CN114931616A - 一种骨质疏松贴及其制备方法 - Google Patents
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- CN114931616A CN114931616A CN202210625122.4A CN202210625122A CN114931616A CN 114931616 A CN114931616 A CN 114931616A CN 202210625122 A CN202210625122 A CN 202210625122A CN 114931616 A CN114931616 A CN 114931616A
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Abstract
本发明公开了一种骨质疏松贴及其制备方法,该骨质疏松贴,包括贴膏剂基质和药效成分,所述药效成分包括如下药材原料:藏红花,乳香,没药,苏木,当归,杜仲,血竭,砂仁,甘草和生地;其中,杜仲、当归为君药,杜仲补益肝肾,强筋健骨,临床上常用于腰痛、腰酸等症;当归补血和血,可促进造血系统功能,改善骨质疏松症状;藏红花、血竭、乳香、没药、苏木为臣药,藏红花、血竭都具有活血化瘀功效,乳香、没药相须为用,乳香行气活血为主,没药活血散瘀为要,二药参合,气血兼顾,取效尤捷,共奏宣通脏腑、流通经络、活血祛瘀、敛疮生肌之功;苏木具有活血祛瘀之功效;砂仁、生地为佐药;甘草为使药,可调和诸药,同时有补气的功效。
Description
技术领域
本发明涉及中药外用制剂技术领域,具体涉及一种骨质疏松贴及其制备方法。
背景技术
骨质疏松症(osteoporosis,OP)是一种全身性骨骼疾病,表现为骨组织微结构退行性变和低骨量,引起骨的脆性和骨折的敏感性增加。OP易导致患者出现腰背全身疼痛、呼吸功能下降、身长缩短、驼背,严重者还可出现骨折、脊柱变形等症状,影响患者生活质量,随着我国社会进入人口老龄化阶段,本病的发病率将持续升高。
OP属中医学“骨痿”“虚劳”“骨痹”“骨枯”等范畴。关于骨质疏松症的中医病因病机,各医家普遍认为骨质疏松症乃是一个涉及多器官、多脏腑的复杂病变,其发生与肾、脾、肝、血瘀等均有关系,其中肾亏为主要病因,肝虚乃关键因素,脾虚是重要病因,血瘀则为促进因素。
目前,OP的发病机理较为复杂,西医学认为与骨形成、骨重塑主要与成骨细胞和破骨细胞密切相关,机体维持正常骨稳态有赖于二者的协同作用,而当骨形成与骨吸收失衡,则会导致骨量、骨质产生变化,进而造成OP。不健康的生活习惯,年龄的增长,长期营养不良,内分泌失调等也是重要的诱因。现西医学治疗OP主要以双膦酸盐类作为一线治疗药物,其次是核转录因子-κB受体活化因子配体(RANKL)抑制剂。甲状旁腺素(甲状旁腺激素的一个片段)是只有经批准的合成代谢剂,激素替代疗法(HRT)包括大量雌激素或雌激素加孕激素联合制剂,其中一些被批准用于预防绝经后骨折高危妇女的OP,补充钙和维生素D经常被认为是治疗OP的辅助手段。尽管这些策略对OP有很好的疗效,但研究显示长期服用这些药物具有较大的不良反应,如对胃肠道损害、耐药等。因此,探求临床疗效显著,副作用少的治疗药物就成为当前医务工作者努力的重要方向。
发明内容
为了解决现有技术的上述问题,本发明的目的之一是:提供一种骨质疏松贴,该骨质疏松贴为中药贴可补肝肾,强筋骨,活血化瘀,主治骨质疏松。中药贴无副作用和不良反应,具有“精准、独特、速效、天然”的特点,使用方便,使患者具有很好的依从性。
为了达到上述目的,本发明采用如下技术方案:
一种骨质疏松贴,包括贴膏剂基质和药效成分,所述药效成分包括如下药材原料:藏红花,乳香,没药,苏木,当归,杜仲,血竭,砂仁,甘草和生地。
优选地,所述药材原料的具体重量份如下:藏红花5-10份,乳香5-15份,没药5-15份,苏木10-20份,当归5-10份,杜仲10-20份,血竭1-3份,砂仁5-10份,甘草5-10份,生地10-20份。
优选地,所述药材原料的具体重量份如下:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份,生地20份。
