CN116139216A - 一种复方中药及其提取物与在治疗糖脂代谢病中的应用 - Google Patents
一种复方中药及其提取物与在治疗糖脂代谢病中的应用 Download PDFInfo
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Abstract
本发明涉及一种复方中药及其提取物与在治疗糖脂代谢病中的应用，所述复方中药提取物由如下重量份的原料药制成：知母1份，黄柏1份，荷叶0.2‑1.0份。
Description
技术领域
本发明属于中药领域，具体涉及一种复方中药及其提取物与在治疗糖脂代谢病中的应用。
背景技术
糖脂代谢病是一类以糖代谢异常、脂代谢异常、非酒精性脂肪肝病、超重、高血压、动脉粥样硬化为主要表现的疾病，发病率位居世界第一，是世界性的难题。国际糖尿病联盟在2019年发布的数据报告中显示：全球约有4.630亿20-79岁成人患糖尿病；预计到2045年，糖尿病患者会达到5.784亿；预计到2045年，糖尿病患者会达到7.002亿。可见，糖脂代谢病严重影响着人们的健康。基于中药治疗的多成分多靶点多途径毒性小等特点，寻找能够治疗糖脂代谢病的复方中药及其活性提取物是本发明的目的。
知母是百合科知母属植物知母的干燥根茎，始载于《神农本草经》，又称为蚳母，连母，野蓼，地参，水参等。其味苦、甘，性寒，归肺、胃、肾经，具有清热泻火、滋阴润燥等功效，主要治疗温热病，高热烦渴，肺热咳嗽气喘，午后潮热，燥咳，肠燥便秘等，临床上用以治疗急性传染病等。黄柏作为临床常用药之一，具有清热燥湿、泻火除蒸、解毒疗疮之功效。黄柏的主要化学成分为黄酮类和生物碱类，具有抗炎、抑菌、抗氧化、抗肿瘤、降糖、保护神经、止泻等多方面的药理作用。荷叶在食用和药用方面都有着广泛的用途，荷叶中主要富含黄酮、生物碱、挥发油、β-胡萝卜素、皂苷、有机酸、甾体、维生素C等多种功能性成分，具有清暑利湿、升发清阳、清心去热和止血利尿等功效。
发明内容
本发明提供一种复方中药，其特征在于所述复方中药由如下重量份的原料组成：知母1份，黄柏1份，荷叶0.2-1.0份。优选知母1份，黄柏1份，荷叶0.5-1.0份。
本发明的另一实施方案提供一种复方中药提取物，其特征在于所述复方中药提取物由如下重量份的原料药制成：知母1份，黄柏1份，荷叶0.2-1.0份。优选知母1份，黄柏1份，荷叶0.5-1.0份。
本发明的另一实施方案提供上述复方中药提取物，其特征在于其制备方法包括如下步骤：
(1)按照上述重量份，将知母、黄柏、荷叶，粉碎混匀，得物料；
(2)取步骤(1)得到的物料用5-12倍量的提取溶媒如水或乙醇等浸泡0.5-2.0h后，第一次回流提取0.5-2.0h，过滤，滤液备用，药渣再加5-10倍量的溶媒，第二次回流提取0.5-2.0h，过滤，合并两次滤液，浓缩、干燥，即得所述复方中药提取物。所述溶媒优先选用水；干燥选自真空干燥、喷雾干燥、冷冻干燥、减压干燥、微波干燥等。
优选使用8-10倍量的水浸泡，药渣优选加入6-8倍量的水，合并两次滤液后优选浓缩至相对密度1.10～1.15(80℃)，喷雾干燥，得所述复方中药提取物。所述水可选用饮用自来水、纯净水、去离子水和蒸馏水等。
本发明的另一实施方案提供上述复方中药提取物的制备方法，其特征在于包括如下步骤：
(1)按照上述重量份，将知母、黄柏、荷叶，粉碎混匀，得物料；
(2)取步骤(1)得到的物料用5-12倍量的提取溶媒如水或乙醇等浸泡0.5-2.0h后，第一次回流提取0.5-2.0h，过滤，滤液备用，药渣再加5-10倍量的溶媒，第二次回流提取0.5-2.0h，过滤，合并两次滤液，浓缩、干燥，即得所述复方中药提取物。所述溶媒优先选用水；干燥选自真空干燥、喷雾干燥、冷冻干燥、减压干燥、微波干燥等。
