CN104435163A - 治疗骨质疏松的药物组合物 - Google Patents
治疗骨质疏松的药物组合物 Download PDFInfo
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Abstract
本发明公开了一种治疗骨质疏松的药物组合物，它由赤芍、矢车菊、五倍子、鸡蛋壳和甘草为原料制成。该药物组合物具有补益肝肾、壮骨止痛的功效，可有效治疗骨质疏松症，症见腰脊疼痛，酸软乏力，不能持重，目眩，骨节疼痛，肢体麻木等。本发明所述药物组合物疗效确切，用药剂量小，且对人体无毒副作用。
Description
技术领域
本发明涉及一种治疗骨质疏松的药物组合物，特别涉及一种由赤芍、矢车菊、五倍子、鸡蛋壳和甘草为原料制成的药物组合物。
背景技术
骨质疏松(osteoporosis)是多种原因引起的一组骨病，骨组织有正常的钙化，钙盐与基质呈正常比例，以单位体积内骨组织量减少为特点的代谢性骨病变。在多数骨质疏松中，骨组织的减少主要由于骨质吸收增多所致。发病多缓慢，个别较快，以骨骼疼痛、易于骨折为特征，生化检查基本正常。
目前，对于本病的治疗主要依靠药物治疗，大体包括雌激素替代治疗、降钙素及钙制剂等。这些药物大多价格昂贵，且有较为明显的副作用。并且具有关报道，长期使用雌激素有诱发乳腺癌的可能。由于患者钙吸收能力的差异，降钙素及钙制剂疗效并不理想，且其他疗法只能作为辅助性治疗。
因此，临床骨质疏松症的发病率很高，但是缺乏安全有效的药物，积极研制开发治疗骨质疏松症的药物非常必要。
发明内容
本发明的目的在于克服现有技术中所存在的上述不足，提供一种治疗骨质疏松的药物组合物。该药物组合物可有效治疗骨质疏松，症见腰脊疼痛，酸软乏力，不能持重，目眩，骨节疼痛，肢体麻木等；且见效快，用药剂量小，无毒副作用。
为了实现上述发明目的，本发明提供了以下技术方案：
本发明所述治疗骨质疏松的药物组合物，它是由以下原料制成的药剂：赤芍、矢车菊、五倍子、鸡蛋壳和甘草。
本发明药物组合物中，赤芍性苦，味微凉，归肝经。清热凉血，能活血通络。《神农本草经》：“芍药，味苦平。主邪气腹痛，除血痹……”长期药理实验表明赤芍能显著降低高脂血兔的血浆总胆固醇含量，显著改善免疫调节，抑制免疫性炎症。
矢车菊，帮助消化、使小便顺畅，舒缓风湿疼痛。鸡蛋壳，性味淡，平；收敛制酸，补钙。
五倍子，味酸，涩，性寒。归肺、大肠、肾经。敛肺；止汗；涩肠；固精；止血；解毒。主治肺虚久咳；自汗盗汗；久痢久泻；脱肛；遗精；白浊；各种出血；痈肿疮疖。
甘草，性味甘、平，归心、肺、脾、胃经，具有益气补中，清热解毒、祛痰止咳、缓急止痛、调和药性的功能。
申请人经多次试验发现，将赤芍、矢车菊、五倍子、鸡蛋壳和甘草为原料制成药物组合物，可有效治疗骨质疏松症。
优选地，所述药物组合物是由以下重量份配比的原料制成：赤芍1～10份、矢车菊2～15份、五倍子1～8份、鸡蛋壳1～6份和甘草1～5份。
申请人经多次实验发现，本发明所述药物组合物由上述重量份配比的原料制成，可以更好的发挥各原料组分的协同增效作用，不仅可有效治疗骨质疏松症，同时见效快，用药剂量小，无毒副作用。
进一步优选地，所述药物组合物是由以下重量份配比的原料制成：赤芍3～8份、矢车菊2～10份、五倍子1～5份、鸡蛋壳1～5份和甘草1～3份。
更进一步优选地，所述药物组合物是由以下重量份配比的原料制成：赤芍5～7份、矢车菊3～7份、五倍子1～4份、鸡蛋壳1～3份和甘草1～3份。
最佳优选地，所述药物组合物是由以下重量份配比的原料制成：赤芍6份、矢车菊6份、五倍子3份、鸡蛋壳3份和甘草1份。
通过以上优选，可以进一步提高药物组合物的疗效。
