CN104491239A - 一种用于降脂的中药组合物及其制剂 - Google Patents
一种用于降脂的中药组合物及其制剂 Download PDFInfo
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- CN104491239A CN104491239A CN201410783564.7A CN201410783564A CN104491239A CN 104491239 A CN104491239 A CN 104491239A CN 201410783564 A CN201410783564 A CN 201410783564A CN 104491239 A CN104491239 A CN 104491239A
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Abstract
本发明涉及一种用于降脂的中药组合物及其制剂，具体涉及葛根等中药组合物用于降脂治疗，属于中药领域。其由重量百分比为30％～60％的葛根、10％～40％的山楂、10％～30％的泽泻、10％～30％的何首乌和10％～30％的当归制成。本发明药物组合物可以根据需要和药学上可接受的辅料制备成合适的口服制剂用于降脂治疗。
Description
技术领域
本发明涉及一种用于降脂的中药组合物及其制剂，具体涉及葛根等中药组合物用于降脂治疗，属于中药领域。
背景技术
心血管病已成为我国城市和乡村人群的第一位死亡原因，我国心血管病的特点是脑卒中高发而冠心病发病率较低，但近20余年冠心病发病率和死亡率逐步上升；在经济发展较快的大城市如北京，监测结果显示，从1984年到1999年出血性脑卒中发病率呈明显下降趋势，而缺血性脑卒中发病率却明显上升，预示以动脉粥样硬化为基础的缺血性心血管病(包括冠心病和缺血性脑卒中)发病率正在升高。研究表明，血清总胆固醇(totalcholesterol,TC)或低密度脂蛋白胆固醇(low density lipoproten-cholesterol,LDL-C)升高是冠心病和缺血性脑卒中发生的独立危险因素之一。为此，对血脂异常的防治必须及早给予重视。
血脂是指血浆中的胆固醇、甘油三酯(triglyceide，TG)和类脂如磷脂等的总称。与临床密切相关的血脂主要是胆固醇和甘油三酯，其他还有游离脂肪酸(FFA)和磷脂等。在人体内胆固醇主要以游离胆固醇及胆固醇酯形式存在。甘油三酯是甘油分子中的三个羟基被脂肪酸酯化而形成。循环血液中的胆固醇和甘油三酯必须与特殊的蛋白质即载脂蛋白(apolipoprotein,ap)结合形成脂蛋白，才能被运输至组织进行代谢。
目前临床上供选用的调脂药物主要分为五类:(I)他汀类；(2)贝特类；(3)烟酸类；(4)树脂类；(5)胆固醇吸收抑制剂。但个体对药物疗效与副作用有很大个体差异，副作用不少，且一般需要长期服用。所以仅在饮食和运动疗法治疗后，仍不能有效地降低血脂时才试用。
葛山降脂颗粒源于安徽省名中医高道凡先生的多年临床经验方。处方由葛根、炒山楂、泽泻、制何首乌和当归五味药组成，该复方各味中药的重量百分比为32％的葛根，32％的山楂，15％的泽泻，13％的何首乌和8％的当归。临床上主要应用于各种诱因导致的高脂血症，具有起效快，疗效高，副作用小等特点。但在临床使用中，少数患者在服用后，会存在上腹饱胀不适等副作用。
近年来随着对中医药现代化研究的不断进步，在此基础上，结合相关的实验研究，对传统验方中存在的主观偏倚，进行处方配伍配比的优化筛选，不但可以显著提高疗效降低其副作用，还将为促进中药的内涵现代化提供相关科学依据。
发明内容
本发明的一个目的是提供一种用于降脂的中药有效部位组合物，其由重量百分比为30％～60％的葛根、10％～40％的山楂、10％～30％的泽泻、10％～30％的何首乌和10％～30％的当归制成。
在本发明进一步地实施方案中，所述组合物的重量百分比优选为40％～50％的葛根总黄酮、15％～30％的山楂、10％～20％的泽泻、10％～20％的何首乌和15％～25％的当归。
在本发明的一个实施方案中，所述组合物的重量百分比可以为45％的葛根、17％的山楂、11％的泽泻、11％的何首乌和16％的当归。所述组合物的重量百分比也可以为43％的葛根、16％的山楂、11％的泽泻、13％的何首乌和17％的当归。
本发明的另一个目的是提供一种含有所述中药组合物的药物制剂，本发明药物组合物可以根据需要和药学上可接受的辅料制备成合适的口服制剂用于降脂治疗。
