CN116898888A - 一种鲜人参活性提取物及其应用 - Google Patents
一种鲜人参活性提取物及其应用 Download PDFInfo
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- CN116898888A CN116898888A CN202310665533.0A CN202310665533A CN116898888A CN 116898888 A CN116898888 A CN 116898888A CN 202310665533 A CN202310665533 A CN 202310665533A CN 116898888 A CN116898888 A CN 116898888A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
- A61K36/258—Panax (ginseng)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
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Abstract
本发明涉及一种鲜人参活性提取物及其应用,本发明所述鲜人参活性提取物由鲜人参经超声提取后浓缩得到。本发明制备得到的鲜人参活性提取物具有显著的镇痛功效,可以应用于制备减轻外科手术病人疼痛的药物,并且可以通过添加填充剂、崩解剂、润滑剂或粘合剂等制备成各种剂型;本发明提供的鲜人参活性提取物的制备方法简单,能耗低,提取溶剂可以循环利用,生产过程无废液排放,且完整的保存了活性成份。
Description
本申请是申请日为2017年06月11日、申请号为201810593651.4、发明名称为《鲜人参活性提取物及其在制备减轻外科手术病人疼痛药物中的应用》的分案申请。
技术领域
本发明涉及医药技术领域,具体涉及一种鲜人参活性提取物及其应用。
背景技术
术后疼痛是机体受到手术伤害刺激(组织损伤)后的一种反应,包括生理、心理和行为上的一系列反应。在临床工作中,疼痛已成为继体温、脉搏、呼吸、血压4大生命体征之后的第5生命体征,日益受到重视。
术后疼痛的影响术后疼痛及其应激反应,将对机体多个方面带来不良反应,直接影响术后康复。术后疼痛导致的机体病理生理改变不容轻视,它不但使循环、呼吸、消化、内分泌、免疫、凝血等系统发生改变,而且剧烈的疼痛可以造成精神创伤,可带来焦虑、恐惧、失眠,产生无助感。这些改变与术后并发症密切相关,对手术预后有明显不利影响。术后疼痛的常见危害有以下几种:1、使冠脉粥样硬化患者心肌缺血和心肌梗死危险增高;2、不敢咳嗽咳痰、呼吸道分泌物无法清除,导致低氧血症、肺炎、肺不张等并发症;3、减少胃肠蠕动和延迟胃肠功能恢复;4、引起尿潴留和泌尿系统感染;5、限制患者机体活动,引发术后高凝状态,促进下肢深静脉血栓和肺栓塞形成;6、抑制免疫功能,导致术后感染和肿瘤细胞扩散;7、导致焦虑、恐惧、烦躁不安、无助、抑郁、沮丧和睡眠障碍。
而完善的术后镇痛治疗能使降低手术并发症发生率和死亡率,缩短术后恢复时间,提高围手术期患者生活质量。
