CN109674833A - 一种治疗勃起功能障碍的外用乳膏及其制备方法 - Google Patents
一种治疗勃起功能障碍的外用乳膏及其制备方法 Download PDFInfo
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- CN109674833A CN109674833A CN201910153927.1A CN201910153927A CN109674833A CN 109674833 A CN109674833 A CN 109674833A CN 201910153927 A CN201910153927 A CN 201910153927A CN 109674833 A CN109674833 A CN 109674833A
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Abstract
本发明公开了一种治疗勃起功能障碍的外用乳膏，本发明是以多种植物提取物为原料，其中含有锁阳提取物、蜂蜡、漆树籽核仁油、小分子肽液、透明质酸钠、黄秋葵、半纤维素。按原料重量份数计：锁阳提取物5～10份、蜂蜡5～10份、漆树籽核仁油5～10份、小分子肽液5～10份、透明质酸钠1～2份、黄秋葵5～10份、半纤维素1～2份、乳化剂2～5份、去离子水20～60份。本发明为外用乳膏，主要由天然植物油和植物提取物制得，产品绿色、安全、吸收好、对皮肤无刺激、生物兼容性高；具有起效快的特点，能快速、有效地进入阴茎组织，疗效显著。
Description
技术领域
本发明涉及医药化工领域，特别涉及一种治疗勃起功能障碍的外用乳膏及其制备方法。
背景技术
随着社会的发展，人们的工作节奏越来越快，生活压力也越来越大，越来越多的男性出现了勃起功能障碍，上海市卫生部门曾公布的一份对2500名年龄在40-65岁的男性抽样调查显示，53％的人患有不同程度的男性勃起功能障碍（简称ED），这严重影响了男性生殖健康。在“2011年中国性健康网络调查结果”发布会上，北京大学第三医院泌尿外科副主任、中华医学会男科学分会主任委员姜辉教授指出，在中国，40岁以上的男性中，40.2%的人曾遇到过勃起功能障碍的困惑。美国麻省的一项相关调查也表明，该地52%的男性出现过勃起功能障碍的问题。这组惊人数据，反映出了男性的真实遭遇。异致患者出现勃起功能障碍的因素有很多，如心理因素、身体条件因素、身体疾病、药物毒副作用以及环境因素等。目前治疗男性勃起功能障碍的药物并不多，主要有前列地尔注射剂和栓剂，但使用极不方便且不安全，且有一定的副作用。
因此，如何实现一种外用型、使用方便、天然、安全、无副作用、起效快速显著的治疗勃起功能障碍的外用乳膏是业内亟待解决的技术问题。
发明内容
本发明的主要目的是提供一种治疗勃起功能障碍的外用乳膏，旨在实现一种外用型、使用方便、天然、安全、无副作用、起效快速显著的治疗勃起功能障碍的外用乳膏。
本发明的另一目的是提供一种治疗勃起功能障碍的外用乳膏的制备方法。
本发明提出一种治疗勃起功能障碍的外用乳膏，按重量份数计，由如下原料制成：锁阳提取物5～10份、蜂蜡5～10份、漆树籽核仁油5～10份、小分子肽液5～10份、透明质酸钠1～2份、黄秋葵提取物5～10份、半纤维素1～2份、乳化剂2～5份、去离子水40～100份。
本发明提出一种治疗勃起功能障碍的外用乳膏的制备方法，包括如下步骤：
