后,在微波功率为360W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取6次;接着在电场强度为20kV/cm、脉冲时间为320μs、脉冲频率为380Hz的条件下进行高压脉冲电场提取6min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.20的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的5倍量的体积浓度为90%的乙醇溶液中浸泡3h,接着在温度为46℃、超声波功率为250W、超声波频率为40kHz的条件下进行超声热提取45min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.14的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
实施例2
本发明实施例中,一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针12g、厚朴花4g、桑椹子9g、地菍3g、桔梗5g和山刺梨2g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的10倍量的体积浓度为75%的乙醇溶液中浸泡3h后,在微波功率为320W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取8次;接着在电场强度为18kV/cm、脉冲时间为340μs、脉冲频率为360Hz的条件下进行高压脉冲电场提取8min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.18的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的6倍量的体积浓度为88%的乙醇溶液中浸泡4h,接着在温度为42℃、超声波功率为280W、超声波频率为40kHz的条件下进行超声热提取40min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.16的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
实施例3
本发明实施例中,一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针8g、厚朴花6g、桑椹子6g、地菍6g、桔梗3g和山刺梨4g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的8倍量的体积浓度为78%的乙醇溶液中浸泡2h后,在微波功率为360W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取6次;接着在电场强度为20kV/cm、脉冲时间为320μs、脉冲频率为380Hz的条件下进行高压脉冲电场提取6min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.20的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的5倍量的体积浓度为90%的乙醇溶液中浸泡3h,接着在温度为46℃、超声波功率为250W、超声波频率为40kHz的条件下进行超声热提取45min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.14的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
实施例4
本发明实施例中,一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针10g、厚朴花5g、桑椹子8g、地菍5g、桔梗4g和山刺梨3g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的10倍量的体积浓度为75%的乙醇溶液中浸泡3h后,在微波功率为320W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取8次;接着在电场强度为18kV/cm、脉冲时间为340μs、脉冲频率为360Hz的条件下进行高压脉冲电场提取8min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.18的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的6倍量的体积浓度为88%的乙醇溶液中浸泡4h,接着在温度为42℃、超声波功率为280W、超声波频率为40kHz的条件下进行超声热提取40min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.16的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