目前常见的镇痛方式主要为术后镇痛,主要有以下方式:1、口服用药;2、皮下注射镇痛,如吗啡镇痛作用开始快而维持时问短,皮下注射10mg,5min起效,维持2h;其副作用有呼吸抑制,成瘾等;3、肌内注射镇痛,与口服给药相比,肌内注射镇痛药物起效快,易于迅速产生峰作用;其缺点在于:注射部位疼痛,血药浓度的波动影响镇痛效果;4、静脉注射镇痛;5、神经阻滞或神经鞘内镇痛;6、椎管内注药镇痛;7、PCA镇痛,PCA技术的原理是运用微电脑据患者的情况设定镇痛机上的各项技术参数,镇痛药在安全、有效的范围内由病人自控给药;8、多模式镇痛,即应用两或两种以上不同作用机制的镇痛药物或方法,作用于疼痛感受器或传导的不同层面,减少单药用量,避免单药过量所致不良反应。
上述各种镇痛药物的使用均产生一定的副作用,往往给病人带来镇痛后的别的痛苦,比如食欲不振、肠胃痉挛等。而人参皂苷镇痛,目前仅有研究表明人参皂苷Rf等单独使用具有镇痛功效,而人参提取物共同联合使用用于镇痛,目前还没有研究表明是否具有协同或抵抗作用。市场对高效、低毒的新型镇痛药物需求迫切,具有生物活性的天然药物越来越受到人们的重视。
发明内容
针对现有技术中的缺陷,本发明目的在于提供一种鲜人参活性提取物及其应用,以简化鲜人参活性提取物的制备方法,降低能耗,溶剂可以循环利用,无废液排放,活性成分被完整保存;制备得到的鲜人参活性提取物具有显著的镇痛的功效,可用于制备镇痛药品或保健食品。
为实现上述目的,本发明提供的技术方案为:
本发明提供了一种鲜人参活性提取物在制备减轻外科手术病人疼痛药物中的应用。
优选地,所述鲜人参活性提取物的有效成分包括人参皂苷Rg1、人参皂苷Re和人参皂苷Rb1。
优选地,所述提取物的制备方法包括:将鲜人参清洗干净后粉碎成人参颗粒;将人参颗粒进行超声提取,得到提取液;将提取液进行离心分离,然后浓缩,得到浓缩液;将浓缩液进行冷冻干燥,得到鲜人参活性提取物。需要说明的是,本发明制备得到的活性提取物重量可达到鲜参干重的30~40%;人参活性提取物中人参皂苷Rg1含量可达3%以上,人参皂苷Re含量可达2%以上,人参皂苷Rb1含量可达2.5%以上,人参皂苷提取率大于98%。
优选地,鲜人参选自鲜野山参、鲜林下山参、鲜园参、鲜高丽参、鲜日本人参和鲜西洋参中的一种或多种;清洗是采用水优选为蒸馏水清洗,人参颗粒的粒径为60~100目;超声提取中采用的提取溶剂为水,水和人参颗粒的质量比为(3~10):1,超声提取采用的超声波频率为20~40kHz,提取的时间为5~30min,提取的温度为0~35℃,超声提取是采用连续逆流超声波提取设备进行;离心分离采用的转速为4000~25000r/min,离心的时间为10~15min;浓缩的温度为0~35℃,浓缩的时间为30~60min,浓缩液浓度达到5%~30%(质量百分比浓度),浓缩是采用反渗透浓缩器进行,浓缩后得到的反渗透水可作为提取溶剂进行循环利用;冷冻干燥的温度为-40~-70℃,冷冻干燥的时间为24~72h。
优选地,本发明提供的鲜人参活性提取物可以通过添加填充剂、崩解剂、润滑剂和粘合剂等按一定比例组合,制成片剂、胶囊剂、口崩片、散剂、丸剂、颗粒剂、糖浆剂、溶液剂、乳剂、注射剂、喷雾剂、凝胶剂、霜剂、酊剂、止血镇痛纱布、巴布剂或贴膏等形式,其均应该在本发明的保护范围内。
本发明提供了一种鲜人参活性提取物口崩片,鲜人参活性提取物口崩片的原料组分按重量份计,包括:鲜人参活性提取物40~60重量份、填充剂20~40重量份、崩解剂8~15重量份、润滑剂0.5~2.0重量份和粘合剂1~2重量份;其中,填充剂是采用微晶纤维素和甘露醇以(5~1):(1~5)的质量比混合而成;崩解剂是采用交联羧甲基魔芋淀粉钠和交联聚维酮以(0~5):(5~0)的质量比混合而成;润滑剂选自硬脂酸镁、滑石粉和微粉硅胶中的一种或多种;粘合剂是无水乙醇和/或甘油混合物。需要说明的是,参照中国药典2010年版崩解时限测定方法,取人参活性提取物口崩片6片,以水为介质,温度为(37.0±1)℃.每次测定l片,从药片接触水面开始计时,直到颗粒全部通过筛网的时间就为崩解时间;共测定6次,计算平均崩解时间,鲜人参活性提取物口崩片平均崩解时间为15~60s。
