CN106237190A - 一种治疗膝骨关节炎的中药组合物及其胶囊剂和制备方法 - Google Patents
一种治疗膝骨关节炎的中药组合物及其胶囊剂和制备方法 Download PDFInfo
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- CN106237190A CN106237190A CN201610788558.XA CN201610788558A CN106237190A CN 106237190 A CN106237190 A CN 106237190A CN 201610788558 A CN201610788558 A CN 201610788558A CN 106237190 A CN106237190 A CN 106237190A
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Abstract
本发明提供了一种治疗膝骨关节炎的中药组合物,制备所述中药组合物的主要原料重量份组成为:牛膝、凤凰衣、当归、鸡内金、大黄炭、狗脊、农吉利、五灵脂、鱼腥草、鸡血藤、猫爪草、老鹳草、枫香脂、淫羊藿、豨签草、龙芽草、土槿皮、威灵仙、四季青、乳香、五加皮、巴戟肉、乌梢蛇、菝葜叶、骨碎补;本发明还提供了一种治疗膝骨关节炎的中药组合物的制备方法。该中药组合物配方科学合理,各组分协同配伍,能快速发挥药效,具有阴祛风止痛、舒筋活络,消肿止痛、强壮筋骨之功效,经大量试验证明,本发明能够有效改善人体肝肾亏虚、寒湿入侵、阻滞经络,对膝骨关节炎疗效显著,且疗效优异,标本兼顾,安全方便且无毒副作用,没有任何西药或者激素药成分。
Description
技术领域
本发明涉及中药技术领域,特别涉及一种治疗膝骨关节炎的中药组合物及其胶囊剂和制备方法。
背景技术
膝骨关节炎是以关节软骨退变为核心的累及骨质、滑膜、关节囊及关节其他结构的多方位、多层次、不同程度的慢性炎症。其临床表现多为膝关节疼痛、肿胀、功能障碍、关节粗大、内翻畸形等。膝骨关节炎的发生多为老年人,乃本虚标实之症,加之由于膝关节疼痛而长期缺乏活动,致局部气血运行不足,筋失所养,酸痛麻木,久之易致筋肉萎缩和骨质疏松。
上述治疗膝骨关节炎的手段虽然能够起到缓解疼痛的作用,但是其治标不治本,停止服药后或治疗完毕后依然存在膝骨关节疼痛症状,此外,上述治疗手段无法从根本上去除病患的疼痛,为此急需开发一种能够方便服用,且见效较快的中药组合物。
发明内容
针对上述现有技术中存在的问题与缺陷,本发明提供了一种治疗膝骨关节炎的中药组合物及其胶囊剂和制备方法,该组合物疗效显著、安全方便且无毒副作用,其制备方法高效,提取有效成分效果好,适合工业生产。
本发明具体技术方案如下:
本发明的治疗膝骨关节炎的中药组合物,制备所述中药组合物的主要原料重量份组成为:牛膝10-50份、凤凰衣5-30份、当归10-50份、鸡内金15-55份、大黄炭10-50份、狗脊10-50份、农吉利10-50份、五灵脂5-35份、鱼腥草10-50份、鸡血藤20-60份、猫爪草10-50份、老鹳草10-50份、枫香脂30-60份、淫羊藿10-50份、豨签草10-50份、龙芽草15-55份、土槿皮10-50份、威灵仙5-30份、四季青10-50份、乳香1-20份、五加皮10-50份、巴戟肉10-50份、乌梢蛇1-20份、菝葜叶5-30份、骨碎补5-30份。
进一步地,制备所述中药组合物的主要原料重量份组成为:牛膝20-40份、凤凰衣10-20份、当归20-40份、鸡内金25-45份、大黄炭20-40份、狗脊20-40份、农吉利20-40份、五灵脂10-30份、鱼腥草20-40份、鸡血藤30-50份、猫爪草20-40份、老鹳草20-40份、枫香脂40-50份、淫羊藿20-40份、豨签草20-40份、龙芽草25-45份、土槿皮20-40份、威灵仙10-25份、四季青20-40份、乳香5-15份、五加皮20-40份、巴戟肉20-40份、乌梢蛇5-15份、菝葜叶10-20份、骨碎补10-20份。