（1）先在容器中加入透明质酸钠，再加入漆树籽核仁油200～300r/min搅拌至透明质酸钠全部溶解后得油相A；
（2）取半纤维素后加入固液比1：20～30的去离子水、加热至80～90℃搅拌溶解后在50～60℃保温；
（3）将步骤2）的半纤维素溶液加入步骤1）的油相A中，水浴温度加热至60～70℃时，再加入锁阳提取物、黄秋葵提取物、蜂蜡和乳化剂并混合搅拌均匀，备用；
（4）最后补加剩余水和小分子肽液后，继续搅拌1～2h直到完全溶解均匀，得混合液B；
（5）将步骤4）得到的混合液B放入轨道式摇床在转速200～300rpm、温度30～40℃、震摇2～5h；
（6）将步骤5）处理的混合液B放入40～50℃水浴中陈化36～72h，得乳膏C；
（7）将步骤6）得到的乳膏C放入冷藏室在2～5℃存储18～32h后分装即得一种治疗勃起功能障碍的外用乳膏。
本发明中所述的锁阳提取物为锁阳药材粉碎成粉，用70～80%乙醇浸泡回流提取1～2h，滤去药渣后再减压回收乙醇至无醇味，将剩余水分散提取液调节pH为5.0，过大孔树脂柱，上样量与树脂体积的比例为1∶10～15，先用水洗脱，继用乙醇洗脱，收集乙醇洗脱液，减压回收乙醇，浓缩至干，即得锁阳提取物。
本发明中所述的锁阳为来自甘肃省酒泉市瓜州县锁阳城野生锁阳。
本发明中所述的蜂蜡通过下述步骤制备：
（1）将粗蜂蜡加热溶解完全后，趁热用滤网过滤，重复2～3次后，取下层过滤物凝固后得精制蜂蜡；
（2）再将上述步骤1）的精制蜂蜡加热溶解后加入脱色剂过氧化氢在温度70～80℃、搅拌转速600～700r/min、脱色时间40～70min、脱色剂用量0.2～0.3ml/g条件下脱色，完毕后即得本发明所述蜂蜡。
本发明中所述的蜂蜡中含有15%～25%的三十烷醇。
本发明中所述的蜂蜡中含有二十八烷醇。
本发明中所述的漆树籽核仁油为漆树籽核仁在180～250℃蒸炒5～10min后趁热送入压榨机上进行榨油处理，获得漆树籽核仁油。
本发明中所述的漆树籽核仁来自云南怒江州大叶漆树漆树籽核仁。
本发明中所述的漆树籽核仁油其功效为顺滑剂，且易于吸收。
本发明中所述的小分子肽液为小分子肽原液。
本发明中所述的小分子肽液中小分子肽的分子量应在200～500Dal之间。
本发明中所述的黄秋葵提取物是将黄秋葵清洗切碎后，用70～90%乙醇回流提取1～2h，提取液浓缩得黄秋葵提取物。
本发明中所述的乳化剂为天然有机橄榄油乳化蜡、赛比克S305
、小麦胚芽乳化剂Montanov L、聚山梨酯-80中的一种或几种混合物。
锁阳为锁阳科肉质寄生草本植物锁阳的肉质茎，主要成分全草含锁阳萜、已酰熊果酸、熊果酸等有效成分，锁阳具有壮阳作用，经盐炮制后，对正常和阳虚小鼠的睾丸、附睾和包皮腺的功能有明显促进作用，在锁阳水提物中，精子的活动率增强，是治疗男性不育的常用药。锁阳提取物通常入药，锁阳提取物的提取方式有很多比如有水蒸馏、甲醛，乙醚溶剂萃取以及超临界萃取等。
蜂蜡是由工蜂蜡腺分泌出来的一种复杂的有机物，主要成分是高级脂肪酸和高级一元醇所形成的酯。此外，还有游离脂肪酸、游离脂肪醇、碳水化合物、胡萝卜素、维生素A、芳香物质等。在食品、医药、化妆品、农业、畜牧业等领域都有着广泛的应用。蜂蜡具有治疗解毒、生肌、止痢、止血、定痛、久泻不止、遗精的功效。蜂蜡还是三十烷醇和二十八烷醇的重要来源之一，三十烷醇(TA)是由30个碳原子组成的长链脂肪醇，化学名叫三十烷醇-1或正三十烷醇，简称三十醇或TA，或TRIA，又称蜂花醇。蜂蜡中TA含量可高达10%～25%，是TA很好的来源。三十烷醇是对人畜十分安全的植物生长调节剂，对作物具有促进生根、发芽、开花、茎叶生长、早熟、提高结实率的作用。在作物生长期使用，可提高种子发芽率、改善秧苗素质、增加有效分蘖。在作物生长中、后期使用，可增加蕾花、坐果率（结实率）、千粒重，从而增产。二十八烷醇是一种天然存在的一元高级脂肪醇，是世界公认的抗疲劳功能性物质，可刺激动物及人类的性行为。
