CN104474131B - 一种用于治疗肝病引起的骨量减少及骨质疏松症的药物 - Google Patents
一种用于治疗肝病引起的骨量减少及骨质疏松症的药物 Download PDFInfo
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Abstract
本发明公开了一种用于治疗肝病引起的骨量减少及骨质疏松症的药物。它由活性维生素D3和中药制剂组成;所述中药制剂主要由下述中药制成:锁阳、枸杞子、旱莲草、瓦楞子、鳖甲粉和三七粉。本发明药物适用肝病并骨量减少及骨质疏松症所致的骨痛、骨折、肌无力的患者,特别适用于单纯西医西药治疗无效或疗效欠佳的、久治不愈的患者。以该药物治疗肝病引起的骨量减少及骨质疏松症,有效率达82.98%。本发明药物为中西药复方制剂,操作简便,服用方便。
Description
技术领域
本发明涉及一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,属于中西药复方制剂技术领域。
背景技术
骨量减少及骨质疏松症是一种以骨量降低、骨微结构破坏、骨脆性增加、骨强度下降、骨折风险性增大为特征的全身性、代谢性骨骼系统疾病,可分为原发性骨质疏松症和继发性骨质疏松症。肝病时并发骨量减少及骨质疏松症较为常见,是较难以治疗的疾病之一。其发生机理有以下:①肝病特别是阻塞性黄疸时,胆汁分泌不足,导致不能乳化脂肪,使脂肪和脂溶性维生素吸收障碍,从肠道吸收的维生素D减少,而且肝功能减退,肝内25-羟化酶活性降低,肝脏合成25-OH-D3减少,导致体内缺乏维生素D,影响到肠道钙磷吸收,导致缺钙;肝病时脂肪吸收障碍,脂肪酸在肠道内与钙结合形成不溶性钙复合物;②酒精性肝硬化患者酒精刺激肾上腺皮质分泌肾上腺皮质激素,肝硬化患者激素代谢障碍,引起肾上腺皮质激素或甲状旁腺素(PTH)增多。肾上腺糖皮质激素促进肾脏对钙的排出,抑制肠道对钙的吸收;PTH的作用是动员骨钙入血,直接促进肾小管重吸收Ca2+和间接促进小肠对Ca2+的吸收,因而使血钙升高,同时也使尿磷增多,血磷减少;③血清中离子钙和蛋白结合钙各约占50%,肝病时的低蛋白血症,会使血浆结合钙降低。④肝硬化患者为预防肝性脑病而控制蛋白饮食,致赖氨酸、精氨酸减少。由于上述多种因素,常导致机体缺乏维生素D和钙,从而引起骨形成减少(约半数病人)和骨吸收亢进,骨小梁容积和骨小梁厚度均明显减少,造成骨质疏松。肝硬化肝功能受损,使PTH的代谢、降解发生障碍,使之水平升高,影响肝硬化患者的钙磷代谢,再加上肝硬化患者的消化、吸收不良等因素,而引发肝性骨营养不良。
骨质疏松症较轻者无临床症状,病情较重者可出现骨痛(脊柱压缩性骨折时,可有背部慢性深部疼痛,每于早晨或晚上散步时发生,持续几周或几个月才逐渐消失,可引起脊柱卷曲、身材变矮;也可致全身痛,伴有疲倦和乏力)和骨折(常在轻微碰撞、跌倒甚至正常的动作时即发生骨折,好发于挠骨和尺骨远端、股骨颈和跟骨等部位,而骨盆、肩胛骨、肋骨、趾骨也较多见)。
目前,治疗骨量减少及骨质疏松的药物有:钙剂(800~1200mg/d)、活性维生素D3(0.25~0.5ug/d)、双膦酸盐、降钙素、甲状旁腺激素、雌激素、选择性雌激素受体调节剂(SERMs)、锶盐类,其中后三者仅适用于绝经后女性患者。
发明内容
本发明的目的在于提供一种用于治疗肝病引起的骨量减少及骨质疏松症的药物。该药物采用中药制剂提高了该病的治愈率,为众多患者解除顽疾之苦。
本发明的技术方案是:一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25ug的活性维生素D3和中药制剂组成;所述中药制剂主要由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g。
