CN111558016A - 一种具有护牙壮骨功效的中药组合物及中药制剂 - Google Patents
一种具有护牙壮骨功效的中药组合物及中药制剂 Download PDFInfo
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Abstract
本发明公开了一种具有护牙壮骨功效的中药组合物及中药制剂,属于中药领域。该中药组合物和中药制剂包括如下重量份的组分:阿胶2‑5份,熟地4‑7份,枸杞2‑5份,黄芪4‑8份,人参1‑3份,牡蛎1‑4份,骨碎补1‑3份,巴戟天0.5‑1.5份,乌梅0.7‑1.8份,乳香0.8‑1.5份,没药0.8‑1.3份,砂仁0.6‑1.6份,甘草0.5‑1.4份。该中药组合物和中药制剂可治疗干槽症、牙槽骨萎缩、肌肉萎缩及骨质疏松症,针对性更强、组合功能更为完善,相得益彰,疗效显著。
Description
技术领域
本发明属于中药领域,尤其涉及一种具有护牙壮骨功效的中药组合物及中药制剂。
背景技术
随着时代的发展,老龄化社会的出现,很多老年人都出现了拔牙、修牙、补牙、种牙引起的干槽症,牙槽骨萎缩的症状非常普遍。因此治疗干槽症,牙槽骨萎缩是急需解决的问题。
当牙龈老化萎缩后,牙槽骨也随之萎缩变短,口腔医学称为“骨吸收现象”。这也是导致牙齿脱落的主要原因,牙槽骨萎缩的常见危害:
1、导致牙齿脱落
对牙槽骨的营养输送能力日趋下降,牙槽骨也就随之萎缩变短,导致稳定性降低,牙齿开始松动,同时牙槽骨被吸收,使牙齿根基变浅,牙齿变长,随着骨吸收现象的日趋加剧,牙齿自然也就脱落了。
2、致使牙齿过敏
牙槽骨萎缩导致牙根外露,牙根的表面没有牙釉质,一旦没有了牙龈的保护,不仅容易在刷牙时受到磨损,同时对冷、热、酸的刺激非常敏感,口腔医学上称为“牙本质过敏”。
3、引发各种口腔炎症
牙槽骨萎缩后不能再像从前一样紧紧包裹牙根,结果导致牙周组织也被暴露出来,口腔中的各种细菌及牙结石直接侵袭牙周组织引发牙周炎。牙周炎又会反过来加剧牙龈萎缩,加速牙槽骨被吸收,形成一种恶性循环。
骨痹病,一种多发于中老年人的疾病。病因是人到中年后,肝肾开始虚衰,人的活动量减少,气血有所不足,加之外受寒邪湿气,客于骨髓,发面为痹。劳伤筋骨者,肝肾自伤。因此,越是青壮年时期运动量大的人和干重体力劳动的人,进入中老年后如不坚持活动,越容易患此病。
骨痹病肌肉萎缩(myatrophy;myophagism)是指横纹肌营养障碍,肌肉纤维变细甚至消失等导致的肌肉体积缩小。多由肌肉本身疾患或神经系统功能障碍所致,病因主要有:神经源性肌萎缩、肌源性肌萎缩、废用性肌萎缩和其他原因性肌萎缩。肌肉营养状况除肌肉组织本身的病理变化外,更与神经系统有密切关系。脊髓疾病常导致肌肉营养不良而发生肌肉萎缩。肌萎缩患者由于肌肉萎缩、肌无力而长期卧床,易并发肺炎、压疮等,加之大多数患者出现延髓麻痹症状,给患者生命构成极大的威胁。
骨关节炎(OA),骨质疏松病是中老年人常见的一种退行性关节疾病,由于该病是关节软骨退化引起,所以患者会出现不同程度的关节肿胀、疼痛和活动能力受限。随着我国人口不断老龄化,其发病率和患病率都呈逐年增高的趋势,给患者和社会带来巨大的负担。可因创伤、劳损及组织细胞衰老等因素引起,多发于中老年人,以疼痛、肿胀和功能障碍为主要表现。其病理过程主要是由于关节长期受力异常,并且随着年龄的增长,关节代谢能力减退,营养障碍,造成关节局部组织中炎性刺激因子和炎性介质增多,使关节出现滑膜组织增生,关节积液和软骨营养障碍,骨赘形成和软骨下骨质硬化等一系列OA的病理改变。OA是临床上最常见的老年性骨关节疾病,随着现代社会人口的老龄化,OA会更普遍。根据流行病学调查,65岁以上人群中的OA发病率男性为60%,女性为70%,且随着年龄的增长而增高。
