CN104258090A - 妇女经期延长收敛固涩制剂及制备方法 - Google Patents
妇女经期延长收敛固涩制剂及制备方法 Download PDFInfo
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Abstract
本发明公开了妇女经期延长收敛固涩制剂,主要由下列原料药制备而成,均为重量份:白术8-14,狮子七5-10,生龙骨20-40,白芍12-22,人头七6-15,地榆炭8-16,大金香炉4-9,甘草4-9,茺蔚子8-12,熟地8-15,玄参15-25。本发明有活血化瘀,止血调经,补血滋润之功效,服用安全,效果确切,药源广,成本低,能减轻患者负担。
Description
技术领域
本发明涉及中医中药领域,特别是涉及一种治疗经期延长的中药制剂及其制备方法。
背景技术
经期超过七天以上,甚或淋漓半月方净者,称为“经期延长”。西医学上,认为经期延长是由于排卵型功能失调性子宫出血病的黄体萎缩不全者、盆腔炎症、子宫内膜炎等引起的经期延长。宫内节育器和输卵管结扎后引起的经期延长也按本病治疗。临床上中医,此病的病因有三种:气虚、虚热、血瘀。气虚:素体虚弱,或劳倦过度,损伤脾气,中气不足,冲任不固,不能制约经血,以致经期延长,临床表现为经血过期不净,量多,色淡,质稀,倦怠乏力,气短懒言,小腹空坠。虚热:素体阴虚,或病久伤阴,产多乳众,或忧思积念,阴血亏耗,阴虚内热,热扰冲任,冲任不固,不能制约经血以致经期延长,临床表现为色鲜红,量少,质稠,咽燥口干,潮热颧红,手足心热,大便燥结,舌红,少苔,脉细数。血瘀:素体抑郁,或大怒伤肝,肝气郁结,气滞血瘀;或经期交合阴阳,以致外邪客于胞内,邪与血相搏成瘀,瘀阻冲任,经血妄行,临床表现:量或多或少,经色紫暗有块,经行小腹疼痛拒按,倦怠乏力,头晕心悸,面色无华,舌质淡有瘀斑。经期延长失治误治常常可发展为崩漏。经期延长为临床常见病,由于阴道流血的时间长,易导致女性阴虚阳浮,外邪乘虚而入,从而导致疾病的发生,影响着女性的工作和生活。
公开号CN 102940723 A(申请号201210527452.6)的中国专利文献公开了一种治疗气虚型经期延长的中药组合物,该中药组合物由人参、黄芪、白术、炙甘草、熟地、升麻、阿胶、艾叶、乌贼骨、三七、茜草、艾叶制成。公开号CN 102824625 A(申请号201210340600.3)的中国专利文献公开了一种调经粉与调经口服液的组合中药配制,调经粉由鸡矢藤30份,珍珠菜30份,朱砂莲30份,煅牡蛎50份,水蛭15份,姜15份,土鳖虫6个,梅花鹿胎1,调经口服液配比由益母草50份,玄胡20份,石决明20份,五灵脂20份,丹皮20份,甜酒30份,月月红根20份,木香10份组成。将调经粉与调经口服液配比后以1:5按重量份作为配比组合包装在一起。公开号CN 102861202 A(申请号201110190673.4)的中国专利文献公开了一种治疗月经不调的中药,配方包括黄芪30-50份、西洋参30-40份、熟地黄30-40份、当归30-50份、白芍20-30份、延胡索20-30份、炒白术25-35份、茯苓35-45份、阿胶30-50份、川芎20-30份、益母草40-50份、山药30-40份、熟地10-20份、鸡血藤20-30份。
经期延长是妇科常见疾病,西医治疗多以补充孕激素为主,对合并经量过多或经期延长者对症止血,往往副作用较大,复发率高。因此,患者多将中医药治疗作为首选,但各种中医配方中,或多或少的存在一些问题,使得治疗效果并不理想,关于此病的中医配方研究仍需继续。
发明内容
为弥补现有技术的缺陷,本发明的目的是提供一种制备简单、服用方便的治疗妇女经期延长的收敛固涩制剂及其制备方法。该中药制剂疗效显著,安全可靠。
本发明的技术方案是:
妇女经期延长收敛固涩制剂,主要由下列原料药制备而成,均为重量份:白术8-14,狮子七5-10,生龙骨20-40,白芍12-22,人头七6-15,地榆炭8-16,大金香炉4-9,甘草4-9,茺蔚子8-12,熟地8-15,玄参15-25。
优选的方案中,白术10-12,狮子七6-9,生龙骨26-34,白芍16-18,人头七9-12,地榆炭10-14,大金香炉5-8,甘草5-8,茺蔚子9-11,熟地10-13,玄参17-23。
更加优选的,白术11,狮子七7.5,生龙骨30,白芍17,人头七10.5,地榆炭12,大金香炉6.5,甘草6.5,茺蔚子10,熟地11.5,玄参20。
