CN104491315A - 一种用于治疗月经先后无定期的中药组合物 - Google Patents

一种用于治疗月经先后无定期的中药组合物 Download PDF

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CN104491315A
CN104491315A CN201510012644.7A CN201510012644A CN104491315A CN 104491315 A CN104491315 A CN 104491315A CN 201510012644 A CN201510012644 A CN 201510012644A CN 104491315 A CN104491315 A CN 104491315A
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卞毓平
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Abstract

本发明提供了一种治疗月经先后无定期的中药组合物，它由如下原料制备得到：双飞蝴蝶、小金牛草、茯苓、党参等，本发明能治疗月经先后无定期。

Description

一种用于治疗月经先后无定期的中药组合物
技术领域
本发明涉及中药制剂技术领域，具体涉及一种用于治疗月经先后无定期的中药组合物及其制备方法和应用。
背景技术
月经先后无定期系由肝郁肾虚，气血失调导致血海蓄溢失常，出现月经周期提前或延后7天以上而至的月经病。目前发病率高，为此，急要开发出更多安全有效的治疗月经先后无定期的药物满足临床治疗的需要。
发明内容
为了解决上述问题，本发明的目的在于提供一种可治疗月经先后无定期疾病的中药制剂。为了达到这个目的，采用如下技术方案：
技术方案：一种用于治疗月经先后无定期的中药组合物，它所含的活性成分由下列重量份原料药提取制备而成：双飞蝴蝶12份、小金牛草10份、茯苓10份、党参10份、怀牛膝12份、山药20份、淫羊藿15份、菟丝子20份、橘皮6份、丹参10份、续断10份、香附10份、熟地黄10份、桑葚子10份、川楝子10份、益母草10份、当归10份、鹿角霜10份、杜仲10份、锁阳10份、山茱萸10份、青皮6份、乌药10份。
所述用于治疗月经先后无定期的中药组合物，剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
所述用于治疗月经先后无定期的中药组合物，制备步骤为：取上述中药，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加辅料制成胶囊剂、片剂、颗粒剂。
所述用于治疗月经先后无定期的中药组合物在制备治疗月经先后无定期药物中的应用。
上述双飞蝴蝶为萝藦科娃儿藤属植物双飞蝴蝶Tylophora floribunda Miq.，以根入药，具有祛风化痰、通经散瘀的功效。直立草本。茎纤细，高50至90厘米，上部有细绒毛，祛风化痰，通经散瘀。用于小儿惊风，白喉，支气管炎，月经不调，毒蛇咬伤，跌打损伤。小金牛草为远志科远志属植物小花远志Polygala arvensis Willd.，以全草入药。秋季采集，晒干。散瘀止血，化痰止咳，解毒消肿。用于咳嗽胸痛，肺结核，咳血，尿血，便血，月经不调，跌打损伤，小儿麻痹后遗症，肝炎，毒蛇咬伤。鹿角霜为鹿科动物梅花鹿或马鹿的角熬制鹿角胶后剩余的骨渣。其余中药均为药典品种。
有益效果：本发明双飞蝴蝶、小金牛草活血化瘀为君药，茯苓、党参、怀牛膝、山药、淫羊藿、菟丝子、橘皮、丹参、续断、香附、熟地黄、桑葚子、川楝子、益母草、当归、鹿角霜、杜仲、锁阳、山茱萸补中益气、温补肾阳为臣药，青皮、乌药为佐使药，调和猪药，全方配伍，活血化瘀，治疗月经先后无定期效果明显。
具体实施方式
以下通过实施例形式，对本发明的上述内容再作进一步的详细说明，但不应将此理解为本发明上述主题的范围仅限于以下的实例，凡基于本发明上述内容所实现的技术均属于本发明的范围。
1、颗粒剂实施例的制备：取双飞蝴蝶12g、小金牛草10g、茯苓10g、党参10g、怀牛膝12g、山药20g、淫羊藿15g、菟丝子20g、橘皮6g、丹参10g、续断10g、香附10g、熟地黄10g、桑葚子10g、川楝子10g、益母草10g、当归10g、鹿角霜10g、杜仲10g、锁阳10g、山茱萸10g、青皮6g、乌药10g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加淀粉，制粒，制成颗粒剂。
2、片剂实施例的制备：取双飞蝴蝶12g、小金牛草10g、茯苓10g、党参10g、怀牛膝12g、山药20g、淫羊藿15g、菟丝子20g、橘皮6g、丹参10g、续断10g、香附10g、熟地黄10g、桑葚子10g、川楝子10g、益母草10g、当归10g、鹿角霜10g、杜仲10g、锁阳10g、山茱萸10g、青皮6g、乌药10g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加糊精，制粒，压片，制成片剂。
3、胶囊剂实施例的制备：取双飞蝴蝶12g、小金牛草10g、茯苓10g、党参10g、怀牛膝12g、山药20g、淫羊藿15g、菟丝子20g、橘皮6g、丹参10g、续断10g、香附10g、熟地黄10g、桑葚子10g、川楝子10g、益母草10g、当归10g、鹿角霜10g、杜仲10g、锁阳10g、山茱萸10g、青皮6g、乌药10g，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加淀粉，制粒，灌装，制成胶囊剂。
4、本发明中药组合物治疗月经先后无定期临床研究
4.1一般性资料：本中药组合物应用于临床观察月经先后无定期病例40例，年龄18～39岁。病程最短者1年，最长者达2年，平均1.5年。
4.2诊断标准：
4.2.1月经周期或前或后，均逾7天以上，并连续2个月经周期以上。
4.2.2月经周期紊乱应与青春期、更年期月经紊乱相区别。
4.2.3妇科检查及B超等排除器质性病变。测基础体温，阴道涂片、宫颈粘液结晶检查以了解卵巢功能情况。
4.2.4证候分类
4.2.4.1肝气郁滞：月经周期不定，经量或多或少，色紫红有块，经行不畅，胸胁、乳房以及小腹胀痛，脘闷不舒，时叹息。苔薄白或薄黄，脉弦。
4.2.4.2肾气不足：月经周期不定，量少，色淡黯，质稀，神疲乏力，腰骶酸痛，头晕耳鸣。舌淡苔少，脉细尺弱。
4.3试验方法：按上述颗粒剂制备方法制备临床样品，规格为每袋10克，五天为一疗程，一天三袋，分早、中、晚三次饭前半小时服用。服药期间忌食生冷、辛辣、刺激及腐烂之物。空白组口服安慰剂颗粒剂，五天为一疗程，一天三袋，分早、中、晚三次饭前半小时服用。
4.4疗效标准：(1)临床痊愈：月经周期恢复正常，维持3个月以上。好转：月经周期恢复正常，但不能维持3个月以上。无效：月经周期末见变化。
4.5治疗效果：见表1。
表1 两组疗效比较
组别 n 痊愈 好转 无效 总有效率(％)
治疗组 20 8 10 2 90
空白组 20 1 1 18 10
可见本发明对月经先后无定期有良好的治疗效果，治疗期间未发生毒副作用。
4.6典型病例：
王某，女，28岁，月经周期不定，经量或多或少，色紫红有块，经行不畅，胸胁、乳房、小腹胀痛，脘闷不舒，时叹息。苔薄白或薄黄，脉弦。诊断为肝气郁滞，服用上述颗粒剂制备方法制备临床样品，规格为每袋10克，一天三袋，分早、中、晚三次饭前半小时服用。服药期间忌食生冷、辛辣、刺激及腐烂之物。2个月后月经周期恢复正常，并维持1年。