进一步地,上述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、龟板胶7.5~15g。
进一步地,上述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、淫羊藿10~20g。
进一步地,上述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、补骨脂10~20g。
进一步地,上述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、巴戟天10~20g。
进一步地,上述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、续断10~20g。
上述原料药的重量为单剂药量,即病人的每天剂量。
本发明为活性维生素D3 0.25ug/d加中药制成,剂型为散剂或口服液。
散剂的制作方法为:(1)将中药水煎煮,经浓缩、干燥、粉碎后得到中药颗粒,与活性维生素D3一起配齐包装;(2)采用市售的单剂的中药配方颗粒(按采用的中药饮片的质量计)与活性维生素D3一起配齐包装。
口服液的制作方法是:将中药(龟板胶、鳖甲粉、三七粉另包)混匀,加冷水浸泡1小时,水煎2次,每次水开后煎25分钟,每次剩液100ml,两次混合在一起,龟板胶烊化后加入,鳖甲粉、三七粉冲入,装入250ml瓶,然后加入活性维生素D3,制成口服液。
服用方法:每日一剂配方颗粒,混匀,冲服(分早晚两次);或每日1瓶200毫升,于早晚饭后1小时,分早晚两次。1个月为1个疗程。
主治:肝病引起的骨量减少及骨质疏松症:骨痛、骨折、肌无力。X线照片可见骨折及骨密度降低(不规则、常在脊柱最显著)。常伴有腰膝酸软、头晕目眩、耳鸣健忘、畏寒怕冷、小便困难或失禁、牙齿松动、阳痿、面色晦暗,肝掌,蜘蛛痣,舌暗胖有瘀斑或有齿痕、舌下静脉怒张,脉沉迟。
治疗过程中,部分患者出现全身发热,此为正常现象。此外,还应嘱患者慎起居、调寒热,预防感冒以免病情反复。活动量及幅度易循序渐进,不过活动过度或久坐。慢性乙肝患者常规服用抗乙肝病毒药物(最好为恩替卡韦,其次拉米夫定、替比夫定阿德福韦),一般肝病患者尽量保持肝功能正常或接近正常。
作用机理:中医基础理论认为:肝肾同源,肝病日久常出现肾虚,骨质疏松的发生主要是由肾虚所致,肾藏精,主骨,生髓,髓藏于骨腔内,滋养骨骼,骨的生长发育依赖肾脏精气的滋养与推动。《素问·四时刺逆从论》:“肾主身之骨髓”、“肾生骨髓”、“其充在骨”之说。《素问·阴阳应象大论》日:“肾主骨髓,在体为骨”。《医精经义》日:“肾藏精,精生髓,髓生骨,故骨者肾之所主也;髓者,肾精所生,精足则髓足,髓足者则骨强”。骨之强劲与脆弱是肾中精气盛衰的重要标志,肾中精气充盈,则骨髓生化有源,骨才能得到骨髓的滋养,骨矿含量正常而骨强健有力;人体衰老则肾气衰,肾精虚少,骨髓化源不足,不能营养骨骼而致骨髓空虚,骨矿含量下降,因而发生骨质疏松。故治以补肾健骨、养血活血、止痛。方中锁阳、枸杞子、巴戟天、淫羊藿、补骨脂均能补肾壮阳;旱莲草滋养肾阴、凉血;续断,性微温,味辛苦、甘,补肝肾,行血脉、续筋骨;诸药合用温补肾阳。瓦楞子,甘、咸,性平,消痰软坚、化瘀散结,可治疗肝脾肿大;鳖甲粉味咸,性寒,由鳖甲深加工而成,滋阴退蒸、软坚散结;龟板胶,性寒,味甘、咸,滋阴潜阳、益肾健骨;二药工专补益肾阴。慢性肝病多存在血瘀表现,三七粉,性温,味甘、微苦,散瘀止血,行气止痛之功。本方寒温并用、精血同补、养血活血并使,实为攻克本病之良方。
各原料作用:
维生素D3:维生素D3是胆固醇的衍生物,也称胆钙化醇,其活性形式有25-羟维生素D3,1,25-二羟维生素D3两种,其中以1,25-二羟维生素D3为主要活性形式,属于固醇类激素。维生素D3能调节骨钙的沉积和释放;刺激成骨细胞的活动,促进骨钙沉积和骨的形成,此外还可增强骨钙素(PTH)对骨的作用。
