CN114252550A - 一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法及应用 - Google Patents
一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法及应用 Download PDFInfo
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- CN114252550A CN114252550A CN202111542342.2A CN202111542342A CN114252550A CN 114252550 A CN114252550 A CN 114252550A CN 202111542342 A CN202111542342 A CN 202111542342A CN 114252550 A CN114252550 A CN 114252550A
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Abstract
一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法及应用,本发明的质量控制方法通过对六种中药组分的薄层色谱鉴别,使得该中药组合物的质量能够得到精确的控制;另外,该中药组合物能够用于治疗血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭。本发明通过当归补血活血,养心肝之血,以补血和营,补血且能行血调经,调经止痛,熟地黄补血且能滋阴,填精益髓,二味为君药,黄芪补脾肺之气,以益生血之源,白芍善于敛阴养血,柔肝止痛,川芎辛散温通,功能活血行气,为血中气药,紫草具有解毒,凉血活血之效,诸药合用,共凑益气生血,养血理血,补血养阴,行气止痛,养血柔肝调经。
Description
技术领域
本发明涉及中药技术领域,尤其是涉及一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法及应用。
背景技术
现代社会工作压力较大,熬夜加班成为常态,长时间处于压力较大的环境下,很容易出现血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭、两目昏花、视物不明等病症。
发明内容
为了克服背景技术中的不足,本发明公开了一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法及应用,本发明通过当归补血活血,养心肝之血,以补血和营,补血且能行血调经,调经止痛,熟地黄补血且能滋阴,填精益髓,二味为君药,黄芪补脾肺之气,以益生血之源,白芍善于敛阴养血,柔肝止痛,川芎辛散温通,功能活血行气,为血中气药,紫草具有解毒,凉血活血之效,诸药合用,共凑益气生血,养血理血,补血养阴,行气止痛,养血柔肝调经。
为了实现所述发明目的,本发明采用如下技术方案:
一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法,所述的中药组合物是由以下中药成分组成:当归、熟地黄、白芍、川芎、黄芪和紫草,所述的质量控制方法包括鉴别和含量测定;
鉴别:
(1)对当归药材的薄层色谱鉴别
取加工成品5g,研细,加乙醚30ml,浸渍30分钟,时时振摇,滤过,滤液挥干,残渣加无水乙醇1ml使溶解,作为供试品溶液,另取当归对照药材1g,同法制成对照药材溶液,照薄层色谱法试验,吸取上述两种溶液各5µl,分别点于同一硅胶G薄层板上,以正己烷和乙酸乙酯按9:1混合后为展开剂,展开,取出,晾干,置紫外光灯下检视,供试品色谱中,在与对照药材色谱相应的位置上,显相同的亮蓝白色荧光斑点;
(2)对黄芪药材的薄层色谱鉴别