骨关节疾病也正在青年化发展,尤以颈肩关节综合症、腰椎关节病更为突出。
以上各种病症都是常见病,多发病,反复发作性疾病,如何预防和治疗以上病症成为急需解决的问题。
发明内容
为了解决上述技术问题,本发明提供一种具有护牙壮骨功效的中药组合物及中药制剂。
本发明在阿胶強骨方(发明专利号ZL 200410046400.2)的基础上,总结出临床效果显著的固定中药方剂,并可制成中成药制剂,包括丸、散、冲剂、口服液等。该中药组合物及中药制剂由以下重量份的中药材制成:阿胶2-5份,熟地4-7份,枸杞2-5份,黄芪4-8份,人参1-3份,牡蛎1-4份,骨碎补1-3份,巴戟天0.5-1.5份,乌梅0.7-1.8份,乳香0.8-1.5份,没药0.8-1.3份,砂仁0.6-1.6份,甘草0.5-1.4份。
本发明提供的一些实施例中,本发明提供的中药组合物包括如下重量份的原料:阿胶3份,熟地6份,枸杞3份,黄芪6份,人参2份,牡蛎3份,骨碎补2份,巴戟天1份,乌梅1份,乳香1份,没药1份,砂仁1份,甘草1份。
阿胶:味甘,性平。归肝、心、肺、肾经。质粘而润,可升可降。阿胶属明胶蛋白,水解可产生多种氨酸,功效如下:(1)促进造血功能。(2)可明显提高腹腔M的吞噬能力,对NK细胞有促进作用。(3)抗肌营养障碍作用,可使肌细胞再生而出现正常肌纤维。(4)可增加体内钙的摄入量,有效地改善因缺钙导致的骨钙丢失、钙盐外流、骨质疏松和骨质增生及各类骨折。(5)阿胶有抗疲劳、耐缺氧、耐寒冷、健脑和延缓衰老等作用,并有改善男女生育的作用。
熟地:本品味甘浓厚,入肝经血分,补血调经,滋阴益精。《本草纲目》:“熟地填骨髓,长肌肉,生精血,补五脏内伤不足,通血脉,利耳目,黑须发。男子五劳七伤,女子伤中胞漏,经候不调,胎产百病。”
枸杞:(1)具有使白细胞数回升,促进机体造血功能恢复、(2)抑制血清及肝中的脂质变化,促使肝损伤恢复。(3能促进人牙龈成纤维细胞在牙病根面上附着和生长,使病变根面上的附着细胞数量显著增多,分布均匀,生长较旺盛,可能直接参与了牙周结缔)组织新附着形成的过程。
黄芪:(1)能明显减少血栓形成,降低血小板粘附。(2)使骨髓单粒系祖细胞数明显增高;能阻止骨髓有核细胞数的明显减少,对白細胞、血小坂数、网织红细胞数和巨核细胞数下降有明显回升作用。(3)可显著促进骨髓造血细胞DNA合成,加快有核细胞分裂过程,并能促进体外培养肝细胞RNA及蛋白质合成,提示其能延长细胞寿命,增强细胞代谢,推迟老化。(4)可提高机体抗氧化酶和抗氧化剂含量的活力,降低血清脂褐质的含量。(5)能显著促进体外培养的兔关节软骨细胞代谢,有可能促进软骨损伤的修复。连续给类固醇性骨质疏松大鼠灌胃,可使骨吸收减少,骨形成率增加,骨小梁面积增加。
牡蛎:含有碳酸钙90%以上,并含磷酸钙、硫酸钙。另外含有人体所需蛋白质、各种氨基酸。对人体补充钙提供充足的钙质。
人参:对骨髓的造血功能有保护和刺激作用,可使正常和贫血动物红细胞数、白细胞数和Hb量增加。人参总皂苷可以刺激分离的大鼠胰岛释放胰岛素,并可促进葡萄糖引起的胰岛素释放。
上述六种中药成份是在阿胶強骨组方的基础上将党参改为人参,其目的减少党参对升高血糖的作用,提高机体对血液和造血系统的影响,人参具有广泛的调节内分泌、抗氧化、增加物质代谢、提高机体的免疫功能等作用,能对衰老机体的各种生理生化变化起到良好的调整作用,从而显示提高抗衰老作用。《本草正》:“人参,气虚血虚俱能补。阳气虚竭者,此能回之于无何有之乡;阴血崩溃者,此能障之于已决裂之后。”在改方之后方中增加如下七味中药成份:
骨碎补:可促进骨对钙的吸收,提高血钙和血磷水平,促骨的钙化和骨质形成。另外,骨碎补在试管内能抑制葡萄球菌的生长,促进体外培养的人牙银或纤维细胞在牙周病根面的附着生长。
巴戟天:可以显著升高降钙素含量,降低甲状旁素含量,降低血钙和羟脯氨酸含量,提高ALP活性,从而抑制骨量丢失,促进成骨作用。
乳香:具有活血行气,通经止痛,消肿生肌。
没药:《本草述》中:“久服舒筋膜,通血脉,固齿牙,长须发。”《本草纲目》:“乳香活血,沒药散血,皆能止痛消肿生肌。故二药每每相兼而用。”另加三味辅助中药:甘草、砂仁、乌梅。
甘草:具有抗氧化和抗衰老作用,在临床上与黄芪配伍有增长肌肉作用,甘草类黄酮可明显抑制小鼠肝MDA升高,对氧自由基和.OH有显著的清除作用。
乌梅:可以刺激唾液腺、胃腺分泌消化液,增加食欲,促进消化,因此增加老年人的消化功能,改善老年的营养吸收功能。
乌梅与熟地有协同作用,《得配本草》:“熟地得乌梅,引入骨髓;得砂仁,纳气归阴;”。《本草经疏:“乌梅味酸,能敛浮热,能吸气归元,故主下气、除热烦满及安心也。肝主筋,酸入肝而养筋,肝得所养,则骨正筋柔,机关通利而证除矣。”》。
砂仁:按明韩懋《韩氏医通》:“肾恶燥,以辛润之,缩砂仁之辛,以润肾燥。缩砂属土,主醒脾调胃,引诸药归宿丹田,香而能窜,和合五脏冲和之气,如天地以土为冲和之气,故补肾药用同地黄丸蒸,取其达下之旨也。”《本草汇言》:“砂仁,温中和气之药也,若上焦之气梗逆而不下,下焦之气抑遏而不上,中焦之气凝聚而不舒,用砂仁治之,奏效最捷。此药辛香而窜,温而不烈,利而不削,和而不争,通畅三焦,温行六腑,暖肺醒脾,养胃养肾,舒达肝胆不顺不平之气所以善安胎也。(此证明:孕妇能服,安全有效。寿胎丸是中药成常用的保胎药内含阿胶,)”。
人参主升,乌梅主降,一生一降,通利三焦之气。金元四大医家李东垣:“人参得黄芪、甘草,乃甘温除大热,泻阴火,补元气,--”(引自《本草纲目》)。三种组合补而不生热,加之阿胶,熟地气血双补,加之乌梅,砂仁补而不滞。
与现有技术相比,本发明具有如下有益效果:
本发明提供的中药方剂可治疗干槽症,牙槽骨萎缩,肌肉萎缩及骨质疏松症,针对性更强、组合功能更为完善,相得益彰,疗效显著。
具体实施方式
对比例1
以发明专利ZL 200410046400.2中实施例5提供的阿胶强骨口服液作为对比例,上述阿胶强骨口服液按重量百分比含有10%的阿胶、2.90%的牡蛎、20%的熟地、10%的枸杞子、20%的黄芪、10%的党参、0.15%的山梨酸和余量的水。
实施例1
本实施例提供的中药制剂的组分为:阿胶2份,熟地6份,枸杞4份,黄芪4份,人参3份,牡蛎4份,骨碎补2份,巴戟天1.5份,乌梅1.5份,乳香0.8份,没药1份,砂仁1.3份,甘草0.5份。
褚**女、51岁,2015年10月被医院诊断为干槽症,无基础疾病。做血常规;尿常规;肾功能;肝功能,检查结果均为正常。除正常清洗外,术前(清理牙龈,残余牙根)。按上述方案内服中药汤剂,每天1付,水煎服,早晚各1次,连续服用1个月。复查:做血常规;尿常规;肾功能;肝功能检查,结果均为正常。临床症状消失,X光检查正常。
实施例2
本实施例提供的中药制剂的组分为:阿胶5份,熟地4份,枸杞2份,黄芪8份,人参1份,牡蛎2份,骨碎补1份,巴戟天0.5份,乌梅0.7份,乳香1.5份,没药1.3份,砂仁0.6份,甘草1份。
李**女、62岁,2017年10月被医院诊断为牙槽骨萎缩,无基础疾病。血常规、尿常规、肾功能、肝功能检查,结果均为正常。按上述方案服用中药汤剂,每天1付,水煎服,早晚各1次,连续服用3个月,复查:血常规、尿常规、肾功能、肝功能检查,结果均为正常,临床症状消失,X光牙槽骨恢复正常。
实施例3
