CN107468829A - 一种用于治疗骨质疏松的外用软膏 - Google Patents

一种用于治疗骨质疏松的外用软膏 Download PDF

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CN107468829A
CN107468829A CN201710926543.XA CN201710926543A CN107468829A CN 107468829 A CN107468829 A CN 107468829A CN 201710926543 A CN201710926543 A CN 201710926543A CN 107468829 A CN107468829 A CN 107468829A
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李洋
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Nanjing Zhengkuan Pharmaceutical Technology Co Ltd
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Abstract

本发明属于中药制剂领域，具体提供了一种用于治疗骨质疏松的外用软膏，它所含的活性成分由下列重量份原料药提取制备而成：大叶紫珠20‑30份、双飞蝴蝶15‑25份、小叶双眼龙10‑25份、延胡索15‑25份、丹皮10‑20份，本发明能治疗骨质疏松和驱蚊。

Description

一种用于治疗骨质疏松的外用软膏
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骨质疏松的外用软膏及其制备方法和应用。
背景技术
骨质疏松即骨质疏松症，是多种原因引起的一组骨病，骨组织有正常的钙化，钙盐与基质呈正常比例，以单位体积内骨组织量减少为特点的代谢性骨病变。在多数骨质疏松中，骨组织的减少主要由于骨质吸收增多所致。以骨骼疼痛、易于骨折为特征。为此，急要开发出更多安全有效的治疗骨质疏松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骨质疏松疾病的外用软膏。为了达到这个目的，采用如下技术方案：
技术方案：一种用于治疗骨质疏松的外用软膏，它所含的活性成分由下列重量份原料药提取制备而成：大叶紫珠20-30份、双飞蝴蝶15-25份、小叶双眼龙10-25份、延胡索15-25份、丹皮10-20份。
所述用于治疗骨质疏松的外用软膏，它所含的活性成分由下列重量份原料药提取制备而成：大叶紫珠25份、双飞蝴蝶20份、小叶双眼龙20份、延胡索20份、丹皮15份。
所述用于治疗骨质疏松的外用软膏，制备步骤为：取上述中药，其中丹皮粉碎成超微粉；将大叶紫珠、双飞蝴蝶、小叶双眼龙、延胡索加水煎煮3次，每次煎煮1-4小时，每次加水量为6-12倍，滤过，滤液浓缩成50度时相对密度1.08-1.20的清膏，加乙醇使含醇量达60-80％，搅匀，放置1-3天，滤过，回收乙醇至无醇味，并浓缩至80度时相对密度为1.25-1.40的稠膏，减压干燥，粉碎成细粉，与上述丹皮超微粉及适量辅料混匀，制备成软膏剂。
所述用于治疗骨质疏松的外用软膏在制备治疗骨质疏松药物中的应用。
所述用于治疗骨质疏松的外用软膏在制备驱蚊药物中的应用。
大叶紫珠为马鞭草紫珠属植物大叶紫珠Callicarpa macrophylla Vahl，以根和叶入药。夏、秋采叶，洗净鲜用或晒干研末备用；全年都可采根，切片，晒干。散瘀止血，消肿止痛。叶：用于吐血，咯血，衄血，便血；外用治疗外伤出血。根：跌打肿痛，风湿骨痛。
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，***，毒蛇咬伤，跌打损伤。
小叶双眼龙为大戟科巴豆属植物毛果巴豆Croton lachnocarpus Benth.，以根和叶入药。采收储藏：全年均可采收。根，洗净，切片，晒干；叶，鲜用或晒干。祛风除湿、瘀消肿。风湿关节痛，跌打肿痛，毒蛇咬伤。本发明以根入药。
有益效果：中医把骨质疏松症归属“骨痿、骨枯、骨痹”范畴，认为其发病机理为肾虚及脾虚，故针对病机而采用散瘀止血、消肿止痛的治疗法则。本发明大叶紫珠散瘀止血，消肿止痛，双飞蝴蝶祛风化痰、通经散瘀为君药，小叶双眼龙祛风除湿、瘀消肿为臣药，延胡索和丹皮为佐使药，全方相互配伍，治疗骨质疏松效果明显，另发现本发明能驱蚊。
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。
实施例1、取大叶紫珠20份、双飞蝴蝶25份、小叶双眼龙10份、延胡索25份、丹皮10份，其中丹皮粉碎成超微粉；将大叶紫珠、双飞蝴蝶、小叶双眼龙、延胡索加水煎煮3次，每次煎煮1小时，每次加水量为12倍，滤过，滤液浓缩成50度时相对密度1.08的清膏，加乙醇使含醇量达80％，搅匀，放置1天，滤过，回收乙醇至无醇味，并浓缩至80度时相对密度为1.25的稠膏，减压干燥，粉碎成细粉，与上述丹皮超微粉及适量辅料混匀，制备成软膏剂。
实施例2、取大叶紫珠30份、双飞蝴蝶15份、小叶双眼龙25份、延胡索15份、丹皮20份，其中丹皮粉碎成超微粉；将大叶紫珠、双飞蝴蝶、小叶双眼龙、延胡索加水煎煮3次，每次煎煮4小时，每次加水量为6倍，滤过，滤液浓缩成50度时相对密度1.20的清膏，加乙醇使含醇量达60％，搅匀，放置3天，滤过，回收乙醇至无醇味，并浓缩至80度时相对密度为1.40的稠膏，减压干燥，粉碎成细粉，与上述丹皮超微粉及适量辅料混匀，制备成软膏剂。
实施例3、取大叶紫珠25份、双飞蝴蝶20份、小叶双眼龙20份、延胡索20份、丹皮15份，其中丹皮粉碎成超微粉；将大叶紫珠、双飞蝴蝶、小叶双眼龙、延胡索加水煎煮3次，每次煎煮2小时，每次加水量为8倍，滤过，滤液浓缩成50度时相对密度1.10的清膏，加乙醇使含醇量达70％，搅匀，放置2天，滤过，回收乙醇至无醇味，并浓缩至80度时相对密度为1.35的稠膏，减压干燥，粉碎成细粉，与上述丹皮超微粉及适量辅料混匀，制备成软膏剂。。
实施例4：本发明对实验动物的骨密度的影响的药效学研究
样品制备：按实施例1方法制备本发明软膏剂。维A酸片，山东良福制药有限公司，批号：150120
动物：Wistar大鼠，雄性，体重180-240g，上海斯莱克实验动物有限公司提供。
实验分组及骨质疏松大鼠模型的建立：取正常Wistar大鼠40只随机分为4组，取其中10只为NS组；取其中10只作为模型组，单纯按维A酸70mg/kg灌胃两周；取其中20只作为本发明高低剂量组。作为本发明高、低剂量组按70mg/kg的剂量灌服维A酸的同时在腿部外用本发明相应的软膏剂，灌服两周后停服维A酸继续给药两周测定各项指标。大鼠断头处死，取其股骨按组排列，使用X-线乳腺摄像机摄制光片，用黑白密度计于股骨的大转子、股骨头、股骨颈、转子间线上及转子间线下5部位定点测定并记录骨密度值。
本发明对大鼠骨密度的影响
注：与模型组比较，*P<0.05；**P<0.01
实验结果：本发明与模型组比较，具有显著性差异，说明本发明能提高骨密度，治疗骨折，可用于制备增加骨密度药物中的应用。
实施例5：本发明对驱蚊的影响
试验方法：按照GB 24330-2009《家用卫生杀虫用品安全通用技术条件》中驱避剂药效进行测定，测定方法如下，测定结果如表所示。
受试样品：本发明实施1-3软膏剂以及对照组(六神花露水，上海家化联合股份有限公司，180m1/瓶)。供试虫种和品系：白纹伊蚊，室内饲养正常品系，羽化后4-5天雌成蚊后供测定。
试验方法：攻击力试验：在长×宽×高为40cm×30cm×40cm的蚊笼内放入300只试验蚊虫，待其恢复正常活动后，将志愿者的手背暴露4cm×4cm皮肤，其余部分严密遮蔽，手伸入蚊笼中放置2分钟，前来停落的蚊虫多于30只者为攻击力合格，此人及此蚊笼虫可用于驱避试验。
驱避试验：将上述攻击力合格的志愿者分为4组，每组3名，在各攻击力合格的志愿者双手背上各画出5cm×5cm的皮肤面积，其中一只手为空白对照，另一只手按1.5μL/cm2的剂量均匀涂抹待测的本发明，暴露其中的4cm×4cm皮肤，严密遮蔽其余部分。涂抹本发明2小时后，将手伸入放有攻击力合格蚊子的蚊笼中2分钟，观察有无蚊虫前来叮咬，以后每隔半小时测试一次，只要有1头蚊虫前来叮咬即可判作本发明失效。
测试结果如表所示。
本发明软膏剂使用效果评价表
结果表明：本发明实施例1-3所述软膏剂具有显著的驱蚊效果。