进一步地,制备所述中药组合物的主要原料重量份组成为:牛膝30份、凤凰衣15份、当归30份、鸡内金35份、大黄炭30份、狗脊30份、农吉利30份、五灵脂20份、鱼腥草30份、鸡血藤40份、猫爪草30份、老鹳草30份、枫香脂45份、淫羊藿30份、豨签草30份、龙芽草35份、土槿皮30份、威灵仙15份、四季青30份、乳香10份、五加皮30份、巴戟肉30份、乌梢蛇10份、菝葜叶15份、骨碎补15份。
以上组成原料药的重量是以生药计算的,以重量份作为配比,在生产时可按照比例增大或减少,如大规模生产可以以公斤为单位,或以吨为单位,小规模生产也可以以克或毫克为单位,重量可以增大或者减小,但各组成之间的生药材重量配比的比例不变。且以上重量配比的比例是经过科学筛选得到的,可以相应调整组成的量的配比,增加或减少不超过100%,药效不变。
作为本发明的进一步改进,本发明提供了一种治疗膝骨关节炎的制剂,所述制剂由中药组合物单独制成或由和中药组合物和药学上可接受的载体组成。
进一步地,所述制剂为口服制剂或外用制剂,所述口服制剂为水提物、片剂、丸剂、水蜜丸、浓缩丸、散剂、胶囊剂、口服液、颗粒剂或保健茶饮口服制剂;所述外用制剂为熏蒸剂、洗剂或膏剂。
进一步地,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比为1:1-2.5中药组合物与辅料。
进一步地,所述辅料包括以下重量份数的成分:预凝胶淀粉5-15份、硬脂棕榈酰胺5-15份、甲基苯基环氧丙酸乙酯3-7份、羧甲基淀粉钠3-7份、微晶硅胶10-20份、棕榈酸钠3-7份、乙基环糊精5-15份。
进一步地,所述胶囊填充物包括以下重量份数的成分:中药组合物30份、预凝胶淀粉10份、硬脂棕榈酰胺10份、甲基苯基环氧丙酸乙酯5份、羧甲基淀粉钠5份、微晶硅胶15份、棕榈酸钠5份、乙基环糊精10份。
作为本发明的进一步改进,本发明还提供了一种治疗膝骨关节炎的中药组合物的制备方法,该方法包括如下步骤:
S1、称取处方量的牛膝、凤凰衣、当归、鸡内金、大黄炭、狗脊、农吉利、五灵脂、鱼腥草、鸡血藤、猫爪草、老鹳草12味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为150-180目,加水煎煮3次,第一次12倍水量煎煮3h,第二次10倍水量煎煮2h,第二次8倍水量煎煮1h,合并得煎液,温度50℃条件下浓缩成相对密度为1.30的清膏1,冷却,加75%的乙醇进行醇沉2h,过滤,在50℃下浓缩成相对密度为1.45的干浸膏1;
S2、称取处方量的枫香脂、淫羊藿、豨签草、龙芽草、土槿皮、威灵仙、四季青、乳香、五加皮、巴戟肉、乌梢蛇、菝葜叶、骨碎补13味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为60-100目,在搅拌均匀后,加入10倍75%乙醇的回流提取3次,每次1.5h,过滤,合并回流液,浓缩至在55℃下相对密度为1.20的清膏2,用5倍水量将清膏溶解,上大孔树脂柱,依次用水和45%的乙醇洗脱,回收乙醇洗脱液,在55℃下浓缩至相对密度为1.35的干浸膏2;
S3、合并干浸膏1和干浸膏2,将其粉碎成粉,然后置于槽型混合机内混合1h,即得治疗膝骨关节炎的中药组合物。
另外的,本发明还提出了治疗膝骨关节炎的中药组合物作为治疗膝骨关节炎药物中的应用。
由此可见,本发明提供的治疗膝骨关节炎的中药组合物,该中药组合物配方科学合理,各组分协同配伍,能快速发挥药效,具有祛风止痛、舒筋活络,消肿止痛、强壮筋骨之功效,经大量试验证明,本发明能对膝骨关节炎疗效显著,且疗效优异,标本兼顾,疗效肯定,安全方便且无毒副作用,没有任何西药或者激素药成分。
具体实施方式
下面结合具体实施例来进一步描述本发明,本发明的优点和特点将会随着描述而更为清楚。但是应理解所述实施例仅是范例性的,不对本发明的范围构成任何限制。本领域技术人员应该理解的是,在不偏离本发明的精神和范围下可以对本发明技术方案的细节和形式进行修改或替换,但这些修改或替换均落入本发明的保护范围。
