CN109453224A - 一种泻根醇酸和中药提取物的组合物和用途 - Google Patents
一种泻根醇酸和中药提取物的组合物和用途 Download PDFInfo
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- CN109453224A CN109453224A CN201811341554.2A CN201811341554A CN109453224A CN 109453224 A CN109453224 A CN 109453224A CN 201811341554 A CN201811341554 A CN 201811341554A CN 109453224 A CN109453224 A CN 109453224A
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Abstract
本发明公开了一种药物组合物和用途,它是由泻根醇酸与中药提取物的重量之比为1:79‑99组成;所述的中药提取物按以下方法制备:将人参150g,当归450g,川穹100g,黄芪550g加重量比浓度为75%的乙醇12500g在38‑42℃下浸泡168小时,滤取浸泡提取液,回收乙醇得浸提液保存备用,另将药渣按药材重量8倍、5倍、3倍加水煎煮3次,煎煮时间分别为第1次2小时,第二次1小时,第三次0.5小时,合并3次煎煮液,经过滤,浓缩至比重为1.0时,再与上述浸提液合并,再进一步浓缩,干燥至含水量小于5%的浸膏。该组合物按常规工艺制成片剂、胶囊剂、颗粒剂、口服液或酒品作为制备保健品的用途或作为制备化妆品中的添加剂的用途。
Description
技术领域
本发明涉及药物制剂和/或保健食品加工领域,具体涉及由泻根醇酸和中药提取物组成的药物组合物和用途。
背景技术
泻根醇酸是从葫芦科瓜类植物的根及茎中提取出来的一种酸性异文墩果烷型三帖系化合物。泻根醇酸最为突出的药用效果表现在抗过敏作用上,具有抗过敏、保湿、促进皮肤细胞生长、抑制黑色素细胞增长、抗肿瘤等多种功效。目前,在日本,泻根醇酸已广泛应用于医药、化妆品、食品等领域,并进行了相应的专利保护(刘婷婷 田野2014),但在我国对于泻根醇酸的开发利用鲜有报道。
江苏千药堂国医研究院有限公司利用专利(ZL201410882120.8)技术,于2015年6月间成功开发出泻根醇酸结晶性产品,含量C30H18O30≥96.0%,且具有良好的稳定性。我国作为瓜类植物种植大国,具有丰富的原材料资源,开发利用好这一资源优势,能够推动种植业、制造业等的产业链的经济效果,开发利用好泻根醇酸产品是拉动行业发展的必然选择。
由于现代人生活节奏加快,生活压力大,生活结构的改变,现代生活中一些特有的疾病也相应的呈现增多趋势。如因气血不足、气血阻滞或气虚血瘀等所致的内分泌紊乱、黄褐斑(黧黑斑)、雀斑等病例明显增加,直到目前也未有确切疗效的治疗药物。利用泻根醇酸具有抗过敏、促进皮肤细胞生长、抑制黑色素细胞增长的有益功效,结合我国传统的中医用药理念,将泻根醇酸这种天然活性物质与传统医学和现代制药工艺技术有机结合,组成一种新的药物组合物,使该药物组合物能给上述疾病的治疗中起到辅助治疗作用。
发明内容
本发明的目的在于提供一种由泻根醇酸和一种中药提取物组成的药物组合物和用途。
本发明的目的还在于提供一种药物组合物在制备辅助治疗黄褐斑药物中作为制备保健品的用途。本发明还在于提供一种药物组合物在制备化妆品中的添加剂的用途。
本发明提供的一种药物组合物,其特征在于,它是由泻根醇酸和中药提取物的重量比为1:79-99组成,所述的中药提取物按以下方法制备:将人参150g,当归450g,川穹100g,黄芪550g加入浓度为75%(v/v)的乙醇12500g在38-42℃下浸泡168小时,滤取浸泡提取液,回收乙醇得浸提液保存备用,另将药渣分别按药材重量8倍、5倍、3倍加水煎煮3次,煎煮时间为第1次2小时,第二次1小时,第三次0.5小时,合并3次煎煮液,经过滤,经浓缩至比重为1.0的浓缩液时,再与上述回收乙醇后的浸提液合并,再进一步浓缩成稠膏,干燥至含水量小于5%w/w的浸膏。