本发明还提供了鲜人参活性提取物口崩片的制备方法,包括步骤:将鲜人参活性提取物、填充剂和崩解剂混合均匀,得到混合物;采用粘合剂将混合物制备成软材,然后以15~30目筛挤压制粒,再在30~45℃下恒温干燥8~12h,接着15~30目筛整粒,再加入润滑剂,混合均匀,压制成鲜人参活性提取物口崩片。
本发明还提供了一种鲜人参活性提取物片剂,鲜人参活性提取物片剂的原料组分按重量份计,包括:鲜人参活性提取物1000重量份、淀粉0~800重量份、滑石粉0~18重量份和硬脂酸镁0~18重量份;其中,所有原料组分的重量份均不为0;鲜人参活性提取物片剂的制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成颗粒;在颗粒中加入硬脂酸镁和滑石粉,混合均匀后压制成片,使得每片中含0.1g鲜人参活性提取物,得到鲜人参活性提取物片剂。
本发明还提供了一种鲜人参活性提取物胶囊剂,鲜人参活性提取物胶囊剂的原料组分按重量份计,包括:鲜人参活性提取物1000重量份和淀粉0~800重量份;其中,淀粉的重量份不为0;鲜人参活性提取物胶囊剂的制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成胶囊剂,使得每粒胶囊中含0.2g鲜人参活性提取物,得到鲜人参活性提取物胶囊剂。
本发明还提供了一种鲜人参活性提取物散剂,鲜人参活性提取物散剂的原料组分按重量份计,包括:鲜人参活性提取物1000重量份和微晶纤维素0~800重量份;其中,微晶纤维素的重量份不为0;鲜人参活性提取物散剂的制备方法包括步骤:将鲜人参活性提取物和微晶纤维素混合均匀后制成散剂,然后装瓶,使得每瓶中含0.5g鲜人参活性提取物,得到鲜人参活性提取物散剂。
本发明还提供了一种具有镇痛作用的可吸收止血纱布,具有镇痛作用的可吸收止血纱布的原料组分按重量份计,包括:鲜人参活性提取物5~10重量份、可吸收止血纱布30~40重量份和水90~120重量份;具有镇痛作用的可吸收止血纱布的制备方法包括步骤:将鲜人参活性提取物溶于水中,得到浸泡液;将可吸收止血纱布放入浸泡液中浸湿,得到浸湿后的止血纱布;将浸湿后的止血纱布冷冻干燥,密封包装,制得具有镇痛作用的可吸收止血纱布;其中,冷冻干燥的温度为-40~-70℃,冷冻干燥的时间为24~72h。
本发明提供的技术方案,具有如下的有益效果:
(1)本发明制备得到的活性提取物重量可达到鲜参干重的30~40%;人参活性提取物中人参皂苷Rg1含量可达3%以上,人参皂苷Re含量可达2%以上,人参皂苷Rb1含量可达2.5%以上,人参皂苷提取率大于98%;
(2)本发明提供的鲜人参活性提取物的制备方法简单,能耗低,溶剂可以循环利用,生产过程无废液排放,活性成分被完整保存;
(3)本发明制备得到的鲜人参活性提取物具有显著的镇痛的功效,可用于制备镇痛药品或保健食品;本发明制备得到的鲜人参活性提取物可以通过添加填充剂、崩解剂、润滑剂、粘合剂等按一定比例组合,制成片剂、胶囊剂、口崩片、散剂、丸剂、颗粒剂、糖浆剂、溶液剂、乳剂、注射剂、喷雾剂、凝胶剂、霜剂、酊剂、止血镇痛纱布、巴布剂或贴膏等形式,应用广泛;本发明制备得到的鲜人参活性提取物在制备减轻外科手术病人疼痛药物中的应用属于首次公开。