取加工成品5g,研细,加甲醇30ml,置水浴上回流30分钟,滤过,滤液置水浴上蒸干,残渣加水30ml使溶解,用以水饱和的正丁醇提取3次,每次20ml,合并正丁醇溶液,用水洗涤3次,每次20ml,弃去水液,正丁醇液置水浴上蒸干,残渣加甲醇5ml使溶解,加于已处理好的中性氧化铝柱上,用40%甲醇50ml洗脱,收集洗脱液,置水浴上蒸干,残渣加甲醇0.5ml使溶解,作为供试品溶液,另取黄芪甲苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液,照薄层色谱法试验,吸取上述对照品溶液5μl、供试品溶液10μl,分别点于同一硅胶G薄层板上,以三氯甲烷和甲醇按照65:35的比例在10℃以下放置的下层溶液为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在105℃烘约5分钟,分别置日光及紫外光灯下检视,供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点或荧光斑点;
(3)对熟地黄药材的薄层色谱鉴别
取加工成品2.5g,研细,加水10ml使溶解,用水饱和正丁醇振摇提取3次,每次10ml,合并正丁醇液,蒸干,残渣加甲醇1ml使溶解,作为供试品溶液;另取熟地黄对照药材1g,加水50ml,煎煮30分钟,滤过,滤液浓缩至10ml,同法制成对照药材溶液;再取毛蕊花糖苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液和对照药材溶液各2~5μl、对照品溶液 2μl,分别点于同一聚酰胺薄膜上,以甲醇-冰醋酸-水按照2∶1∶7的比例混合后为展开剂,取出,晾干,置紫外光灯下检视;供试品色谱中,在与对照药材色谱和对照品色谱相应的位置上,显相同颜色的荧光斑点;
(4) 对川芎的的薄层色谱鉴别
取加工成品适量,研细,取 5g,加水 25ml,回流提取 30 分钟,放冷,滤过,滤液蒸干,残渣加甲醇 1ml 使溶解,作为供试品溶液;另取川芎对照药材1g,同法制成对照药材溶液;照薄层色谱法试验,吸取上述二种溶液各 4~10μl,分别点于同一硅胶 G 薄层板上,以环己烷-二氯甲烷-冰醋酸按照8∶8∶1混合为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在 105℃加热至斑点显色清晰,置紫外光灯下检视;供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的荧光斑点;
(5) 对白芍的的薄层色谱鉴别
取加工成品5g,研细,加乙醇 20ml,超声处理 5 分钟,滤过,滤液浓缩至约 1ml,作为供试品溶液;另取白芍对照药材 2g,同法制成对照药材溶液;再取芍药苷对照品,加乙醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液与对照药材溶液各 2µl、对照品溶液 5µl,分别点于同一硅胶G薄层板上,以三氯甲烷-乙酸乙酯-甲醇-甲酸按照40:5:10:0.2的比例混合后为展开剂,展开,取出,晾干,喷以5%香草醛硫酸溶液,加热至斑点显色清晰;供试品色谱中,在与对照药材和对照品色谱相应的位置上,显相同颜色的斑点;
(6)对紫草的的薄层色谱鉴别
取加工成品粉末2g,加60~90℃石油醚20ml,超声处理20分钟,滤过,滤液浓缩至1ml,作为供试品溶液;另取紫草对照药材0.5g,同法制成对照药材溶液;照薄层色谱法试验,吸取两种溶液各4μ1,分别点于同一硅胶G薄层板上,以环己烷-甲苯-乙酸乙酯-甲酸按照5:5:0.5:0.1混合为展开剂,展开,取出,晾干;供试品色谱中,在与对照药材色谱相应的位置上,显相同的紫红色斑点;再喷以10%氢氧化钾甲醇溶液,斑点变为蓝色;
含量测定:
(1)色谱条件与系统适用性试验:用十八烷基硅烷键合硅胶为填充剂,乙腈和1%磷酸溶液按照15:85的比例混合后为流动相,检测波长为236nm,理论板数按芍药苷峰计算应不低于1000;
(2)对照品溶液的制备:精密称取经五氧化二磷干燥至恒重的芍药苷对照品适量,加甲醇制成每1ml含100μg的溶液,摇匀,即得;
(3)供试品溶液的制备:取本品2g,研细,精密称定,置50ml量瓶中,加甲醇40ml,超声处理30分钟,放冷至室温,加甲醇稀释至刻度,摇匀,滤过,弃去初滤液,精密量取续滤液25ml,置蒸发皿中,在水浴上蒸干,残渣加水适量使溶解,移至10ml量瓶中,加水稀释至刻度,摇匀,用微孔滤膜,滤过,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各10μl,注入液相色谱仪,测定,即得。
