CN106266971A - 一种用于治疗乳腺增生的药物制剂 - Google Patents
一种用于治疗乳腺增生的药物制剂 Download PDFInfo
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Abstract
本发明属于中药制剂领域，具体提供了一种治疗乳腺增生的药物制剂，它由如下原料制备得到：铃茵陈25份、树扁竹20份、竹叶兰22份、石柑子20份、赤芍18份、皂角刺20份、十大功劳叶20份、莪术25份、全蝎20份、乳香20份、没药20份、丹参25份、鱼腥草20份、甘草5份，本发明能治疗乳腺增生。
Description
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乳腺增生的药物制剂及其制备方法和应用。
背景技术
乳腺增生是指乳腺上皮和纤维组织增生，乳腺组织导管和乳小叶在结构上的退行性病变及进行性结缔组织的生长，其发病原因主要是由于内分泌激素失调。乳腺增生症是女性最常见的乳房疾病，其发病率占乳腺疾病的首位。近些年来该病发病率呈逐年上升的趋势，年龄也越来越低龄化。据调查约有70％～80％的女性都有不同程度的乳腺增生，多见于25～45岁的女性。为此，急要开发出更多安全有效的治疗乳腺增生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乳腺增生疾病的中药制剂。为了达到这个目的，采用如下技术方案：
技术方案：一种用于治疗乳腺增生的药物制剂，它所含的活性成分由下列重量份原料药提取制备而成：铃茵陈25份、树扁竹20份、竹叶兰22份、石柑子20份、赤芍18份、皂角刺20份、十大功劳叶20份、莪术25份、全蝎20份、乳香20份、没药20份、丹参25份、鱼腥草20份、甘草5份。
所述用于治疗乳腺增生的药物制剂，剂型是药学上可接受的颗粒剂、片剂、胶囊剂。
所述用于治疗乳腺增生的药物制剂，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。
所述用于治疗乳腺增生的药物制剂在制备治疗乳腺增生药物中的应用。
铃茵陈，拉丁学名为RootofDivaricateHoundstongue，为玄参科草本植物姻行草之全草，产江苏、安徽、浙江、云南、广西等地。功用与茵陈蒿相似，清热利湿，活血祛瘀。治黄疸，小便不利，水肿腹胀，跌损瘀痛，血痢，血淋，白带过多，月经不调，症瘕积聚，产后停瘀腹痛。
树扁竹为兰科莪白兰属植物鸢尾扁竹兰OberoniairidifoliaLindl.，以全草入药。四季可采，开水烫后，晒干。理气消食，清热利尿，止咳止痛。用于消化不良，胃痛，肠炎，尿路感染，咳嗽，支气管炎，哮喘，跌打损伤，骨折，毒蛇咬伤。
竹叶兰，拉丁学名Arundinagraminifolia，兰科科，树兰族，竹叶兰属，性味苦，平。清热解毒，祛风除湿，止痛，利尿。用于肝炎，关节痛，腰酸腿痛，胃痛，淋证，小便涩痛，脚气水肿，瘰疬，肺痨，牙痛，咽喉痛，感冒，小儿惊风，小儿疳积，咳嗽，食物中毒，跌伤，蛇咬伤，外伤出血。本发明以全草入药。
石柑子为天南星科石柑子属植物石蒲藤Pothoschinensis(Raf.)Merr.，以全草入药。全年可采，鲜用或晒干。祛风除湿，活血散瘀，消积，止咳。用于跌打损伤，晚期血吸虫病肝脾肿大，风湿性关节炎，小儿疳积，咳嗽；外用治骨折，中耳炎，鼻窦炎。其余中药为药典品种。
有益效果：中医将乳腺增生病称为“乳癖”。一般认为，乳癖是由于各种原因导致肝郁气滞或冲任失调造成，临床应予疏肝解郁，调摄冲任为大法进行辨治。本发明铃茵陈、树扁竹、竹叶兰、石柑子、鱼腥草清热解毒为君药，赤芍、皂角刺、十大功劳叶、莪术、全蝎、乳香、没药、丹参活血化瘀为臣药，甘草为佐使药，全方相互配伍，治疗乳腺增生效果明显。
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：取铃茵陈25g、树扁竹20g、竹叶兰22g、石柑子20g、赤芍18g、皂角刺20g、十大功劳叶20g、莪术25g、全蝎20g、乳香20g、没药20g、丹参25g、鱼腥草20g、甘草5g，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50g，制粒，制成颗粒剂。
2、片剂实施例的制备：取铃茵陈25g、树扁竹20g、竹叶兰22g、石柑子20g、赤芍18g、皂角刺20g、十大功劳叶20g、莪术25g、全蝎20g、乳香20g、没药20g、丹参25g、鱼腥草20g、甘草5g，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50g，制粒，压片，制成片剂。
3、胶囊剂实施例的制备：取铃茵陈25g、树扁竹20g、竹叶兰22g、石柑子20g、赤芍18g、皂角刺20g、十大功劳叶20g、莪术25g、全蝎20g、乳香20g、没药20g、丹参25g、鱼腥草20g、甘草5g，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50g，制粒，灌装，制成胶囊剂。
4、本发明药物制剂治疗乳腺增生临床研究
4.1一般性资料：本药物制剂应用于临床观察乳腺增生病例50例，年龄28～54岁。病程最短者4个月，最长者达3年。
4.2诊断标准：参照《最新国内外疾病诊疗标准》(陈贵廷.最新国内外疾病诊疗标准[M].北京：学苑出版社，1991.807.)：①单侧或双侧乳房胀痛，常于经前期加剧；②临床体验单侧或双侧乳房触及一个或数个肿块；③利用乳房X线钼靶摄片、红外线扫描仪、肿块穿刺涂片等现代检测手段为辅助诊断。排除其它良性、恶性病变。
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，一个月为一疗程，一天三袋，分早、中、晚三次饭前半小时服用。
4.4疗效标准：痊愈：肿块和乳痛消失，停止治疗半年不复发；显效：肿块最大直径缩小1/2以上且乳痛消失；有效：肿块最大直径缩小不足1/2但乳痛减轻或肿块缩小1/2以上，乳痛为减轻；无效：肿块无缩小或反而增大变硬，或单纯乳痛缓解，而肿块不缩小者。
4.5治疗效果：见表1。
表1两组疗效比较
可见，本发明制得的药物能够安全有效治疗乳腺增生，且无毒副作用。
Claims (4)
1.一种用于治疗乳腺增生的药物制剂，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：铃茵陈25份、树扁竹20份、竹叶兰22份、石柑子20份、赤芍18份、皂角刺20份、十大功劳叶20份、莪术25份、全蝎20份、乳香20份、没药20份、丹参25份、鱼腥草20份、甘草5份。
2.如权利要求1所述用于治疗乳腺增生的药物制剂，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所述用于治疗乳腺增生的药物制剂，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所述用于治疗乳腺增生的药物制剂在治疗乳腺增生药物中的应用。
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