本发明的附加方面和优点将在下面的描述中部分给出,部分将从下面的描述中变得明显,或通过本发明的实践了解到。
具体实施方式
下面将结合本发明实施例,对本发明的技术方案进行清楚、完整地描述。以下实施例仅用于更加清楚地说明本发明的技术方案,因此只是作为示例,而不能以此来限制本发明的保护范围。
下述实施例中的实验方法,如无特殊说明,均为常规方法。下述实施例中所用的试验材料,如无特殊说明,均为自常规商店购买得到的。以下实施例中的定量试验,均设置三次重复实验,数据为三次重复实验的平均值或平均值±标准差。
下面结合具体实施例对本发明提供的技术方案作进一步说明。
实施例一(鲜人参活性提取物的制备方法)
本实施例提供一种鲜人参活性提取物的制备方法,由以下步骤组成:
取鲜林下山参10kg,用蒸馏水清洗干净,然后粉碎成60~100目的人参颗粒;
在30℃的条件下,以水为提取溶剂,使用连续逆流超声波提取设备进行提取,得到提取液;其中,水和人参颗粒的质量比为5:1,超声提取采用的超声波频率为30kHz,提取的时间为20min,提取的温度为25℃;
将提取液进行离心分离,然后经反渗透浓缩器(合肥智轩膜分离技有限公司)浓缩,得到浓缩液和反渗透水;反渗透水作为提取溶剂循环利用,实现绿色化生产;其中,离心分离采用的转速为15000r/min,离心的时间为12min;浓缩的温度为25℃,浓缩的时间为45min;
将浓缩液在-50℃冷冻干燥48h,得到鲜人参活性提取物。
结果:(1)鲜人参活性提取物的质量为1.02kg。
(2)对鲜人参活性提取物中人参皂苷Rg1、Re、Rb1的含量进行测定,其中:a.仪器采用的是Agilent1260高效液相色谱仪;b.试药包括:人参皂苷Rg1、Re、Rb1对照品(中国生物制品检定所),甲醇、乙腈、磷酸均为色谱纯试剂;c.色谱条件:色谱柱为C18(250mm×4.6mm,5um);流动相为乙腈:1%磷酸溶液(20:80);流速为1.0ml/min;检测波长为203nm,柱温30℃;进样量10μl。在本色谱条件下,色谱柱理论塔板数按人参皂苷Rg1、Re、Rb1计>4000。
经过测定,人参活性提取物中人参皂苷Rg1含量为3.15%,人参皂苷Re含量为2.2%,人参皂苷Rb1含量为2.7%。人参皂苷提取率为99.0%。
实施例二(鲜人参活性提取物镇痛实验)
本实施例提供一种鲜人参活性提取物镇痛的实验研究方法(以实施例一制备得到的鲜人参活性提取物作为研究对象),包括步骤:取昆明种小鼠110只,随机分成11组,每组10只,即生理盐水组;阿司匹林组200mg/kg;鲜人参活性提取物高剂量组(200mg/kg)、鲜人参活性提取物中剂量组(100mg/kg)、鲜人参活性提取物低剂量组(50mg/kg);人参糖蛋白(按专利申请号为201210361575.7的方法制备)高剂量组(200mg/kg)、人参糖蛋白中剂量组(100mg/kg)、人参糖蛋白低剂量组(50mg/kg);人参皂苷Rf(购自中国生物制品检定所)高剂量组(200mg/kg)、人参皂苷Rf中剂量组(100mg/kg)、人参皂苷Rf低剂量组(50mg/kg),连续灌胃给药3d,每天早晚各一次,最后一次灌胃后1h,给各组小鼠腹腔注射0.5%乙酸溶液0.2ml/只。然后以腹部内陷、肢体伸展及臀部抬高为疼痛反应指标,观察15min出现扭体反应的次数。结果见表1。
表1鲜人参活性提取物扭体法镇痛结果(n=10)
注:与模型组比较,*p<0.05。
实验证明:鲜人参活性提取物对小鼠醋酸致痛具有很好的抑制作用。证明鲜人参活性提取物具有良好的镇痛作用,生产过程安全,无毒性,可以作为手术镇痛药物在临床使用。