一种通过上述质量控制方法获得中药组合物的应用,该中药组合物能够应用于治疗血虚、血瘀或兼阴虚妇科疾病。
所述妇科疾病包括血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭。
由于采用了上述技术方案,本发明具有如下有益效果:
本发明的质量控制方法通过对六种药组成分分别进行照薄层色谱法试验,尤其是对熟地黄药材的薄层色谱鉴别,采用毛蕊花糖苷对照品,提高了药品的质量标准的可控性,进一步确保产品内在质量和疗效。
另外,在本发明中,通过当归补血活血,养心肝之血,以补血和营,补血且能行血调经,调经止痛,熟地黄补血且能滋阴,填精益髓,二味为君药,黄芪补脾肺之气,以益生血之源,白芍善于敛阴养血,柔肝止痛,川芎辛散温通,功能活血行气,为血中气药,紫草具有解毒,凉血活血之效,诸药合用,共凑益气生血,养血理血,补血养阴,行气止痛,养血柔肝调经。
本发明具有益气生血,养血理血,补血养阴,行气止痛,养血柔肝调经,适用于血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭,两目昏花,视物不明等。
具体实施方式
通过下面的实施例可以详细的解释本发明,公开本发明的目的旨在保护本发明范围内的一切技术改进。
一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法,所述的中药组合物是由以下中药成分组成:当归、熟地黄、白芍、川芎、黄芪和紫草,所述的质量控制方法包括鉴别和含量测定;
鉴别:
(1)对当归药材的薄层色谱鉴别
取加工成品5g,研细,加乙醚30ml,浸渍30分钟,时时振摇,滤过,滤液挥干,残渣加无水乙醇1ml使溶解,作为供试品溶液,另取当归对照药材1g,同法制成对照药材溶液,照薄层色谱法试验,吸取上述两种溶液各5µl,分别点于同一硅胶G薄层板上,以正己烷和乙酸乙酯按9:1混合后为展开剂,展开,取出,晾干,置紫外光灯365nm下检视,供试品色谱中,在与对照药材色谱相应的位置上,显相同的亮蓝白色荧光斑点;
(2)对黄芪药材的薄层色谱鉴别
取加工成品5g,研细,加甲醇30ml,置水浴上回流30分钟,滤过,滤液置水浴上蒸干,残渣加水30ml使溶解,用以水饱和的正丁醇提取3次,每次20ml,合并正丁醇溶液,用水洗涤3次,每次20ml,弃去水液,正丁醇液置水浴上蒸干,残渣加甲醇5ml使溶解,加于已处理好的中性氧化铝柱上,用40%甲醇50ml洗脱,收集洗脱液,置水浴上蒸干,残渣加甲醇0.5ml使溶解,作为供试品溶液,另取黄芪甲苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液,照薄层色谱法试验,吸取上述对照品溶液5μl、供试品溶液10μl,分别点于同一硅胶G薄层板上,以三氯甲烷和甲醇按照65:35的比例在10℃以下放置的下层溶液为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在105℃烘约5分钟,分别置日光及紫外光灯365nm下检视,供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点或荧光斑点;
(3)对熟地黄药材的薄层色谱鉴别
取加工成品2.5g,研细,加水10ml使溶解,用水饱和正丁醇振摇提取3次,每次10ml,合并正丁醇液,蒸干,残渣加甲醇1ml使溶解,作为供试品溶液;另取熟地黄对照药材1g,加水50ml,煎煮30分钟,滤过,滤液浓缩至10ml,同法制成对照药材溶液;再取毛蕊花糖苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液和对照药材溶液各2~5μl、对照品溶液 2μl,分别点于同一聚酰胺薄膜上,以甲醇-冰醋酸-水按照2∶1∶7的比例混合后为展开剂,取出,晾干,置紫外光灯365nm下检视;供试品色谱中,在与对照药材色谱和对照品色谱相应的位置上,显相同颜色的荧光斑点;
(4) 对川芎的的薄层色谱鉴别