优选使用8-10倍量的水浸泡，药渣优选加入6-8倍量的水，合并两次滤液后优选浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得所述复方中药提取物。所述水可选用饮用自来水、纯净水、去离子水和蒸馏水等。
本发明所述的复方中药提取物，其特征在于其包含12种具体成分明确的活性成分，分别为新芒果苷、绿原酸、芒果苷、异芒果苷、1-羟基-2-甲氧基阿朴啡、槲皮素-3-O-桑布双糖苷、金丝桃苷、异槲皮苷、槲皮素-3-O-葡萄糖醛酸苷、荷叶碱、紫云英苷、盐酸小檗碱。
本发明所述的上述复方中药提取物，其特征在于在如下色谱条件下，所述复方中药提取物具有基本如图2所述的HPLC图谱，色谱条件：采用色谱柱Lamdo Stamsil C18(4.6mm×250.0mm，5μm)柱，流动相为A(乙腈)-B(0.1％磷酸-水)，梯度洗脱，洗脱时间(0～35min，93％→85％B；35～45min，85％→83％B；45～55min，83％→81.7％ B；55～95min，81.7％→81.5％ B；95～120min，81.5％→50％ B)，流速为0.8mL/min，检测波长为260nm，柱温为24℃，进样量为10μL。峰1：新芒果苷；峰2：绿原酸；峰3：芒果苷；峰4：异芒果苷；峰5：1-羟基-2-甲氧基阿朴啡；峰6：槲皮素-3-O-桑布双糖苷；峰7：金丝桃苷；峰8：异槲皮苷；峰9：槲皮素-3-O-葡萄糖醛酸苷；峰10：荷叶碱；峰11：紫云英苷；峰12：盐酸小檗碱。
本发明的另一实施方案提供上述复方中药、复方中药提取物和/或其药学上可接受的盐在制备预防和/或治疗糖脂代谢病的药物中的应用。
本发明的另一实施方案提供上述复方中药、复方中药提取物和/或其药学上可接受的盐在制备预防和/或治疗高血脂的药物中的应用。
本发明的另一实施方案提供上述复方中药、复方中药提取物和/或其药学上可接受的盐在制备改善2型糖尿病血脂水平的药物中的应用。
本发明的另一实施方案提供一种预防和/或治疗糖脂代谢病、高血脂、2型糖尿病血脂水平的药物组合物，其特征在于该药物组合物以上述复方中药提取物和/或其药学上可接受的盐作为有效成分。该药物组合物还任选包括其他预防和/或治疗糖脂代谢病、高血脂、2型糖尿病血脂水平的药物。该药物组合物还可包括药学上可接受的辅料(例如注射用水、药用载体、表面活性剂、稀释剂、赋形剂、抗氧剂、稳定剂、增溶剂等)。所述药物组合物的剂型可以是固体制剂、液体制剂或半固体制剂。优选为缓释、控释和肠溶性胶囊、片剂、混悬剂、微乳剂、亚微乳剂或注射剂。
本发明所述的知母、黄柏、荷叶，可以是中药材，也可以是中药饮片。
本发明提取中使用几倍量的溶媒主要指的是制药工业许可的提取溶剂，包括但不限于水、乙醇等，几倍量指的是几倍质量等。
本发明中术语“药学上可接受的盐”是指非毒性的无机或有机酸和/或碱的加成盐。可参见“Salt selection for basic drugs”,Int.J.Pharm.(1986),33,201-217。
本发明药物组合物涉及的各种剂型可按照制药领域技术规范和要求(例如药典、教科书或其他现有技术中的方法)分别制备成符合临床治疗和/或预防糖脂代谢病、高血脂、2型糖尿病血脂水平需求的制剂及其适宜的各种规格与剂型(包括固体制剂、液体制剂和半固体制剂)如缓释、控释和肠溶性胶囊、片剂、混悬剂、微乳剂、亚微乳剂或含有与之相同单一及多成分组合性各种注射剂。