优选地,所述贴膏剂基质包括如下重量份的原料:聚丙烯酸钠2-10份,羧甲基纤维素钠1-6份,聚乙烯醇1-6份,明胶2-10份,高岭土6-18份,亚磷酸0.1-1份,硫酸铝钾0.1-0.8份,水30-60份,甘油2-10份。
本发明的目的之二是:提供一种骨质疏松贴的制备方法。
为了达到上述目的,本发明采用如下技术方案:
一种骨质疏松贴的制备方法,具体步骤如下:
(1)将藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加水润透后,使用纯蒸汽提取法进行挥发油提取得混合挥发油A和药渣;
(2)将药渣与杜仲、生地混合,并加乙醇,提取得提取液,浓缩,干燥,粉碎,得浸膏粉;
(3)将浸膏粉用乙醇渗漉,回收乙醇,浓缩得稠膏;
(4)将混合挥发油A和稠膏加入贴膏剂基质中,搅拌炼合均匀后,涂布于裱褙材料上,经切割制成骨质疏松巴布剂,即为骨质疏松贴。
优选地,步骤(1)和步骤(2)中药材原料的具体重量份如下:藏红花5-10份,乳香5-15份,没药5-15份,苏木10-20份,当归5-10份,杜仲10-20份,血竭1-3份,砂仁5-10份,甘草5-10份,生地10-20份;步骤(2)中乙醇的体积浓度为55-65%。
优选地,步骤(3)中乙醇的体积浓度为90%。
优选地,步骤(4)中贴膏剂基质包括如下重量份的原料:聚丙烯酸钠2-10份,羧甲基纤维素钠1-6份,聚乙烯醇1-6份,明胶2-10份,高岭土6-18份,亚磷酸0.1-1份,硫酸铝钾0.1-0.8份,水30-60份,甘油2-10份;步骤(4)中稠膏与贴膏剂基质的质量比为1∶4-10。
本发明的有益效果在于:
(1)本发明的骨质疏松贴,其药膏中的药效成分以藏红花,乳香,没药,苏木,当归,杜仲,血竭,砂仁,甘草,生地制成。其中杜仲、当归为君药,杜仲补益肝肾,强筋健骨,临床上常用于腰痛、腰酸等症;当归补血和血,可促进造血系统功能,改善骨质疏松症状;藏红花、血竭、乳香、没药、苏木为臣药,藏红花、血竭都具有活血化瘀功效,乳香、没药相须为用,乳香行气活血为主,没药活血散瘀为要,二药参合,气血兼顾,取效尤捷,共奏宣通脏腑、流通经络、活血祛瘀、敛疮生肌之功;苏木具有活血祛瘀之功效;砂仁、生地为佐药,砂仁主要作用于人体的胃、肾和脾,能够行气调味,和胃醒脾,生地是养阴生津很重要的药物,同时它入肾经,可用于阴虚发热、骨蒸潮热,以及温病后期余热未尽、阴液已伤、夜热早凉等症状,适用于更年期骨质疏松;甘草为使药,可调和诸药,同时有补气的功效。
(2)本发明的制备方法中,对藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加水提取挥发油,然后将提取完挥发油的药渣又与杜仲、生地合用乙醇浸提,得浸膏粉,借此实现了对藏红花、苏木等所含天然药物成分被吃干榨尽,使药材价值充分发挥作用。巴布贴长期使用无副作用和不良反应,具有“精准、独特、速效、天然”的特点,使用方便、可发挥“补肝肾,强筋骨,活血化瘀”的作用、患者依从性好。
具体实施例
为使本发明实施例的目的、技术方案和优点更加清楚,下面将对本发明实施例中的技术方案进行清楚、完整地说明,显然,所描述的实施例是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1
一种骨质疏松贴,包括贴膏剂基质和药效成分,所述药效成分包括如下重量份的药材原料:藏红花5份,乳香5份,没药5份,苏木10份,当归5份,杜仲10份,血竭1份,砂仁5份,甘草5份和生地10份;
所述贴膏剂基质包括如下重量份的原料:聚丙烯酸钠2份,羧甲基纤维素钠1份,聚乙烯醇1份,明胶2份,高岭土6份,亚磷酸0.1份,硫酸铝钾0.1份,水30和甘油2份。
实施例2
一种骨质疏松贴,包括贴膏剂基质和药效成分,所述药效成分包括如下重量份的药材原料:藏红花8份,乳香10份,没药10份,苏木15份,当归8份,杜仲15份,血竭2份,砂仁8份,甘草8份和生地15份;
所述贴膏剂基质包括如下重量份的原料:聚丙烯酸钠8份,羧甲基纤维素钠4份,聚乙烯醇4份,明胶5份,高岭土13份,亚磷酸0.5份,硫酸铝钾0.4份,水40份和甘油6份。
实施例3