漆树籽核仁油是将漆籽核提取油脂，常温下为液态，不饱和脂肪酸（油酸、亚油酸）含量高达80%，有很好的保健作用，具有催乳、补血、止血、消炎、止痛、止咳止喘、恢复体力、提神补气、舒筋活血等功效，且易于被人体皮肤吸收、滋养、润滑。
黄秋葵是锦葵科秋葵属一年生草本植物，别名咖啡黄葵、羊角豆等，嫩果含有丰富的蛋白质、游离氨基酸、丰富的Vc、Va、Ve和磷、铁、钾、钙、锌、锰等矿质元素及由果胶和多糖等组成的粘性物质，是一种具有较高营养价值的新型保健蔬菜。黄秋葵广泛生长于热带和地中海气候地带，是一种分布于热带到亚热带的植物，除用作日常蔬菜外，黄秋葵还具有抗疲劳、健胃保肝、能减少肺损伤、提高机体免疫力等保健功能，被称作“植物伟哥”、“绿色人参”。
半纤维素(hemicellulose)是由几种不同类型的单糖构成的异质多聚体，这些糖是五碳糖和六碳糖，包括木糖、阿拉伯糖和半乳糖等。半纤维素木聚糖在木质组织中占总量的50%，它结合在纤维素微纤维的表面，并且相互连接，这些纤维构成了坚硬的细胞相互连接的网络。半纤维素生物兼容性好，有显著的免疫调节作用,并可提高生物反应性和耐受性。
本发明的治疗勃起功能障碍的外用乳膏优点如下：
（1）将锁阳提取物、蜂蜡、漆树籽核仁油、小分子肽液、透明质酸钠、黄秋葵提取物和半纤维素组合而成，均可快速透皮吸收，增效明显；
（2）上述原料主要成分为氨基酸、醇、脂类和多糖及其衍生物，与人体皮肤的主要构成成份类似，生物兼容性和降解性极高，能快速、有效而安全地吸收进入阴茎组织，并具有给药安全、起效快速的特点；
（3）蜂蜡中含有三十烷醇和二十八烷醇，可有效提高性能力、治疗勃起障碍；
（4）半纤维素可提高机体反应性和耐受性；
（5）野生锁阳可对睾丸、附睾和包皮腺产生明显促进作用，增强精子的活动率；
（6）漆树籽核仁油具有恢复体力、提神补气、舒筋活血等功效，且易于被人体皮肤吸收、滋养、润滑；
（7）黄秋葵具有抗疲劳、提高机体免疫力、提高性能力、治疗勃起障碍的功效；
（8）本发明的治疗勃起功能障碍的外用乳膏可丰富市场上此类药物品种，以更好地满足和保障人们的用药需求；
（9）本发明的治疗勃起功能障碍的外用乳膏制备工艺较简单，容易制备，价格低廉；
（10）本发明真正实现一种外用型、使用方便、天然、安全、无副作用、起效快的治疗勃起功能障碍的外用乳膏。
具体实施方式
应当理解，此处所描述的具体实施例仅仅用以解释本发明，并不用于限定本发明。下面结合具体实施例对本发明作进一步说明。
实施例1
本实施例提出的一种治疗勃起功能障碍的外用乳膏，按重量份数计，由如下原料制成：锁阳提取物5份、蜂蜡5份、漆树籽核仁油5份、小分子肽液5份、透明质酸钠1份、黄秋葵提取物5份、半纤维素1份、乳化剂（天然有机橄榄油乳化蜡）2份、去离子水40份。
本实施例提出的一种治疗勃起功能障碍的外用乳膏，包括如下步骤：
（1）先在容器中加入透明质酸钠，再加入漆树籽核仁油200r/min搅拌至透明质酸钠全部溶解后得油相A；
（2）取半纤维素后加入固液比1：20的去离子水、加热至80℃搅拌溶解后在50℃保温；
