CN104861036A - 一种防治前列腺疾病的提取物及其制法 - Google Patents
一种防治前列腺疾病的提取物及其制法 Download PDFInfo
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Abstract
本发明涉及医药技术领域,是以大豆脱臭馏出物为原料制备的一种植物甾醇提取物。经动物实验证明具有防治前列腺炎、前列腺增生、前列腺肥大等相关病症的作用,可用于制备防治前列腺炎、前列腺增生及前列腺肥大等相关病症的药物及食品。
Description
技术领域
本发明涉及医药技术领域,系以大豆脱臭馏出物为原料制备的一种提取物,以及将其用于制备防治前列腺疾病的药物中的用途。
背景技术
常见前列腺疾病包括前列腺炎和前列腺肥大,是一种男性常见病,多见于中老年人。前列腺炎常与慢性精囊炎同时存在,病变从急性可转成慢性,但绝大多数并无急性阶段。主要症状是会阴、精索、睾丸部不适、腰痛,轻度尿频、尿道刺痛,尿道有分泌物,有些病人常有神经衰弱;前列腺肥大多见于老年男性,据统计大约有70%的男性老年人患有前列腺肥大症,晚期会出现严重的尿频、尿细流、尿滴沥和尿潴留等症状,给患者带来极大痛苦。在现有技术中,治疗前列腺炎的手段很多,包括中药汤剂口服、中成药口服、中药坐浴、中药栓剂直肠给药、中药汤剂灌肠、经络穴位针灸、穴位按摩、西药口服、西药肌肉注射、西药会阴部直接注射;微波射频及红外照射等。由于前列腺独特的解剖位置,经口服或肌肉注射给药,药物到达该部位后,剂量已经很少,且难以穿透前列腺被膜,故对病灶的作用很小,治疗效果极微。
由于前列腺炎大多都病程长,病因复杂,对于细菌性前列腺炎,无论使用何种形式的西药消炎都只能在短期内奏效,时间一长,细菌对西药产生了抗药性,药效就会明显降低,而且抗菌药物对于前列腺炎中90%以上的非细菌性前列腺炎和前列腺痛不起作用。中药坐浴虽然有效,但不能持久,治疗也很费事,对药物的浪费也大。直肠栓剂给药、灌肠虽然也有治疗效果,但药力自然吸收差,病人治疗使用不方便,而且容易带来副作用。电子治疗、微波射频治疗、红外照射治疗的疗效亦不理想,且治疗的价格昂贵。总之,对于前列腺疾病的治疗迫切需要安全、有效的药品和治疗方法。
发明内容
本发明的目的在于提供一种防治前列腺疾病的大豆甾醇提取物,经动物实验证明其具有较好的防治前列腺疾病的作用,因而可用于制备防治前列腺疾病的药物或食品。本发明提取物有效成分含量高,质量易于控制,安全、高效、稳定、价廉。本发明提取物制备方法及药理实验结果如下:
一、制备方法
1.酯化
将大豆油脱臭馏出物与溶剂按比例混合均匀后,在浓硫酸催化作用下,于恒温水浴中回流酯化。所述的酯化反应系指大豆油脱臭馏出物中所含脂肪酸类成分的酯化,这种酯化试剂即可以采用甲醇,也可以采用乙醇等其他化学上可接受的酯化试剂。所述的酯化反应中,原料与酯化试剂的比例10∶1~1∶1,优选为5∶1~2∶1,最优选为3∶1。
2.制备粗结晶
酯化反应完毕,冷却后加碱液中和至不同pH值,转移至分液漏斗分层,收集上层油相冷析结晶。
本步骤调节可加碱液中和至pH值5-11,优选为6-10,最优选为7。
3.脱色除杂
将上述油相冷却析出的结晶,抽滤,得滤饼,滤饼热溶,趁热过滤除杂脱色,滤液放冷析出结晶,得粗制大豆植物甾醇。
4.精制
上述粗制大豆植物甾醇,重结晶即得精制大豆植物甾醇提取物。
本步骤重结晶溶剂可选择无水乙醇、无水丙酮、正丁醇、乙酸乙酯等,溶剂用量5-25倍,优选为10-15倍丙酮。最优选为15倍丙酮。
以上所述的提取物制备方法在具体实施例中加以详细阐述。
由上述可以看出,本发明所述的大豆甾醇提取物制备方法简便,具有安全、无毒、简便、成本低等优点。本提取物经GC-MS分析,主要含有β-谷甾醇、豆甾醇、莱油甾醇等化学成分。
二、药理实验