实施例5
本发明实施例中,一种治疗癫痫的中药制剂,按照质量份数计,由以下原料制成:太阳针9g、厚朴花5g、桑椹子7g、地菍5g、桔梗4g和山刺梨3g。
所述的治疗癫痫的中药制剂的制备方法,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的8倍量的体积浓度为78%的乙醇溶液中浸泡3h后,在微波功率为350W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取8次;接着在电场强度为20kV/cm、脉冲时间为330μs、脉冲频率为370Hz的条件下进行高压脉冲电场提取7min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.18的稠膏,备用;
(3)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的6倍量的体积浓度为90%的乙醇溶液中浸泡3h,接着在温度为45℃、超声波功率为260W、超声波频率为40kHz的条件下进行超声热提取42min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.16的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
本发明配方科学合理,具有镇惊安神、祛痰解痉、消肿散结、理气、清热泻火、燥湿解毒、开窍提神、镇静止痛作用。
药物毒理学试验
1、急性毒性试验
以本发明实施例5制得的胶囊剂为试验,采用灌胃给药方式,在24h内连续给药3次,每次间隔4h,每次给药20g生药量,累积药物总量达60g生药/kg,相当于人临床用量的120倍。给药后7d内,小鼠活动、进食、排泄均正常,生长良好,毛色光亮,其平均体重均随实验时间的延长而增加。第8d处死后解剖每只小鼠,肉眼观察心、肝、脾、肺、肾、脑、胸腺、胃、肠等均未发现颜色及形态异常,未能测出半数致死量(LD50)。结果表明:本发明中药制剂无急性毒性反应。
2、长期毒性试验
以本发明实施例5制得的胶囊剂为试验,采用灌胃给药方式,将本发明中药制剂分为低剂量、中剂量、高剂量三组,各组的药物用量分别为7.5、15、30g生药/kg/d,相当于临床剂量的15、30、60倍。灌胃给药12周后,本发明中药制剂对动物的一般状况、血液学指标、血液生化指标均无明显的影响,系统解剖、脏器系数及组织病理学检查也未发现异常病理改变。停药2周也未见明显改变。结果表明:本发明中药制剂在长期毒性试验中,未发现明显毒性反应和延迟毒性反应。可见,本发明中药制剂无毒性反应,长期用药安全可靠。因此,将本发明中药制剂用于癫痫病的临床治疗上,以下为其临床试验的基础资料。
临床试验
1、病例选择
选择确诊的癫痫患者480例临床观察,其中男性254例,女性226例,年龄12~68岁,平均年龄36岁,病程2个月~6年,平均病程2.4年。将该480例患者随机分为治疗1~5组、对照1~3组共八组,每组60例,各组病例的病程、症状轻重程度基本一致,无显著差异,具有可比性。
2、治疗方法
治疗1~5组分别服用本发明实施例1~5制得的胶囊剂,口服,每日三次,分早、中、晚服用,饭后半小时温开水送服,每次服用相当于10g生药量的剂量。20天为一个疗程,2~3个疗程即可痊愈,病情严重者需遵医嘱酌增用量。
对照1组服用癫痫宁片,口服,一次2~4片,一日3次。
对照2组服用的胶囊剂,仅含有太阳针、厚朴花、桑椹子、地菍和桔梗五种组分,其余与实施例5完全相同。口服,每日三次,分早、中、晚服用,饭后半小时温开水送服,每次服用相当于10g生药量的剂量。20天为一个疗程,2~3个疗程即可痊愈,病情严重者需遵医嘱酌增用量。
对照3组服用的胶囊剂,仅含有山刺梨这一种组分,其余与实施例5完全相同。口服,每日三次,分早、中、晚服用,饭后半小时温开水送服,每次服用相当于10g生药量的剂量。20天为一个疗程,2~3个疗程即可痊愈,病情严重者需遵医嘱酌增用量。
各组在治疗期间禁食羊肉、烟、酒等躁热之品和肥甘生冷之品,防止过度劳累、驾驶、高温、水上作业以免发作时发生意外,保持心情舒畅,避免精神刺激。
3、疗效判定标准
(1)治愈:四肢抽搐、气高息粗、斜头畸形、头晕目眩等症状消失;呼吸顺畅,身体痊愈。
(2)有效:上述症状有所缓解,呼吸顺畅,身体痊愈。
(3)无效:病症无变化。
4、治疗结果
表1各组的疗效比较
| 项目 | 病例数 | 治愈数 | 有效数 | 无效数 | 治愈率 | 总有效率 |