（3）将步骤2）的半纤维素溶液加入步骤1）的油相A中，水浴温度加热至60℃时，再加入锁阳提取物、黄秋葵提取物、蜂蜡和乳化剂并混合搅拌均匀，备用；
（4）最后补加剩余水和小分子肽液后，继续搅拌1h直到完全溶解均匀，得混合液B；
（5）将步骤4）得到的混合液B放入轨道式摇床在转速200rpm、温度40℃、震荡时间5h；
（6）将步骤5）处理的混合液B放入40℃水浴中陈化36h，得乳膏C；
（7）将步骤6）得到的乳膏C放入冷藏室在2℃存储18h后分装即得一种治疗勃起功能障碍的外用乳膏。
实施例2
本实施例提出的一种治疗勃起功能障碍的外用乳膏，按重量份数计，由如下原料制成：锁阳提取物10份、蜂蜡10份、漆树籽核仁油10份、小分子肽液10份、透明质酸钠2份、黄秋葵提取物10份、半纤维素2份、乳化剂（天然有机橄榄油乳化蜡、赛比克S305，质量比1：1）5份、去离子水100份。
本实施例提出的一种治疗勃起功能障碍的外用乳膏，包括如下步骤：
（1）先在容器中加入透明质酸钠，再加入漆树籽核仁油300r/min搅拌至透明质酸钠全部溶解后得油相A；
（2）取半纤维素后加入固液比1： 30的去离子水、加热至90℃搅拌溶解后在60℃保温；
（3）将步骤2）的半纤维素溶液加入步骤1）的油相A中，水浴温度加热至70℃时，再加入锁阳提取物、黄秋葵提取物、蜂蜡和乳化剂并混合搅拌均匀，备用；
（4）最后补加剩余水和小分子肽液后，继续搅拌2h直到完全溶解均匀，得混合液B；
（5）将步骤4）得到的混合液B放入轨道式摇床在转速300rpm、温度40℃、震荡时间5h；
（6）将步骤5）处理的混合液B放入50℃水浴中陈化72h，得乳膏C；
（7）将步骤6）得到的乳膏C放入冷藏室在5℃存储32h后分装即得一种治疗勃起功能障碍的外用乳膏。
实施例3
本实施例提出的一种治疗勃起功能障碍的外用乳膏，按重量份数计，由如下原料制成：锁阳提取物8份、蜂蜡8份、漆树籽核仁油8份、小分子肽液8份、透明质酸钠1份、黄秋葵提取物6份、半纤维素2份、乳化剂（天然有机橄榄油乳化蜡、小麦胚芽乳化剂Montanov L、聚山梨酯-80，质量比1：1：1）3份、去离子水80份。
本实施例提出的一种治疗勃起功能障碍的外用乳膏，包括如下步骤：
（1）先在容器中加入透明质酸钠，再加入漆树籽核仁油200r/min搅拌至透明质酸钠全部溶解后得油相A；
（2）取半纤维素后加入固液比1：25的去离子水、加热至85℃搅拌溶解后在55℃保温；
（3）将步骤2）的半纤维素溶液加入步骤1）的油相A中，水浴温度加热至65℃时，再加入锁阳提取物、黄秋葵提取物、蜂蜡和乳化剂并混合搅拌均匀，备用；
（4）最后补加剩余水和小分子肽液后，继续搅拌1.5h直到完全溶解均匀，得混合液B；
（5）将步骤4）得到的混合液B放入轨道式摇床在转速250rpm、温度35℃、震荡时间4h；
（6）将步骤5）处理的混合液B放入45℃水浴中陈化48h，得乳膏C；
（7）将步骤6）得到的乳膏C放入冷藏室在3℃存储24h后分装即得一种治疗勃起功能障碍的外用乳膏。
本发明的乳膏的使用方法如下：
（1）用药前先排尿，清洗双手及生殖器。
（2）打开包装，挤压乳膏瓶，取产品1～3g。
（3）反复均匀擦拭阴茎1～3次，每次至吸收完再进行下一次擦拭，每次间隔30～60s。