本发明还提供了将前述收敛固涩制剂制成药学上可接受的稠膏、粉剂、片剂或汤剂的制备方法。
所述稠膏的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加水大火煮开转小火煎20-30分钟(优选25分钟),然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮30-50分钟(优选40分钟),过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎50-70分钟(优选60分钟),过滤,合并两次滤液,真空浓缩至相对密度为1.24-1.28(70℃)(优选1.25-1.27,更加优选1.26)的稠膏,即得稠膏剂。
所述的收敛固涩制剂,步骤(2)中的水面高出所煮全部药材的3厘米。
所述粉剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过140-160目(优选150目)筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过140-160目(150目)筛,备用;
(3)将步骤(1)和(2)所得粉末混合,加入粉末质量5%的蔗糖,搅拌均匀,粉碎灭菌,即得粉剂。
所述片剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过140-160目(优选150目)筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过140-160目(150目)筛,备用;
(3)将步骤(1)和(2)所得粉末混合,搅拌均匀,按照0.25-0.35g/片(优选0.3g/片)计量,按照片剂的加工制备方法压制成圆形片状剂型。
所述汤剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加所煮药材重量6倍的水,大火煮开转小火煎20-30分钟(优选25分钟),然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮30-50分钟(优选40分钟),过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎50-70分钟(优选60分钟),过滤,合并两次滤液,真空浓缩至原来体积的三分之一,即得汤剂。
本发明还提供了所述的收敛固涩制剂在制备治疗妇女经期延长的药物时的应用。
本发明所用主要中药原料的药理如下:
白术:性味:苦、甘,温。归经:脾经;胃经。功效:健脾益气;燥湿利水;止汗;安胎。 主治:脾气虚弱;神疲乏力;食少少腹胀;大便溏薄;水饮内停;小便不利;水肿;痰饮眩晕;温痹酸痛;气虚自汗;胎动不安。
狮子七:基原:为景天科红景天属植物狭叶红景天的根及根茎。成分:全草含酪醇,胡萝卜苷,红景天苷,百脉跟苷。药性:苦、涩,温。归肺、心、肝、大肠经。功用主治:养心安神,化瘀,止血。主治气虚体弱,短气乏力心悸失眠,头昏眩晕,胸闷疼痛,跌打损伤,月经不调,崩漏,吐血,痢疾,腹泻。
生龙骨:基原:为古代哺乳动物如象类、犀牛类、三趾马等的骨胳的化石。主含碳酸钙、磷酸钙。性味: 甘涩平。归经:入心、肝、肾经。功效与主治:生品潜阳安神,用于阴虚阳亢,烦躁易怒,心悸失眠,头晕目眩,癫狂惊等症;煅后功偏收敛固涩,多用于遗精早泄,带下崩漏,虚汗久泻,湿疮痒疹,疮口不敛,外伤出血等。
白芍:性味:苦;酸;微寒。归经:肝经;脾经。功效:养血和营;缓急止痛;敛阴平肝。 主治:主月经不调;经行腹痛;崩漏;自汗;盗汗;胁肋脘腹疼痛;四肢挛痛;头痛;眩晕。
人头七:基原:为兰科角盘兰属植物角盘兰的带块根茎。药性:《山西中草药》:“味甘,性温。”功用主治:补肾健脾,活血调经,解毒。主治头昏失眠,须发早白,不欲食,月经不调,毒蛇咬伤。
地榆炭:地榆:为蔷薇科植物地榆、长叶地榆的根。地榆属于止血药,具有凉血止血,解毒敛疮作用。是治疗血热各种出血及水火烫伤等常用药物。临床多炒炭入药。炮制方法:取地榆饮片放于炒锅内,用大火炒至药物表面呈现焦黑色,内部棕褐色时取出,放凉即得地榆炭。地榆炭性味:苦、酸,凉。归经:归肝、胃、大肠经。功效:凉血止血,泻火敛疮。
大金香炉:基原:为野牡丹科野牡丹属植物展毛野牡丹的根或叶。药性:苦、涩,凉。功用主治:行气利湿,化瘀止血。主治腹痛泻痢,疝气,淋证,脱疽,疮疡,咳血,吐血,衄血,便血,月经不调,跌打损伤。宜忌:孕妇慎服。