实施例1:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝30g、凤凰衣15g、当归30g、鸡内金35g、大黄炭30g、狗脊30g、农吉利30g、五灵脂20g、鱼腥草30g、鸡血藤40g、猫爪草30g、老鹳草30g、枫香脂45g、淫羊藿30g、豨签草30g、龙芽草35g、土槿皮30g、威灵仙15g、四季青30g、乳香10g、五加皮30g、巴戟肉30g、乌梢蛇10g、菝葜叶15g、骨碎补15g。
其中,本实施例提供了一种治疗膝骨关节炎的中药组合物的制备方法,包括如下步骤:
S1、称取处方量的牛膝、凤凰衣、当归、鸡内金、大黄炭、狗脊、农吉利、五灵脂、鱼腥草、鸡血藤、猫爪草、老鹳草12味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为150-180目,加水煎煮3次,第一次12倍水量煎煮3h,第二次10倍水量煎煮2h,第二次8倍水量煎煮1h,合并得煎液,温度50℃条件下浓缩成相对密度为1.30的清膏1,冷却,加75%的乙醇进行醇沉2h,过滤,在50℃下浓缩成相对密度为1.45的干浸膏1;
S2、称取处方量的枫香脂、淫羊藿、豨签草、龙芽草、土槿皮、威灵仙、四季青、乳香、五加皮、巴戟肉、乌梢蛇、菝葜叶、骨碎补13味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为60-100目,在搅拌均匀后,加入10倍75%乙醇的回流提取3次,每次1.5h,过滤,合并回流液,浓缩至在55℃下相对密度为1.20的清膏2,用5倍水量将清膏溶解,上大孔树脂柱,依次用水和45%的乙醇洗脱,回收乙醇洗脱液,在55℃下浓缩至相对密度为1.35的干浸膏2;
S3、合并干浸膏1和干浸膏2,将其粉碎成粉,然后置于槽型混合机内混合1h,即得治疗膝骨关节炎的中药组合物。
实施例2:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝10g、凤凰衣5g、当归10g、鸡内金15g、大黄炭10g、狗脊10g、农吉利10g、五灵脂5g、鱼腥草10g、鸡血藤20g、猫爪草10g、老鹳草10g、枫香脂30g、淫羊藿10g、豨签草10g、龙芽草15g、土槿皮10g、威灵仙5g、四季青10g、乳香1g、五加皮10g、巴戟肉10g、乌梢蛇1g、菝葜叶5g、骨碎补5g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例3:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝15g、凤凰衣8g、当归15g、鸡内金25g、大黄炭15g、狗脊15g、农吉利5g、五灵脂8g、鱼腥草15g、鸡血藤25g、猫爪草15g、老鹳草15g、枫香脂35g、淫羊藿15g、豨签草15g、龙芽草20g、土槿皮15g、威灵仙7g、四季青15g、乳香3g、五加皮15g、巴戟肉15g、乌梢蛇2g、菝葜叶8g、骨碎补7g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例4:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝20g、凤凰衣10g、当归20g、鸡内金25g、大黄炭20g、狗脊20g、农吉利20g、五灵脂10g、鱼腥草20g、鸡血藤30g、猫爪草20g、老鹳草20g、枫香脂40g、淫羊藿20g、豨签草20g、龙芽草25g、土槿皮20g、威灵仙10g、四季青20g、乳香5g、五加皮20g、巴戟肉20g、乌梢蛇5g、菝葜叶10g、骨碎补10g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