本发明药物组合物的剂型可以是滴丸、片剂、胶囊剂、软胶囊剂、散剂、颗粒剂中任何一种现有药物剂型。
本发明药物组合物的制备方法如下：
(1)取赤芍，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，即得赤芍提取物。
(2)取矢车菊，加入8～10倍体积的乙醇或水，回流提取三次，提取时间分别为2.0h、1.5h、1.5h，收集合并提取液并浓缩成浸膏，干燥，得到矢车菊提取物。
(3)取五倍子，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，得到五倍子提取物。
(4)取鸡蛋壳，研磨成细粉，得鸡蛋壳粉末。
(5)取甘草，加8-10倍体积的水煎煮提取2次，每次1.5-2h，合并提取液，浓缩、干燥，得到甘草提取物。
(6)将鸡蛋壳粉末和赤芍、矢车菊、五倍子、甘草提取物混合，制成可接受的各种药物剂型。
根据制备各种剂型药物的需要，本发明药物在制备过程中还可加入适当的药用辅料如填充剂、崩解剂、粘合剂、润滑剂、防腐剂等。
本发明所述的制备方法可以有效提取出各原料药中的有效成分，使其更好的发挥协同增效的作用。
本发明所用的各种原料药材均为符合国家或地方标准规定的中药材。本发明所述的治疗骨质疏松症的药物组合物，是以中医理论为基础，结合临床实践，从中医药材宝库中筛选出赤芍、矢车菊、五倍子、鸡蛋壳和甘草六味纯中药精制而成，并调节各原料的重量份配比，使各原料之间发挥协同增效的作用，可有效治疗骨质疏松，症见腰脊疼痛，酸软乏力，不能持重，目眩，骨节疼痛，总有效率达95％以上。同时本发明所述的药物组合物见效快，用药剂量小，无毒副作用。
具体实施方式
下面结合试验例及具体实施方式对本发明作进一步的详细描述。但不应将此理解为本发明上述主题的范围仅限于以下的实施例，凡基于本发明内容所实现的技术均属于本发明的范围。
实施例1
本实施例所述的治疗骨质疏松的药物组合物，由以下重量的原料制成：
赤芍6g、矢车菊6g、五倍子3g、鸡蛋壳3g和甘草1g。
将上述原料制备成散剂，制备方法如下：
(1)取赤芍，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，即得赤芍提取物。
(2)取矢车菊，加入9倍体积的乙醇或水，回流提取三次，提取时间分别为2.0h、1.5h、1.5h，收集合并提取液并浓缩成浸膏，干燥，得到矢车菊提取物。
(3)取五倍子，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，得到五倍子提取物。
(4)取鸡蛋壳，研磨成细粉，得鸡蛋壳粉末。
(5)取甘草，加9倍体积的水煎煮提取2次，每次2h，合并提取液，浓缩、干燥，得到甘草提取物。
(6)将鸡蛋壳粉末和赤芍、矢车菊、五倍子、甘草提取物混合均匀。
(7)将上述混合物加入100g糊精，混匀，分装成10g/袋，得散剂的药物组合物。
实施例2
本实施例所述的治疗骨质疏松的药物组合物，由以下重量的原料制成：
赤芍10g、矢车菊5g、五倍子8g、鸡蛋壳2g和甘草5g。
将上述原料制备成片剂，制备方法如下：
(1)取赤芍，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，即得赤芍提取物。
(2)取矢车菊，加入9倍体积的乙醇或水，回流提取三次，提取时间分别为2.0h、1.5h、1.5h，收集合并提取液并浓缩成浸膏，干燥，得到矢车菊提取物。
(3)取五倍子，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，得到五倍子提取物。
(4)取鸡蛋壳，研磨成细粉，得鸡蛋壳粉末。
(5)取甘草，加9倍体积的水煎煮提取2次，每次2h，合并提取液，浓缩、干燥，得到甘草提取物。