茺蔚子:基原:为唇形科益母草属植物益母草和细叶益母草的果实。成分:益母草果实含生物碱:益母草宁碱,水苏碱,脂肪油,油中主要成分为油酸等。全草含酚苷类:A、B;黄酮苷:芦丁,异槲皮苷,银椴苷异鼠李素-3-O-芸香糖苷。环烯醚萜苷类。细叶益母草果实种油含丙二烯类脂肪酸:7,8-二十碳二烯酸。药性:甘、辛,微寒,小毒。归肝经。功用主治:活血调经,清肝明目。主治妇女月经不调,痛经,闭经,产后瘀滞腹痛;肝热头痛,头晕,目赤肿痛,目生翳障。
熟地(熟地黄):来源:为玄参科植物地黄的块根,经加工蒸晒而成。性味:味甘;性温。归经:肝经;肾经。功效:补血滋润;益精填髓。主治:血虎萎黄;眩晕心悸;月经不调;崩不止;肝肾阴亏;潮热盗汗;遗精阳痿;不育不孕;腰膝酸软;耳鸣耳聋;头目昏花;须发早白;消渴;便秘;肾虚喘促。
玄参:性味:味甘;苦;咸;性微寒。归经:归肺经;胃经;肾经。功效:清热解毒药;养阴。玄参滋阴作用不及生地黄,但降火之力较生地黄大。玄参又能解毒,瘰疬疮毒多用之,而生地黄善于滋阴养血,阴血不足之证多用之。主治:温热病热和营血、身热、烦渴、舌绛、发斑、骨蒸劳嗽、虚烦不寤、津伤便秘、目涩昏花、咽喉喉肿痛、瘰疬痰核、痈疽疮毒。
蔗糖:人类基本的食品添加剂之一,蔗糖是有机化合物,属双糖,分子量342。白色晶体,具有旋光性,但无变旋。蔗糖容易被酸水解,水解后产生等量的D-葡萄糖和D-果糖。不具还原性。发酵形成的焦糖可以用作酱油的增色剂。
本发明提供的中药组合物组方科学,各种剂型的制备方法简单,所得产品服用方便。除此之外,本发明的优良效果还表现在:
1、本发明配方严格遵循中医用药原则,经临床验证,具有活血化瘀、止血调经等功效,各剂型疗效显著,治愈率高;
2、所选组分均为天然中药材料,无任何毒副作用;
3、药源广,成本低,能减轻患者负担。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案,但保护范围不限于此。
实施例1 妇女经期延长收敛固涩制剂,由下列原料药制备而成:白术8g,狮子七5g,生龙骨20g,白芍12g,人头七6g,地榆炭8g,大金香炉4g,甘草4g,茺蔚子8g,熟地8g,玄参15g。
上述妇女经期延长收敛固涩制剂稠膏的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加水,水面高出所煮全部药材的3厘米,大火煮开转小火煎25分钟,然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮40分钟,过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎60分钟,过滤,合并两次滤液,真空浓缩至相对密度为1.26(70℃)的稠膏,即得稠膏剂。
实施例2 妇女经期延长收敛固涩制剂,由下列原料药制备而成:白术14g,狮子七10g,生龙骨40g,白芍22g,人头七15g,地榆炭16g,大金香炉9g,甘草9g,茺蔚子12g,熟地15g,玄参25g。
上述妇女经期延长收敛固涩制剂粉剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过150目筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过150目筛,备用;
(3)将步骤(1)和(2)所得粉末混合,加入粉末质量5%的蔗糖,搅拌均匀,粉碎灭菌,即得粉剂。
典型病例:xxx,女,38岁。主诉:半年来,经期延长,经量较多,经期伴有神倦乏力,腰膝酸软,舌淡,苔白,经检查,诊断为气虚型经期延长。
服用本实施例中所得收敛固涩粉剂,月经来之前7天开始服用,每天两次,每次0.5g,用温开水冲服,20天为一疗程。服用两个疗程后,经期恢复正常,经量也减少为正常,其他不适症状也完全消失,痊愈,一年后随访,未复发。
实施例3 妇女经期延长收敛固涩制剂,由下列原料药制备而成:白术10g,狮子七6g,生龙骨26g,白芍16g,人头七9g,地榆炭10g,大金香炉5g,甘草5g,茺蔚子9g,熟地10g,玄参17g。
上述妇女经期延长收敛固涩制剂片剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过150目筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过150目筛,备用;