为了验证本发明治疗勃起功能障碍的疗效，做了病例试验，选取有勃起障碍的患者共90例，年龄在30岁到45岁之间，均为已婚或者是有固定性伴侣，并且均有性经验。患者的外生殖器、架丸、前列腺以及附架等均没有发现有器质性病变。排除恶性肿瘤患者、精神病史患者、吸毒或者酒精依赖患者、高血压和糖尿病患者以及严重肝肾功能不全患者。采用数字随机表法随机将患者分为三组，每组30人。其中三组患者分别使用实施例1、2、3中乳膏，每4周为1个疗程,共观察3个疗程。观察其症状改善情况以及治疗过程中发生的不良反应。观察并记录患者的国际勃起功能指数调查问卷评分、性交不成功次数与成功次数的改变情况。疗效判断标准：治愈为症状完全消失，见效为症状基本消失或有所减轻，无效为与治疗前没有变化或者下降。治疗试验结果如下表：
结论:本发明中所述实施例1～3制备的乳膏对治疗勃起功能障碍ED具有比较明显的疗效，有效率均在90%以上，治疗后患者整体性生活质量有明显提高，且使用安全可靠无不良副作用影响。
Claims (6)
1.一种治疗勃起功能障碍的外用乳膏的制备方法，其特征在于，包括如下制备步骤：
（1）先在容器中加入透明质酸钠，再加入漆树籽核仁油200～300r/min搅拌至透明质酸钠全部溶解后得油相A；
（2）取半纤维素后加入固液比1：20～30的去离子水、加热至80～90℃搅拌溶解后在50～60℃保温；
（3）将步骤2）的半纤维素溶液加入步骤1）的油相A中，水浴温度加热至60～70℃时，再加入锁阳提取物、黄秋葵提取物、蜂蜡和乳化剂并混合搅拌均匀，备用；
（4）最后补加剩余水和小分子肽液后，继续搅拌1～2h直到完全溶解均匀，得混合液B；
（5）将步骤4）得到的混合液B放入轨道式摇床在转速200～300rpm、温度30～40℃、震摇2～5h；
（6）将步骤5）处理的混合液B放入40～50℃水浴中陈化36～72h，得乳膏C；
（7）将步骤6）得到的乳膏C放入冷藏室在2～5℃存储18～32h后分装即得一种治疗勃起功能障碍的外用乳膏。
2.根据权利要求1所述的一种治疗勃起功能障碍的外用乳膏的制备方法，其特征在于，所述锁阳提取物为将锁阳药材粉碎成粉，用70～80%乙醇浸泡回流提取1～2h，滤去药渣后再减压回收乙醇至无醇味，将剩余水分散提取液调节pH为5.0，过大孔树脂柱，上样量与树脂体积的比例为1∶10～15，先用水洗脱，继用乙醇洗脱，收集乙醇洗脱液，减压回收乙醇，浓缩至干，即得锁阳提取物。
3.根据权利要求1所述的一种治疗勃起功能障碍的外用乳膏的制备方法，其特征在于，所述漆树籽核仁油为漆树籽核仁在180～250℃蒸炒5～10min后趁热送入压榨机上进行榨油处理，获得漆树籽核仁油。
4.根据权利要求1所述的一种治疗勃起功能障碍的外用乳膏的制备方法，其特征在于，所述黄秋葵提取物是将黄秋葵清洗切碎后，用70～90%乙醇回流提取1～2h，提取液浓缩得黄秋葵提取物。
5.根据权利要求1所述的一种治疗勃起功能障碍的外用乳膏的制备方法，其特征在于，所述蜂蜡通过下述步骤制备：
（1）将粗蜂蜡加热溶解完全后，趁热用滤网过滤，重复2～3次后，取下层过滤物凝固后得精制蜂蜡；
（2）再将上述步骤1）的精制蜂蜡加热溶解后加入脱色剂过氧化氢在温度70～80℃、搅拌转速600～700r/min、脱色时间40～70min、脱色剂用量0.2～0.3ml/g条件下脱色，完毕后即得本发明所述蜂蜡。
6.一种治疗勃起功能障碍的外用乳膏，其特征在于，按重量份数计，由如下原料制成：锁阳提取物5～10份、蜂蜡5～10份、漆树籽核仁油5～10份、小分子肽液5～10份、透明质酸钠1～2份、黄秋葵提取物5～10份、半纤维素1～2份、乳化剂2～5份、去离子水40～100份。
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