例5:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝40g、凤凰衣20g、当归40g、鸡内金45g、大黄炭40g、狗脊40g、农吉利40g、五灵脂30g、鱼腥草40g、北冬虫夏50g、猫爪草40g、老鹳草40g、枫香脂50g、淫羊藿40g、豨签草40g、龙芽草45g、土槿皮40g、威灵仙25g、四季青40g、乳香15g、五加皮40g、巴戟肉40g、乌梢蛇15g、菝葜叶20g、骨碎补20g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例6:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝45g、凤凰衣25g、当归45g、鸡内金50g、大黄炭45g、狗脊45g、农吉利45g、五灵脂32g、鱼腥草45g、北冬虫夏55g、猫爪草45g、老鹳草45g、枫香脂55g、淫羊藿45g、豨签草45g、龙芽草50g、土槿皮45g、威灵仙27g、四季青45g、乳香17g、五加皮45g、巴戟肉45g、乌梢蛇18g、菝葜叶25g、骨碎补25g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例7:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝50g、凤凰衣30g、当归50g、鸡内金55g、大黄炭50g、狗脊50g、农吉利50g、五灵脂35g、鱼腥草50g、鸡血藤60g、猫爪草50g、老鹳草50g、枫香脂60g、淫羊藿50g、豨签草50g、龙芽草55g、土槿皮50g、威灵仙30g、四季青50g、乳香20g、五加皮50g、巴戟肉50g、乌梢蛇20g、菝葜叶30g、骨碎补30g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
实施例8:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物30g、预凝胶淀粉10g、硬脂棕榈酰胺10g、甲基苯基环氧丙酸乙酯5g、羧甲基淀粉钠5g、微晶硅胶15g、棕榈酸钠5g、乙基环糊精10g。
实施例9:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:1中药组合物与辅料,具体含量如下:
实施例1的中药组合物34g、预凝胶淀粉5g、硬脂棕榈酰胺5g、甲基苯基环氧丙酸乙酯3g、羧甲基淀粉钠3g、微晶硅胶10g、棕榈酸钠3g、乙基环糊精5g。
实施例10:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2.5中药组合物与辅料,具体含量如下:
实施例1的中药组合物34g、预凝胶淀粉15g、硬脂棕榈酰胺15g、甲基苯基环氧丙酸乙酯7g、羧甲基淀粉钠7g、微晶硅胶20g、棕榈酸钠7g、乙基环糊精15g。
实施例11:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物30g、硬脂棕榈酰胺30g、甲基苯基环氧丙酸乙酯14g、棕榈酸钠16g。
实施例12:
本实施例提出了治疗膝骨关节炎的中药组合物作为治疗膝骨关节炎药物的应用。
对照例1:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物22g、硬脂棕榈酰胺30g、甲基苯基环氧丙酸乙酯14g。
对照例2:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物23g、硬脂棕榈酰胺30g、棕榈酸钠16g。
对照例3:
本实施例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物15g、甲基苯基环氧丙酸乙酯14g、棕榈酸钠16g。
对比例4:
本对照例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物30g、预凝胶淀粉10g、硬脂棕榈酰胺10g、甲基苯基环氧丙酸乙酯8g、羧甲基淀粉钠2g、微晶硅胶15g、棕榈酸钠5g、乙基环糊精10g。
对比例5:
本对照例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:2中药组合物与辅料,具体含量如下:
实施例1的中药组合物30g、预凝胶淀粉10g、硬脂棕榈酰胺10g、羧甲基淀粉钠10g、微晶硅胶15g、棕榈酸钠5g、乙基环糊精10g。
对照例6:
本对照例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:3中药组合物与辅料,具体含量如下:
实施例1的中药组合物20g、预凝胶淀粉10g、硬脂棕榈酰胺10g、甲基苯基环氧丙酸乙酯5g、羧甲基淀粉钠5g、微晶硅胶15g、棕榈酸钠5g、乙基环糊精10g。
对照例7:
本对照例提供治疗膝骨关节炎的中药组合物和辅料制备的外用制剂,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比1:4中药组合物与辅料,具体含量如下:
实施例1的中药组合物15g、预凝胶淀粉10g、硬脂棕榈酰胺10g、甲基苯基环氧丙酸乙酯5g、羧甲基淀粉钠5g、微晶硅胶15g、棕榈酸钠5g、乙基环糊精10g。
以上实施例和对比例中的胶囊剂均用常规制法制备。
对照例8:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝60g、凤凰衣25g、当归13g、鸡内金40g、大黄炭80g、狗脊10g、农吉利35g、五灵脂15g、鱼腥草50g、鸡血藤35g、猫爪草50g、老鹳草70g、枫香脂40g、淫羊藿50g、豨签草60g、龙芽草30g、土槿皮50g、威灵仙30g、四季青50g、乳香20g、五加皮30g、巴戟肉20g、乌梢蛇40g、菝葜叶15g、骨碎补10g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
对照例9:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝30g、当归30g、鸡内金35g、大黄炭30g、狗脊30g、农吉利30g、五灵脂20g、鱼腥草30g、鸡血藤40g、猫爪草30g、老鹳草30g、枫香脂45g、龙芽草35g、土槿皮30g、威灵仙15g、四季青30g、乳香10g、五加皮30g、乌梢蛇10g、菝葜叶15g、骨碎补15g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
对照例10:
本实施例提供了一种治疗膝骨关节炎的中药组合物,该中药组合物包括以下重量克数的原料:
牛膝5g、凤凰衣10g、当归15g、鸡内金8g、大黄炭7g、狗脊4g、农吉利5g、五灵脂15g、鱼腥草20g、鸡血藤10g、猫爪草5g、老鹳草8g、枫香脂15g、淫羊藿5g、豨签草15g、龙芽草10g、土槿皮8g、威灵仙5g、四季青7g、乳香5g、五加皮5g、巴戟肉15g、乌梢蛇5g、菝葜叶10g、骨碎补8g。
其中,本实施例的治疗膝骨关节炎的中药组合物的制备方法,和实施例1相同。
试验例1、本发明提供的包括中药组合物的胶囊剂的体外释放度测定试验
药物组合物的释放度检测:参照2010版《中国药典》附录XIXD体外药物释放度检查。
分别取以上实施例11、对照例1、对照例2和对照例3提供的胶囊剂,并将取出的胶囊剂分别置入溶出仪中,于1h、2h、4h、6h、12h、16h、24h分别取样,并将取出的样品用高效液相色谱法检测溶出百分率,并计算药物的累积释放百分率。
表1.本发明样品的溶出度(%)试验结果