实施例三(鲜人参活性提取物口崩片)
本实施例提供一种鲜人参活性提取物口崩片,制备方法由以下步骤组成:
称取实施例一制备得到的鲜人参活性提取物粉末200g,微晶纤维素(MCC)100g,甘露醇20g,交联羧甲基魔芋淀粉钠25g,将上述物料在三维混合机中充分混合均匀,得到混合物;其中,交联羧甲基魔芋淀粉钠为自制新型崩解剂,将2500g魔芋淀粉加于5000mL体积分数为95%的乙醇中充分搅拌均匀分散成淀粉乳液,加入1200gNaOH固体碱化,同时加人淀粉质量0.12%的交联剂环氧氯丙烷,置于10L三角瓶中,装上回流冷凝管;在35℃下预处理约20min,然后投入1200g氯乙酸进行羧甲基化,在55℃下反应2.5h结束,经中和、趁热过滤,所得滤饼用体积分数为95%的乙醇洗涤,然后在50℃下真空干燥后得到交联羧甲基魔芋淀粉;
在混合物中加入无水乙醇6ml制备成软材,以20目筛挤压制粒,30℃下恒温干燥8h,20目筛整粒,加入5g硬脂酸镁,混合均匀,压制成每片重为500mg的人参活性提取物口崩片。
结果:对鲜人参活性提取物口崩片进行崩解时限测定,参照中国药典2010年版崩解时限测定方法:取人参活性提取物口崩片6片,以水为介质,温度为(37.0±1)℃.每次测定l片,从药片接触水面开始计时,直到颗粒全部通过筛网的时间为崩解时间。共测定6次,计算平均崩解时间。结果表明鲜人参活性提取物口崩片平均崩解时间为26s。
实施例四(鲜人参活性提取物口片剂)
本实施例提供一种鲜人参活性提取物口片剂,原料组分有:实施例一制备得到的鲜人参活性提取物1000g、淀粉500g、滑石粉18g和硬脂酸镁1g;制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成颗粒;在颗粒中加入硬脂酸镁和滑石粉,混合均匀后压制成10000片。
实施例五(鲜人参活性提取物胶囊剂)
本实施例提供一种鲜人参活性提取物胶囊剂,原料组分有:实施例一制备得到的鲜人参活性提取物1000g和淀粉800g;制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成颗粒;将鲜人参活性提取物和淀粉混合均匀后制成5000粒胶囊剂。
实施例六(鲜人参活性提取物散剂)
本实施例提供一种鲜人参活性提取物散剂,原料组分有:实施例一制备得到的鲜人参活性提取物1000g和微晶纤维素300g;制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成颗粒;将鲜人参活性提取物和微晶纤维素混合均匀后制成散剂,装管制西林瓶制成2000瓶。
实施例七(具有镇痛作用的可吸收止血纱布)
本实施例提供一种具有镇痛作用的可吸收止血纱布,原料组分有:实施例一制备得到的鲜人参活性提取物5重量份、可吸收止血纱布(强生牌)30重量份和蒸馏水90重量份;制备方法包括步骤:将鲜人参活性提取物溶于蒸馏水中,得到浸泡液;将可吸收止血纱布放入浸泡液中浸湿,得到浸湿后的止血纱布;将浸湿后的止血纱布-50℃冷冻干燥48h,密封包装,制得具有镇痛作用的可吸收止血纱布。
实施例八(临床应用例一)
在医院随机选取做子宫切除术的患者共20例,服用本发明实施例一制备的鲜人参活性提取物,手术前2d开始服用,每天服用2次,每次1g,手术前再服用1g,术后患者的痛感较轻,其中无痛感的患者有16例,有轻微痛感的患者3例,有较明显痛感的患者1例,镇痛有效率95%。
实施例九(临床应用例二)
