CN104173521B - 一种生精壮阳的药物组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种生精壮阳的药物组合物，涉及医药技术领域。其由活性成分和药学上可用的辅料制备而成，所述的活性成分是丰花草原料的乙醇提物的正丁醇部位，其中丰花草原料为草科植物丰花草的地上部分。本发明有补肾生精、燮理阴阳的功效，可提高男性患者的生殖能力，适用于因房事不节导致肾精亏虚的男性不育症患者。
Description
技术领域
本发明属于植物提取技术领域，具体涉及一种生精壮阳的药物组合物及其制备方法。
背景技术
婚后性生活是男女的一种生理需要，正常性生活应以每周2～3次为宜，具体地说，应该以性交后第二天没有疲倦不适感为标准。若性交后感到周身无力、精神不振、头晕头昏、四肢无力、心悸气短、食欲减退、腰酸背痛、整日昏昏沉沉的，甚至出现无精、少精、死精等症状，说明性生活已经过度至病，需要及时治疗。
CN103100025A公开了一种用于益肾壮阳的药物组合物，包含人参5～10份、黄芪2.5～5份、补骨脂(盐炒)2.5～5份、巴戟天(制)2.5～5份、肉苁蓉2.5～5份、山茱萸(制)2.5～5份、枸杞子2.5～5份、覆盆子2.5～5份、制何首乌2.5～5份、杜仲(盐制)2.5～5份、肉桂2.5～5份、菟丝子2.5～5份、山药2.5～5份、砂仁2.5～5份、白术2.5～5份、麦冬2.5～5份、天冬2.5～5份、五味子2.5～5份、熟地黄2.5～5份、菊花2.5～5份、黄柏(盐炒)2.5～5份、车前子(盐炒)2.5～5份、柏子仁2.5～5份、远志(制)2.5～5份，具有明确的补肾壮阳、益气补血、固精止泻、提高机体免疫力、明显提高男性性功能、改善性生活质量，并可用于预防和治疗阳痿、早泄等性功能障碍，具有较好的临床效果。锁阳补肾胶囊，主要由锁阳、仙茅、巴戟天、当归、蛇床子、肉苁蓉、韭菜子、五味子、红参、牛鞭、狗肾、鹿茸、黑顺片、肉桂、小茴香、阳起石、花椒、菟丝子、杜仲等药物制备而成，补肾壮阳，填精固真，用于肾阳虚或肾阴虚引起的阳萎、遗精、早泄等症。
虽然目前可补肾壮阳、改善男性性功能障碍的处方众多，但是，其组方中药味数量多，成本高，且不利于对中药植物品种的保护。
发明内容
鉴于现有技术的不足，本发明的目的在于通过对祖传秘方进行深入研究，提供一种一种生精壮阳的药物组合物及其制备方法。
本发明的目的是这样实现的：
一种生精壮阳的药物组合物，该药物组合物由活性成分和药学上可用的辅料制备而成，其中所述的活性成分是丰花草原料的乙醇提物的正丁醇部位。
在本发明所优选出的实施例中，如上所述的生精壮阳的药物组合物中采用的丰花草原料为草科植物丰花草的地上部分，可以为鲜品或者干品。
本发明还提供了一种上述生精壮阳的药物组合物的制备方法，该方法包括如下步骤：将丰花草原料用浓度为93-96%的乙醇溶液回流提取1-3h，过滤，滤液减压浓缩至干，得粗提取物，用水溶解成混悬液，加正丁醇萃取，得到正丁醇萃取液，将正丁醇萃取液回收溶剂后浓缩成稠膏，干燥，粉碎，得到丰花草原料的乙醇提物的正丁醇部位，再与药学上可用的辅料混匀制备成口服固体制剂。作为对上述制备方法中萃取步骤的优化，其中的正丁醇萃取步骤为等体积萃取。
本发明人在以往的试验中均通过灌胃给药的方式予以实验动物相应剂量的药物，并发挥了生精壮阳的药效，因此将该药物组合物制备成口服制剂，所述的口服制剂包括片剂、胶囊剂和颗粒剂。为使上述剂型能够实现，需在制备这些剂型时加入药学可接受的辅料，例如：填充剂、崩解剂、润滑剂、助悬剂、粘合剂、甜味剂、矫味剂、防腐剂、基质等。填充剂包括：淀粉、预胶化淀粉、乳糖、甘露醇、甲壳素、微晶纤维素、蔗糖等；崩解剂包括：淀粉、预胶化淀粉、微晶纤维素、羧甲基淀粉钠、交联聚乙烯吡咯烷酮、低取代羟丙纤维素、交联羧甲基纤维素钠等；润滑剂包括：硬脂酸镁、十二烷基硫酸钠、滑石粉、二氧化硅等；助悬剂包括：聚乙烯吡咯烷酮、微晶纤维素、蔗糖、琼脂、羟丙基甲基纤维素等；粘合剂包括，淀粉浆、聚乙烯吡咯烷酮、羟丙基甲基纤维素等；甜味剂包括：糖精钠、阿斯帕坦、蔗糖、甜蜜素、甘草次酸等；矫味剂包括：甜味剂及各种香精；防腐剂包括：尼泊金类、苯甲酸、苯甲酸钠、山梨酸及其盐类、苯扎溴铵、醋酸氯乙定、桉叶油等；基质包括：PEG6000，PEG4000，虫蜡等。
本发明人通过研究丰花草乙醇提取物的正丁醇部位对肾精亏虚小鼠的治疗试验研究结果显示，治疗组用药后房劳小鼠的一般情况、睾丸和附睾质量、精子密度和畸形率、血清睾酮含量等明显优于对照组，说明本发明的提取物可以改善房劳小鼠的生活质量，提高其生精能力及精子质量，抑制生精细胞的凋亡。因此，本发明的第三个目的在于提供一种制药用途，即上述的丰花草原料的乙醇提物的正丁醇部位在制备生精壮阳的药物中的应用。
