CN105477249A - 一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物 - Google Patents
一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物 Download PDFInfo
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- CN105477249A CN105477249A CN201510970212.7A CN201510970212A CN105477249A CN 105477249 A CN105477249 A CN 105477249A CN 201510970212 A CN201510970212 A CN 201510970212A CN 105477249 A CN105477249 A CN 105477249A
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Abstract
本发明提供了一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，它由如下重量份数的原料制备得到：石楠叶5-15份、石菖蒲5-15份、苍术5-15份、制半夏5-15份、制香附5-15份、广陈皮4-8份、熟地黄3-7份，通过祛湿化痰，理气止痛的功效，用于治疗胰岛素抵抗型多囊卵巢综合征的目的，并公开了制备方法和用途。
Description
技术领域
本发明涉及中药技术领域，具体涉及一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其制备方法和应用。
背景技术
多襄性卵巢综合征(polycysticovarysyndrome，PCOS)是育龄妇女最常见的内分泌紊乱综合征。本病原因涉及中枢神经系统垂体卵巢轴、肾上腺、胰岛及遗传等方面。其典型的临床表现为月经异常、不孕、多毛、肥胖等，并随年龄的增长而出现胰岛素抵抗或高胰岛素血症和高脂血症。1935年Sterin-Leventhae根据临床表现及卵巢形态首先报道本征。近年来随着不断深人研究，认识到PCOS并非是一种单一的疾病，而是一种多病因、表现极不均一的临床综合征。胰岛素抵抗(insulinresistance)与高胰岛素血症目前认为胰岛素抵抗与高胰岛素血症是PCOS常见的表现。PCOS妇女胰岛素水平升高能使卵巢雄激素合成增加，雄激素活性增高可明显影响葡萄糖和胰岛素内环境稳定。伴有高雄激素血症的PCOS患者无论肥胖与否，即使月经周期正常，均伴有明显的胰岛素抵抗。也有学者认为高浓度的胰岛素可与胰岛素样的生长因子1(IGF-1)受体结合，PCOS患者卵巢间质组织上IGF-1受体数目比正常者高，在胰岛素抵抗状态下，胰岛素对卵巢的作用可通过IGF-I受体发挥作用。胰岛素和黄体激素具有协同作用，前者可刺激颗粒细胞使之分泌孕酮，使颗粒细胞黄体化，诱导颗粒细胞的LH受体，同时改变肾上腺皮质对ACTH的敏感性。中医认为，多囊卵巢综合症主要与肾的先天禀赋不足、脾胃后天运化失调以及肝气郁结有关。
人们迫切需要一种行之有效、己被大多数人证实能起良好效果的治疗胰岛素抵抗型多囊卵巢综合征的中药组合物。
发明内容
发明目的：为了解决上述问题，本发明的目的在于提供一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物及其制备方法和应用。
技术方案：本发明的目的是通过如下的方案实现的：
一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，它由如下重量份数的原料制备得到：石楠叶5-15份、石菖蒲5-15份、制苍术5-15份、制半夏5-15份、制香附5-15份、广陈皮4-8份、熟地黄4-8份。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，它由如下重量份数的原料制备得到：石楠叶10份、石菖蒲10份、制苍术10份、制半夏10份、制香附10份、广陈皮6份、熟地黄6份。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，所述原料经提取后添加辅料制成口服液、片剂、胶囊或颗粒剂。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，制备方法包括如下步骤：取石楠叶、石菖蒲、制苍术、制半夏、制香附、广陈皮、熟地黄药材合并，加水煎煮两次，合并煎液，减压浓缩至65℃时相对密度为1.15-1.20的浸膏，加乙醇使含醇量的体积百分比达75-85％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25-1.30，并回收乙醇，得浓缩液，将浓缩液加水及辅料配制成口服液，或将浓缩液喷雾干燥，添加辅料制成胶囊剂、片剂、颗粒剂。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，制备方法步骤中，煎煮条件为：第一次加水为药材重量的8-12倍量，煎煮1-2h，第二次加水为药材重量的6-10倍量，煎煮1-2h。
所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，制备方法步骤中，喷雾干燥条件为：进风温度为100-120℃，出风温度为80-90℃，物料温度为70-90℃，雾化压力为0.2-0.4兆帕，喷雾速度为5-10ml/s。