本实施例提供的中药制剂的组分为:阿胶4份,熟地6份,枸杞4份,黄芪7份,人参2份,牡蛎3份,骨碎补2份,巴戟天1份,乌梅1.5份,乳香1.2份,没药1份,砂仁1.5份,甘草1.3份。
朱**男63岁,2014年11月,双膝关节疼痛,行走困难,被医院诊断为骨关节病及骨质疏松症,无基础疾病,血常规、尿常规、肾功能、肝功能检查,均为正常。按上述方案内服中药汤剂,每天1付,水煎服,早晚各1次,连续服用3个月,复查:血常规、尿常规、肾功能、肝功能检查,结果均为正常,临床症状消失,X光检查及骨密度测试指标均为正常。
实施例4
本实施例提供的中药制剂的组分为:阿胶2份,熟地7份,枸杞5份,黄芪5份,人参1份,牡蛎1份,骨碎补3份,巴戟天0.5份,乌梅1.8份,乳香1份,没药0.8份,砂仁1.6份,甘草1.4份。
王**男78岁,2017年8月,全身无力,颈椎、腰椎、膝关节均疼痛,被医院诊断为骨关节炎,无基础疾病,血常规、尿常规、肾功能、肝功能检查,均为正常。按上述方案服用方药每天1付,水煎服,早晚各1次,连续服3个月,复查:血常规、尿常规、肾功能、肝功能检查,结果均为正常,临床症状消失,X光检查及骨密度测试指标均为正常。
实施例5
本实施例提供的中药制剂的组分为:阿胶3份,熟地4份,枸杞2份,黄芪8份,人参3份,牡蛎4份,骨碎补3份,巴戟天1.5份,乌梅0.7份,乳香1.3份,没药1份,砂仁1份,甘草1.1份。
自2015年至今,1300名干槽症、牙槽骨萎缩患者服用上述中药制剂,每天1付,水煎服,早晚各1次,一般服用1至3个月,总有效率为93%。其中1298名患者治疗前全部做:血常规、尿常规、肾功能、肝功能检查,结果均为正常,服药后1至3个月内复查血常规、尿常规、肾功能、肝功能,结果均正常。
实施例6
本实施例提供的中药制剂的组分为:阿胶4份,熟地7份,枸杞4份,黄芪8份,人参2份,牡蛎4份,骨碎补1份,巴戟天1.5份,乌梅1.8份,乳香0.8份,没药1.3份,砂仁1.6份,甘草0.5份。
牙科疾病患者均按照随机数字表法分为观察组和对照组。观察组按疗程要求完成治疗1~6个月和对照组只服用0-15天,或其他清热消炎的中成药;消炎止痛药,每组56例。观察组男23例,女33例;年龄18~82岁,平均(45.8±9.0)岁;病程3~15年。对照组男28例,女38例;年龄19~78岁,平均(40.8±3.0)岁;病程2~8年。两组在性别、年龄、病程方面比较差异均无统计学意义(P>0.05),具有可比性,观察组和对照组的统计数据如表1所示。
表1两组患者临床疗效比效(例)
组别 | 例数 | 治愈 | 有效 | 无效 | 总有效率 |
观察组 | 56 | 41 | 12 | 3 | 94.7 |
对照组 | 56 | 6 | 21 | 29 | 48.3 |
由上表可知,本实施例提供的中药制剂比其他中成药、消炎药具有更好的疗效。
实施例7
本实施例提供的中药制剂的组分为:阿胶3份,熟地6份,枸杞3份,黄芪6份,人参2份,牡蛎3份,骨碎补2份,巴戟天1份,乌梅1份,乳香1份,没药1份,砂仁1份,甘草1份。
自2017年至今,2000名颈椎病,腰椎,各种关节疾病,老年性骨质疏松,骨外伤患者临床服用上述具体方药,每天1付,水煎服,早晚各1次,一般服用1至3个月,总有效率为86%,其中1866名患者治疗前检查血常规、尿常规、肾功能、肝功能,结果均为正常,服药后1至4个月内复查血常规、尿常规、肾功能、肝功能,结果均正常。
实施例8
本实施例提供的中药制剂的组分为:阿胶5份,熟地7份,枸杞2份,黄芪4份,人参1份,牡蛎4份,骨碎补3份,巴戟天1份,乌梅0.7份,乳香0.8份,没药0.8份,砂仁0.6份,甘草1.4份。