本发明药物组合物涉及到的剂型的制备方法，属于药剂学领域常规的制备方法，是本领域技术人员根据现有技术(例如药典、教科书及制药领域的其他技术规范)就可以实现制备，本发明对上述剂型的常规制备方法不再赘述。
与现有技术相比，本发明的优点在于：(1)本发明在传统知母-黄柏的基础上，增加一味药食两用的荷叶，起到协同增强药效的作用；同时本发明给出了复方中药提取物的指纹图谱，并经分析已确定了12种化学成分，为进一步优化确定成分的中药组合物提供依据和参考。(2)本发明知母-黄柏-荷叶(1:1:0.2-1.0)复方中药提取物的活性明显优于其他配比时的药效。(3)本发明所述复方中药及其提取物中的三味中药成分缺一不可，且各成分的配比对治疗效果产生重要影响，三味中药在本发明特定的配比范围内达到最佳治疗效果。
附图说明
图1是混合标准品的HPLC图；
图2是产品A的HPLC图；
图3是产品G的HPLC图；
图4是产品H的HPLC图；
图5是产品I的HPLC图；
图6是知母水提物的HPLC图；
图7是黄柏水提物的HPLC图；
图8是荷叶水提物的HPLC图；
图9是各组对糖脂代谢病小鼠葡萄糖耐量的影响图；
图10是各组小鼠血清中甘油三脂的含量图；
图11是各组小鼠血清中低密度脂蛋白胆固醇的含量图。
具体实施方式
为了便于对本发明的进一步理解，下面提供的实施例对其做了更详细的说明。但是这些实施例仅供更好的理解发明而并非用来限定本发明的范围或实施原则，本发明的实施方式不限于以下内容。
实施例1
(1)中药材：知母100g，黄柏100g，荷叶100g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品A)。
(2)中药材：知母100g，黄柏100g，荷叶50g
将上述中药材粉碎混匀，得物料；用1.25kg水浸泡1.0h后，(第一次)加热至回流温度提取0.5h，过滤，滤液备用，药渣再加1.25kg水，(第二次)加热至回流温度提取1.0h，过滤，合并两次滤液，浓缩后，真空干燥，即得所述复方中药提取物(以下简称产品B)
(3)中药材：知母100g，黄柏100g，荷叶20g
将上述中药材粉碎混匀，得物料；用2.2kg水浸泡40min后，(第一次)加热至回流温度提取40min，过滤，滤液备用，药渣再加2.2kg水，(第二次)加热至回流温度提取30min，过滤，合并两次滤液，浓缩后，真空干燥，即得所述复方中药提取物(以下简称产品C)
(4)中药材：知母100g，黄柏100g，荷叶150g
将上述中药材粉碎混匀，得物料；用2.8kg水浸泡50min后，(第一次)加热至回流温度提取50min，过滤，滤液备用，药渣再加2.1kg水，(第二次)加热至回流温度提取50min，过滤，合并两次滤液，浓缩后，干燥，即得所述复方中药提取物(以下简称产品D)
(5)中药材：知母100g，黄柏60g，荷叶100g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品E)。
(6)中药材：知母70g，黄柏50g，荷叶90g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品F)。
(7)中药材：知母100g，黄柏100g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品G)。
(8)中药材：黄柏100g，荷叶100g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品H)。
(9)中药材：知母100g，荷叶100g
