CN115089677A - 一种治疗类风湿的药物组合物及其制备方法 - Google Patents
一种治疗类风湿的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗类风湿的药物组合物及其制备方法。由如下重量份数的组分组成：龙葵10～12份；小茴香10～12份；艾叶10～15份；芡实10～12份；春砂仁15～25份；黄药子8～10份；苍耳子8～10份；沙棘12～15份；山楂2～8份；王不留行2～5份。本发明的治疗类风湿的药物组合物，其原料配方中各组份的选择和组份用量的确定均是发明人通过大量的实验方案设计和数据比较优化后才获得的，各个组分发挥协同作用，对治疗类风湿具有显著的疗效，且痊愈后不易复发，患者不需长期依赖药物维持。本发明的制备方法采用闪式提取结合膜浓缩技术，可以充分提取药材中的有效成分，发挥最大的功效作用。
Description
技术领域
本发明涉及中药技术领域，尤其涉及一种治疗类风湿的药物组合物及其制备方法。
背景技术
类风湿的概念需与风湿相区别。二者是完全不同的两种疾病。类风湿关节炎是一种病因未明的慢性、以炎性滑膜炎为主的系统性疾病。风湿性关节炎是一种常见的急性或慢性结缔组织炎症。类风湿关节炎往往侵犯小关节(尤其是掌指关节、近端指间关节、腕关节)，也会侵及其他大小关节，晚期往往造成关节的畸形。
目前类风湿关节炎的治疗是以防止关节破坏，保护关节功能，最大限度的提高患者的生活质量为目标。
春砂仁浑身是宝，花、果、根、茎、叶均可入药。《本草纲目》上记载有：“姜科植物春砂仁，性温味辛，功用行气调味，和胃醒脾，主治胸脘胀满，胃果食滞，噎膈呕吐等症。”对阳春砂仁推崇之至。
春砂仁为阳春市特产，阳春市位于广东省西南部，光照充足，热量丰富，雨量充沛，空气湿度大，由于全境群山环抱、四面环山，风速小，风害少，气候温和，年平均气温22℃，平均日照2000h，平均无霜期342天，年积温6500—8000℃，年均降雨量1800—2200毫米，相对湿度75％—90％。阳春市全境以赤红壤为主。土壤疏松、湿润、肥沃，表面有机质含量大。阳春市的春砂仁，列入姜科，豆蔻属，是热带亚热带季雨林植物。
沙棘，产地华北、西北及四川等，9-10月果实成熟时采收，鲜用或晒干。药用部位为果实。常用于咳嗽痰多，消化不良，食积腹痛，瘀血经闭，跌扑瘀肿。
中药是我国独有的瑰宝，迫切需要效果显著的治疗类风湿药物组合物。
发明内容
本发明的目的是针对现有技术的不足，提供一种对类风湿疗效显著、治愈后不易复发，且不会产生药物依赖性的药物组合物。
本发明的另一个目的是提供上述药物组合物的制备方法。
本发明的上述目的是通过如下方案予以实现的：
一种治疗类风湿的药物组合物，由如下重量份数的组分组成：
龙葵10～12份；小茴香10～12份；艾叶10～15份；芡实10～12份；春砂仁15～25份；黄药子8～10份；苍耳子8～10份；沙棘12～15份；山楂2～8份；王不留行2～5份。
作为优选的，在上述治疗类风湿的药物组合物中，由如下重量份数的组分组成：
龙葵12份；小茴香10份；艾叶12份；芡实12份；春砂仁20份；黄药子10份；苍耳子8份；沙棘12份；山楂3份；王不留行4份。
龙葵，为茄科值物龙葵的全草。主要成分：全草含生物碱甙，澳洲茄碱等多种生物碱。主要用于感冒发烧，牙痛，慢性支气管炎，急性肾炎，乳腺炎等。
小茴香，为伞形科植物，入药部位为干燥成熟果实。味辛，性温。用于寒疝腹痛，睾丸偏坠，痛经，少腹冷痛，脘腹胀痛，食少吐泻。
