CN106511549A - 一种含牛大力的中药组合物及其制备方法 - Google Patents
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Abstract
本发明公开了一种含牛大力的中药组合物及其制备方法,由以下重量份比的原料药制成:西洋参1‑6份、牛大力5‑30份、狗脊5‑30份、杜仲5‑30份、女贞子5‑25份、巴戟天5‑30份、大枣1‑15份、葡萄糖酸钙0.05‑2.0份。本发明组方严谨,药少力专,具补益肝肾、强筋骨等功效,可有效降低骨质疏松的几率,提高免疫力,有效延缓衰老,达到治疗、保健、提高生活质量的目的。
Description
技术领域
本发明属于药品领域,涉及一种含牛大力的能够起到抗骨质疏松功效的中药组合物及其制备方法。
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。随着我国老年人口的不断扩大,骨质疏松的患者也日趋增多,但有效缓解或治疗骨质疏松症的药物或保健食品的不多。本发明通过中医理论指导、科学配方,起到极大缓解患者痛苦,有效提高中老年人的生活质量。本发明外尚未见有西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣组合物的报道。
(1)西洋参,为五加科植物西洋参Panax quinquefolium L.的干燥根。《中国药典》2010年版记载:【性味与归经】甘、微苦,凉。归心、肺、肾经。【功能与主治】补气养阴,清热生津。用于气虚阴亏,虚热烦倦,咳喘痰血,内热消渴,口燥咽干。
(2)牛大力,为豆科崖豆藤属植物美丽崖豆藤Millettia specisoa Champ.的干燥根。【性味归经】甘,平。归肺,肾经。【功能主治】补虚润肺,强筋活络。用于腰肌劳损,风湿性关节炎,治肺热,肺虚咳嗽,肺结核,慢性支气管炎,慢性肝炎,遗精,白带。
(3)狗脊,为蚌壳蕨科植物金毛狗脊Cibotium barometz(L.)J.Sm.的干燥根茎。《中国药典》2015年版记载:【性味与归经】苦、甘,温。归肝、肾经。【功能与主治】祛风湿,补肝肾,强腰膝。用于风湿痹痛,腰膝酸软,下肢无力。
(4)杜仲,为杜仲科植物杜仲Eucommia ulmoides Oliv.的干燥树皮。《中国药典》2015年版记载:【性味与归经】甘,温。归肝、肾经。【功能与主治】补肝肾,强筋骨,安胎。用于肝肾不足,腰膝酸痛,筋骨无力,头晕目眩,妊娠漏血,胎动不安。
(5)女贞子,为木犀科植物女贞Ligustrum lucidum Ait.的干燥成熟果实。《中国药典》2015年版记载:【性味与归经】甘、苦,凉。归肝、肾经。【功能与主治】滋补肝肾,明目乌发。用于肝肾阴虚,眩晕耳呜,腰膝酸软,须发早白,目暗不明,内热消渴,骨蒸潮热。
(6)巴戟天,为茜草科植物巴戟天Morinda offinalis How的干燥根。《中国药典》2015年版记载:【性味与归经】甘,辛,微温。归肾、肝经。【功能主治】补肾阳,强筋骨,祛风湿。用于阳痿遗精,宫冷不孕,月经不调,少腹冷痛,风湿痹痛,筋骨痿软。
(7)大枣,为鼠李科植物枣Ziziphus jujuba Mill.的干燥成熟果实。《中国药典》2015年版记载:【性味与归经】甘,温。归脾、胃、心经。【功能与主治】补中益气,养血安神。用于脾虚食少,乏力便溏,妇人脏躁。
发明内容
本发明的目的是提供一种含牛大力的能够起到抗骨质疏松功效的中药组合物及其制备方法。
本发明人通过中医理论的指导,采用民间中草药的用法与现代中药先进制剂技术相结合,通过合理配制,制成一种含牛大力的中药组合物,此中药组合物含有丰富的营养物质及治疗疾病和改善人体健康的有效成分,制备成药品或保健食品类产品,可以有效降低骨质疏松的几率、提高免疫力,有效延缓衰老,达到治疗、保健、提高生活质量的目的。
本发明所采用的技术方案如下:
一种含牛大力的中药组合物,其特征在于,原料由以下重量份的中药组分组成:西洋参1-6份、牛大力5-30份、狗脊5-30份、杜仲5-30份、女贞子5-25份、巴戟天5-30份、大枣1-15份、葡萄糖酸钙0.05-2.0份。
以上所述含牛大力的中药组合物,优选由以下重量份的中药组分组成:西洋参3-6份、牛大力15-25份、狗脊10-20份、杜仲10-20份、女贞子10-15份、巴戟天10-20份、大枣3-9份、葡萄糖酸钙0.1-1份。