将上述中药材粉碎混匀，得物料；用2.4kg水浸泡0.5h后，(第一次)加热至回流温度提取1.0h，过滤，滤液备用，药渣再加1.8kg水，(第二次)加热至回流温度提取0.5h，过滤，合并两次滤液，浓缩至相对密度1.10～1.15(80℃)喷雾干燥，得干粉，即为所述复方中药提取物(以下简称产品I)。
实施例2复方中药提取物成分分析
(1)供试品溶液的配制
精密称定产品A(0.10g)，置15mL离心管中，精密加入纯化水10mL，称定重量，超声溶解30min，放冷，再称定重量，用纯化水补足减失的重量，摇匀，离心(4000rpm，5min)，上清液过0.45μm微孔滤膜，即得供试品溶液。其余产品B-I的供试品溶液可按照同法制得。
(2)混合对照品溶液的配制
精密称取新芒果苷、绿原酸、芒果苷、异芒果苷、1-羟基-2-甲氧基阿朴啡、槲皮素-3-O-桑布双糖苷、金丝桃苷、异槲皮苷、槲皮素-3-O-葡萄糖醛酸苷、荷叶碱、紫云英苷、盐酸小檗碱适量于10mL容量瓶中，用甲醇溶解定容，配制混合对照品溶液，其中各标准品浓度为，新芒果苷0.2056mg/mL、绿原酸1.0900mg/mL、芒果苷0.2280mg/mL、异芒果苷0.0420mg/mL、1-羟基-2-甲氧基阿朴啡0.6840mg/mL、槲皮素-3-O-桑布双糖苷0.5300mg/mL、金丝桃苷0.6000mg/mL、异槲皮苷0.9400mg/mL、槲皮素-3-O-葡萄糖醛酸苷0.1556mg/mL、荷叶碱0.9500mg/mL、紫云英苷1.0200mg/mL、盐酸小檗碱0.8800mg/mL，混合标准品放4℃冰箱保存备用。
(3)色谱条件
采用色谱柱Lamdo Stamsil C18(4.6mm×250.0mm，5μm)柱，流动相为A(乙腈)-B(0.1％磷酸-水)，梯度洗脱，洗脱时间(0～35min，93％→85％B；35～45min，85％→83％B；45～55min，83％→81.7％ B；55～95min，81.7％→81.5％B；95～120min，81.5％→50％B)，流速为0.8mL·min–1，检测波长为260nm，柱温为24℃，进样量为10μL。
(4)线性关系考察
精密吸取混合对照品溶液，将混合对照品溶液等比稀释成6个系列浓度。分别按照上述色谱条件进行分析，以对照品浓度(X)为横坐标，标准品浓度(Y)为纵坐标，进行线性回归，拟合线性方程、线性范围及相关系数(R2)，结果表明，线性关系良好。
(5)精密度试验
精密吸取同一浓度的对照品混合溶液10μL，按照上述色谱条件进行分析，连续重复进样6次，测定峰面积，计算新芒果苷、绿原酸、芒果苷、异芒果苷、1-羟基-2-甲氧基阿朴啡、槲皮素-3-O-桑布双糖苷、金丝桃苷、异槲皮苷、槲皮素-3-O-葡萄糖醛酸苷、荷叶碱、紫云英苷、盐酸小檗碱的峰面积和保留时间的RSD％均小于2.86％，表明仪器精密度良好。
(6)重复性试验
取同一批次的产品A供试品溶液6份，按照上述色谱条件进样检测，记录供试品溶液中各成分的峰面积，计算得到各成分的平均含量的RSD值均小于2.58％表明该方法重复性良好。
(7)稳定性试验
取产品A供试品溶液，分别在制备后的0、3、6、9、12、24h，按照上述的色谱条件进样测定，记录供试品中各成分的峰面积并计算得到RSD均小于1.77％，说明供试品溶液在24h内稳定性良好。
