CN102114070B - 一种治疗骨质疏松的复方中药及其制备方法 - Google Patents
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Abstract
本发明公开了一种治疗骨质疏松症的中药复方制剂及其制备方法，该制剂的组方按照重量配比为鹿茸60-140，淫羊藿500-700、槐角300-500，将鹿茸粉碎成细粉，淫羊藿、槐角用水煎煮得到的液体浓缩成膏，干燥，粉碎后与鹿茸细粉混匀，按照需要制作成药效学上所说的任何剂型。与现有技术相比，本发明构成简单，明确，原料易取得，制备方法简单，治疗效果确切，具有补肾活血、强筋壮骨、补充天然雌激素的功能，用于骨质疏松引起的骨折、骨痛、骨关节炎，对预防及治疗更年期骨质疏松症具有较好疗效。
Description
技术领域：本发明涉及一种复方中药及其制备方法，尤其涉及一种预防及治疗骨质疏松症的复方中药及其制备方法。
技术背景：骨质疏松症(Osteoporosis OP)是一种全身性代谢性骨病，以单位体积内骨量的绝对减少为特点，是老年人常见的多发病。目前用于治疗骨质疏松症的药物有很多，西药以激素类药物为主，其副作用较大，不易长期服用；而中药主要以滋肝补肾、温阳补阴、行气活血的复方制剂为主，现有技术中有一些中药制剂要么是处方药味繁多、制备工艺复杂、服用量大、服用次数多、成本高；要么是处方过于简单，导致疗效不明显、针对性不强等。
发明内容：为了克服现有技术的不足，本发明旨在提供一种药味较少、疗效确切、针对性较强的预防及治疗骨质疏松的复方中药及这种药物的制备方法。这种药物能够补肾活血、强筋健骨、补充天然雌激素，用于骨质疏松引起的骨痛、骨折、骨关节炎及预防、治疗更年期骨质疏松症的中药制剂。按照重量配比它由鹿茸60-140、淫羊藿500-600、槐角300-500制作而成。具体地说，按照重量配比它由鹿茸100、淫羊藿600、槐角400制作而成。所述剂型为任何药效学上所说的剂型；预防和治疗更年期骨质疏松症中药制剂的制备方法，按照重量配比，将鹿茸60-140粉碎成细粉，淫羊藿500-700、槐角300-500用水煎煮或乙醇提取的方法处理，将得到的提取液浓缩成膏干燥、粉碎，再加入粉碎的鹿茸细粉混匀，按照需要制作成需要的剂型，具体地说：按照重量配比，将鹿茸100g粉碎成细粉，把淫羊藿600g、槐角400g用水煎煮三次，每次1.5小时，合并煎液，滤过，滤液浓缩至相对密度为1.35(60℃)的浸膏干燥，粉碎，与鹿茸细粉混匀，制成400g。
与现有技术相比，本发明构成简单，明确，原料易取得，制备方法简单，治疗效果确切，具有补肾活血、强筋壮骨、补充天然雌激素的功能，用于骨质疏松引起的骨折、骨痛、骨关节炎，对预防及治疗更年期骨质疏松症具有较好疗效。
本发明实施例1：将鹿茸100g粉碎成细粉，淫羊藿600g、槐角400g用水煎煮三次，每次1.5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25(60℃)的浸膏干燥，粉碎，与鹿茸细粉混匀，制粒，得到400g，装胶囊。口服一日3次，每次4粒。
本发明实施例2：将鹿茸60kg粉碎成细粉，淫羊藿500kg、槐角300kg用水煎煮2-3次，合并煎液，滤过，滤液浓缩至浸膏干燥，粉碎，与鹿茸细粉、适量的蔗糖或甜菊苷混匀，按照需要制成颗粒剂。
本发明实施例3：将鹿茸140g粉碎成细粉，淫羊藿700g、槐角500g用乙醇提取的方法处理，将得到的提取液浓缩成浸膏、干燥，粉碎，与鹿茸细粉混匀，按照需要制成片剂。
本发明实施例4：将鹿茸200g粉碎成细粉，淫羊藿1200g、槐角800g用水煎煮三次，每次1.5小时，合并煎液，滤过，滤液浓缩至相对密度为1.25(60℃)的浸膏干燥，粉碎，与鹿茸细粉混匀，制粒，得到800g，装胶囊。取本次制剂，以钙尔奇D为阳性药进行如下对比实验，发现本发明具有增加模型大鼠骨密度、钙、磷和降低AKP含量的作用。