所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物在制备治疗胰岛素抵抗型多囊卵巢综合征的药物中的应用。
有益效果：1、从中医理论看，多囊卵巢综合症主要与肾的先天禀赋不足、脾胃后天运化失调以及肝气郁结有关，其中痰湿阻滞，冲任失调，胞脉不利，以月经周期延后，经量少，色淡质黏稠，渐至闭经，或婚久不孕，形体丰满或肥胖，多毛，或乳房胀痛，神疲肢重，苔白腻，脉滑或沉滑为常见症的多囊卵巢综合征证候。本方中石楠叶祛风，通络，益肾，石菖蒲化湿开胃，开窍豁痰，醒神益智，苍术燥湿健脾，祛风散寒，明目，制半夏燥湿化痰，石楠叶、石菖蒲、苍术、制半夏合用，共为君药，香附理气解郁，调经止痛，南星具有散风、祛痰、镇惊、止痛，制香附、熟地黄合为臣药，增加君药化湿功能，广陈皮理气开胃，为佐使药，全方合用，相得益彰，共奏祛湿化痰，理气止痛的功效，用于治疗胰岛素抵抗型多囊卵巢综合征。2、本发明处方设计合理，配伍严谨，经长期的临床验证，疗效确切。3、本发明组成为中药材，石楠叶为为蔷薇科植物石楠PhotiniaserrulataLindl.的叶，石菖蒲为天南星科植物石菖蒲AcorustatarinowiiSchott的干燥根茎，其余为药典品种，无毒副作用，价格便宜。
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、制备实施例
实施例1：取石楠叶5g、石菖蒲15g、苍术5g、制半夏15g、制香附15g、广陈皮4g、熟地黄4g药材合并，加水煎煮两次，第一次加水为药材重量的8倍量，煎煮1h，第二次加水为药材重量的6倍量，煎煮1h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.10，加95％(v/v)乙醇使含醇量达85％(v/v)，搅拌，静置24小时，滤液减压回收乙醇并浓缩，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.30，喷雾干燥(条件为进风温度为120℃，出风温度为100℃，物料温度为90℃，雾化压力为0.4兆帕，喷雾速度为10ml/s。)，加入淀粉，混合均匀，用适量80％(v/v)乙醇润湿，制软材，过30目筛制粒，于70～80℃干燥，用60目筛整粒，压片，包糖衣，分装，外包装，送检合格，得片剂。
实施例2：取石楠叶10g、石菖蒲10g、苍术10g、制半夏10g、制香附10g、广陈皮6g、熟地黄5g药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15，加95％(v/v)乙醇使含醇量达75％(v/v)，搅拌，静置24小时，滤液减压回收乙醇并浓缩，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，喷雾干燥(条件为进风温度为100℃，出风温度为80℃，物料温度为80℃，雾化压力为0.2兆帕，喷雾速度为5ml/s。)，加入糊精等，干法制粒，过60目筛，装入1号胶囊即可得胶囊剂。
实施例3：取石楠叶15g、石菖蒲5g、苍术15g、制半夏5g、制香附5g、广陈皮8g、熟地黄8g药材合并，加水煎煮两次，第一次加水为药材重量的12倍量，煎煮2h，第二次加水为药材重量的10倍量，煎煮2h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15，加95％(v/v)乙醇使含醇量达75％(v/v)，搅拌，静置24小时，滤液减压回收乙醇并浓缩，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，喷雾干燥(条件为进风温度为110℃，出风温度为85℃，物料温度为85℃，雾化压力为0.3兆帕，喷雾速度为7.5ml/s。)，加入上述β-环糊精包合物，粉碎，再加入适当乳糖，用适量80％(v/v)乙醇润湿，制软材，过14目筛制粒，50-80℃干燥，60目整粒，得颗粒剂。
实施例4：取石楠叶10g、石菖蒲10g、苍术10g、制半夏10g、制香附10g、广陈皮6g、熟地黄6g药材合并，加水煎煮两次，第一次加水为药材重量的10倍量，煎煮1.5h，第二次加水为药材重量的8倍量，煎煮1.5h，合并煎液，0.07MPa、60-70℃下减压浓缩至65℃时相对密度为1.15，加95％(v/v)乙醇使含醇量达75％(v/v)，搅拌，静置24小时，滤液减压回收乙醇并浓缩，滤液在0.07MPa、65℃条件下减压浓缩成至65℃时相对密度为1.25，加水及蔗糖，制备成口服液。
2.对实验动物的影响药效学研究
实验药物和试剂：按上述口服液实施例的制备方法制备，得口服液成品10支。规格：10ml/支(相当于含生药7.1g)，注射用人绒毛膜促性腺激素，丽珠集团丽珠制药厂生产，丙酸睾丸酮注射液，天津金耀氨基酸有限公司生产，T、FSH、LH、E2，放射免疫试剂盒；购自武汉博士德生物技术有限公司。
给药剂量：按照《人和动物间按体表面折算的等效剂量比值表》，每日70公斤人的用量为20g，每日每只200g大鼠的用量为20*0.018＝0.36g，因每支口服液10ml含生药量为7.1g，即每只大鼠的用量为0.51ml，因此确定小剂量每只灌胃0.5ml口服液，中剂量和高剂量分别灌胃1ml和2ml，每日每只200g大鼠灌胃的口服液含生药量分别为0.35g，0.7g，1.4g，则按大鼠体重计，低剂量、中剂量和高剂量分别为1.75g生药量/kg、3.5g生药量/kg和7g生药量/kg。