枸杞子:枸杞子中的枸杞多糖能有效减少脂肪褐素的沉积,进而对肝脏中过氧化脂质的形成起到有效的抑制作用,并促进肝细胞新生,发挥其对肝脏的保护作用。
旱莲草:别称墨旱莲等。具有滋补肝肾,凉血止血的效果。旱莲草中三萜皂甙类化合物对肝星形细胞具有抗增殖活性,而肝星形细胞在肝纤维化的发病机理中起着重要作用,因此,旱莲草具有治疗肝纤维化的潜在应用价值。
锁阳:又名不老药,锁阳多年生肉质寄生草本。一种寄生植物,野生于沙漠戈壁,在零上20℃生长最宜,生长之处不积雪、地不冻。有补肾润肠、治阳痿,尿血等功效。锁阳体内含有性激素样成分,有些成分经过结构改变以后合成性激素的中间体,如β一谷甾醇去掉侧链后成睾丸酮和雌二醇的中间体。性激素即可直接与受体结合起作用,亦可作为合成性激素的原料,增加其合成,还可以促进体内原有性激素发挥作用,提高靶器官对性激素的敏感性;锁阳对去卵巢大鼠有增加骨量的趋势,提示其可能有增加骨激活频率和刺激骨形成的作用。
瓦楞子:消痰化瘀,软坚散结,制酸止痛。瓦楞子煅品水煎液中钙盐含量是生品的4.6倍,差异显著,说明瓦楞煅后,质地酥脆,确实能有利于有效成份煎出,而提高效果。
鳖甲:养阴清热,平肝熄风,软坚散结。鳖甲提取物能显著增加小鼠LDH活力,有效清除剧烈运动时机体的代谢产物,能延缓疲劳的发生,也能加速疲劳的消除,高、中剂量鳖甲提取物还能增加小鼠的耐缺氧能力。
淫羊藿:补肾阳,强筋骨,祛风湿。淫羊藿及其主要成分均能促进成骨细胞增殖,提高碱性磷酸酶,促进骨形成;淫羊藿明显提高性激素水平,清除活性氧,可能是其防治骨质疏松症的主要机制。
龟板胶:滋阴,养血,止血。龟板胶能促进骨髓间充质干细胞向成骨细胞方向分化。
补骨脂:温肾助阳,纳气平喘,温脾止泻。药理研究表明补骨脂具有较弱雌激素样作用,其丙酮提取物的非极性部分能增加大鼠骨强度,提高血中无机磷酸盐水平;另外,补骨脂的乙醇粗提物、醋酸乙酯萃取部位及其中的补骨脂宁和补骨脂甲素等黄酮类成分均能促进成骨样细胞UMRl06增殖和分化;补骨脂还能抑制破骨细胞性骨吸收陷窝的形成与扩张,且抑制作用与补骨脂浓度有关。
三七:散瘀止血,消肿定痛。药理研究表明三七总苷可促进大鼠成骨细胞的增殖和分化,促进成骨细胞OPG(骨保护素)的表达,且当含量为50ug/ml时,其作用最明显。
巴戟天:Mn是人体必需的微量元素,人体缺锰时,破骨细胞活性增强,成骨细胞活性降低,动态平衡破坏,出现骨质疏松;巴戟天中锰元素含量高达559ug/g,并含大量丰富钙、镁等对骨骼有特殊亲和力的第2主族(A)元素;研究证实:巴戟天能促进体外培养成骨细胞(OB)增殖、促进成骨细胞分泌碱性磷酸酶与骨钙素、促进成骨细胞转化生长因子B1mRNA的表达;王和鸣等发现巴戟天能诱导骨髓基质细胞(BMSCs)向成骨细胞分化,机理主要是通过增加细胞内碱性磷酸酶的活性、骨钙素的含量而发挥作用。
续断:对骨质疏松症防治有确切疗效、对成骨细胞增殖有促进作用;续断能促进实验性骨折的愈合并可增加骨痂羟脯氨酸的含量和钙的含量。提高成骨细胞的活性和数量、促进基质钙化、促进骨痂生长、加快骨痂的改建;续断能有效促进成骨细胞的分化、增殖,防止成骨细胞凋亡,可能是该药促进骨折愈合、防治骨质疏松的机制之一。
本发明的有益效果是:本发明药物适用肝病并骨量减少及骨质疏松症所致的骨痛、骨折、肌无力的患者,特别适用于单纯西医西药治疗无效或疗效欠佳的、久治不愈的患者。以该药物治疗肝病引起的骨量减少及骨质疏松症,有效率达82.98%,显效率61.70%,自觉症状改善率91.49%。本发明药物为中西药复方制剂,操作简便,服用方便,患者也可以在家里制作。
以下结合临床资料及典型病例来进一步说明其有益效果
一、临床数据