一种骨质疏松贴,包括贴膏剂基质和药效成分,所述药效成分包括如下重量份的药材原料:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份和生地20份;
所述贴膏剂基质包括如下重量份的原料:聚丙烯酸钠10份,羧甲基纤维素钠6份,聚乙烯醇6份,明胶10份,高岭土18份,亚磷酸1份,硫酸铝钾0.8份,水60份和甘油10份。
实施例4
一种骨质疏松贴(骨质疏松巴布剂)的制备方法,具体步骤如下:
(1)将藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加5倍质量的水润透(优选地,此处润透时间为1小时左右),使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取得混合挥发油A和药渣(优选地,此处挥发油提取的具体过程如下:先在常压下保持微沸蒸馏1小时后停止加热,待冷却至室温后,将液体流入容量瓶内,用乙酸乙酯萃取10min后取上层液体在0.9mpa下旋转蒸发得混合挥发油A和药渣);
(2)将药渣与杜仲、生地混合,并加12倍质量65%乙醇,提取至少2次,合并提取液,浓缩,干燥,粉碎,得浸膏粉;
(3)将浸膏粉用90%乙醇渗漉,回收乙醇,浓缩至相对密度1.2-1.3的稠膏(此处的相对密度为相对空气的密度);
(4)将混合挥发油A和稠膏加入贴膏剂基质中,稠膏与贴膏剂基质的比例为1∶10,搅拌炼合均匀后,涂布于裱褙材料上,经切割即制成骨质疏松巴布剂,即为骨质疏松贴;
其中,步骤(1)和步骤(2)中药材原料的具体重量份如下:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份和生地20份。
步骤(4)中贴膏剂基质包括如下重量份的原料:聚丙烯酸钠8份,羧甲基纤维素钠4份,聚乙烯醇4份,明胶5份,高岭土13份,亚磷酸0.5份,硫酸铝钾0.4份,水40份和甘油6份。
实施例5
一种骨质疏松贴(骨质疏松巴布剂)的制备方法,具体步骤如下:
(1)将藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加2倍质量的水润透,使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A和药渣;
(2)将药渣与杜仲、生地混合,并加7倍质量55%乙醇,提取至少2次,合并提取液,浓缩,干燥,粉碎,得浸膏粉;
(3)将浸膏粉用90%乙醇渗漉,回收乙醇,浓缩至相对密度1.2-1.3的稠膏(此处的相对密度为相对空气的密度);
(4)将混合挥发油A和稠膏加入贴膏剂基质中,稠膏与贴膏剂基质的比例为1∶4,搅拌炼合均匀后,涂布于裱褙材料上,经切割即制成骨质疏松巴布剂,即为骨质疏松贴;
其中,步骤(1)和步骤(2)中药材原料的具体重量份如下:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份和生地20份。
步骤(4)中贴膏剂基质包括如下重量份的原料:聚丙烯酸钠8份,羧甲基纤维素钠4份,聚乙烯醇4份,明胶5份,高岭土13份,亚磷酸0.5份,硫酸铝钾0.4份,水40份和甘油6份。
实施例6
一种骨质疏松贴(骨质疏松巴布剂)的制备方法,具体步骤如下:
(1)将藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加4倍质量的水润透,使用挥发油智能提取收集分离器的纯蒸汽提取法进行挥发油提取,得混合挥发油A和药渣;
(2)将药渣与杜仲、生地混合,并加10倍质量60%乙醇,提取至少2次,合并提取液,浓缩,干燥,粉碎,得浸膏粉;
(3)将浸膏粉用90%乙醇渗漉,回收乙醇,浓缩至相对密度1.2-1.3的稠膏(此处的相对密度为相对空气的密度);
(4)将混合挥发油A和稠膏加入贴膏剂基质中,稠膏与贴膏剂基质的比例为1∶6,搅拌炼合均匀后,涂布于裱褙材料上,经切割即制成骨质疏松巴布剂,即为骨质疏松贴;
其中,步骤(1)和步骤(2)中药材原料的具体重量份如下:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份和生地20份。