(3)将步骤(1)和(2)所得粉末混合,搅拌均匀,按照0.25-0.35g/片(优选0.3g/片)计量,按照片剂的加工制备方法压制成圆形片状剂型。
典型病例:xxx,女,24岁。主诉:上次经期延长至11天,量较多,色淡,质清稀,伴有腰疼,面色晦暗,倦怠乏力,气短懒言,小腹空坠,经检查,确诊为气虚型经期延长。
服用本实施例中所得收敛固涩片剂,月经来之前7天开始服用,每天两次,早晚各一次,每次2-4片,温水送服,20天为一疗程。服用一个疗程后,经期恢复至7天,量减少,其他症状均消失,继续巩固疗效服用了一个疗程,患者精神饱满,无不适症状,痊愈,两年后随访未复发。
实施例4 妇女经期延长收敛固涩制剂,由下列原料药制备而成:白术12g,狮子七9g,生龙骨34g,白芍18g,人头七12g,地榆炭14g,大金香炉8g,甘草8g,茺蔚子11g,熟地13g,玄参23g。
上述妇女经期延长收敛固涩制剂汤剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加所煮药材重量6倍的水,大火煮开转小火煎25分钟,然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮40分钟,过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎60,过滤,合并两次滤液,真空浓缩至原来体积的三分之一,即得汤剂。
典型病例:xxx,女,45岁。主诉:三个月来,无明显诱因经期延长10天,行经第10天,经量不多,色鲜红,质稠,手足心热,颧红潮热,口干舌燥,大便燥结,舌质红,少苔,脉细数,确诊为虚热型经期延长。
服用本实例中所得收敛固涩汤剂,月经来之前7天开始服用,每天两次,早晚各一次,温热,每次100-150ml,20天为一疗程。服用一个疗程后,经期缩短为7天,不适症状明显缓解,继续服用10天,经期恢复正常,行经期间无不适症状,痊愈,半年后随访月经正常。
实施例5 妇女经期延长收敛固涩制剂,由下列原料药制备而成:白术11g,狮子七7.5g,生龙骨30g,白芍17g,人头七10.5g,地榆炭12g,大金香炉6.5g,甘草6.5g,茺蔚子10g,熟地11.5g,玄参20g。
上述妇女经期延长收敛固涩制剂稠膏的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加水,水面高出所煮全部药材的3厘米,大火煮开转小火煎25分钟,然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮40分钟,过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎60分钟,过滤,合并两次滤液,真空浓缩至相对密度为1.26(70℃)的稠膏,即得稠膏剂。
试验例1 实施例5所得妇女经期延长收敛固涩制剂稠膏的临床应用:2012年1月-2013年6月,在3所医院筛选620例患者,年龄18-45岁间,平均年龄30.2岁,病程3个月-1年,平均半年。诊断标准根据《中药新药临床研究指导原则实行》经期延长的中医症候诊断标准主要是经期延长,经量少或多,倦怠乏力,腰膝酸软,小腹疼痛,苔薄,脉细数。随机分为两组,实验组和对照组,两组患者性别、年龄、病程等方面均无显著差异。实验组服用实施例5所得产品,使用方法为:月经来之前7天开始服用,每天服用两次,早晚各一次,每次3-5g(视具体情况有所调整),20天一个疗程,共治疗两个疗程。对照组服用其它药品(妇科止血灵片、致康胶囊或宫血宁胶囊等常规药品)。
疗效情况判定标准: 参照中华人民共和国中医药行业标准《中医病证诊断疗效标准》中经期延长疗效评定标准:治愈:月经经期、经量恢复正常,正常月经周期维持3个月以上;有效:经期经量基本正常,伴随的症状也明显减轻,但不能维持3个月正常月经周期;无效:经期和经量均无改变,不适症状无变化。两组患者治疗情况如表1所示。
表1 两组患者治疗情况
根据表1两组治疗情况可知,治疗两个疗程后,实验组治愈267例(73.3%), 有效90例(24.8%),无效7例(1.9%),总有效率98.1%。对照组治愈率和有效率分别为59.8%和23.4%,总有效率为83.2%,疗效明显不如实验组。结果说明本发明对经期延长,及其表现出的血色质异常,小腹疼痛,腰膝酸痛,神疲乏力等症状均有显著治疗效果。
