CN1215876C - 一种抗痛风药物组合物及其制备方法 - Google Patents
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Abstract
一种抗痛风的药物组合物，由侧柏叶总黄酮和川芎总生物碱所组成；其用量为侧柏叶总黄酮0.5-2g、川芎总生物碱0.4-1.6g。其制法是按上述重量配比，混合而获得CX的药物组合物，加入适量辅料，便可制成片剂、颗粒剂和胶囊剂。该组合物能显著降低高尿酸血症动物血清尿酸水平，该组合物可用于制备治疗高尿酸血症和痛风疾病的药物，且具有疗效稳定、安全可靠之功效。
Description
本发明专利申请是由2002年9月5日提交的“抗痛风组合物及其制备工艺”专利申请(申请号02138216.6)的分案申请。
一、技术领域：
本发明涉及天然植物有效成分的组合物及其制备方法和药物用途，特别是涉及将侧柏叶总黄酮和川芎总生物碱制备成治疗或预防高尿酸血症和痛风疾病的药物。
二、背景技术：
痛风是一种嘌呤代谢紊乱引起的疾病。临床特点为高尿酸血症、痛风性关节炎、关节畸形、肾脏病变和尿酸结石、痛风结石形成等。其中高尿酸血症是血中尿酸超过正常的一种状态，是痛风疾病发展过程中的一个阶段；痛风性关节炎是血清尿酸水平增高后，尿酸盐沉积在关节组织，刺激关节并引发一系列的炎性反应。痛风症状以反复下肢关节红肿热痛为主，在中医辩证上多属湿热痹范畴。其病机或因先天禀赋不足，或因后天饮食不节，脏腑功能失调，分清别浊失常，于是湿、热、瘀、浊诸症随之而生。
现有西药针对痛风患者在不同时期所表现的症状选择性进行治疗。如抗炎镇痛药物秋水仙碱和消炎痛用于痛风急性发作治疗，排泄尿酸药物如丙磺舒、苯溴马龙用于间隙期及慢性期治疗，黄嘌呤氧化酶抑制剂药物别嘌呤醇(唯一在临床上使用)抑制尿酸合成。但上述药物毒副作用大，患者往往不能坚持长期服用，以致不易控制病情。如秋水仙碱和消炎痛具有胃肠道刺激作用，前者还产生白细胞降低和脱发等；丙磺舒、苯溴马龙具有胃肠道反应、肾绞痛及激发痛风急性发作等副作用；别嘌呤醇有致变态反应(发生率高达10-15％)、超敏Stevena-Johnson综合症(可导致27.5％出现斑丘疹患者死亡)、骨髓抑制(虽较少见，但后果严重)等严重的毒副作用。
中医药治疗痛风可根据不同病因病机进行辩证施治。湿热型治以泄浊清热通络为主，方多用加味二妙散。寒湿型治以温散寒湿，祛风除湿为主，方选乌头煎，合薏苡红汤或蠋痹汤、鸡鸣散。寒热错杂型兼治以祛风利湿、理气活血、软坚化痰为主，用麻黄连翘、赤豆汤加味以治风寒湿痹蕴久化热、外邪还在。瘀血阻络型治以养血活血，逐瘀通络为主，方用身痛逐瘀汤加减或四物汤加桑枝、首乌、牛膝、薏苡红等，或选用丹参、鸡血藤、泽兰、红花、川芎以活血化瘀。痰瘀痹阻型治以祛瘀化痰、搜邪通络为主，选用穿山甲、土鳖虫、乌梢蛇、蜈蚣、防己、威灵仙、地龙等。脾虚湿阻型治以健脾益气化浊，泄浊通络为主，方用升阳益胃汤加减，或选用黄芪、当归、萆、牛膝、红花、白术、薏苡红等。
侧柏叶为柏科植物侧柏Platycladus orientalis(L.)Franco.的嫩枝与叶，清热凉血，治湿热痹痛，临床常用于治疗肺结核、百日咳等；侧柏叶主要含黄酮、鞣质和挥发油等，新鲜的侧柏叶的粗制总黄酮含量为1.72％，主要为槲皮素等成分。川芎为伞形科植物川芎Ligusticum chuanxiong Hort.的根茎，活血行气，散风止痛。川芎含挥发油、生物碱、酚性成分、内酯类和阿魏酸等，生物碱含量较高，从其中分离出的川芎嗪具有活血化瘀、抗血小板凝集、扩张血管、抗自由基、利尿等作用，临床广泛用于治疗心脑血管疾病、肺心病慢性肾病与肝病等。
三、发明内容：
1.发明目的
