CN107661425B - 一种消痛膏及其制备方法 - Google Patents
一种消痛膏及其制备方法 Download PDFInfo
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- CN107661425B CN107661425B CN201710975259.1A CN201710975259A CN107661425B CN 107661425 B CN107661425 B CN 107661425B CN 201710975259 A CN201710975259 A CN 201710975259A CN 107661425 B CN107661425 B CN 107661425B
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Abstract
本发明公开了一种消痛膏及其制备方法,该消痛膏按重量份计,包括以下原料:威灵仙140‑180份、三七4‑6份、五加皮58‑72份、鹿角8‑12份、大血藤58‑72份、血竭1.8‑2.4份、鸡血藤58‑72份、麝香0.08‑0.12份、川牛膝58‑72份、西红花0.08‑0.12份。按重量份称取各原料,配合辅料,通过粉碎、提取、浓缩、混合等步骤制备。本发明效果好、无毒副作用、成本低且使用方便,能祛风除湿、舒经活络从而消除或缓解颈、肩、腰、腿等骨质增生引起的关节疼痛,有明显保健作用。
Description
技术领域
本发明属于保健品领域,具体涉及一种消痛膏,同时还涉及该消痛膏的制备方法。
背景技术
骨质增生症又称为增生性骨关节炎、骨性关节炎、退变性关节病、老年性关节炎、肥大性关节炎,是由于构成关节的软骨、椎间盘、韧带等软组织变性、退化,关节边缘形成骨刺,滑膜肥厚等变化,而出现骨破坏,引起继发性的骨质增生,导致关节变形,当受到异常载荷时,引起关节疼痛,活动受限等症状的一种疾病。
其为隐匿发作、持续,多发生于关节活动以后的骨关节钝痛,休息可以缓解。随着病情进展,可出现关节畸形、不稳定、休息痛、负重时疼痛加重,甚至发生功能障碍。
增生的骨质本身不需要治疗,但有关节疼痛、肿胀、关节功能障碍等临床症状的患者,需要进行止痛甚至手术治疗。止痛常用非甾体抗炎药,糖皮质激素等。但非甾体类药等西药止痛副作用大、费用昂贵,且长时间使用会导致重要脏器的损伤。而中药制剂服用时间又通常较长且煎药环节较为复杂。
发明内容
本发明的目的在于提供一种效果好、无毒副作用、成本低且使用方便的消痛膏,该消痛膏能祛风除湿、舒经活络从而消除或缓解颈、肩、腰、腿等骨质增生引起的关节疼痛,有明显保健作用。
本发明的另一目的在于提供前述消痛膏的制备方法。
本发明的一种消痛膏,按重量份计,由以下原料组成:威灵仙140-180份、三七4-6份、五加皮58-72份、鹿角8-12份、大血藤58-72份、血竭1.8-2.4份、鸡血藤58-72份、麝香0.08-0.12份、川牛膝58-72份、西红花0.08-0.12份、硬脂酸110-119份、棕榈酸异丙酯43-50份、单硬脂酸甘油酯10-13份、十二烷基硫酸钠38-45份、二甲硅油11.2-13.4份、甘油5-6份、卡波姆9804-4.8份、尼泊金酯0.5-0.6份、苯甲酸钠0.5-0.6份、三乙醇胺13-18份。
上述的一种消痛膏,按重量份计,由以下原料组成:威灵仙150份、三七5份、五加皮60份、鹿角10份、大血藤60份、血竭2份、鸡血藤60份、麝香0.1份、川牛膝60份、西红花0.1份、硬脂酸112份、棕榈酸异丙酯45份、单硬脂酸甘油酯12份、十二烷基硫酸钠40份、二甲硅油11.2份、甘油6.3份、卡波姆9804份、尼泊金酯0.5份、苯甲酸钠0.5份、三乙醇胺16.9份。
上述的一种消痛膏,其中,所述苯甲酸钠的质量百分比浓度为0.05%。
本发明的一种消痛膏的制备方法,包括以下步骤:
(1)按重量份称取原料威灵仙140-180份、三七4-6份、五加皮58-72份、鹿角8-12份、大血藤58-72份、血竭1.8-2.4份、鸡血藤58-72份、麝香0.08-0.12份、川牛膝58-72份、西红花0.08-0.12份;