Claims (5)

1.一种用于治疗骨质疏松的外用软膏，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：大叶紫珠20-30份、双飞蝴蝶15-25份、小叶双眼龙10-25份、延胡索15-25份、丹皮10-20份。
2.如权利要求1所述用于治疗骨质疏松的外用软膏，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：大叶紫珠25份、双飞蝴蝶20份、小叶双眼龙20份、延胡索20份、丹皮15份。
3.如权利要求1所述用于治疗骨质疏松的外用软膏，其特征在于，制备步骤为：取上述中药，其中丹皮粉碎成超微粉；将大叶紫珠、双飞蝴蝶、小叶双眼龙、延胡索加水煎煮3次，每次煎煮1-4小时，每次加水量为6-12倍，滤过，滤液浓缩成50度时相对密度1.08-1.20的清膏，加乙醇使含醇量达60-80％，搅匀，放置1-3天，滤过，回收乙醇至无醇味，并浓缩至80度时相对密度为1.25-1.40的稠膏，减压干燥，粉碎成细粉，与上述丹皮超微粉及适量辅料混匀，制备成软膏剂。
4.根据权利要求1所述用于治疗骨质疏松的外用软膏在制备治疗骨质疏松药物中的应用。
5.根据权利要求1所述用于治疗骨质疏松的外用软膏在制备驱蚊药物中的应用。
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