以上所述含牛大力的中药组合物,最佳优选由以下重量份的中药组分组成:西洋参5份、牛大力20份、狗脊15份、杜仲15份、女贞子12份、巴戟天15份、大枣6份、葡萄糖酸钙0.5份。
以上所述的含牛大力的中药组合物,可制备成固体制剂,例如药品、保健食品、食品上允许的制剂,如:散剂、颗粒剂(冲剂)、丸剂、片剂、胶囊等。作为优选,所述固体制剂为胶囊剂、片剂或颗粒剂。
提取是制剂的关键步骤。中药有效成分的提取是一个复杂的过程,当中药样品加入溶剂后,溶剂通过浸泡扩散作用,将中药所含的化学成分逐渐溶解,使其扩散到溶剂中,直到细胞内外溶液中被溶解的化学成分的浓度达到平衡。因此,在提取过程中,中药的粉碎度、提取温度、时间、次数、溶剂等,都是影响提取的因素,选用合理的条件,才能提高有效成分的提取率,达到不同的使用效果。
上述含牛大力的中药组合物制备成制剂的提取方法,包括以下步骤:
((1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按重量份称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
上述含牛大力的中药组合物制备成胶囊剂的方法,包括以下步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按重量份称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
(4)将滤液浓缩成稠膏,干燥,粉碎;
(5)加入西洋参细粉、葡萄糖酸钙、填充剂、润滑剂,混匀,装入胶囊,即得。
其中所述填充剂为本领域普通技术人员所熟知的,如:淀粉、微晶纤维素、乳糖、糊精等中的一种或两种以上组合,所述润滑剂为硬脂酸镁、滑石粉、二氧化硅等中的一种或两种以上组合。
上述含牛大力的中药组合物制备成片剂的方法,包括以下步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按重量份称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
(4)将滤液浓缩,干燥,粉碎。
(5)加入西洋参细粉、葡萄糖酸钙、黏合剂、填充剂、润滑剂、崩解剂,混匀,制粒,干燥,整粒,压片,包糖衣片或薄膜衣片。
其中所述黏合剂有淀粉、羧甲基纤维素钠、羟丙基纤维素、甲基纤维素、乙基纤维素等;润滑剂有硬脂酸镁、微粉硅胶、滑石粉等;崩解剂有干淀粉、羧甲基淀粉钠、低取代羟丙基纤维素、交联聚乙烯吡咯烷酮等。
上述含牛大力的中药组合物制备成颗粒剂的方法,包括以下步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按重量份称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
(4)将滤液浓缩,干燥,粉碎。
(5)加入西洋参细粉、葡萄糖酸钙、甜味剂、辅料,混匀,制粒,干燥,整粒,分装。
以上颗粒剂制备中所述辅料为本领域普通技术人员所熟知的,如:淀粉、糊精、乳糖、糖粉、蔗糖、甘露醇等中的一种或两种以上的组合,所述矫味剂为蔗糖、单糖浆、山梨醇、甘露醇、甜菊苷、天冬甜精等中的一种或两种以上的组合。
本发明含牛大力的中药组合物是在中医药传统理论的基础上,结合民间用药经验,运用现代科学理论配制而成。方中牛大力,具有补虚、强筋骨之功效,为君药;西洋参具有补气养阴之功,亦为君药;狗脊、杜仲、巴戟天、女贞子具有补益肝肾、强筋骨的功效,为臣药;葡萄糖酸钙能有效补充钙质,为方中佐药;大枣补中益气,养血安神,为方中使药。诸药合用共奏补益肝肾、强筋骨之功。本发明组方严谨,药少力专,对骨质疏松、病后虚弱、腰膝酸软有良好的疗效。
本发明的有益效果是:
(1)组分均为无毒“中草药”品种,使用安全。
(2)组方严谨,药少力专,具有补益肝肾、强筋骨之功效,对骨质疏松、病后虚弱有良好的疗效。
(3)含有丰富的营养物质及改善人体健康和的治疗疾病有效成分,且有宜人的芳香气味、口感好,加入适量辅料制备成药品、保健食品类产品,可以补充人体所需的物质、提高免疫力,达到提高生活质量的目的。
具体实施方式
下面结合具体实施例对本发明作进一步描述,但不限制本发明的保护范围和应用范围:
一、胶囊剂的制备
1.试验设计:
本试验用5个实施例分别制备成胶囊剂,具体参数详见表1。
表1胶囊剂实施例制备参数表