艾叶，为菊科植物，入药部位为植物的干燥叶。性辛、苦，温。主治用于吐血，衄血，崩漏，月经过多，胎漏下血，少腹冷痛，经寒不调，宫冷不孕；外治皮肤瘙痒。
芡实，为睡莲科植物，入药部位为干燥成熟种仁。分布于从黑龙江至云南、广东等地。味甘、涩，性平。用于遗精滑精，遗尿尿频，脾虚久泻，白浊，带下。
黄药子，为薯蓣科薯蓣属植物，入药部位为干燥块茎。具有解毒消肿，化痰散结，凉血止血之功效。常用于甲状腺肿大，淋巴结结核，咽喉肿痛，吐血，咯血，百日咳，癌肿；外用治疮疖。
苍耳子，属草本菊科植物，入药部位为干燥成熟带总苞的果实。味苦、甘、辛，性温。用于风寒感冒，鼻渊，风湿痹痛，风疹瘙痒等证。
山楂，为蔷薇科植物，入药部位为干燥成熟果实。酸、甘，微温。用于肉食积滞，胃脘胀满，泻痢腹痛，瘀血经闭，产后瘀阻，心腹刺痛，胸痹心痛，疝气疼痛，高脂血症。焦山楂消食导滞作用增强。
王不留行，为石竹科植物，入药部位为干燥成熟种子。除华南外，全国各地区都有分布。具有活血通经，下乳消肿，利尿通淋的功效。用于经闭，痛经，乳汁不下，乳痈肿痛，淋证涩痛。
上述治疗类风湿的药物组合物的制备方法，包括如下步骤：
(1)药材的预处理：按照比例将各种药材混合后清洗、60℃烘3～5小时，粉碎至50～100目备用；
(2)闪式提取：将预处理后的药材与提取溶剂混合后放入闪式提取罐中，控制转速在8000～10000r/min，提取时间5～20min，提取次数1～5次，提取完毕后过滤，收集滤液；
(3)膜浓缩：经过粗滤、精滤、微滤，提取液再通过截留分子量为100～500的纳滤膜浓缩，操作压力为0.5～3MPa，得到浓缩液。
作为优选的，在上述的制备方法中，步骤(2)所述提取溶剂为体积百分比60％的乙醇溶液；溶剂的用量为原料重量的5～10倍。
作为优选的，在上述的制备方法中，步骤(3)所述纳滤膜为陶瓷纳滤膜。
与现有技术相比，本发明具有如下有益效果：
1.本发明的治疗类风湿的药物组合物，其原料配方均采用中药材，原料绿色安全，不含激素等添加剂，无任何毒副作用。
2.本发明的治疗类风湿的药物组合物，其原料配方中各组份的选择和组份用量的确定均是发明人通过大量的实验方案设计和数据比较优化后才获得的，各个组分发挥协同作用，对治疗类风湿具有显著的疗效，且痊愈后不易复发，患者不需长期依赖药物维持。
3.本发明的制备方法采用闪式提取结合膜浓缩技术，可以充分提取药材中的有效成分，发挥最大的功效作用。
具体实施方式
下面结合具体实施例对本发明做进一步地描述，但具体实施例并不对本发明做任何限定。
1.原料配方如表1：
表1(表1的数据为重量份数)
| 实施例1 | 实施例2 | 实施例3 | 对比例1 | |
| 龙葵 | 12 | 10 | 11 | 12 |
| 小茴香 | 10 | 12 | 11 | 10 |
| 艾叶 | 12 | 10 | 15 | 0 |
| 芡实 | 12 | 11 | 10 | 12 |
| 春砂仁 | 20 | 15 | 25 | 0 |
| 黄药子 | 10 | 8 | 9 | 10 |
| 苍耳子 | 8 | 10 | 9 | 8 |
| 沙棘 | 12 | 15 | 13 | 12 |
| 山楂 | 3 | 5 | 8 | 3 |
| 王不留行 | 4 | 5 | 2 | 4 |
2.实施例1-3和对比例1的制备方法包括以下步骤：
(1)药材的预处理：按照比例将各种药材混合后清洗、60℃烘4小时，粉碎至50～100目备用；