从表中可以看出实施例11的药物组合物在10h内全部释放,对照例1的药物组合物在6h内全部释放,对照例2和对照例3的药物组合物的胶囊剂在24小时之内仅分别释放了90%和85%,因此,本发明提供的药物组合物在添加硬脂棕榈酰胺、甲基苯基环氧丙酸乙酯和棕榈酸钠后,能够显著提高药物组合物原料的稳定性,起到缓释效果,促进中药主料中活性成分的吸收,同时,参照上表,可以发现硬脂棕榈酰胺、甲基苯基环氧丙酸乙酯和棕榈酸钠三者具有协同作用,缺少任意其中一种租房,其释放效果均不理想。
试验例2、本发明提供的包括中药组合物的胶囊剂的崩解时限效果测定
根据中国药典中的规定,测胶囊剂的崩解时限测其对药物组合物的乳化效果。
分别取以上实施例8、对照例4及对照例5提供的胶囊剂,分别测试崩解时限,测试数据结果如下:
表2.不同辅料对胶囊剂崩解时限的影响
从表中可看出,本发明实施例8提供的胶囊剂与对照例4、对照例5提供的胶囊剂相比,本发明含有甲基苯基环氧丙酸乙酯和羧甲基淀粉钠,可以有效提高中药组合物在胶囊剂内的崩解时限,缺少任意其中一个,崩解效果均不好,此外,蔗糖单月桂酸脂和淀粉甘醇酸钠的比例接近1:1时,其崩解效率越快,由此可以证明,蔗糖单月桂酸脂和淀粉甘醇酸钠具有协同促进崩解的作用,故本发明提供的胶囊剂能够快速崩解,能够使药效成分充分快速到达病理部位,从而缓解病患的疼痛。
试验例3、稳定性试验
1.加速试验
取实施例1、实施例6、实施例7、对照例6和对照例7的合剂,分成3批,分别编号为样品1、样品2、样品3、样品4和样品5,在温度40℃±2℃下,相对湿度为75%±5%的条件下放置6个月,在试验期间1个月、2个月、3个月、6个月末分别取样一次,按中国药典中的规定,检测合剂的性状、色泽、气味和主要成分的含量(标示量%)、溶出度以及有关物质,结果发现,样品1、样品2和样品3各项指标均无明显变化,而样品4和样品5颜色变深,出现沉淀,并在6个月的时候均出现轻微异味。
2.长期试验
取实施例1、实施例6、实施例7、对照例6和对照例7的合剂,分成3批,分别编号为样品1、样品2、样品3、样品4和样品5,在温度25℃±2℃下,相对湿度为60%±10%的条件下放置24个月,在试验期间0个月、3个月、6个月、9个月、12个月、18个月、24个月末分别取样一次,按中国药典中的规定,检测合剂的性状、色泽、气味和主要成分的含量(标示量%)、溶出度以及有关物质,结果发现,样品1、样品2和样品3各项指标均无明显变化,而样品4和样品5颜色变深,出现沉淀,并在6个月的时候均出现轻微异味,在12个月时候出现轻微臭味。
结论本发明中药组合物制成的合剂由于辅料的合理选择,药品稳定性好、储存时间长,而硬脂棕榈酰胺和乙基环糊精的加入更显著提高了合剂的稳定性。
试验例4、毒性试验
(一)急性毒性试验
1.试验对象:健康SD大鼠
试验组50例,雄鼠,年龄5周龄;
对照组50例,雄鼠,年龄5周龄。
2.试验方法:
试验组:将本发明治疗膝骨关节炎的中药组合物用生理盐水配制成65%浓度的溶液,给大鼠按一次40mL/kg灌胃,一日内连续两次,然后停药,停药后继续观察7天。
对照组:用生理盐水给大鼠按一次40mL/kg灌胃,一日内连续两次,然后停药,停药后继续观察7天。
3.统计方法:分别在试验1天、2天、3天、4天、5天、6天、7天,记录两组大鼠的死亡率及大鼠行为有无明显异常;在观察期结束后,于第8天处死大鼠,进行剖检,记录两组大鼠的脏器异常改变情况。
4.试验结果:
试验结果见表3。
表3.急性毒性试验结果
表3的比较结果如下:
由试验组和对照组的比较可知,本发明治疗膝骨关节炎的中药组合物对大鼠没有急性毒性。
5.结论:本发明治疗膝骨关节炎的中药组合物,安全度高,无急性毒性。
(二)长期毒性试验
1.试验对象:健康SD大鼠
试验组50例,雄鼠,年龄5周龄;
对照组50例,雄鼠,年龄5周龄。
2.试验方法:
试验组:将本发明治疗膝骨关节炎的中药组合物溶解在水中灌胃,用药剂量以白鼠体重计,每日0.05g/kg,连续180天,停药后继续观察30天。
对照组:喂食与试验组一样且不含本发明中药组合物的食物,食物量也与试验组一样,并灌胃等量生理盐水,连续180天;随后的30天观察期期间,大鼠与试验组一样对待。