在医院随机选取做剖腹产手术的患者共30例,其中20例服用本发明实施例一制备的鲜人参活性提取物,手术前2d开始服用,每天服用2次,每次1g,手术前再服用1g。另外10例不进行镇痛处理。术后服用鲜人参活性提取物的患者痛感较轻,其中无痛感的患者有18例,有轻微痛感的患者2例,镇痛有效率100%。不进行镇痛处理的患者术后有明显痛感的患者9例,有轻微痛感的患者1例。
实施例十(临床应用例三)
在医院随机选取做完清创缝合术的患者共30例,其中20例服用本发明实施例一制备的鲜人参活性提取物,手术前2d开始服用,每天服用2次,每次1g,手术前再服用1g。另外10例不进行镇痛处理。术后服用鲜人参活性提取物的患者痛感较轻,其中无痛感的患者有19例,有轻微痛感的患者1例,镇痛有效率100%。不进行镇痛处理的患者术后有明显痛感的患者8例,有轻微痛感的患者2例。
实施例十一(临床应用例四)
在医院随机选取做子宫肌瘤剥离除术的患者共20例,手术中使用本发明实施例七制备的具有镇痛作用的可吸收止血纱布填充剥离肌瘤的空隙再进行缝合,术后患者的痛感较轻,其中无痛感的患者有19例,有轻微痛感的患者1例,镇痛有效率100%。
需要注意的是,除非另有说明,本申请使用的技术术语或者科学术语应当为本发明所属领域技术人员所理解的通常意义。除非另外具体说明,否则在这些实施例中阐述的部件和步骤的相对步骤、数字表达式和数值并不限制本发明的范围。在这里示出和描述的所有示例中,除非另有规定,任何具体值应被解释为仅仅是示例性的,而不是作为限制,因此,示例性实施例的其他示例可以具有不同的值。
在本发明的描述中,需要理解的是,术语“第一”、“第二”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个该特征。在本发明的描述中,“多个”的含义是两个以上,除非另有明确具体的限定。
最后应说明的是:以上各实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述各实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分或者全部技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的范围,其均应涵盖在本发明的保护范围当中。
Claims (10)
1.一种鲜人参活性提取物在制备减轻外科手术病人疼痛药物中的应用。
2.根据权利要求1所述的应用,其特征在于,所述鲜人参活性提取物的有效成分包括人参皂苷Rg1、人参皂苷Re和人参皂苷Rb1。
3.根据权利要求1所述的应用,其特征在于,所述提取物的制备方法包括:将鲜人参清洗干净后粉碎成人参颗粒;将所述人参颗粒进行超声提取,得到提取液;将所述提取液进行离心分离,然后浓缩,得到浓缩液;将所述浓缩液进行冷冻干燥,得到所述鲜人参活性提取物。
4.根据权利要求3所述的应用,其特征在于,所述鲜人参选自鲜野山参、鲜林下山参、鲜园参、鲜高丽参、鲜日本人参和鲜西洋参中的一种或多种;所述清洗是采用水清洗,所述人参颗粒的粒径为60~100目;所述超声提取中采用的提取溶剂为水,所述水和所述人参颗粒的质量比为(3~10):1,所述超声提取采用的超声波频率为20~40kHz,提取的时间为5~30min,提取的温度为0~35℃,所述超声提取是采用连续逆流超声波提取设备进行;所述离心分离采用的转速为4000~25000r/min,离心的时间为10~15min;所述浓缩的温度为0~35℃,所述浓缩的时间为30~60min,所述浓缩是采用反渗透浓缩器进行,浓缩后得到的反渗透水可作为提取溶剂进行循环利用;所述冷冻干燥的温度为-40~-70℃,所述冷冻干燥的时间为24~72h。