(2)闪式提取：将预处理后的药材与体积百分比60％的乙醇溶液混合后放入闪式提取罐中，乙醇溶液重量为药材重量的6倍，控制转速在10000r/min，提取时间10min，提取次数5次，提取完毕后过滤，收集滤液；
(3)膜浓缩：经过粗滤、精滤、微滤，提取液再通过截留分子量为100～500的陶瓷纳滤膜浓缩，操作压力为2MPa，得到浓缩液。
实施例4疗效试验
试验对象：对150例类风湿病例临床观察，其中男性70例，女性80例，年龄最大70岁，最小20岁，病史从3个月～20年均有。
试验药物：分别采用实施例1-3和对比例1制备的药物组合物浓缩液，均匀分成两份，早晚各一份服用，连续服用30天为一个疗程，连续使用2个疗程，还可根据病情需要延长服药疗程。
实施例1的试验结果：150例病例中138人有效，有效率为92％，121人治愈，治愈率达81％。
实施例2的试验结果：150例病例中120人有效，有效率为80％，100人治愈，治愈率达67％。
实施例3的试验结果：150例病例中122人有效，有效率为81％，102人治愈，治愈率达68％。
对比例1的试验结果：150例病例中90人有效，有效率为60％，70人治愈，治愈率达47％。
典型病例：
病例1：唐某，女，60岁，患类风湿15年，手脚关节全部变形，服用实施例1的试验药物2个疗程后，关节伸展较以前大为自如，疼痛消失，再继续服用2个疗程后痊愈，一年后随访，未再复发。
病例2：李某，男，35岁，患类风湿关节炎，游走性疼痛，服用实施例1的试验药物2个疗程后，病情痊愈，一年后随访，未再复发。
病例3：曹某，女，45岁，患类风湿关节炎10年，部分关节有畸形，疼痛难忍，服用实施例1的试验药物2个疗程后，病情大为缓解，继续服用2个疗程后治愈，并不再复发。
病例4：梁某，男，21岁，患类风湿关节炎，病史半年，服用实施例1的试验药物2个疗程后运动基本自如，继续服用2个疗程后痊愈，并不再复发。
Claims (5)
1.一种治疗类风湿的药物组合物，其特征在于由如下重量份数的组分组成：
龙葵10～12份；小茴香 10～12份；艾叶10～15份；芡实10～12份；春砂仁15～25份；黄药子8～10份；苍耳子8～10份；沙棘12～15份；山楂2～8份；王不留行2～5份。
2.根据权利要求1所述治疗类风湿的药物组合物，其特征在于由如下重量份数的组分组成：
龙葵12份；小茴香 10份；艾叶12份；芡实12份；春砂仁20份；黄药子10份；苍耳子8份；沙棘12份；山楂3份；王不留行4份。
3.权利要求1所述治疗类风湿的药物组合物的制备方法，其特征在于包括如下步骤：
（1）药材的预处理：按照比例将各种药材混合后清洗、60℃烘3~5小时，粉碎至50~100目备用；
（2）闪式提取：将预处理后的药材与提取溶剂混合后放入闪式提取罐中，控制转速在8000~10000 r/min，提取时间5~20 min，提取次数1~5次，提取完毕后过滤，收集滤液；
（3）膜浓缩：经过粗滤、精滤、微滤，提取液再通过截留分子量为100~500的纳滤膜浓缩，操作压力为0.5~3 MPa，得到浓缩液。
4.根据权利要求3所述的制备方法，其特征在于步骤（2）所述提取溶剂为体积百分比60%的乙醇溶液；溶剂的用量为原料重量的5~10倍。
5.根据权利要求3所述的制备方法，其特征在于步骤（3）所述所述纳滤膜为陶瓷纳滤膜。
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