| 治疗1组 | 60 | 56 | 4 | 0 | 93.33% | 100% |
| 治疗2组 | 60 | 56 | 4 | 0 | 93.33% | 100% |
| 治疗3组 | 60 | 57 | 3 | 0 | 95.00% | 100% |
| 治疗4组 | 60 | 57 | 3 | 0 | 95.00% | 100% |
| 治疗5组 | 60 | 59 | 1 | 0 | 98.33% | 100% |
| 对照1组 | 60 | 37 | 16 | 7 | 61.67% | 88.33% |
| 对照2组 | 60 | 20 | 15 | 25 | 33.33% | 58.33% |
| 对照3组 | 60 | 0 | 14 | 46 | 0.00% | 23.33% |
经过2~3个疗程的治疗后,各组的疗效如表1所示:治疗1~5组的治愈率为93.33~98.33%,总有效率为100%;与对照组相比,治疗1~5组的治愈率和总有效率均远远优于对照组,差异有统计学意义(P<0.05),尤其治疗5组的疗效较对照2组和对照3组的疗效之和仍具有显著差异性,说明山刺梨在本发明中药制剂中具有不可替代的、重要的作用,山刺梨与本发明中药制剂中其余组分有明显的协同增效作用。且在整个治疗过程中,各组均未发生明显不良反应。
5、典型病例
病例1:侯某,男,16岁,患者患有癫痫多年,发作时胡跑乱骂,跪卧无常,近期病情逐渐加重,到处打人、毁物。曾服用过各种药物,效果均不佳。服用本发明实施例5制得的胶囊剂1个疗程后,症状好转,继续服用1个疗程后,症状消失,各项指标正常,身体恢复健康。
病例2:詹某,女,54岁,患者患有癫痫多年,近年发作越来越频繁,且持续时间加长,平均每月发病,短则一星期发作一次。服用本发明实施例5制得的胶囊剂2个疗程后,症状明显缓解,继续服用1个疗程,症状消失,生活恢复正常。
病例3:周某,男,32岁,患者右侧肢体麻木、无力、不能行走,一段时间后可自行缓解,后期口角歪斜、言语不清、头晕目眩。服用本发明实施例5制得的胶囊剂1个疗程后,症状明显减轻,继而服用2个疗程后,化验指标正常,身体恢复正常。
对于本领域技术人员而言,显然本发明不限于上述示范性实施例的细节,而且在不背离本发明的精神或基本特征的情况下,能够以其他的具体形式实现本发明。因此,无论从哪一点来看,均应将实施例看作是示范性的,而且是非限制性的,本发明的范围由所附权利要求而不是上述说明限定,因此旨在将落在权利要求的等同要件的含义和范围内的所有变化囊括在本发明内。
此外,应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,说明书的这种叙述方式仅仅是为清楚起见,本领域技术人员应当将说明书作为一个整体,各实施例中的技术方案也可以经适当组合,形成本领域技术人员可以理解的其他实施方式。
Claims (5)
1.一种治疗癫痫的中药制剂,其特征在于,按照质量份数计,由以下原料制成:太阳针7~12g、厚朴花4~7g、桑椹子5~9g、地菍3~7g、桔梗2~5g和山刺梨2~5g。
2.根据权利要求1所述的治疗癫痫的中药制剂,其特征在于,按照质量份数计,由以下原料制成:太阳针8~10g、厚朴花5~6g、桑椹子6~8g、地菍5~6g、桔梗3~4g和山刺梨3~4g。
3.根据权利要求1所述的治疗癫痫的中药制剂,其特征在于,按照质量份数计,由以下原料制成:太阳针9g、厚朴花5g、桑椹子7g、地菍5g、桔梗4g和山刺梨3g。
4.根据权利要求1~3任一所述的治疗癫痫的中药制剂的制备方法,其特征在于,包括以下步骤:
(1)将山刺梨和地菍洗净、粉碎,置于其质量之和的8~10倍量的体积浓度为75~78%的乙醇溶液中浸泡2~3h后,在微波功率为320~360W、微波频率为2000Hz的条件下进行间断式微波提取,提取5s,间断3s,控制温度在25~30℃,如此提取6~8次;接着在电场强度为18~20kV/cm、脉冲时间为320~340μs、脉冲频率为360~380Hz的条件下进行高压脉冲电场提取6~8min,过滤得到滤液和滤渣;滤液经减压浓缩为55℃下相对密度为1.18~1.20的稠膏,备用;
(2)将太阳针、厚朴花、桑椹子和桔梗洗净,粉碎,与步骤(1)的滤渣混合,置于其质量之和的5~6倍量的体积浓度为88~90%的乙醇溶液中浸泡3~4h,接着在温度为42~46℃、超声波功率为250~280W、超声波频率为40kHz的条件下进行超声热提取40~45min,过滤得到提取液,经减压浓缩为60℃下相对密度为1.14~1.16的浸膏,备用;
(3)将步骤(1)的稠膏与步骤(2)的浸膏混合,制成胶囊剂,即为所述的治疗癫痫的中药制剂。
5.如权利要求1~3任一所述的中药制剂在制备治疗癫痫药物中的应用。
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