3.统计方法:分别在试验0天、30天、60天、90天、120天、150天、180天、及观察期结束时,记录两组大鼠的死亡率及大鼠行为有无明显异常;在观察期结束后,处死大鼠,进行剖检,记录两组大鼠的饮食、饮水、体重增长和脏器异常改变情况。
4.试验结果:试验结果见表4。
表4.长期毒性试验结果
表4的比较结果如下:
由试验组和对照组的比较可知,本发明治疗膝骨关节炎的中药组合物对大鼠无长期毒性;
5.结论:本发明的治疗膝骨关节炎的中药组合物,安全度高,无长期毒性。
(三)结论
由急性毒性试验结果和长期毒性试验结果可知,本发明的治疗膝骨关节炎的中药组合物,安全度高,无毒性。
试验例5、抑菌试验
使用下列化合物,采用本领域中经典的滤纸片法来进行抑菌试验。
供试菌种荚膜红细菌ATCC11166购自上海北诺生物科技有限公司。
培养液
营养琼脂和营养肉汤,购自北京中科晨宇实验设备有限公司。
试验方法
将荚膜红细菌ATCC11166接种于琼脂平板营养液平面上,接种时均匀密布。
取无菌圆形滤纸片,分别喷洒5mL的实施例1中药组合物溶解成的溶液、5mL的实施例2中药组合物溶解成的溶液,至完全润湿,贴在已接种细菌的琼脂平板营养液平面上。将琼脂平板置于37℃的培养箱内,温育4小时。测量抑菌环的直径。测定3次取平均值。
结论
实施例1中药组合物溶解成的溶液的荚膜红细菌ATCC11166的抑菌环的平均直径为11.20mm,实施例2中药组合物溶解成的溶液的荚膜红细菌ATCC11166的抑菌环的平均直径为13.75mm。
治疗膝骨关节炎的效果评价试验
本发明的治疗膝骨关节炎的中药组合物效果如下:
1、临床资料
本发明的各优选实施例已经在150人的规模性测试中获得了验证。
2、疗效评定
痊愈:临床症状全部消失,停药后半年于一年复查未见任何病理性改变:
显效:临床症状全部消失,停药半年后复查病理改变趋于治愈;
无效:临床症状虽有改善,但病理改变无明显好转。
3、统计标准
采用SPSS forWindows 10.0.7统计软件包,计数资料采用x2检验,等级资料采用Ridit分析,计量资料采用t检验,组内不同时点比较采用单因素方差分析,P<0.05为有差异性,测试结果如以下表:
本发明的各优选实施例已经在150人的规模性测试中获得了验证,在用药后,具有祛风止痛、舒筋活络,消肿止痛、强壮筋骨之功效,对膝骨关节炎有很好的治疗效果,痊愈率在85%以上,显效率在90%以上。
典型病例1:
宋某,女,48岁,农民,1年前膝骨关节疼痛、活动不利,初步诊断为膝骨关节炎。服用了本发明的中药组合物,三个月后,症状全部消失,随访至今未再复发。
典型病例2:
王某,男,30岁,运动员,运动受伤致膝骨关节疼痛难忍,长期疼痛5个月,加重,医院治疗无效。服用了本发明的中药组合物,两个个月后,症状全部消失,随访至今未再复发。
典型病例3:
孙某,男,50岁,工人,膝骨关节疼痛不适,行动不利,久治不愈,痛苦不堪。服用了本发明的中药组合物,两个月后,症状全部消失,随访至今未再复发
虽然,上文中已经用一般性说明、具体实施方式及试验,对本发明作了详尽的描述,但在本发明基础上,可以对之作一些修改或改进,这对本领域技术人员而言是显而易见的。因此,在不偏离本发明精神的基础上所做的这些修改或改进,均属于本发明要求保护的范围。
Claims (10)
1.一种治疗膝骨关节炎的中药组合物,其特征在于,制备所述中药组合物的主要原料重量份组成为:牛膝10-50份、凤凰衣5-30份、当归10-50份、鸡内金15-55份、大黄炭10-50份、狗脊10-50份、农吉利10-50份、五灵脂5-35份、鱼腥草10-50份、鸡血藤20-60份、猫爪草10-50份、老鹳草10-50份、枫香脂30-60份、淫羊藿10-50份、豨签草10-50份、龙芽草15-55份、土槿皮10-50份、威灵仙5-30份、四季青10-50份、乳香1-20份、五加皮10-50份、巴戟肉10-50份、乌梢蛇1-20份、菝葜叶5-30份、骨碎补5-30份。