1、临床资料:于2008年10月~2013年5月,在聊城市第二人民医院对47例肝病引起的骨量减少及骨质疏松症患者(年龄40-70岁)进行了临床验证。40-49岁为Ⅰ组,50-59岁为Ⅱ组;60-69岁为Ⅲ组。患者分为男女两大组,男女两组又分别分为Ⅰ组(40-49岁)、Ⅱ组(50-59岁)、Ⅲ组(60-69岁)。男Ⅰ组轻度骨量减少3人、中度骨量减少4人、重度骨量减少3人;男Ⅱ组轻度骨量减少2人、中度骨量减少4人、重度骨量减少4人;男Ⅲ组轻度骨量减少1人、中度骨量减少1人、重度骨量减少1人、骨质疏松症1人。女Ⅰ组轻度骨量减少3人、中度骨量减少5人、重度骨量减少2人;女Ⅱ组中度骨量减少3人、重度骨量减少5人;骨质疏松症2人。女Ⅲ组重度骨量减少1人;骨质疏松症2人。
2、诊断标准:
(1)骨量减少:其中:①轻度骨量减少:T值下降在1﹣1.5个标准差。②中度骨量减少:T值下降在1.5﹣2个标准差。③重度骨量减少:T值下降在2.0﹣2.5个标准差。
(2)骨质疏松:T值下降大于2.5个标准差。
3、治疗方法:所有病例诊断明确后,随投以本发明用于治疗肝病引起的骨量减少及骨质疏松症的药物口服液/配方颗粒剂每日1剂,分2次服用。本制剂还可以按单剂量在家里自制,非常方便病人,无需住院。
4、疗效评定标准:T值较前上升幅度>1个标准差为显效,>0.5-1个标准差为有效,<0.5为无效。
5、经过8个月的治疗,治疗结果如表1所示。
表1治疗结果
二、典型病例:
病例1:刘某某,男,52岁,工人。慢性乙肝病史20年,近2年来出现四肢、腰背部疼痛,伴有腰膝酸软、头晕目眩、耳鸣健忘、畏寒怕冷、面色晦暗、舌暗瘀斑或有齿痕、舌下静脉怒张,脉沉迟。开始以为是关节炎,服用元胡止痛片及局部贴万通筋骨贴,疼痛减轻,但停用后疼痛又同前,于2011年4月6日到我院就诊,查骨密度0.4267,T值为-2.13,诊断为中度骨量减少。服用本制剂30天后四肢、腰背部疼痛减轻,4月后四肢、腰背部疼痛消失,复查骨密度0.566,T值为-1.24;8月后复查骨密度0.601,T值为-1.01。
病例2:辛某某,女,56岁,农民。慢性乙肝病史23年,近3年来出现四肢、肘腕、髋、膝、踝关节及腰背部疼痛,伴有乏力、头晕、健忘、畏寒怕冷、面色晦暗、舌暗瘀斑或有齿痕、舌下静脉怒张,脉沉迟。开始以为是关节炎,服用元胡止痛片及局部贴活血止痛膏,疼痛减轻,但停用后疼痛又同前,于2012年2月3日到医院就诊,查骨密度0.3581,T值为-2.23,诊断为中度骨量减少。服用本制剂后30天后四肢、腰背部疼痛减轻,3月后四肢、腰背部疼痛消失,4月复查骨密度0.486,T值为-1.75;8月后复查骨密度0.53748,T值为-1.42。
具体实施方式
下述鳖甲粉由山东省丁马生物科技有限公司提供,为中华鳖的背甲加工制成的纳米级粉剂。中药为中药饮片或中药配方颗粒剂,中药后面标注的重量为中药饮片重量,配方颗粒剂用量可按上述重量换算。
实施例1:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g。
制备及服用方法:将中药水煎煮,经浓缩、干燥、粉碎后得到中药颗粒,与活性维生素D3一起配齐包装。每日一剂配方颗粒,混匀,冲服(分早晚两次)。
实施例2:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、龟板胶15g。
制备及服用方法同实施例1。
实施例3:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、淫羊藿20g。
制备及服用方法同实施例1。
实施例4:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、补骨脂20g。
制备及服用方法同实施例1。
实施例5:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、巴戟天20g。