该中药浸膏在下文中称作“本文(或上文)所述的中药提取物”。
本发明药物组合物的制备方法,可取配比重量较小的泻根醇酸按等量递加方法依次逐步递加中药提取物充分研磨至均匀,过筛,即得。
上述所述的干燥采用本领域公知的干燥技术条件下的干燥手段,如真空干燥、冷冻干燥或热风低温干燥等,在考虑到避免或减少中药提取物中有效成分的流失的条件,选择避免高温的干燥方法均适用于本发明中的干燥处理。
本发明提供的一种药物组合物,泻根醇酸和中药提取物的用量之比优选的:泻根醇酸:中药提取物为:1:85-95组成。
本发明提供的一种药物组合物,泻根醇酸和中药提取物的用量之比更优选的:泻根醇酸:中药提取物为:1:89组成。
所述的药物组合物按常规工艺制成片剂、胶囊剂、颗粒剂、口服液或酒品作为制备保健品的用途。
所述的药物组合物作为制备化妆品中的添加剂的用途。
本发明利用泻根醇酸具有的抗过敏作用、促进皮肤细胞生长和抑制黑色素细胞生长的作用,与具有益气化瘀,调经祛斑,滋养肌肤作用的中药配方组合,用于气虚血瘀所致的黄褐斑、雀斑的辅助治疗,经实践考察具有良好的应用效果。临床治疗患有黄褐斑的患者32人,均为女性,年龄在23-36岁之间,分别服用本发明药物组合物制成的片剂、胶囊剂、口服液等不同制剂,服用量为药用组合物1克,日服3次,其中有16人用药80天后黄褐斑消失,5人用药65天后黄褐斑消失,6人用药65天后明显好转,其中5人在用药65天后未见明显效果。80天内治愈率为58.3%,总有效率为84.37%,实践证明,本发明一种药用组合物对黄褐斑具有良好的辅助治疗作用。
人参,甘,微苦,微温。归脾、肺、心肾经。具有大补元气,复脉固脱,补脾益肺,生津养血、安神益智功能。人参大补元气,元气充则心气得养,心神得宁,心智得聪,而具安神益智的功效,用于治疗心气不足或心肾气虚、心脾两虚的失眠、健忘等。人参甘温,大补元气,益气以生血,具气血双补之效,故可用治脾胃气虚,化源不足,血虚萎黄之证。
当归,甘、辛,温。归肝、心、脾经。具有补血活血,调经止痛,润肠通便功能,用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,风湿痹痛,跌扑损伤,痈疽疮疡,肠燥便秘。当归甘温,养血补虚,为补血良药,故可用治心肝血虚,血色萎黄,眩晕心悸。
川穹,辛,温。归肝、胆、心包经。具有活血行气,祛风止痛功能。川穹辛散温通,功能活血行气,有“血中气药”(《本草汇言》)之称。既活血祛瘀通脉,善治心脉瘀阻、胸痹心痛;又行气开郁止痛,为肝郁气滞之胸肋刺痛所多用。川穹善于“下调经水”(《本草汇言》)、活血调经,优为月经不调、痛经、经闭等证之要药;亦治癥瘕腹痛,具有活血祛瘀、消癥散结之功。
黄芪,甘,微温。归肺、脾经。具有补气升阳,固表止汗,利水消肿,生津养血,行滞通痹,托毒排脓,敛疮生肌功效,用于气血乏力,食少便溏,中气下陷,腹泻脱肛,便血崩漏,表虚自汗,气虚水肿,内热消渴,气虚萎黄之证。黄芪甘微温,益气升阳,盖阳生阴长,气旺血生,故有补气生血之功,长用于劳倦内伤,气亏血虚,血虚阳浮,肌热面赤,脉大无力之血虚发热证。及思虑过度,劳伤心脾,气血双亏,面色萎黄,心悸失眠者。
以上4种中药组成制备提取物,按照中医药理论证明具有益气化瘀,调经祛斑,滋养肌肤作用,按现代中药理论研究,如组份中当归为主药之一,其有效成分阿魏酸能减少H2O2含量,并与磷脂酰乙醇胺结合抑制氧化反应和自由基反应,拮抗自由基对组织的损害,促进血液循环,增进肌肤细胞发育的作用。阿魏酸不仅能淬灭自由基。而且还能调节人体生理机制,抑制产生自由基的酶,促进清除自由基的酶的产生。
泻根醇酸活性成分与中药组合提取物能产生不同成分、不同作用机制的协同治疗作用,能强化促进皮肤的细胞生长,抑制黑色素细胞增长、滋养肌肤的作用。经临床实践证明,本发明药物组合物对辅助治疗黄褐斑具有很好的应用效果,这对扩大中药的临床应用,提高疗效很有实际意义。