2.如权利要求1所述的治疗膝骨关节炎的中药组合物,其特征在于,制备所述中药组合物的主要原料重量份组成为:牛膝20-40份、凤凰衣10-20份、当归20-40份、鸡内金25-45份、大黄炭20-40份、狗脊20-40份、农吉利20-40份、五灵脂10-30份、鱼腥草20-40份、鸡血藤30-50份、猫爪草20-40份、老鹳草20-40份、枫香脂40-50份、淫羊藿20-40份、豨签草20-40份、龙芽草25-45份、土槿皮20-40份、威灵仙10-25份、四季青20-40份、乳香5-15份、五加皮20-40份、巴戟肉20-40份、乌梢蛇5-15份、菝葜叶10-20份、骨碎补10-20份。
3.如权利要求1所述的治疗膝骨关节炎的中药组合物,其特征在于,其特征在于,制备所述中药组合物的主要原料重量份组成为:牛膝30份、凤凰衣15份、当归30份、鸡内金35份、大黄炭30份、狗脊30份、农吉利30份、五灵脂20份、鱼腥草30份、鸡血藤40份、猫爪草30份、老鹳草30份、枫香脂45份、淫羊藿30份、豨签草30份、龙芽草35份、土槿皮30份、威灵仙15份、四季青30份、乳香10份、五加皮30份、巴戟肉30份、乌梢蛇10份、菝葜叶15份、骨碎补15份。
4.如权利要求1-3中任一项所述的治疗膝骨关节炎的中药组合物的制剂,其特征在于,所述制剂由中药组合物单独制成或由和中药组合物和药学上可接受的载体组成。
5.如权利要求4所述的制剂,其特征在于,所述制剂为口服制剂或外用制剂,所述口服制剂为水提物、片剂、丸剂、水蜜丸、浓缩丸、散剂、胶囊剂、口服液、颗粒剂或保健茶饮口服制剂;所述外用制剂为熏蒸剂、洗剂或膏剂。
6.如权利要求5所述的制剂,其特征在于,所述外用制剂为胶囊剂,所述胶囊剂包括重量份数比为1:1-2.5中药组合物与辅料。
7.如权利要求6所述的制剂,其特征在于,所述辅料包括以下重量份数的成分:预凝胶淀粉5-15份、硬脂棕榈酰胺5-15份、甲基苯基环氧丙酸乙酯3-7份、羧甲基淀粉钠3-7份、微晶硅胶10-20份、棕榈酸钠3-7份、乙基环糊精5-15份。
8.如权利要求6或7所述的制剂,其特征在于,所述胶囊填充物包括以下重量份数的成分:中药组合物30份、预凝胶淀粉10份、硬脂棕榈酰胺10份、甲基苯基环氧丙酸乙酯5份、羧甲基淀粉钠5份、微晶硅胶15份、棕榈酸钠5份、乙基环糊精10份。
9.一种如权利要求1-3中任一项所述的治疗膝骨关节炎的中药组合物的制备方法,其特征在于,所述方法包括如下步骤:
S1、称取处方量的牛膝、凤凰衣、当归、鸡内金、大黄炭、狗脊、农吉利、五灵脂、鱼腥草、鸡血藤、猫爪草、老鹳草12味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为150-180目,加水煎煮3次,第一次12倍水量煎煮3h,第二次10倍水量煎煮2h,第二次8倍水量煎煮1h,合并得煎液,温度50℃条件下浓缩成相对密度为1.30的清膏1,冷却,加75%的乙醇进行醇沉2h,过滤,在50℃下浓缩成相对密度为1.45的干浸膏1;
S2、称取处方量的枫香脂、淫羊藿、豨签草、龙芽草、土槿皮、威灵仙、四季青、乳香、五加皮、巴戟肉、乌梢蛇、菝葜叶、骨碎补13味原料药,粉碎、碾磨、过筛制成细粉,所述筛网的数目为60-100目,在搅拌均匀后,加入10倍75%乙醇的回流提取3次,每次1.5h,过滤,合并回流液,浓缩至在55℃下相对密度为1.20的清膏2,用5倍水量将清膏溶解,上大孔树脂柱,依次用水和45%的乙醇洗脱,回收乙醇洗脱液,在55℃下浓缩至相对密度为1.35的干浸膏2;
S3、合并干浸膏1和干浸膏2,将其粉碎成粉,然后置于槽型混合机内混合1h,即得治疗膝骨关节炎的中药组合物。
10.一种权利要求1-3任一项所述的中药组合物作为治疗膝骨关节炎药物中的应用。
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