本发明组方所选用的白术:健脾益气,燥湿利水;狮子七:养心安神,止血化瘀;白芍:养血和营,缓急止痛,敛阴平肝;人头七:补肾健脾,活血调经;地榆炭:凉血止血,泻火敛疮;大金香炉:行气利湿,化瘀止血;茺蔚子:活血调经,清肝明目;玄参:清热解毒,降火补阴。诸药合用,共同发挥功效,以达到活血化瘀,止血调经,补血滋润之功效,服用安全,效果确切,故可获得良好的治疗效果。
应当指出的是,具体实施方式只是本发明比较有代表性的例子,显然本发明的技术方案不限于上述实施例,还可以有很多变形。本领域的普通技术人员,以本发明所明确公开的或根据文件的书面描述毫无异议的得到的,均应认为是本专利所要保护的范围。
Claims (10)
1.妇女经期延长收敛固涩制剂,其特征在于,主要由下列原料药制备而成,均为重量份:白术8-14,狮子七5-10,生龙骨20-40,白芍12-22,人头七6-15,地榆炭8-16,大金香炉4-9,甘草4-9,茺蔚子8-12,熟地8-15,玄参15-25。
2.如权利要求1所述的收敛固涩制剂,其特征在于,白术10-12,狮子七6-9,生龙骨26-34,白芍16-18,人头七9-12,地榆炭10-14,大金香炉5-8,甘草5-8,茺蔚子9-11,熟地10-13,玄参17-23。
3.如权利要求1所述的收敛固涩制剂,其特征在于,白术11,狮子七7.5,生龙骨30,白芍17,人头七10.5,地榆炭12,大金香炉6.5,甘草6.5,茺蔚子10,熟地11.5,玄参20。
4.如权利要求1-3任一所述的收敛固涩制剂,其特征在于,将该收敛固涩制剂制成药学上可接受的稠膏、粉剂、片剂或汤剂。
5.如权利要求4所述的收敛固涩制剂,其特征在于,所述稠膏的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加水大火煮开转小火煎20-30分钟(优选25分钟),然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮30-50分钟(优选40分钟),过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎50-70分钟(优选60分钟),过滤,合并两次滤液,真空浓缩至相对密度为1.24-1.28(70℃)(优选1.25-1.27,更加优选1.26)的稠膏,即得稠膏剂。
6.如权利要求4所述的收敛固涩制剂,其特征在于,步骤(2)中的水面高出所煮全部药材的3厘米。
7.如权利要求4所述的收敛固涩制剂,其特征在于,所述粉剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过140-160目(优选150目)筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过140-160目(150目)筛,备用;
(3)将步骤(1)和(2)所得粉末混合,加入粉末质量5%的蔗糖,搅拌均匀,粉碎灭菌,即得粉剂。
8.如权利要求4所述的收敛固涩制剂,其特征在于,所述片剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉,粉碎过140-160目(优选150目)筛,备用;
(2)将生龙骨、白术、地榆炭、大金香炉、甘草、熟地、玄参去杂质,洗净,置于50-70℃的恒温干燥箱中干燥,然后粉碎过140-160目(150目)筛,备用;
(3)将步骤(1)和(2)所得粉末混合,搅拌均匀,按照0.25-0.35g/片(优选0.3g/片)计量,按照片剂的加工制备方法压制成圆形片状剂型。
9.如权利要求4所述的收敛固涩制剂,其特征在于,所述汤剂的制备方法是:
(1)将颗粒均匀干净的粗砂置于锅中,加热至80-90℃,然后加入狮子七、白芍、人头七和茺蔚子,不断翻炒,使药材受热均匀,炒至表面鼓起为止,筛去粗砂,晾凉;
(2)将生龙骨敲碎,纱布包裹,置于砂锅中,加所煮药材重量6倍的水,大火煮开转小火煎20-30分钟(优选25分钟),然后加入白术、地榆炭、大金香炉、甘草、熟地、玄参和步骤(1)所得药材,继续煎煮30-50分钟(优选40分钟),过滤,收集滤液;
(3)将步骤(2)剩余滤渣,兑水再次煎煮,大火煮开后转小火煎50-70分钟(优选60分钟),过滤,合并两次滤液,真空浓缩至原来体积的三分之一,即得汤剂。
10.如权利要求1-3任一所述的收敛固涩制剂在制备治疗妇女经期延长的药物时的应用。
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