本发明的一种药物组合物,可以根据需要配制成不同的口服剂型。可以将药用组合物与药学上可接受的辅料混合配制成片剂,胶囊剂,颗粒剂,口服液或酒制品等,其中胶囊剂可制备成软胶囊剂和硬胶囊剂;其中片剂优选泡腾片,咀嚼片,口含片,因为泡腾片,咀嚼片,口含片与普通片剂相比有以下几点优势:(1)服用方便,可嚼服、含服,可化水,由于配制这些片剂都要加入一定量的糖份作为赋形剂,因而口感好,人们乐意服用,泡腾片加水自溶后犹如一杯饮料,使人们乐于饮用;(2)吸收快,因为经口腔或泡饮使药物成分离子化,使之吸收快,生物利用度高;(3)便于携带,方便运输;其中所述的酒品可制成白酒、葡萄酒、黄酒和啤酒制品。本发明一种药物组合物,还可以根据需要配制成化妆品。
具体实施方式
通过以下实施例对本发明进行更详细的说明,但对本发明的范围不构成任何限制。
实施例1
中药提取物的制备
分别称取净药材人参150g,当归450g,川穹100g,黄芪550g,置于提取罐中,加入浓度为75%的乙醇12.5kg,在40℃条件下密闭浸泡168小时,浸泡期间每隔6小时进行搅拌1次,浸泡结束后,滤取浸泡提取液,将浸泡提取液回收乙醇得浸提液另器保存备用;将醇浸提后的药渣加入纯净水10公斤,加热煎煮2小时,滤取煎煮液,药渣再加入纯净水6.25公斤,加热煎煮1小时,滤取煎煮液,再将药渣加纯净水3.75公斤,加热煎煮0.5小时,滤取煎煮液,将3次煎煮液合并,过滤,将滤液浓缩至比重为1.0的浓缩液时,再与上述浸提液合并,再进一步浓缩成稠膏后,置于真空干燥机内进行真空干燥至含水量<5%w/w,即得中药提取物。
实施例2
中药提取物的制备
分别称取净药材人参150g,当归450g,川穹100g,黄芪550g,置于提取罐中,加入浓度为75%的乙醇12.5kg,在42℃条件下密闭浸泡168小时,浸泡期间每隔6小时进行搅拌1次,浸泡结束后,滤取浸泡提取液,将浸泡提取液回收乙醇得浸提液另器保存备用;将醇浸提后的药渣加入纯净水10公斤,加热煎煮2小时,滤取煎煮液,药渣再加入纯净水6.25公斤,加热煎煮1小时,滤取煎煮液,再将药渣加纯净水3.75公斤,加热煎煮0.5小时,滤取煎煮液,将3次煎煮液合并,过滤,将滤液浓缩至比重为1.0的浓缩液时,再与上述浸提液合并,再进一步浓缩成稠膏后,置于真空干燥机内进行真空干燥至含水量<5%w/w,即得中药提取物。
实施例3
中药提取物的制备
分别称取净药材人参150g,当归450g,川穹100g,黄芪550g,置于提取罐中,加入浓度为75%的乙醇12.5kg,在38℃条件下密闭浸泡168小时,浸泡期间每隔6小时进行搅拌1次,浸泡结束后,滤取浸泡提取液,将浸泡提取液回收乙醇得浸提液另器保存备用;将醇浸提后的药渣加入纯净水10公斤,加热煎煮2小时,滤取煎煮液,药渣再加入纯净水6.25公斤,加热煎煮1小时,滤取煎煮液,再将药渣加纯净水3.75公斤,加热煎煮0.5小时,滤取煎煮液,将3次煎煮液合并,过滤,将滤液浓缩至比重为1.0的浓缩液时,再与上述浸提液合并,再进一步浓缩成稠膏后,置于真空干燥机内进行真空干燥至含水量<5%w/w,即得中药提取物。
实施例4
可按常规方式生产含有下列组份的口服液:
组份:
本发明药物组合物 50g
果脯糖浆 100g
柠檬酸 10g
纯净水 加至 1000ml
取药物组合物、果脯糖浆和柠檬酸分别依次加入适量的纯净水中使溶,然后再加纯净水至1000ml,经过滤,分装于容量为10ml小瓶中,经封口,置于100℃水浴中30分钟灭菌,制成规格为药用组合物0.5g/10ml的口服溶液。
其中组合物由泻根醇酸和实施例1所得中药提取物以重量比1:99组成。
实施例5
可按常规方式生产含有下列组份的胶囊:
组份:
本发明药物组合物 100g
淀粉 200g
现将淀粉干燥处理后,过120目筛,与药物组合物混合均匀,再经过三次120目筛,使之充分混匀,分别装入胶囊中,制得1000粒胶囊,每粒重量为0.3g。
其中组合物由泻根醇酸和实施例1所得中药提取物以重量比1:85组成。
实施例6
可按常规方式生产含有下列组份的泡腾片:
组份:
药物组合物 500g
枸橼酸 600g
碳酸氢钠 1100g
乳糖 900g
将药物组合物和其他辅助材料分别过100尼龙目筛,然后以等量递加的方法混合后再过100尼龙筛,并充分混匀,以重量5%-10%聚维酮乙醇溶液(内加适量聚山梨酯80和甜味剂)制软材,以20目尼龙筛制粒,40℃烘干,整粒,加入适量聚乙二醇6000作润滑剂,压片,制得2000粒泡腾片,每粒重量为1.55g。