5.根据权利要求1所述应用,其特征在于,所述药物的剂型包括片剂、胶囊剂、口崩片、散剂、丸剂、颗粒剂、糖浆剂、溶液剂、乳剂、注射剂、喷雾剂、凝胶剂、霜剂、酊剂、止血镇痛纱布、巴布剂或贴膏。
6.一种鲜人参活性提取物口崩片,其特征在于:所述鲜人参活性提取物口崩片的原料组分按重量份计,包括:权利要求2~4任一项所述应用中的的鲜人参活性提取物40~60重量份、填充剂20~40重量份、崩解剂8~15重量份、润滑剂0.5~2.0重量份和粘合剂1~2重量份;其中,所述填充剂是采用微晶纤维素和甘露醇以(5~1):(1~5)的质量比混合而成;所述崩解剂是采用交联羧甲基魔芋淀粉钠和交联聚维酮以(0~5):(5~0)的质量比混合而成;所述润滑剂选自硬脂酸镁、滑石粉和微粉硅胶中的一种或多种;所述粘合剂是无水乙醇和/或甘油混合物;所述口崩片的制备方法,包括步骤:将鲜人参活性提取物、填充剂和崩解剂混合均匀,得到混合物;采用粘合剂将所述混合物制备成软材,然后以15~30目筛挤压制粒,再在30~45℃下恒温干燥8~12h,接着15~30目筛整粒,再加入润滑剂,混合均匀,压制成鲜人参活性提取物口崩片。
7.一种鲜人参活性提取物片剂,其特征在于:所述鲜人参活性提取物片剂的原料组分按重量份计,包括:权利要求2~4任一项所述应用中的鲜人参活性提取物1000重量份、淀粉0~800重量份、滑石粉0~18重量份和硬脂酸镁0~18重量份;其中,所有原料组分的重量份均不为0;所述鲜人参活性提取物片剂的制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成颗粒;在所述颗粒中加入硬脂酸镁和滑石粉,混合均匀后压制成片,使得每片中含0.1g鲜人参活性提取物,得到所述鲜人参活性提取物片剂。
8.一种鲜人参活性提取物胶囊剂,其特征在于:所述鲜人参活性提取物胶囊剂的原料组分按重量份计,包括:权利要求2~4任一项所述应用中的鲜人参活性提取物1000重量份和淀粉0~800重量份;其中,所述淀粉的重量份不为0;所述鲜人参活性提取物胶囊剂的制备方法包括步骤:将鲜人参活性提取物和淀粉混合均匀后制成胶囊剂,使得每粒胶囊中含0.2g鲜人参活性提取物,得到所述鲜人参活性提取物胶囊剂。
9.一种鲜人参活性提取物散剂,其特征在于:所述鲜人参活性提取物散剂的原料组分按重量份计,包括:权利要求2~4任一项所述应用中的鲜人参活性提取物1000重量份和微晶纤维素0~800重量份;其中,所述微晶纤维素的重量份不为0;所述鲜人参活性提取物散剂的制备方法包括步骤:将鲜人参活性提取物和微晶纤维素混合均匀后制成散剂,然后装瓶,使得每瓶中含0.5g鲜人参活性提取物,得到所述鲜人参活性提取物散剂。
10.一种具有镇痛作用的可吸收止血纱布,其特征在于:所述具有镇痛作用的可吸收止血纱布的原料组分按重量份计,包括:权利要求2~4任一项所述应用中的鲜人参活性提取物5~10重量份、可吸收止血纱布30~40重量份和水90~120重量份;所述具有镇痛作用的可吸收止血纱布的制备方法包括步骤:将鲜人参活性提取物溶于水中,得到浸泡液;将可吸收止血纱布放入所述浸泡液中浸湿,得到浸湿后的止血纱布;将所述浸湿后的止血纱布冷冻干燥,密封包装,制得具有镇痛作用的可吸收止血纱布;其中,所述冷冻干燥的温度为-40~-70℃,所述冷冻干燥的时间为24~72h。
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