取Wister大鼠60只(250~300g),按体重随机均衡分成6组,分别为假手术对照组、模型对照组、阳性对照组、实施例1提取物低、中、高剂量组。于造模前96、72、48、24、1h连续给药5次,并于致炎前用10%硫化钠溶液脱去腹毛(3cm×3cm),末次给药后1h,20%乌拉坦1.2g/kg腹腔注射;麻醉成功后,仰卧位固定于固定器上,无菌条件下,下腹正中切开皮肤约1.5~2cm,逐层分离肌肉组织,暴露腹腔,在与前列腺相接的精液囊头叶注射无菌1%角叉菜胶生理盐水溶液,随即送复脏器,缝合肌肉、皮肤。致炎后24、48、72、96、120h给药5次。末次给药1h后,电子天平称重,将大鼠脱颈处死,无菌操作,暴露前列腺,取前列腺液20μL,取前列腺液10μL放入1mL白细胞稀释液中,充分混匀后吸取1μL混合液镜检白细胞数。无菌操作取下前列腺,观察前列腺及精囊腺的质地及颜色改变,电子天平称重,计算前列腺指数[前列腺指数=(前列腺重/体重)×100%]。结果见表1、表2。结果表明提取物低、中、高剂量组可以明显降低非细菌性前列腺液中白细胞数;提取物中、高剂量组可以明显降低大鼠的前列腺指数。总的药理实验结果表明本发明所述提取物具有显著的治疗非细菌性前列腺炎、前列腺增生、前列腺肥大的作用。
表1提取物对大鼠非细菌性前列腺液白细胞数的影响
注:与空白溶剂组比,P<0.05
表2提取物对大鼠非细菌性前列腺指数的影响
注:与空白溶剂组比,P<0.05
具体实施方式
下面结合具体实施例对本发明作进一步阐述,但不限于以下实施例。
实施例1取1000ml大豆油脱臭馏出物,加入3000ml无水乙醇作反应溶剂,再加入催化剂硫酸150ml,水浴加热回流,反应3h后冷却,加适量Na0H溶液中和至pH=7,转移至分液漏斗中静置分层,上层油相4℃冷析过夜,真空抽滤,滤饼以新鲜溶剂热溶,热滤除杂,滤液4℃冷析结晶,再抽滤得粗制大豆甾醇提取物,此粗制大豆甾醇提取物以15倍丙酮重结晶,抽滤,干燥,即得精制大豆甾醇提取物41.50g,GC法测定β-谷甾醇、豆甾醇含量之和为71.30%。
实施例2取1000ml大豆油脱臭馏出物,加入5000ml甲醇作反应溶剂,其余同实施例1,得精制大豆甾醇提取物45.24g,GC法测定β-谷甾醇、豆甾醇含量之和为67.25%。
实施例3取1000ml大豆油脱臭馏出物,以无水乙醇作为重结晶溶剂,其余同实施例1,得精制大豆甾醇提取物37.13g,GC法测定β-谷甾醇、豆甾醇含量之和为64.56%。
实施例4取1000ml大豆油脱臭馏出物,酯化反应后加适量NaOH溶液中和至pH=10,其余同实施例1,得精制大豆甾醇提取物50.13g,GC法测定β-谷甾醇、豆甾醇含量之和为59.21%。
实施例5取1000ml大豆油脱臭馏出物,其余同实施例1,以30倍丙酮重结晶,其余同实施例1,得精制大豆甾醇提取物30.13g,GC法测定β-谷甾醇、豆甾醇含量之和为74.70%。
实施例6取1000ml大豆油脱臭馏出物,其余同实施例1,以15倍乙酸乙酯重结晶,其余同实施例1,得精制大豆甾醇提取物32.13g,GC法测定β-谷甾醇、豆甾醇含量之和为69.54%。
Claims (5)
1.大豆甾醇提取物的制备方法,包括如下步骤:
(1)酯化将大豆油脱臭馏出物与酯化溶剂按比例混合均匀后,在浓硫酸催化作用下,于恒温水浴中回流酯化。
(2)制备粗结晶
酯化反应完毕,冷却后加碱液中和至不同pH值,转移至分液漏斗分层,收集上层油相冷析结晶。
(3)脱色除杂
将上述油相冷却析出的结晶,抽滤,得滤饼,滤饼热溶,趁热过滤除杂脱色,滤液放冷析出结晶,得粗制大豆植物甾醇。
(4)精制
上述粗制大豆植物甾醇重结晶,即得精制大豆甾醇提取物。
2.按权利要求1所述的制备方法,其特征在于酯化试剂为乙醇或甲醇。
3.按权利要求1所述的制备方法,其特征在于原料与酯化试剂的比例10∶1~1∶1。
4.权利要求1或2或3所述方法制备的提取物。
5.权利要求1或2或3所述方法制备的提取物在制备防治前列腺炎、前列腺增生以及前列腺肥大药物和食品中的应用。
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