步骤(4)中贴膏剂基质包括如下重量份的原料:聚丙烯酸钠8份,羧甲基纤维素钠4份,聚乙烯醇4份,明胶5份,高岭土13份,亚磷酸0.5份,硫酸铝钾0.4份,水40份和甘油6份。
以上涉及到乙醇浓度的百分数均为体积百分数。
动物实验及其效果验证
建立大鼠骨质疏松模型,以骨质疏松模型大鼠为研究对象,研究本发明的骨质疏松贴在大鼠骨质疏松过程中的作用。
方法:40只大鼠适应性喂养1周后随机分为假手术组(10只)和去势组(30只)。1周后去势组根据随机数字表随机分3组,每组10只,即模型组,尼尔雌醇组,骨质疏松贴片组。除假手术组外,其余3组大鼠行卵巢切除术造模:在无菌条件下,使用20%乌拉坦(4ml/kg)腹腔注射麻醉。麻醉成功后,将动物固定,下腹部剪毛,用碘酒、酒精常规消毒局部,于无菌条件下取下腹正中切口,长约1.5cm,逐层钝性分离进入腹腔,完整切除双侧卵巢,止血后逐层缝合、关腹。伤口涂抹红霉素软膏、肌注青霉素,预防伤口感染。假手术组切口同前,进入腹腔后,找到卵巢后并不切除,只切除与双侧卵巢重量相近的左右大网膜各一段,清创缝合及术后处置与去卵巢组相同。骨质疏松贴片组贴敷于肾俞穴,每日1次,每次6-8小时,共12周。尼尔雌醇组给予尼尔雌醇片(1mg/kg体质量),配成0.15g/L混悬液,每周1次,每次2mL,余6次灌胃与假手术组相同,共12周。模型组和假手术组以生理盐水(8mL/kg体质量)灌胃,每日1次,共12周。实验过程中每周称体质量1次,根据体质量调整给药剂量。各组动物用药12周后,在无菌条件下,使用20%乌拉坦(4mL/kg)腹腔注射麻醉,取腰椎和双侧股骨,剥离并剔除肌肉等组织。腰椎和一侧股骨下端采用双能X线骨密度仪,应用小动物软件,进行离体骨密度测定。另一侧股骨放于生理盐水(20℃)下浸泡,复温3~4h后,进行加工,首先将牙托粉与自凝液以5∶1融合,待牙托粉变为黏稠的淡粉色膏状物后,将股骨远近端分别用牙托粉作以定型,使股骨两端稳定,不发生侧向旋转并基本处于同一水平面。标本处理好后,采用电子万能试验机作股骨三点弯曲试验,两端跨距为20mm,加载速度为2mm/min,检测过程由计算机自动记录股骨的载荷-变形曲线。
结果显示,与假手术组比较,模型组骨密度有明显降低(P<0.01),表明造模成功。与模型组比较,骨质疏松贴片组的腰椎骨和股骨远端骨密度有显著性增加(P<0.01),详见表1。通过载荷-变形曲线,计算出最大载荷、断裂挠度、弯曲能量。结果显示,与假手术组比较,模型组最大载荷、断裂挠度和弯曲能量明显降低(P<0.01);与模型组比较,骨质疏松贴片组与尼尔雌醇组的最大载荷显著性增高(P<0.01);与模型组比较,尼尔雌醇组的断裂挠度显著性增高(P<0.01),骨质疏松贴片组与模型组相比较,虽有升高趋势,但无明显变化(P>0.05);与模型组比较,尼尔雌醇组、骨质疏松贴片组的弯曲能量显著性增高(P<0.01),详见表2。
组别 | n | 腰椎骨密度 | 股骨远端骨密度 |
假手术组 | 10 | 0.311 6±0.023 1 | 0.322 8±0.005 6 |
模型组 | 10 | 0.213 3±0.021 4<sup>▲</sup> | 0.215 1±0.004 9<sup>▲</sup> |
尼尔雌醇组 | 10 | 0.309 5±0.035 1 | 0.308 9±0.004 5 |
骨质疏松贴片组 | 10 | 0.301 1±0.023 5<sup>*</sup> | 0.296 4±0.002 8<sup>*</sup> |
注:与模型组比较,*P<0.01;与假手术组比较,▲P<0.01
注:与模型组比较,*P<0.01;与假手术组比较,▲P<0.01;与模型组比较,▼P>0.05。
临床验证