对骨科疾病患者(颈椎病、腰椎、各种关节疾病、老年性骨质疏松、骨外伤)均按照随机数字表法分为观察组和对照组。观察组按疗程要求完成治疗1~6个月,对照组沒有服用上述方剂或沒完成疗程,每组84例,观察组男35例,女49例,年龄18~82岁,平均(55.8±6.0)岁;病程3~15年。对照组男28例,女38例;年龄19~78岁,平均(40.8±7.0)岁;病程2~11年。两组在性别、年龄、病程方面比较差异均无统计学意义(P>0.05),具有可比性,观察组和对照组的统计数据如表2所示。
表2两组患者临床疗效比效(例)
组别 | 例数 | 治愈 | 有效 | 无效 | 总有效率 |
观察组 | 84 | 51 | 24 | 9 | 89.3 |
对照组 | 84 | 4 | 23 | 57 | 32.2 |
由表2可知,本实施例提供的中药制剂只要疗程服用,效果显著。
实施例9
本实施例提供的中药制剂的组分同实施例7,同时以对比例1中的阿胶强骨口服液作为对比,进行ALP活性检测,过程如下:
选取昆明种小鼠100只,雌雄各半(体重20±2g),随机分为5组,每组20只,分别为对照组(肌注生理盐水,0.1ml/20g);模型组(肌注氢化可的松,125mg/kg,以下各组相同);本实施例中药制剂组、阿胶强骨口服液组分别灌服0.45ml/10g。小鼠连续灌胃给药及肌注氢化可的松二周后,测定血清ALP活性。结果进行组间均数t检验。结果,模型组磷含量明显低于NS组;本实施例中药制剂组和阿胶强骨口服液使血清磷显著高于模型组,本实施例中药制剂组与阿胶强骨口服液相比,血清磷含量提高更多。
实施例10
本实施例提供的中药制剂的组分同实施例7,同时以对比例1中的阿胶强骨口服液作为对比,研究其对缺乏维生素D致佝偻病大鼠的防治作用,步骤如下:
取出生20天健康wistar大鼠60只,雌雄兼用,随机分为6组,即为NS对照组,佝偻病模型组,本实施例中药制剂组及阿胶强骨组(分别灌服0.45ml/10g)。除正常对照组给复合饲料常规饲养外,其余各组均给予改良维生素D缺乏饲料,避光饲养,同时各组灌服给药。第60天大鼠尾静脉取血,测定血清钙、磷及碱性磷酸酶活性,并依上述方法摄X-ray片,测定大鼠股骨钙、磷含量。结果,本实施例中药制剂和阿胶强骨口服液可使佝偻病大鼠模型血清钙高于模型组,x光片显示,模型组有明显骨软化等改变,本实施例中药制剂组比阿胶强骨口服液组相比,光片改善更加明显。
以上所述的实施例仅是对本发明的优选方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案做出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (4)
1.一种具有护牙壮骨功效的中药组合物,其特征在于,包括如下重量份的组分:阿胶2-5份,熟地4-7份,枸杞2-5份,黄芪4-8份,人参1-3份,牡蛎1-4份,骨碎补1-3份,巴戟天0.5-1.5份,乌梅0.7-1.8份,乳香0.8-1.5份,没药0.8-1.3份,砂仁0.6-1.6份,甘草0.5-1.4份。
2.根据权利要求3所述的中药组合物,其特征在于,包括如下重量份的组分:阿胶3份,熟地6份,枸杞3份,黄芪6份,人参2份,牡蛎3份,骨碎补2份,巴戟天1份,乌梅1份,乳香1份,没药1份,砂仁1份,甘草1份。
3.一种具有护牙壮骨功效的中药制剂,其特征在于,由权利要求1或2所述的中药组合物及药学上可接受的辅料制成。
4.根据权利要求3所述的中药制剂,其特征在于,其为颗粒剂、胶囊剂、片剂、丸剂或口服液。
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