(2)按重量份称取辅料硬脂酸110-119份、棕榈酸异丙酯43-50份、单硬脂酸甘油酯10-13份、十二烷基硫酸钠38-45份、二甲硅油11.2-13.4份、甘油5-6份、卡波姆9804-4.8份、尼泊金酯0.5-0.6份、苯甲酸钠0.5-0.6份、三乙醇胺13-18份;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过7-9号筛;麝香粉碎成细粉,过5-6号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加水回流提取2-3次,每次加8-10倍量水提取1.5-2小时,过滤,合并两次提取液,在70-80℃下浓缩成相对密度为1.05-1.10的浸膏,加乙醇至乙醇质量百分比浓度达80-85%,静置过夜,过滤,滤液回收乙醇后继续在60-65℃下浓缩成相对密度为1.08-1.10的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至60-65℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润24-25小时后,加水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
上述的一种消痛膏的制备方法,其中,所述水为纯化水。
本发明与现有技术相比,具有明显的有益效果,从以上技术方案可知:本发明选用威灵仙、三七、五加皮、鹿角、大血藤、血竭、鸡血藤、麝香、川牛膝及西红花为原料,其中,威灵仙祛风除湿、通络止痛;三七散瘀止血,消肿定痛;五加皮可治风湿骨痛;鹿角行血、消肿、益肾;大血藤清热解毒、活血通络、祛风止痉;血竭散瘀定痛、止血、生肌敛疮;鸡血藤活血补血、调经止痛、舒筋活络;麝香开窍、活血、散结、止痛;川牛膝逐瘀通经、通利关节、利尿通淋;西红花有镇静、祛痰、解痉作用;各原料相辅相成即可通过其协同作用达到祛风除湿、舒经活络之功效,从而发挥消除骨关节疼痛的作用。
其效果好、成本低、无毒副作用且使用方便。临床50例使用,治愈率12%,总有效率98%。
具体实施方式
以下通过试验例来进一步阐述本发明所述消痛膏的有益效果。
试验例:
1、急性经口毒性试验
(1)试验动物及环境:昆明种二级小鼠。温度:20-26℃、湿度40-70%。
(2)样品处理:称取实施例4所得本发明消痛膏5克,用蒸馏水混匀定容至20mL,备用。
(3)试验方法:选用实验动物10只,体重18-22克,雌雄各半,24小时内经口一次给受试物,灌胃量为0.02mL/gBW。
(4)试验剂量:5000mg/kgBW。
(5)观察时间:2周。
(6)试验结果:
①雄性小组,剂量分组为5000mg/kg,体重(X±SD)第0天为21.20±1.30g、第7天为29.40±2.30、第14天为33.20±2.59,死亡动物数0只,死亡率0%;
②雌性小组,剂量分组为5000mg/kg,体重(X±SD)第0天为20.60±1.52g、第7天为26.60±2.07g、第14天为30.80±2.28g,死亡动物数0只,死亡率0%。
未观察到试验小鼠出现中毒表现及死亡。试验结束对试验动物进行大体解剖,未见异常。
LD50〉5000mg/kgBW。
(7)结论:
参照卫生部《化妆品卫生规范》(2007年版)急性毒性(LD50)剂量分级,本发明消痛膏属实际无毒范围。
2、多次皮肤刺激性试验
(1)试验动物及环境:新西兰种大白兔,体重2.0-3.0千克。温度18-24℃、湿度40-70%。单笼喂养。
(2)样品处理:取实施例4所得本发明沐浴粉用蒸馏水调匀敷贴。
(3)试验动物检疫3天后,选用健康、成年、皮肤无损伤的家兔4只,试验前24小时将试验动物背部脊柱两侧被毛剪掉,不损伤表皮,去毛范围各为3cmx3cm。敷贴面积2.5cmx2.5cm。取受试物0.5g敷贴于一侧去毛皮肤上,另一侧作为对照,每天敷贴一次,连续敷贴14天。从第二天开始,每次敷贴前剪毛,用温水清除残留受试物,一小时后观察结果,并观察刺激性以外其他毒性作用。
(4)试验结果:从试验第1天至第14天,4只家兔敷贴受试物一侧及对照一侧均未出现红斑、水肿,积分值为0。
(5)结论:本发明消痛膏多次皮肤刺激性试验的皮肤反应积分值为0.00,属无刺激性。
3、临床观察:
(1)临床资料:
全部病例50例,均患有因骨质增生所致颈、肩、腰或腿的骨关节疼痛;其中,男性25例,女性25例,最大年龄65岁,最小年龄28岁。
诊断标准:
《中医病症诊断疗效标准》
(2)使用方法:
每日使用本发明消痛膏一次。取本发明消痛膏适量涂抹于皮肤表面,反复按摩至吸收。观察7-14日。
局部有出血倾向者严禁使用。
有中草药过敏或过敏性皮肤病者禁用。
(3)疗效标准:
治愈:症状消失;
好转:症状明显减轻;
未愈:症状无明显改善。
(4)使用结果:
50例骨关节疼痛患者使用本发明消痛膏,治愈8例,好转41例,未愈1例,治愈率16%,总有效率98%。
实施例1
一种消痛膏,包括以下步骤:
(1)称取原料威灵仙140kg、三七6kg、五加皮58kg、鹿角12kg、大血藤58kg、血竭2.4kg、鸡血藤58kg、麝香0.12kg、川牛膝58kg、西红花0.12kg;
(2)称取辅料硬脂酸110kg、棕榈酸异丙酯50kg、单硬脂酸甘油酯10kg、十二烷基硫酸钠45kg、二甲硅油11.2kg、甘油6kg、卡波姆9804kg、尼泊金酯0.6kg、苯甲酸钠0.5kg、三乙醇胺18kg;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过7号筛;麝香粉碎成细粉,过5号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加水回流提取2次,每次加8倍量水提取1.5小时,过滤,合并两次提取液,在70℃下浓缩成相对密度为1.05的浸膏,加乙醇至乙醇质量百分比浓度达80%,静置过夜,过滤,滤液回收乙醇后继续在60℃下浓缩成相对密度为1.08的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至60℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润24小时后,加水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
实施例2
一种消痛膏,包括以下步骤:
(1)称取原料威灵仙180kg、三七4kg、五加皮72kg、鹿角8kg、大血藤72kg、血竭1.8kg、鸡血藤72kg、麝香0.08kg、川牛膝72kg、西红花0.08kg;
(2)称取辅料硬脂酸119kg、棕榈酸异丙酯43kg、单硬脂酸甘油酯13kg、十二烷基硫酸钠38kg、二甲硅油13.4kg、甘油5kg、卡波姆9804.8kg、尼泊金酯0.5kg、苯甲酸钠0.6kg、三乙醇胺13kg;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过9号筛;麝香粉碎成细粉,过6号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加水回流提取3次,每次加10倍量水提取2小时,过滤,合并两次提取液,在80℃下浓缩成相对密度为1.10的浸膏,加乙醇至乙醇质量百分比浓度达85%,静置过夜,过滤,滤液回收乙醇后继续在60-65℃下浓缩成相对密度为1.10的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至65℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润25小时后,加水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
实施例3
一种消痛膏的制备方法,包括以下步骤:
(1)称取原料威灵仙160kg、三七5kg、五加皮65kg、鹿角10kg、大血藤65kg、血竭2.1kg、鸡血藤65kg、麝香0.1kg、川牛膝65kg、西红花0.1kg;
(2)称取辅料硬脂酸114.5kg、棕榈酸异丙酯46.5kg、单硬脂酸甘油酯11.5kg、十二烷基硫酸钠41.5kg、二甲硅油12.3kg、甘油5.5kg、卡波姆9804.4kg、尼泊金酯0.55kg、苯甲酸钠0.55kg、三乙醇胺15.5kg;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过7号筛;麝香粉碎成细粉,过6号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加水回流提取2次,每次加9倍量水提取1.7小时,过滤,合并两次提取液,在75℃下浓缩成相对密度为1.07的浸膏,加乙醇至乙醇质量百分比浓度达82%,静置过夜,过滤,滤液回收乙醇后继续在62℃下浓缩成相对密度为1.09的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至63℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润24.5小时后,加水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
实施例4
一种消痛膏,包括以下步骤:
(1)称取原料威威灵仙150kg、三七5kg、五加皮60kg、鹿角10kg、大血藤60kg、血竭2kg、鸡血藤60kg、麝香0.1g、川牛膝60g、西红花0.1kg;