(8)按照该实施例中的方法，对实施例1中制备的产品A-I进行HPLC分析，产品A-F整体出峰位置基本一致(峰1-峰12全有，仅存在含量的个别差异以及保留时间在4-10min内可能存在的差异)，产品G、H、I的HPLC如图3-5所示(峰1：新芒果苷；峰2：绿原酸；峰3：芒果苷；峰4：异芒果苷；峰5：1-羟基-2-甲氧基阿朴啡；峰6：槲皮素-3-O-桑布双糖苷；峰7：金丝桃苷；峰8：异槲皮苷；峰9：槲皮素-3-O-葡萄糖醛酸苷；峰10：荷叶碱；峰11：紫云英苷；峰12：盐酸小檗碱)。其中在产品D-E在保留时间21min附近有明显的出峰与产品A-C(不存在该峰)不同，为进一步分析原因，对知母、黄柏、荷叶单独药材进行回流提取成分分析，结果见图6-8。分析结果显示，荷叶水提物在21min位置存在出峰，初步推测是三味药材特定配比可能增加(或抑制)某种成分的溶出，导致不同药材配比得到提取物的种类、含量存在差异(可能是基于植物提取物伴生原理，有待进一步论证)。
实施例3活性测试
(1)实验材料
链脲佐菌素(美国MP Biomedicals公司)，盐酸二甲双胍片(山东明仁福瑞达制药股份有限公司)，葡萄糖粉剂(福州海王福药制药有限公司)，柠檬酸(Citric acid)(天津市化学试剂三厂)，柠檬酸钠(Trisodium citrate dihydrate)(天津市河东区红岩试剂厂)，高糖高脂饲料(成都派尚飞克生物科技有限公司)，生理盐水(辰欣药业股份有限公司)，多聚甲醛固定液(武汉塞维尔生物科技有限公司)，甘油三酯(TG)测定试剂盒(南京建成生物工程研究所)，低密度脂蛋白胆固醇(LDL-C)测定试剂盒A113-1-1(南京建成生物工程研究所)，胰岛素(INS)酶联免疫检测试剂盒(南京建成生物工程研究所)，血糖试纸(BeechwoodPark North Inverness,UK)。
(2)实验动物
将120只雄性C57BL/C小鼠在空军军医大学药物研究所动物实验室饲养，环境温度为22±2℃，湿度在60±5％之间，普通饲料适应性饲养一周后随机分为正常组(control，12只)和造模组(108只)；正常组给予正常普通饲料喂养，造模组给予高糖高脂饲料喂养，喂养8周后，将小鼠禁食12h，正常组小鼠腹腔注射同等剂量的枸橼酸-枸橼酸钠缓冲液(pH＝4.2～4.5)，造模组小鼠连续三天腹腔注射30mg/kg STZ(枸橼酸-枸橼酸钠缓冲液)，7天后测定血糖值，血糖值≥11.1mmol/L，则认为造模成功。
将造模成功的小鼠随机分为9组，每组12只动物，分别为模型组(modle)、盐酸二甲双胍片+辛伐他丁组(positive)、产品A组、产品B组、产品D组、产品E组、产品G组、产品H组、产品I组；正常组(control)和模型组(modle)动物给予等容量生理盐水；阳性药组(positive)动物给予盐酸二甲双胍(300mg/kg)+辛伐他丁(6mg/kg)，产品A-B、D-E、G-I组(均为800mg/kg)，各组小鼠均灌胃给药，给药体积均为1mL/100g。治疗期间正常组给予普通饲料，其余各组均为高糖高脂饲料，治疗共8周。
(3)葡萄糖耐量测定
在饲养的第8周内，选一日对小鼠禁食12h不禁水。禁食结束后剪尾测定血糖值，首次测定的血糖值记为0时刻的血糖值，测完后迅速在小鼠腹腔注射浓度为0.2g/mL的葡萄糖溶液，注射量为100μL/10g体重。在注射后的30、60、90、120min分别测定小鼠的血糖值，实验过程中保持环境安静，避免小鼠产生应激反应而影响测量值。以时间为横坐标、血糖值为纵坐标作图(图9)。
(4)血脂生化指标的测定
采用酶标仪检测各组小鼠血清中甘油三脂(Triglycerides，TG)、低密度脂蛋白胆固醇(Low density lipoprotein cholesterol，LDL-C)的含量(图10-11)。
以上实验结果，可以看出本发明特定配方(知母1份，黄柏1份，荷叶0.2-1.0份)中药提取物能够改善糖脂代谢病血糖血脂水平，通过多靶点，多途径，多成分治疗糖脂代谢病。
Claims (10)