方法Wistar大鼠72只，随机分为正常对照组；模型对照组；钙尔奇D 1300mg/kg组；鹿茸骨宝1800mg/kg、900mg/kg和450mg/kg三个剂量组。试验共分6组，每组12只，雌雄各半。大鼠骨质疏松模型的建立，除正常对照组外，其余各组动物按80mg/kg灌服维甲酸，连续两周。两周后，各实验组均随机处死动物2只，观测骨密度(BMD)，判断是否造模成功。模型组大鼠BMD与正常组比较，降低2.5个标准差，确定有骨质疏松症模型成功。模型复制成功后，各实验组灌服相应药物，受试药物用蒸馏水配制成相应的混悬液，大鼠ig体积为10ml/kg，阳性对照组灌服钙尔奇D 1300mg/kg，本发明三个给药组分别灌服鹿茸骨宝1800mg/kg、900mg/kg和450mg/kg。每天上午给药1次，连续4周。正常对照组及模型对照组灌服等体积的蒸馏水。用药期间每周称重一次，并按体质量变化调整给药量。测定指标：①血清生化学指标末次给药1h后，断头取血，离心取血清，按钙、磷和碱性磷酸酶试剂盒操作规程测定血清中的Ca2+、P和AKP含量(Ca2+测定为甲基百里香酚蓝即MTB法，P测定为孔雀绿直接显色法，AKP测定为比色法)。②骨密度(BMD)检测取血结束后，分别取各组动物右侧股骨，将肌肉剥离干净后，将股骨中上三分之一置于单光子骨矿物密度测定仪检测板上，测定各实验鼠的BMD。所列数据以均数加减标准差表示，统计学处理方法采用组间t检验。
本发明对大鼠血清中Ca2+、P、AKP含量及股骨BMD的影响
注：与模型对照组比较：***P＜0.001；**P＜0.01；*P＜0.05。
从上表可以看出，与对照组相比，模型组的Ca2+、P、BMD均有不同程度下降，AKP含量有不同程度升高，表现出明显的骨质疏松改变，相对于模型组，本发明高、中剂量均能不同程度的改善去势大鼠上述骨质疏松症状，具有与阳性对照药相当的疗效。
根据中医理论，“肾主骨”，骨质疏松症属“痹症”和肾虚所致腰背痛之范畴。近年来大量临床应用补肾壮骨中药治疗骨质疏松症，取得了满意的效果，能明显减轻病人的自觉病症。处方由鹿茸、淫羊藿、槐角组成。方中鹿茸填精补肾，强筋健骨，补而不滞，益阳通络；淫羊藿补肾助阳，祛风除湿，强筋健骨；槐角，味苦，性微寒，用以缓和补肾壮阳之品的燥烈之性。现代科学证明，鹿茸含有大量的钙、镁、磷等骨生长必需的元素，且这些元素以无机或有机状态存在，比例协调，故易于被吸收利用；另外鹿茸还含有骨胶原蛋白、多种活性多肽、多种单胺类成分，对骨的生成有较强的促进作用；淫羊藿含有的黄酮成分是其主要活性成分之一，现代科学研究证明，淫羊藿总黄酮可以促进体外成骨细胞增殖及分化成熟，有效地预防维甲酸诱导及低钙饲料结合去卵巢诱发的大鼠骨质疏松，可使去卵巢大鼠股骨钙、磷含量增加；槐角中含有大量的槐属苷，它在一定条件下能水解为更具活性作用的染料木素。染料木素具有雌激素样作用，对骨质疏松症、心血管疾病、肿瘤、妇女绝经期综合症等具有预防和治疗作用。以上三味药协同作用，对骨质疏松具有良好的预防和治疗作用。
Claims (5)
1.一种治疗骨质疏松症的复方中药，其特征在于：按照重量配比，它由鹿茸60～140∶淫羊藿500～700∶槐角300～500制作而成。
2.根据权利要求1所述的治疗骨质疏松症的复方中药，其特征在于：按照重量配比，它由鹿茸100∶淫羊藿600∶槐角400制作而成。
3.根据权利要求1、2所述的治疗骨质疏松症的复方中药，其特征在于：所述剂型为任何药效学上所说的剂型。
4.一种治疗骨质疏松症的复方中药的制备方法，其特征在于：按照重量配比，将鹿茸60～140粉碎成细粉，淫羊藿500～700、槐角300～500用水煎煮或乙醇提取的方法处理，将得到的提取液浓缩成膏干燥、粉碎，再加入粉碎的鹿茸细粉混匀，按照需要制作成需要的剂型。
5.根据权利要求4所述的治疗骨质疏松复方中药的制备方法，其特征在于：按照重量配比，将鹿茸100g粉碎成细粉，把淫羊藿600g、槐角400g用水煎煮三次，每次1.5小时，合并煎液，滤过，滤液浓缩至60℃相对密度为1.35的浸膏，干燥，粉碎，与鹿茸细粉混匀，制粒，制成400g，装胶囊。
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