Claims (4)

1.一种用于治疗月经先后无定期的中药组合物，其特征在于，它所含的活性成分由下列重量份原料药提取制备而成：双飞蝴蝶12份、小金牛草10份、茯苓10份、党参10份、怀牛膝12份、山药20份、淫羊藿15份、菟丝子20份、橘皮6份、丹参10份、续断10份、香附10份、熟地黄10份、桑葚子10份、川楝子10份、益母草10份、当归10份、鹿角霜10份、杜仲10份、锁阳10份、山茱萸10份、青皮6份、乌药10份。
2.如权利要求1所述用于治疗月经先后无定期的中药组合物，其特征在于，剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
3.如权利要求1所述用于治疗月经先后无定期的中药组合物，其特征在于，制备步骤为：取上述中药，加药材10倍重量的水，浸泡0.5h，煎煮1小时，过滤，药渣再加入药材8倍重量的水，煎煮1小时，药液滤出，合并两次煎煮液，减压浓缩至60℃相对密度为1.05，加乙醇使含醇量的体积百分比达75％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25，并回收乙醇，得浓缩液，将浓缩液喷雾干燥，喷雾干燥条件为：进风温度为100℃，出风温度为90℃，物料温度为70℃，雾化压力为0.2兆帕，喷雾速度为10ml/s，添加辅料制成胶囊剂、片剂、颗粒剂。
4.根据权利要求1所述用于治疗月经先后无定期的中药组合物在治疗月经先后无定期药物中的应用。
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CN104800727A (zh) * 2015-05-12 2015-07-29 南京华宽信息咨询中心 一种用于治疗妇科月经后期的中药组合物
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CN104906366A (zh) * 2015-06-22 2015-09-16 王菊明 一种治疗月经后期的药物制剂
CN104922609A (zh) * 2015-07-17 2015-09-23 孙根火 一种用于治疗胆囊炎的药物制剂
CN104922343A (zh) * 2015-07-17 2015-09-23 孙根火 一种用于治疗耳鸣的药物制剂
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