1.一种复方中药，其特征在于所述复方中药由如下重量份的原料组成：知母1份，黄柏1份，荷叶0.2-1.0份。优选知母1份，黄柏1份，荷叶0.5-1.0份。
2.一种复方中药提取物，其特征在于所述复方中药提取物由如下重量份的原料药制成：知母1份，黄柏1份，荷叶0.2-1.0份。优选知母1份，黄柏1份，荷叶0.5-1.0份。
3.权利要求2所述的复方中药提取物，其特征在于其制备方法包括如下步骤：
(1)按照重量份，将知母、黄柏、荷叶，粉碎混匀，得物料；
(2)取步骤(1)得到的物料用5-12倍量的提取溶媒如水或乙醇等浸泡0.5-2.0h后，第一次回流提取0.5-2.0h，过滤，滤液备用，药渣再加5-10倍量的溶媒，第二次回流提取0.5-2.0h，过滤，合并两次滤液，浓缩、干燥，即得所述复方中药提取物。
4.权利要求2-3任一项所述的复方中药提取物的制备方法，其特征在于包括如下步骤：
(1)按照重量份，将知母、黄柏、荷叶，粉碎混匀，得物料；
(2)取步骤(1)得到的物料用5-12倍量的提取溶媒如水或乙醇等浸泡0.5-2.0h后，第一次回流提取0.5-2.0h，过滤，滤液备用，药渣再加5-10倍量的溶媒，第二次回流提取0.5-2.0h，过滤，合并两次滤液，浓缩、干燥，即得所述复方中药提取物。
5.权利要求3-4所述的制备方法，其特征在于步骤(2)优选使用8-10倍量的水浸泡，药渣优选加入6-8倍量的水，合并两次滤液后优选浓缩至相对密度1.10～1.15(80℃)，干燥，得所述复方中药提取物。所述溶媒可选用饮用自来水、纯净水、去离子水和蒸馏水等。干燥选自真空干燥、喷雾干燥、冷冻干燥、减压干燥、微波干燥等。
6.权利要求2-3任一项所述的复方中药提取物，其特征在于其包含12种具体成分明确的活性成分，分别为新芒果苷、绿原酸、芒果苷、异芒果苷、1-羟基-2-甲氧基阿朴啡、槲皮素-3-O-桑布双糖苷、金丝桃苷、异槲皮苷、槲皮素-3-O-葡萄糖醛酸苷、荷叶碱、紫云英苷、盐酸小檗碱等。
7.权利要求2-3任一项所述的复方中药提取物，其特征在于在如下色谱条件下，所述复方中药提取物具有基本如图2所示的HPLC图谱，色谱条件：采用色谱柱Lamdo Stamsil C18(4.6mm×250.0mm，5μm)柱，流动相为A(乙腈)-B(0.1％磷酸-水)，梯度洗脱，洗脱时间(0～35min，93％→85％B；35～45min，85％→83％B；45～55min，83％→81.7％B；55～95min，81.7％→81.5％B；95～120min，81.5％→50％B)，流速为0.8mL/min，检测波长为260nm，柱温为24℃，进样量为10μL。图2所示的HPLC图谱在复方中药提取物成分分析及质量控制中的应用。
8.权利要求1所述的复方中药、权利要求2-3、6-7任一项所述的复方中药提取物和/或其药学上可接受的盐在制备预防和/或治疗糖脂代谢病、高血脂、2型糖尿病血脂水平的药物中的应用。
9.一种用于预防和/或治疗糖脂代谢病、高血脂、2型糖尿病血脂水平的药物组合物，其特征在于该药物组合物以权利要求2-3、6-7任一项所述的复方中药提取物和/或其药学上可接受的盐作为有效成分。
10.权利要求9所述的药物组合物，其特征在于该药物组合物还任选包括其他预防和/或治疗糖脂代谢病、高血脂、2型糖尿病血脂水平的药物。该药物组合物还可包括药学上可接受的辅料(例如注射用水、药用载体、表面活性剂、稀释剂、赋形剂、抗氧剂、稳定剂、增溶剂等)。所述药物组合物的剂型可以是固体制剂、液体制剂或半固体制剂。优选为缓释、控释和肠溶性胶囊、片剂、混悬剂、微乳剂、亚微乳剂或注射剂。
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