所述口服制剂为颗粒剂。所述颗粒剂所选用的辅料选自预胶化淀粉、β-环糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、碳酸氢钠、碳酸钠中的一种或几种。上述制剂的所用辅料及制备方法均可采用其常规的辅料和制备方法制得。
本发明的另一个目的是提供一种所述中药组合物的制备方法，具体步骤如下：
(1)将相应重量份的泽泻药材干燥分别粉碎成细粉；
(2)将相应重量份的葛根、山楂、何首乌和当归加8倍量水煎煮三次，每次为1.5小时，滤过，合并滤液，浓缩至60℃时相对密度为1.10～1.20的浸膏；加乙醇至含醇量达70％，搅匀，静置，取上清液回收乙醇，干燥粉碎得细粉即得所述中药组合物。
本发明通过试验及临床研究发现，在原有处方中，山楂含量过高，在临床应用中，会导致脾胃虚弱及兼有积滞的患者产生较强烈的不适反应，但山楂中的黄酮类、三萜皂苷类和脂肪酸等有效成分可降低血清胆固醇及甘油三酯，可能是通过提高血清中高密度胆固醇及其亚组分浓度，增加胆固醇的排泄而实现的。因此，降低山楂组分可能会影响原有处方的临床疗效。而本发明通过试验摸索及临床试验对原处方中其他中药配比进行了合理优化，不仅没有降低降血脂的疗效，反而在一定程度上提高了的降血脂疗效。
具体实施方式
下面将进一步的举例说明本发明。需要指出的是，以下说明仅仅是对本发明要求保护的技术方案的举例说明，并非对这些技术方案的任何限制。本发明的保护范围以所附权利要求书记载的内容为准。
实施例1中药组合物的制备
(1)将11g的泽泻药材干燥分别粉碎成细粉，过200目筛；
(2)将45g的葛根、17g的山楂、11g的何首乌和16g的当归加8倍量水煎煮三次，每次为1.5小时，滤过，合并滤液，浓缩至60℃时相对密度为1.10～1.20的浸膏；加乙醇至含醇量达70％，搅匀，静置，取上清液回收乙醇，干燥粉碎得细粉即得所述中药组合物。
实施例2中药组合物的制备
(1)将11g的泽泻药材干燥分别粉碎成细粉；过200目筛；
(2)将43g的葛根、16g的山楂、13g的何首乌和17g的当归加8倍量水煎煮三次，每次为1.5小时，滤过，合并滤液，浓缩至60℃时相对密度为1.10～1.20的浸膏；加乙醇至含醇量达70％，搅匀，静置，取上清液回收乙醇，干燥粉碎得细粉即得所述中药组合物。
实施例3中药组合物对喂食高脂饲料大鼠的血脂影响
通过高脂饲料加腹腔注射VD3及卵清白蛋白激发炎症反应，建立大鼠AS模型。造模时间1个半月。具体步骤如下：大鼠适应性喂养一周后，随机分组(每组8只)，分别为空白组(normal state,NS)、模型组及各给药组，NS组大鼠给予普通饲料，其他组给予高脂饲料(含1％胆固醇、0.2％猪胆盐、10％猪油、10％蛋黄粉、78.8％基础饲料)。分组后，除NS组外，其他组大鼠一次性腹腔注射VD36O万IU/kg，NS组给予等体积的生理盐水；次日对大鼠进行免疫损伤(将卵清白蛋白以生理盐水溶解，取等量的卵蛋白溶液和完全福氏佐剂，混匀后制成稳定的油包水型抗原乳剂，以抗原乳剂(3mg/kg)在大鼠背部皮下多点注射；3周后以卵蛋白溶液(2.5mg/kg)腹腔注射激发免疫反应，每周1次，连续3周；NS组按相同途径给予等量的生理盐水。观察大鼠饮水、体重、外观、活动。造模8周后，口服灌胃给予相应组分和药物(给药剂量为100mg/kg)，NS和MS组给予等体积的0.5％CMC-Na，给药时间一个月。末日给药后禁食12h，20％乌拉坦麻醉，腹主动脉取血，血液分为抗凝血与非抗凝血二种收集，4℃静置后，离心(4℃,3000rpm)lOmin，取血清和血装分装备用。同时自主动脉弓根部向下剪至腹主动脉分叉处，剥离结缔组织，纵向剖开，以冷的生理盐水冲洗干净，肉眼观察血管内膜情况，固定于4％多聚甲醛溶液中，备病理检测用。
各给药组中各味中药重量百分比组成情况
| ％ | 对比例1 | 对比例2 |
| 葛根 | 32 | 50 |
| 山楂 | 32 | 14 |
| 泽泻 | 15 | 15 |
| 何首乌 | 13 | 13 |
| 当归 | 8 | 8 |
结果：
(1)各给药组对大鼠血脂水平的影响，具体见下表：
| TC(mmol/L) | TG(mmol/L) | LDL-C(mmol/L) | HDL-C(mmol/L) | |
| 对照组 | 1.1±0.2 | 0.12±0.03 | 0.17±0.03 | 1.2±0.2 |
| 模型组 | 2.8±0.3 | 0.61±0.04 | 0.58±0.04 | 0.8±0.1 |