(6)将鸡蛋壳粉末和赤芍、矢车菊、五倍子、甘草提取物混合均匀。
(7)将上述混合物与100g淀粉，15g聚维酮混合，采用现有压片技术，制得片剂的药物组合物。
实施例3
本实施例所述的治疗骨质疏松的药物组合物，由以下重量的原料制成：
赤芍3g、矢车菊2g、五倍子2g、鸡蛋壳5g和甘草4g。
将上述原料制备成颗粒剂，制备方法如下：
(1)取赤芍，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，即得赤芍提取物。
(2)取矢车菊，加入10倍体积的乙醇或水，回流提取三次，提取时间分别为2.0h、1.5h、1.5h，收集合并提取液并浓缩成浸膏，干燥，得到矢车菊提取物。
(3)取五倍子，用水渗漉，收集渗漉液，将渗漉液通过大孔吸附树脂，先用水洗脱，除去溶于极性溶剂的杂质，将该水洗脱液弃去不用；再用80％的高浓度乙醇洗脱，收集此高浓度乙醇洗脱液，将回收乙醇后的洗脱液干燥，得到五倍子提取物。
(4)取鸡蛋壳，研磨成细粉，得鸡蛋壳粉末。
(5)取甘草，加8倍体积的水煎煮提取2次，每次1.5h，合并提取液，浓缩、干燥，得到甘草提取物。
(6)将鸡蛋壳粉末和赤芍、矢车菊、五倍子、甘草提取物混合均匀。
(7)将上述混合物与100g蔗糖、20g硬脂酸镁，混匀，按照颗粒剂的制剂技术，制成颗粒剂，每袋10g。
对比例1
本对比例所述的治疗骨质疏松的药物组合物，由以下重量的原料制成：
赤芍6g、矢车菊6g、鸡蛋壳3g和甘草1g。
采用实施例1所述的制备方法，制成散剂的药物组合物。
对比例2
本实施例所述的治疗骨质疏松的药物组合物，由以下重量的原料制成：
赤芍6g、矢车菊6g、五倍子3g和甘草1g。
采用实施例1所述的制备方法，制成散剂的药物组合物。
实施例5
临床试验
1.资料与方法
1.1临床资料针对原发性骨质疏松症患者300例，随机分为以下6组(实验组1～3和对照组1～3)：
实验组1：50例，男22例，女28例，年龄为40～75岁，平均59岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
实验组2：50例，男27例，女23例，年龄为43～81岁，平均63岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
实验组3：50例，男24例，女26例，年龄为39～82岁，平均61岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
对照组1：50例，男25例，女25例，年龄为40～80岁，平均60岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
对照组2：50例，男23例，女27例，年龄为42～80岁，平均62岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
对照组3：50例，男25例，女25例，年龄为39～78岁，平均61岁，均符合中国人原发性骨质疏松症及WHO原发性骨质疏松症诊断标准，患者有胸背、四肢或全身疼痛、X线片显示腰椎肥大。
以上六组一般资料比较差异无显著。
1.2方法：实验组1～3分别以实施例一～实施例三制备的药物组合物，每日2次，早晚温服，每次一袋(片)。对照组1和2分别以对比例1和对比例2所述的药物组合物，每日2次，早晚温服，每次一袋。对照组3以钙尔奇D片，每天1次，每次1片。疗程均为3个月。
2.实验结果
2.1疗程三个月后，实验组和对照组的骨密度值如下表1所示。
表1治疗前后的骨密度(g/cm3)指标比较