制备及服用方法同实施例1。
实施例6:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、续断20g。
制备及服用方法:采用市售的单剂的中药配方颗粒(按采用的中药饮片的质量计)与活性维生素D3一起配齐包装。每日一剂配方颗粒,混匀,冲服(分早晚两次)。
实施例7:
配方:活性维生素D3 0.25ug、锁阳20g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g。
制备及服用方法同实施例6。
实施例8:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g。
制备及服用方法同实施例6。
实施例9:
配方:活性维生素D3 0.25ug、锁阳15g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉20g、三七粉1.5g。
制备及服用方法同实施例6。
实施例10:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、龟板胶15g。
制备方法:将中药(龟板胶、鳖甲粉、三七粉另包)混匀,加冷水浸泡1小时,水煎2次,每次水开后煎25分钟,每次剩液100ml,两次混合在一起,龟板胶烊化后加入,鳖甲粉、三七粉冲入,装入250ml瓶中,然后加入活性维生素D3制成中药口服液。每日1瓶200毫升,于早晚饭后1小时,分早晚两次。
实施例11:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、淫羊藿10g。
制备及服用方法同实施例10。
实施例12:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、补骨脂10g。
制备及服用方法同实施例10。
实施例13:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、巴戟天10g。
制备及服用方法同实施例10。
实施例14:
配方:活性维生素D3 0.25ug、锁阳10g、枸杞子15g、旱莲草15g、瓦楞子10g、鳖甲粉15g、三七粉3g、续断10g。
制备及服用方法同实施例10。
Claims (7)
1.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g。
2.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、龟板胶7.5~15g。
3.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、淫羊藿10~20g。
4.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、补骨脂10~20g。
5.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、巴戟天10~20g。
6.一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,按每日服用量计,由0.25μg的活性维生素D3和中药制剂组成;所述中药制剂由下述重量的中药制成:锁阳10~20g、枸杞子10~20g、旱莲草10~15g、瓦楞子10~20g、鳖甲粉10~20g、三七粉1.5~3g、续断10~20g。
7.如权利要求1-6中任意一项所述的一种用于治疗肝病引起的骨量减少及骨质疏松症的药物,其特征是,所述药物为散剂或口服液。
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