(2)称取辅料硬脂酸112kg、棕榈酸异丙酯45kg、单硬脂酸甘油酯12kg、十二烷基硫酸钠40kg、二甲硅油11.2kg、甘油6.3kg、卡波姆9804kg、尼泊金酯0.5kg、质量百分比浓度为0.05%的苯甲酸钠0.5kg、三乙醇胺16.9kg;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过7-9号筛;麝香粉碎成细粉,过5-6号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加纯化水回流提取3次,每次加9倍量纯化水提取1.8小时,过滤,合并两次提取液,在75℃下浓缩成相对密度为1.08的浸膏,加乙醇至乙醇质量百分比浓度达83%,静置过夜,过滤,滤液回收乙醇后继续在63℃下浓缩成相对密度为1.09的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至62℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润24.5小时后,加纯化水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
以上所述,仅是本发明的较佳实施例而已,并非对本发明作任何形式上的限制,任何未脱离本发明技术方案内容,依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰,均仍属于本发明技术方案的范围内。
Claims (5)
1.一种消痛膏,按重量份计,由以下原料组成:威灵仙140-180份、三七4-6份、五加皮58-72份、鹿角8-12份、大血藤58-72份、血竭1.8-2.4份、鸡血藤58-72份、麝香0.08-0.12份、川牛膝58-72份、西红花0.08-0.12份、硬脂酸110-119份、棕榈酸异丙酯43-50份、单硬脂酸甘油酯10-13份、十二烷基硫酸钠38-45份、二甲硅油11.2-13.4份、甘油5-6份、卡波姆9804-4.8份、尼泊金酯0.5-0.6份、苯甲酸钠0.5-0.6份、三乙醇胺13-18份。
2.如权利要求1所述的一种消痛膏,按重量份计,由以下原料组成:威灵仙150份、三七5份、五加皮60份、鹿角10份、大血藤60份、血竭2份、鸡血藤60份、麝香0.1份、川牛膝60份、西红花0.1份、硬脂酸112份、棕榈酸异丙酯45份、单硬脂酸甘油酯12份、十二烷基硫酸钠40份、二甲硅油11.2份、甘油6.3份、卡波姆9804份、尼泊金酯0.5份、苯甲酸钠0.5份、三乙醇胺16.9份。
3.如权利要求1或2所述的一种消痛膏,其中:所述苯甲酸钠的质量百分比浓度为0.05%。
4.一种消痛膏的制备方法,包括以下步骤:
(1)按重量份称取原料威灵仙140-180份、三七4-6份、五加皮58-72份、鹿角8-12份、大血藤58-72份、血竭1.8-2.4份、鸡血藤58-72份、麝香0.08-0.12份、川牛膝58-72份、西红花0.08-0.12份;
(2)按重量份称取辅料硬脂酸110-119份、棕榈酸异丙酯43-50份、单硬脂酸甘油酯10-13份、十二烷基硫酸钠38-45份、二甲硅油11.2-13.4份、甘油5-6份、卡波姆980 4-4.8份、尼泊金酯0.5-0.6份、苯甲酸钠0.5-0.6份、三乙醇胺13-18份;
(3)将三七、鹿角、血竭、西红花分别粉碎成极细粉,过7-9号筛;麝香粉碎成细粉,过5-6号筛;
(4)将威灵仙、五加皮、大血藤、鸡血藤、川牛膝加水回流提取2-3次,每次加8-10倍量水提取1.5-2小时,过滤,合并两次提取液,在70-80℃下浓缩成相对密度为1.05-1.10的浸膏,加乙醇至乙醇质量百分比浓度达80-85%,静置过夜,过滤,滤液回收乙醇后继续在60-65℃下浓缩成相对密度为1.08-1.10的浸膏,加入三七、鹿角、血竭、西红花极细粉、麝香细粉及苯甲酸钠,搅匀,得混合物;
(5)将硬脂酸、棕榈酸异丙酯、单硬脂酸甘油酯、十二烷基硫酸钠混合后,加热至60-65℃,搅拌熔融后,加入二甲硅油、尼泊金酯,搅拌、溶解、混匀,加入所述混合物中,搅匀,得混合乳液;
(6)取甘油加至卡波姆980中浸润24-25小时后,加水制成质量百分比浓度为0.5%的卡波姆980甘油水溶液;
(7)将所述卡波姆980甘油水溶液加至所述混合乳液中,搅匀,加入三乙醇胺,搅匀,制成软膏剂,即得。
5.如权利要求4所述的一种消痛膏的制备方法,其中:所述水为纯化水。
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