| 组别 | 实验组1 | 实验组2 | 实验组3 | 对照组1 | 对照组2 | 对照组3 |
| 治疗前 | 0.683±0.059 | 0.682±0.071 | 0.684±0.076 | 0.683±0.055 | 0.684±0.085 | 0.683±0.069 |
| 治疗后 | 0.749±0.086 | 0.737±0.066 | 0.739±0.046 | 0.723±0.058 | 0.721±0.075 | 0.687±0.084 |
实验组患者服用1个月后症状明显减轻，3个月后疼痛基本消失，骨密度值亦明显上升。
2.2疗程三个月后，将实验组和对照组患者进行疗效评定，具体的评定标准按显效、有效和无效三级进行，具体为：
显效，骨密度增加大于2.5％，无新骨折发生，疼痛消失；有效，骨密度增加小于2.5％，全身无新的骨折发生，疼痛部分缓减或消失；无效，骨密度下降，有新骨折发生，疼痛无变化甚至加重。
实验结果如表2所示。
表2各组患者治疗前后有效率比较
注：愈显率＝临床痊愈率+显效率；总有效率＝临床痊愈率+显效率+有效率。
实验过程中，实验组1～3和对照组1～2的大部分患者用药前后均未发现不良反应，仅有1～6例患者出现过夜晚发热，通过饮食调整均自行缓解，未停药，表明本发明所述的药物组合物对患者身体无副作用。
根据表1和2中的数据可知，本发明所述治疗骨质疏松的药物组合物可有效治疗骨质疏松症，疗程三个月后骨密度值明显上升，较市售的钙尔奇D片，疗效显著。
将表2中实验组1～3和对比例1～2的愈显率和总有效率相比较，实验组的愈显率和总有效率分别提高了30％左右和20％左右，表明本发明所述药物组合物需要各原料组分相互配伍，发挥协同增效的作用，才能达到最佳的治疗效果，缺少任何一味药均会显著降低药物组合物的疗效。
将表2中实验组1～3的愈显率和总有效率相比较，实验组1的愈显率和总有效率较实验组2分别提高了14％、0％，较实验组3分别提高了12％，2％；表明实施例1所述的药物组合物取得了非显而易见的效果，为本发明的最佳实施方案。
Claims (5)
1.一种治疗骨质疏松的药物组合物，其特征在于，它是由以下原料制成的药剂：赤芍、矢车菊、五倍子、鸡蛋壳和甘草。
2.根据权利要求1所述的药物组合物，其特征在于，所述各原料的重量份配比为：赤芍1～10份、矢车菊2～15份、五倍子1～8份、鸡蛋壳1～6份和甘草1～5份。
3.根据权利要求2所述的药物组合物，其特征在于，所述各原料的重量份配比为：赤芍3～8份、矢车菊2～10份、五倍子1～5份、鸡蛋壳1～5份和甘草1～3份。
4.根据权利要求3所述的药物组合物，其特征在于，所述各原料的重量份配比为：赤芍5～7份、矢车菊3～7份、五倍子1～4份、鸡蛋壳1～3份和甘草1～3份。
5.根据权利要求4所述的药物组合物，其特征在于，所述各原料的重量份配比为：赤芍6份、矢车菊6份、五倍子3份、鸡蛋壳3份和甘草1份。
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| CN103800811A (zh) * | 2012-11-15 | 2014-05-21 | 刘江 | 一种治疗骨质疏松的混合液 |
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| CN1338282A (zh) * | 2001-09-12 | 2002-03-06 | 宋德 | 接骨药物及其制备方法 |
| CN103800811A (zh) * | 2012-11-15 | 2014-05-21 | 刘江 | 一种治疗骨质疏松的混合液 |
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