与现有技术相比，本发明的药物组合物有补肾生精、燮理阴阳的功效，可提高男性患者的生殖能力，适用于因房事不节导致肾精亏虚的男性不育症患者。
具体实施方式
以下是本发明所涉及的丰花草醇提物的正丁醇部位的具体制备例和效果试验例，对本发明的技术方案和技术效果做进一步作描述，但是本发明的保护范围并不限于该实施例。需要说明的是，各实施例中的丰花草原料选用草科植物丰花草Borreriastricta(L.f.)G.F.W.Mey.[B.pusilla(Wall.)DC.]的干燥地上部分。
实施例1丰花草的正丁醇部位提取物的制备
丰花草原料500g，用FW135型中药粉碎机粉碎，置于带有圆底烧瓶的提取装置中，用浓度为95%（v/v）乙醇溶液4L回流提取2h，过滤，得到醇提液，重复2次，合并醇提液，减压浓缩至干，得粗提取物，用1.6L纯水溶解成混悬液，用1.6L正丁醇萃取2次，得到正丁醇萃取液，回收正丁醇后继续减压浓缩成稠膏，冷冻干燥，粉碎成细粉，过100目筛，得到丰花草醇提物的正丁醇部位。
实施例2丰花草提取物提高肾精亏虚小鼠生精能力的试验研究
健康性成熟昆明小鼠，体质量(24±2)g。选取动情期雌鼠，每只雌鼠皮下注射避孕针1号0.05mL，以阴道涂片检查角化细胞程度证实。将每只雄鼠与两只动情期雌鼠共笼，次日取出有阴道栓雌鼠笼中的雄鼠为实验用鼠。取所筛选的雄性小鼠24只，每只雄鼠与5只动情期雌鼠同笼，注意每日更换雌鼠以诱导房事不节，持续8周。将房劳雄性小鼠20只随机分成对照组和治疗组，每组10只。对照组给予蒸馏水0.3mL／只灌胃，治疗组给予实施例1制备的丰花草醇提物的正丁醇部位58mg／kg灌胃。两组均每日给予相应的受试物1次，共灌胃4周。给药结束后，观察并记录体质量、体态、皮毛光泽、竖毛现象、反应敏捷度、饮食等变化。然后，摘除小鼠右眼球取血，血液取出后迅速放人4℃冰箱，凝固后离心10min(4000r/min)，分离出的血清用来检测血清睾酮含量。解剖小鼠，将双侧睾丸和附睾用生理盐水洗去血迹，剥净表面血管、脂肪及结缔组织，用滤纸吸干表面水分，取出并分离，用单盘电子天平分别称重。取小鼠左侧附睾尾，同时用剪刀剪碎，放入事先准备好的盛有5mL生理盐水的试管中，静置于电热恒温水浴箱(25℃)10min后，用细钢丝网将组织碎片滤出，制成精子悬液。加入10％甲醛-生理盐水溶液，将精子悬液制动。分别取20μL制动后的精子悬液进行精子密度和畸形率的测定。试验结果发现：
（1）与治疗组相比，对照组小鼠的自主活动减少、倦怠、精神萎靡、眼睛暗淡无光、弓背、蜷缩、拥挤在一起、体毛枯落无光、采食饮水减少、肌肉瘦削、大便稀或干结不调、尿量多、腹毛潮湿。而治疗组小鼠无论是形态还是精神活动都优于对照组。两组小鼠体质量比较，差异有统计学意义(P＜0.01)；另外，治疗组小鼠睾丸、附睾丸质量(均为左侧)均显著大于对照组(P＜0.01)，具体见表1。
表1两组小鼠体质量和睾丸、附睾质量比较
与对照组比较，*P＜0.05，**P＜0.01。
（2）通过表2的试验统计结果可以看出，治疗组精子畸形率低于对照组(P＜0.01)，精子密度明显高于对照组(P＜0.01)，另外，治疗组睾酮含量明显高于对照组(P＜0.01)。该试验结果预示着本发明的提取物可以改善房劳小鼠的生活质量，提高其生精能力及精子质量，抑制生精细胞的凋亡。需要说明的是，本发明提取物抑制生精细胞凋亡的机理可能与该活性成分可提高睾酮含量有关。
表2两组小鼠的血清睾酮含量和精子密度、畸形率比较
与对照组比较，*P＜0.05，**P＜0.01。
Claims (2)
1.一种生精壮阳的药物组合物，该药物组合物由活性成分和药学上可用的辅料制备而成，其特征在于：所述的活性成分是丰花草原料的乙醇提物的正丁醇部位；所述丰花草原料的乙醇提物的正丁醇部位由如下工艺制得：将丰花草原料用浓度为93-96%的乙醇溶液回流提取1-3h，过滤，滤液减压浓缩至干，得粗提取物，用水溶解成混悬液，加正丁醇萃取，得到正丁醇萃取液，将正丁醇萃取液回收溶剂后浓缩成稠膏，干燥，粉碎，得到丰花草原料的乙醇提物的正丁醇部位。
2.根据权利要求1所述的生精壮阳的药物组合物，其特征在于：所述的丰花草原料为草科植物丰花草的地上部分。
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