实验动物：SD清洁级大鼠50只，雌性，体重40～50g，上海斯莱克实验动物中心提供。
实验过程：随机将50只大鼠分为4组，分别为：空白组、模型组、本发明小剂量组、本发明中剂量组、本发明大剂量组，每组l0只，造模，除空白组正常饲养外，其它,4组采用丙酸睾丸酮(T)+绒促性素(HCG)建立PCOS动物模型。21日龄SD大鼠每日颈背部皮下注射HCG5U/只，隔日注射丙酸睾丸酮1.25mg/只(0.05mL)，连续注射21天，空白组给予生理盐水0.05mL。造模结束后进入治疗阶段。各组连续用药14天。于58日龄处死大鼠,心脏取血。经3000r/min离心10min，分离无溶血血清标本置-20度冰箱保存，对PCOS大鼠血清放射免疫法测血睾酮(T)、雌二醇(E2)、卵泡刺激素(FSH)、黄体生成素(LH)的含量定。结果如下：
表1本发明对PCOS大鼠血清T、LH、FSH、E2含量(X±SD)
注：与模型组比较，*P<0.05；**P<0.01
实验结论：本实验中，采用T+HCG联合造模能升高大鼠T、LH，说明造模成功，用药后，本发明能降低模型大鼠T、LH，显示出本发明对胰岛素抵抗型多囊卵巢综合征具有一定的治疗作用。
Claims (8)
1.一种用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，它由如下重量份数的原料制备得到：石楠叶5-15份、石菖蒲5-15份、制苍术5-15份、制半夏5-15份、制香附5-15份、广陈皮4-8份、熟地黄4-8份。
2.根据权利要求1所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，它由如下重量份数的原料制备得到：石楠叶10份、石菖蒲10份、制苍术10份、制半夏10份、制香附10份、广陈皮6份、熟地黄6份。
3.根据权利要求1或2所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，所述原料经提取后添加辅料制成口服液、片剂、胶囊或颗粒剂。
4.根据权利要求3所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，所述辅料为糊精、乳糖、淀粉、蔗糖、葡萄糖、微晶纤维素、甘露糖、甲基纤维素、羟丙基纤维素、羧甲基纤维素和甜菊苷的一种或几种。
5.权利要求1所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，制备方法包括如下步骤：取石楠叶、石菖蒲、制苍术、制半夏、制香附、广陈皮、熟地黄药材合并，加水煎煮两次，合并煎液，减压浓缩至65℃时相对密度为1.15-1.20的浸膏，加乙醇使含醇量的体积百分比达75-85％，搅拌，静置，过滤，滤液减压浓缩至65℃时相对密度为1.25-1.30，并回收乙醇，得浓缩液，将浓缩液加水及辅料配制成口服液，或将浓缩液喷雾干燥，添加辅料制成胶囊剂、片剂、颗粒剂。
6.根据权利要求5所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，制备方法步骤中，煎煮条件为：第一次加水为药材重量的8-12倍量，煎煮1-2h，第二次加水为药材重量的6-10倍量，煎煮1-2h。
7.根据权利要求5所述的用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物，其特征在于，制备方法步骤中，喷雾干燥条件为：进风温度为100-120℃，出风温度为80-90℃，物料温度为70-90℃，雾化压力为0.2-0.4兆帕，喷雾速度为5-10ml/s。
8.权利要求1所述用于治疗胰岛素抵抗型多囊卵巢综合征的中药组合物在制备治疗胰岛素抵抗型多囊卵巢综合征的药物中的应用。
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| CN111317777A (zh) * | 2020-05-08 | 2020-06-23 | 河南中医药大学 | 一种治疗肾虚痰湿型多囊卵巢综合征不孕症的中药汤 |
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| CN105853659A (zh) * | 2016-06-15 | 2016-08-17 | 山东中医药大学附属医院 | 一种治疗多囊卵巢综合征的中药组合物 |
| CN105853659B (zh) * | 2016-06-15 | 2021-06-18 | 山东中医药大学附属医院 | 一种治疗多囊卵巢综合征的中药组合物 |
| CN111317777A (zh) * | 2020-05-08 | 2020-06-23 | 河南中医药大学 | 一种治疗肾虚痰湿型多囊卵巢综合征不孕症的中药汤 |
| CN112316122A (zh) * | 2020-11-02 | 2021-02-05 | 山东省大健康精准医疗产业技术研究院 | 一种治疗多囊卵巢综合征的组合物及其制备方法与应用 |
| CN112316122B (zh) * | 2020-11-02 | 2022-08-09 | 山东省大健康精准医疗产业技术研究院 | 一种治疗多囊卵巢综合征的组合物及其制备方法与应用 |
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