| 实施例1 | 1.3±0.2 | 0.26±0.05 | 0.31±0.04 | 1.2±0.2 |
| 实施例2 | 1.4±0.3 | 0.24±0.03 | 0.27±0.02 | 1.2±0.3 |
| 对比例1 | 1.9±0.2 | 0.42±0.05 | 0.62±0.05 | 1.1±0.3 |
| 对比例2 | 2.4±0.3 | 0.49±0.04 | 0.59±0.04 | 1.0±0.3 |
(2)给药组对血清中内皮细胞功能因子的影响，具体如下：
(3)给药组对血清中炎症因子的影响，具体如下：
| CRP(ng/L) | IL-1β(ng/mL) | |
| 对照组 | 7.9±0.6 | 0.44±0.03 |
| 模型组 | 14.5±0.7 | 0.87±0.07 |
| 实施例1 | 9.3±0.5 | 0.51±0.04 |
| 实施例2 | 8.9±0.4 | 0.53±0.05 |
| 对比例1 | 12.4±0.7 | 0.62±0.05 |
| 对比例2 | 13.5±0.8 | 0.75±0.06 |
实施例4中药组合物对HepG2细胞吸收甘油三酯的影响
在HepG2细胞正常传代后，在含10％胎牛血清和100mg/L中药组合物的培养基中生长，24h后弃去原培养基，换成1％BSA培养基，加入100微摩/L的油酸，培养24h后，弃去培养基，采用己烷/异丙醇混合液原位萃取提取蛋白，通过酶比色法测定细胞中甘油三酯的含量。
具体结果如下：
| 微克/毫克蛋白 | |
| 正常组 | 113±19 |
| 模型组 | 186±22 |
| 实施例1 | 131±16 |
| 实施例2 | 127±15 |
| 对比例1 | 148±18 |
| 对比例2 | 169±17 |
实施例5颗粒剂制备
处方
制备工艺：先将中药有效部位组合物与乙基纤维素混合均匀，然后加入微晶纤维素过16目筛后混合，后再与阿斯巴甜混合均匀。混合物用50％乙醇溶液制粒，干燥，整粒，分装100袋(每袋4.7克)，即得。
实施例6中药组合物颗粒剂的临床效果
对患有高脂血症的患者(共200例，年龄24-55岁，男女各半)服用实施例5制备的颗粒剂，每天3次，每次一袋，共8周。
诊断标准：
显效：治疗后症状基本消失，血清总胆固醇(Tch)降至≤5.0mmol/L。
有效：治疗后症状明显改善，血清总胆固醇(Tch)降至≤6.0mmol/L)。
无效：经二个月以上治疗，血清总胆固醇(Tch)下降未达到有效标准者。
副反应：胃部不适或腹胀
具体结果如下：
| 显效 | 有效 | 无效 | 副反应 | |
| 实施例2(100例) | 188 | 11 | 1 | 0 |
| 对比例1(100例) | 163 | 26 | 11 | 7 |
本发明内容仅仅举例说明了要求保护的一些具体实施方案，其中一个或更多个技术方案中所记载的技术特征可以与任意的一个或多个技术方案相组合，这些经组合而得到的技术方案也在本申请保护范围内，就像这些经组合而得到的技术方案已经在本发明公开内容中具体记载一样。
Claims (6)
1.一种用于降脂的位组合物，其特征在于，其由重量百分比为30％～60％的葛根、10％～40％的山楂、10％～30％的泽泻、10％～30％的何首乌和10％～30％的当归制成。
2.根据权利要求1所述的组合物，其特征在于，所述组合物的重量百分比优选为40％～50％的葛根、15％～30％的山楂、10％～20％的泽泻、10％～20％的何首乌和15％～25％的当归。
3.根据权利要求1所述的组合物，其特征在于，所述组合物的重量百分比可以为45％的葛根、17％的山楂、11％的泽泻、11％的何首乌和16％的当归。
4.根据权利要求1所述的组合物，其特征在于，所述组合物的重量百分比也可以为43％的葛根总黄酮、16％的山楂、11％的泽泻、13％的何首乌和17％的当归。
5.一种含有权利要求1所述中药组合物的药物制剂，其特征在于，所述组合物可以根据需要和药学上可接受的辅料制备成合适的口服制剂。
6.根据权利要求5所述的药物制剂，其特征在于所述口服制剂为颗粒剂；所述颗粒剂所选用的辅料选自预胶化淀粉、β-环糊精、卡波姆、微晶纤维素、羟丙基甲基纤维素、低取代羟丙基纤维素、聚乙二醇(PEG)、羧甲基纤维素钠、甲基纤维素、乙基纤维素、甘露醇、交联羧甲基纤维素钠、乳糖、聚乙烯吡咯烷酮(PVP)、硬脂酸镁、滑石粉、微粉硅胶、阿斯巴甜、碳酸氢钠、碳酸钠中的一种或几种。
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