其中组合物由泻根醇酸和实施例2所得中药提取物以重量比1:89组成。
实施例7
可按常规方式生产含有下列组份的酒:
组份:
药物组合物 80g
50度白酒 920g
取药物组合物加入50度白酒中,充分搅拌,然后放置室温处,密闭贮存21天后,过滤,即得。
其中组合物由泻根醇酸和实施例2所得中药提取物的重量比1:85组成。
实施例8
可按常规方式生产含有下列组份的酒:
组份:
药物组合物 50g
蜂蜜 120g
柠檬酸 11g
22度白酒 加至 1000g
取药物组合物、柠檬酸和蜂蜜分别依次加入适量的22度白酒中使溶,然后加入余量的白酒,搅拌均匀,置于室温暗处,静置1周后,经过滤,分装,密封即得。
其中组合物由泻根醇酸和实施例3所得中药提取物的重量比1:95组成。
实施例9
可按常规方式生产含有下列组份的酒:
组份:
药物组合物 30g
葡萄酒 加至 1000g
取药物组合物加入适量葡萄酒中使溶,然后加入余量的葡萄酒,搅拌均匀,置于3-5℃环境下,置于3-5℃环境下,静置24小时,过滤,装瓶,封口即得。
其中组合物由泻根醇酸和实施例3所得中药提取物的重量比为1:99组成。
Claims (7)
1.一种泻根醇酸与中药提取物的药物组合物,其特征是由泻根醇酸和中药提取物的重量之比为1:79-99组成,所述的中药提取物按以下方法制备:将人参150g,当归450g,川穹100g,黄芪550g加入浓度为75%v/v的乙醇12500g在38-42℃下浸泡168小时,滤取浸泡提取液,回收乙醇得浸提液保存备用,另将药渣分别按药材重量8倍、5倍、3倍加水煎煮3次,煎煮时间为第1次2小时,第二次1小时,第三次0.5小时,合并3次煎煮液,经过滤,经浓缩至比重为1.0的浓缩液时,再与上述回收乙醇后的浸提液合并,再进一步浓缩成稠膏,干燥至含水量小于5%w/w的浸膏;所述泻根醇酸与中药提取物的药物组合物的配制方法是:取配比重量较小的泻根醇酸按等量递加方法依次逐步递加加入中药提取物,充分研磨至均匀,过筛,即得。
2.一种泻根醇酸与中药提取物的药物组合物,其特征是由泻根醇酸和中药提取物的重量之比为1:85-95组成,所述的中药提取物按以下方法制备:将人参150g,当归450g,川穹100g,黄芪550g加入浓度为75%v/v的乙醇12500g在38-42℃下浸泡168小时,滤取浸泡提取液,回收乙醇得浸提液保存备用,另将药渣分别按药材重量8倍、5倍、3倍加水煎煮3次,煎煮时间为第1次2小时,第二次1小时,第三次0.5小时,合并3次煎煮液,经过滤,经浓缩至比重为1.0的浓缩液时,再与上述回收乙醇后的浸提液合并,再进一步浓缩成稠膏,干燥至含水量小于5%w/w的浸膏;所述泻根醇酸与中药提取物的药物组合物的配制方法是:取配比重量较小的泻根醇酸按等量递加方法依次逐步递加加入中药提取物,充分研磨至均匀,过筛,即得。
3.一种泻根醇酸与中药提取物的药物组合物,其特征是由泻根醇酸和中药提取物的重量之比为1:89组成,所述的中药提取物按以下方法制备:将人参150g,当归450g,川穹100g,黄芪550g加入浓度为75%v/v的乙醇12500g在38-42℃下浸泡168小时,滤取浸泡提取液,回收乙醇得浸提液保存备用,另将药渣分别按药材重量8倍、5倍、3倍加水煎煮3次,煎煮时间为第1次2小时,第二次1小时,第三次0.5小时,合并3次煎煮液,经过滤,经浓缩至比重为1.0的浓缩液时,再与上述回收乙醇后的浸提液合并,再进一步浓缩成稠膏,干燥至含水量小于5%w/w的浸膏;所述泻根醇酸与中药提取物的药物组合物的配制方法是:取配比重量较小的泻根醇酸按等量递加方法依次逐步递加加入中药提取物,充分研磨至均匀,过筛,即得。
4.根据权利要求1-3所述的药物组合物按常规工艺制成片剂、胶囊剂、颗粒剂、口服液或酒品作为制备保健品的用途。
5.根据权利要求4所述的药物组合物的用途,用于配制成泡腾片、咀嚼片、口含片。
6.根据权利要求4所述的药物组合物的用途,用于配制成白酒、葡萄酒、黄酒和啤酒。
7.根据权利要求1-3所述的药物组合物作为制备化妆品中的添加剂的用途。
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