将骨质疏松贴片治疗效果与口服骨康胶囊(0.4g/粒,贵州维康药业有限公司生产)治疗效果进行比较:共观察病例100例,随机分为治疗组和对照组各50例,最终97例完成试验。对照组49例,年龄57~75岁,平均年龄(66.3±5.78)岁;治疗组48例,年龄55~75岁,平均年龄(66.24±5.16)岁。两组年龄比较差异无统计学意义(P>0.05),具有可比性。对照组使用骨康胶囊治疗,0.4g/粒,由贵州维康药业有限公司生产。剂量为3~4粒/次,3次/d。进行常规治疗。治疗组用骨质疏松贴片,贴敷于双侧肝俞穴、肾俞穴、腰眼穴、阿是穴、足三里穴治疗,用法:每日1次,每次8~12h,1周不少于4次,3个月1个疗程,观察两个疗程。用药前、用药后3月及6月测定骨形成指标:血清Ⅰ型原胶原N-端前肽(PINP);骨吸收指标:血清Ⅰ型胶原交联C-末端肽(S-CTX),见表3。结果显示:用药3个月后,治疗组骨代谢指标PINP上升明显(P<0.05),S-CTX下降明显(P<0.01);用药6个月后,治疗组骨代谢指标与对照组比较差异有统计学意义(P<0.05)。对照组和治疗组腰椎正位(L1~4)和右股骨颈(Neck)骨密度检测结果中取其较低值,见表4。结果显示:治疗6个月后,治疗组骨密度值显著提高,与对照组相比差异有统计学意义(P<0.05),与治疗前相比差异亦有统计学意义(P<0.05)。
组别 | 例数 | 治疗前 | 治疗后3个月 | 治疗后6个月 |
治疗组 | 48 | -2.94±0.48 | -2.77±0.75 | -2.61±0.44 |
对照组 | 49 | -2.96±0.51 | -2.84±0.58 | -2.80±0.52 |
尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:其依然可以对前述各实施例所记载的技术方案进行修改,或者对其中部分技术特征进行等同替换;而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。
Claims (8)
1.一种骨质疏松贴,其特征在于,包括贴膏剂基质和药效成分,所述药效成分包括如下药材原料:藏红花,乳香,没药,苏木,当归,杜仲,血竭,砂仁,甘草和生地。
2.根据权利要求1所述的一种骨质疏松贴,其特征在于,所述药材原料的具体重量份如下:藏红花5-10份,乳香5-15份,没药5-15份,苏木10-20份,当归5-10份,杜仲10-20份,血竭1-3份,砂仁5-10份,甘草5-10份,生地10-20份。
3.根据权利要求2所述的一种骨质疏松贴,其特征在于,所述药材原料的具体重量份如下:藏红花10份,乳香15份,没药15份,苏木20份,当归10份,杜仲20份,血竭3份,砂仁10份,甘草10份,生地20份。
4.根据权利要求2所述的一种骨质疏松贴,其特征在于,所述贴膏剂基质包括如下重量份的原料:聚丙烯酸钠2-10份,羧甲基纤维素钠1-6份,聚乙烯醇1-6份,明胶2-10份,高岭土6-18份,亚磷酸0.1-1份,硫酸铝钾0.1-0.8份,水30-60份,甘油2-10份。
5.一种骨质疏松贴的制备方法,其特征在于,具体步骤如下:
(1)将藏红花、乳香、没药、苏木、当归、血竭、砂仁、甘草加水润透后,使用纯蒸汽提取法进行挥发油提取得混合挥发油A和药渣;
(2)将药渣与杜仲、生地混合,并加乙醇,提取得提取液,浓缩,干燥,粉碎,得浸膏粉;
(3)将浸膏粉用乙醇渗漉,回收乙醇,浓缩得稠膏;
(4)将混合挥发油A和稠膏加入贴膏剂基质中,搅拌炼合均匀后,涂布于裱褙材料上,经切割制成骨质疏松巴布剂,即为骨质疏松贴。
6.根据权利要求5所述的一种骨质疏松贴的制备方法,其特征在于,步骤(1)和步骤(2)中药材原料的具体重量份如下:藏红花5-10份,乳香5-15份,没药5-15份,苏木10-20份,当归5-10份,杜仲10-20份,血竭1-3份,砂仁5-10份,甘草5-10份,生地10-20份;步骤(2)中乙醇的体积浓度为55-65%。
7.根据权利要求5所述的一种骨质疏松贴的制备方法,其特征在于,步骤(3)中乙醇的体积浓度为90%。
8.根据权利要求5所述的一种骨质疏松贴的制备方法,其特征在于,步骤(4)中贴膏剂基质包括如下重量份的原料:聚丙烯酸钠2-10份,羧甲基纤维素钠1-6份,聚乙烯醇1-6份,明胶2-10份,高岭土6-18份,亚磷酸0.1-1份,硫酸铝钾0.1-0.8份,水30-60份,甘油2-10份;步骤(4)中稠膏与贴膏剂基质的质量比为1∶4-10。
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Application publication date: 20220823 |