本发明的目的就是为了解决上述问题，而提供一种由侧柏叶和川芎的提取物制备成的药物组合物及其制备方法，以及在制备预防或治疗高尿酸血症和痛风疾病中的应用。
2.技术方案
本发明的药物组合物，其特征在于它是由以下重量配比的植物提取物组分所组成：侧柏叶总黄酮0.5-2.0g、川芎总生物碱0.4-1.6g；上述提取物组分的优选用量为，侧柏叶总黄酮1.0g、川芎总生物碱0.8g。
本发明的药物组合物的制备方法，其步骤是：
(1)侧柏叶经0-95％乙醇水溶液提取获得侧柏叶总黄酮；
(2)川芎经水或酸水-有机溶剂、醇-酸水-有机溶剂、碱化-有机溶剂、离子交换树脂或水蒸气提取获得川芎总生物碱；
(3)将侧柏叶总黄酮0.5-2.0g、川芎总生物碱0.4-1.6g，充分混合即得组合物CX；
将上述的组合物CX中加入适量的辅料，用常规的制备方法，可制成片剂、颗粒剂和胶囊剂等固体口服制剂；所用的辅料是常规用的助剂，例如淀粉、明胶、阿拉伯胶、硅石、聚乙二醇。
本发明的药物组合物用于制备治疗高尿酸血症和痛风疾病的药物中的应用。
3。有益效果
本发明的优点在于，本发明的药物组合物是以侧柏叶总黄酮和川芎总生物碱为主要有效成分，组合简洁合理，药效成分明确，治疗效果显著；而且草药的来源广，制备工艺简单，易于实现工业规模化生产。并可分别用槲皮素和川芎嗪等成分作为质量控制指标。
四、具体实施方式：
实施例1抗痛风药物组合物的组成
一种抗痛风药物组合物，由侧柏叶总黄酮1.0g和川芎总生物碱0.8g所组成。
实施例2.抗痛风药物组合物的制备方法，其方法步骤为：
(1)侧柏叶用20倍体积的50％乙醇水溶液热回流4h，提取液蒸干即得侧柏叶总黄酮，得率为1.1％，其中含槲皮素13.5％；
(2)川芎用酸水提取后，再以石灰水碱化，碱化液用乙酸乙酯萃取得川芎总生物碱，得率为1.4％，其中川芎嗪为20％。
(3)取侧柏叶总黄酮1.0g和川芎总生物碱0.8g混合，即得CX。
实施例3.组合物对高尿酸血症小鼠血清尿酸水平的影响
雄性昆明种小鼠，体重24±2g，随机分组，每天i.g.给药一次，连续四天，其中生理盐水组和高尿酸血症模型空白组每天均按100ml/kg剂量i.g生理盐水，各高尿酸血症模型空白组在采血前2小时ip氧嗪酸钾盐，给药模型组在最后一次给药前一小时ip氧嗪酸钾盐。最后一次给药2小时后从动物眼眶后静脉丛采血，测定血清尿酸水平。
组合物CX对高尿酸血症小鼠血清尿酸水平的影响结果见表1。在此实验条件下，CX均显著地降低高尿酸血症小鼠血清尿酸水平；而别嘌呤醇组可显著地降低正常小鼠血清尿酸水平。
表1 组合物CX对高尿酸血症小鼠血清尿酸水平的影响(
x±s)
| 组别 | 剂量(mg/kg) | 小鼠血清尿酸水平(mg/100ml) |
| 生理盐水组模型空白组CX组别嘌呤醇组 | --28010 | 7.87±0.1712.68±0.289.12±0.15**7.46±0.17*** |
与模型空白组比较：*P＜0.05，**P＜0.01，***P＜0.005
小结：组合物CX可降低高尿酸血症模型下动物血清尿酸水平
Claims (5)
1.一种抗痛风的药物组合物，其特征在于它由侧柏叶总黄酮0.5-2g和川芎总生物碱0.4-1.6g组成。
2.一种如权利要求1所述的抗痛风药物组合物，其特征在于它由侧柏叶总黄酮1.0g和川芎总生物碱0.8g组成。
3.一种如权利要求1所述的抗痛风药物组合物，其特征在于它被制成片剂、颗粒剂或胶囊剂。
4.权利要求1所述的药物组合物在制备治疗痛风疾病的药物中的应用。
5.权利要求1的药物组合物在制备治疗高尿酸血症的药物中的应用。
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