2.操作步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按表1所列参数分别称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,按表1所列参数,加5-15倍量水,煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液;
(4)将滤液浓缩成稠膏,干燥,粉碎;
(5)按表1所列参数分别加入西洋参细粉、葡萄糖酸钙以及适量填充剂、润滑剂,混匀,装入胶囊,即得。
二、片剂的制备
1.试验设计:
本试验用5个实施例分别制备成片剂,具体参数详见表2。
表2片剂实施例制备参数表
2.操作步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按表2所列参数分别称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,按表2所列参数,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液;
(4)将滤液浓缩,干燥,粉碎。
(5)按表2所列参数分别加入西洋参细粉、葡萄糖酸钙、黏合剂、填充剂、润滑剂、崩解剂,混匀,制粒,干燥,整粒,压片,包糖衣片或薄膜衣片。
三、颗粒剂的制备
1.试验设计:
本试验用5个实施例分别制备成颗粒剂,具体参数详见表3。
表3颗粒剂实施例制备参数表
2.操作步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按表3所列参数分别称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉(过100目筛);牛大力、狗脊打成粗粉与其余4味中药合并,按表3所列参数,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
(4)将滤液浓缩,干燥,粉碎。
(5)按表3所列参数分别加入西洋参细粉、葡萄糖酸钙、甜味剂、辅料,混匀,制粒,干燥,整粒,分装。
四、临床应用
1、诊断标准
(1)以《中国人骨质疏松症建议诊断标准(第二稿)》为诊断标准,通过双能X线骨密度测量仪(DXA)检测骨密度T值≤-2.5;
(2)临床表现:全身无力、疼痛,多以腰背疼痛为明显,逐渐加重,驼背、身高缩短,轻微外伤可致骨折,脊椎常有突畸形。
2、疗效标淮
根据《中药新药临床研究指导原则》,北京:中国医药科技出版社,作者:郑筱萸;制定疗效标准。
显效:疼痛完全消失,骨密度检查显示骨质密度增加;
有效:疼痛明显缓解,骨密度检查未见骨质密度下降;
无效:与治疗前比较,各方面均无改善。
3.给药方法
(1)胶囊剂治疗组:服用实施例1-5的产品,每次2粒,每天3次,连续服用30天为一个疗程,连续服用3个疗程;
(2)片剂治疗组:服用实施例1-5的产品,每次2片,每天3次,连续服用30天为一个疗程,连续服用3个疗程;
(3)颗粒剂治疗组:服用实施例1-5的产品,每次1袋,每天3次,连续服用30天为一个疗程,连续服用3个疗程;
(2)对照组:服用阿仑膦酸钠片,1日1片(10mg),连续服用30天为一个疗程,连续服用3个疗程。
4、应用结果
本发明含牛大力的中药组合物,曾用于治疗和观察192例骨质疏松症患者。将上述制备好的15种实施例样品,分别用于骨质疏松症患者(男84例,女108例,平均年龄62岁)。结果见表4。
表4临床应用效果表
组别 | 显效(%) | 有效(%) | 无效(%) | 总有效率(%) |
胶囊剂治疗组 | 75.4 | 21.5 | 3.1 | 96.9 |
片剂治疗组 | 73.8 | 21.6 | 4.6 | 95.4 |
颗粒剂治疗组 | 83.1 | 15.4 | 1.5 | 98.5 |
对照组 | 69.2 | 15.4 | 15.4 | 84.6 |
结果表明:采用本发明实施例对骨质疏松症的治疗效果总有效率达95%以上,比对照样品的治疗效果要好,说明本发明中药组合物对抗骨质疏松有良好的疗效,可以有效降低骨质疏松的几率、提高免疫力,有效延缓衰老,达到治疗、保健、提高生活质量的目的。以下为几个典型病例:
病例1:许××,女,69岁,因膝盖碰到沙发角骨折入院,经临床诊断为骨质疏松症,伴随腰脊疼痛、腰膝酸软无力,畏寒肢冷,头晕目眩,舌淡等症状。服用本发明药物实施例1的胶囊剂,每天3次,每次2粒,用药2个疗程病情大有好转,继续用药1个月治愈,随访1年未复发。
病例2:何××,男,68岁,因手腕碰到墙角骨折入院,经临床诊断为骨质疏松症,伴随腰背疼痛、腰膝酸软无力,头晕目眩,精神疲倦,夜尿频多,舌淡等症状。服用本发明药物实施例7的片剂,每天3次,每次2片,用药2个半疗程基本治愈,继续用药半个月治愈,随访1年未复发。
病例3:黄××,女,59岁,因腰脊疼痛难忍入院,经临床诊断为骨质疏松症,伴随腰膝酸软无力,畏寒肢冷,头晕目眩,夜尿频多,体乏困倦等症状。服用本发明药物实施例14的颗粒剂,每天3次,每次1袋,用药2个疗程基本治愈,继续用药1个月治愈,随访1年未复发。
Claims (10)
1.一种含牛大力的中药组合物,其特征在于,由以下重量份的中药组分组成:西洋参1-6份、牛大力5-30份、狗脊5-30份、杜仲5-30份、女贞子5-25份、巴戟天5-30份、大枣1-15份、葡萄糖酸钙0.05-2.0份。
2.根据权利要求1所述的含牛大力的中药组合物,其特征在于,由以下重量份的中药组分组成:西洋参3-6份、牛大力15-25份、狗脊10-20份、杜仲10-20份、女贞子10-15份、巴戟天10-20份、大枣3-9份、葡萄糖酸钙0.1-1份。
3.根据权利要求1所述的含牛大力的中药组合物,其特征在于,由以下重量份的中药组分组成:西洋参5份、牛大力20份、狗脊15份、杜仲15份、女贞子12份、巴戟天15份、大枣6份、葡萄糖酸钙0.5份。
4.根据权利要求1-3中任一所述的含牛大力的中药组合物,其特征在于所述组合物制备成固体制剂。
5.根据权利要求1-3中任一所述的含牛大力的中药组合物,其特征在于所述固体制剂为胶囊剂或片剂、颗粒剂。
6.一种如权利要求5所述的含牛大力的中药组合物制备成制剂的制备方法,其特征在于包括以下步骤:
(1)分别取西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣,净选,干燥;
(2)按重量份称取:西洋参、牛大力、狗脊、杜仲、女贞子、巴戟天、大枣;
(3)将称量好的西洋参打成细粉,过100目筛,备用;
(4)将称量好的牛大力、狗脊打成粗粉与其余4味中药合并,加5-15倍量水煎煮提取1-3次,每次0.5-3小时,滤过,合并滤液,即得;
(5)将上述滤液加入西洋参细粉、葡萄糖酸钙以及适宜的辅料,制成胶囊剂、片剂、颗粒剂。
7.根据权利要求6所述的含牛大力的中药组合物制备成制剂的制备方法,其特征在于所述胶囊剂的制备方法还包括:将步骤(4)所得滤液浓缩成稠膏,干燥,粉碎,然后加入西洋参细粉、葡萄糖酸钙、填充剂和润滑剂,混匀,装入胶囊,即得。
8.根据权利要求6所述的含牛大力的中药组合物制备成胶囊剂的制备方法,其特征在于:所述填充剂为淀粉、微晶纤维素、乳糖和糊精中的一种或一种以上组合;所述润滑剂为硬脂酸镁、滑石粉和二氧化硅中的一种或一种以上组合。
9.根据权利要求6所述的含牛大力的中药组合物制备成制剂的制备方法,其特征在于所述片剂的制备方法还包括:将步骤(4)所得滤液浓缩成稠膏,干燥,粉碎,加入西洋参细粉、葡萄糖酸钙、黏合剂、填充剂、崩解剂、润滑剂,混匀,压片,即得。
10.根据权利要求6所述的含牛大力的中药组合物制备成制剂的制备方法,其特征在于所述颗粒剂的制备方法还包括:将步骤(4)所得滤液浓缩成稠膏,干燥,粉碎,过筛,加入西洋参细粉、葡萄糖酸钙、填充剂、崩解剂、黏合剂、甜味剂,制成软材,制粒,干燥,整粒,分装,即得。
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CN114129662A (zh) * | 2020-09-03 | 2022-03-04 | 华子昂 | 一种孕期女性专用钙片及其制备方法 |
CN114129663A (zh) * | 2020-09-03 | 2022-03-04 | 华子昂 | 一种促进孕期女性补钙的中药组方 |
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CN114129663A (zh) * | 2020-09-03 | 2022-03-04 | 华子昂 | 一种促进孕期女性补钙的中药组方 |
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