取加工成品适量,研细,取 5g,加水 25ml,回流提取 30 分钟,放冷,滤过,滤液蒸干,残渣加甲醇 1ml 使溶解,作为供试品溶液;另取川芎对照药材1g,同法制成对照药材溶液;照薄层色谱法试验,吸取上述二种溶液各 4~10μl,分别点于同一硅胶 G 薄层板上,以环己烷-二氯甲烷-冰醋酸按照8∶8∶1混合为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在 105℃加热至斑点显色清晰,置紫外光灯365nm下检视;供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的荧光斑点;
(5) 对白芍的的薄层色谱鉴别
取加工成品5g,研细,加乙醇 20ml,超声处理 5 分钟,滤过,滤液浓缩至约 1ml,作为供试品溶液;另取白芍对照药材 2g,同法制成对照药材溶液;再取芍药苷对照品,加乙醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液与对照药材溶液各 2µl、对照品溶液 5µl,分别点于同一硅胶G薄层板上,以三氯甲烷-乙酸乙酯-甲醇-甲酸按照40:5:10:0.2的比例混合后为展开剂,展开,取出,晾干,喷以5%香草醛硫酸溶液,加热至斑点显色清晰;供试品色谱中,在与对照药材和对照品色谱相应的位置上,显相同颜色的斑点;
(6)对紫草的的薄层色谱鉴别
取加工成品粉末2g,加60~90℃石油醚20ml,超声处理20分钟,滤过,滤液浓缩至1ml,作为供试品溶液;另取紫草对照药材0.5g,同法制成对照药材溶液;照薄层色谱法试验,吸取两种溶液各4μ1,分别点于同一硅胶G薄层板上,以环己烷-甲苯-乙酸乙酯-甲酸按照5:5:0.5:0.1混合为展开剂,展开,取出,晾干;供试品色谱中,在与对照药材色谱相应的位置上,显相同的紫红色斑点;再喷以10%氢氧化钾甲醇溶液,斑点变为蓝色;含量测定:
(1)色谱条件与系统适用性试验:用十八烷基硅烷键合硅胶为填充剂,乙腈和1%磷酸溶液按照15:85的比例混合后为流动相,检测波长为236nm,理论板数按芍药苷峰计算应不低于1000;
(2)对照品溶液的制备:精密称取经五氧化二磷干燥至恒重的芍药苷对照品适量,加甲醇制成每1ml含100μg的溶液,摇匀,即得;
(3)供试品溶液的制备:取本品2g,研细,精密称定,置50ml量瓶中,加甲醇40ml,超声处理30分钟,放冷至室温,加甲醇稀释至刻度,摇匀,滤过,弃去初滤液,精密量取续滤液25ml,置蒸发皿中,在水浴上蒸干,残渣加水适量使溶解,移至10ml量瓶中,加水稀释至刻度,摇匀,用微孔滤膜,滤过,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各10μl,注入液相色谱仪,测定,即得。
一种通过上述质量控制方法获得中药组合物的应用,该中药组合物能够应用于治疗血虚、血瘀或兼阴虚妇科疾病。
所述妇科疾病包括血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭。
该中药组合物是本申请人在先已获得的授权发明专利,即:“六味补血颗粒,授权公告号为CN03124713.X”,该六味补血颗粒的制备方法为:
(1)、取当归400g、熟地黄400g、白芍400g、川芎200g、黄芪400g和紫草400g等药材加工成饮片或粉碎成粗粉,备用;
(2)、将当归放置到容器内用70%的乙醇回流提取两次,第一次加8倍量,提取2小时,第二次加6倍量,提取1.5小时,合并提取液,滤过,滤液回收乙醇,静置24小时,滤过,滤液浓缩至相对密度为1.18(60~70℃)的清膏,或减压干燥,或喷雾干燥,得当归醇提取物,备用;
(3)、将当归药渣与其余黄芪等五味,加水煎煮两次,第一次加水8倍量,煎煮2小时,第二次加水5倍量,煎煮1小时,合并滤液,滤过,滤液浓缩至相对密度1.05(60~70℃)的清膏,加6倍量的95%乙醇搅拌均匀,静置过夜,取上清液,滤渣用70%乙醇洗涤二次,合并洗液、上清液,回收乙醇,浓缩至相对密度1.15(60~70℃)的清膏,或减压干燥,或喷雾干燥,得黄芪等水提取物;
(4)、将黄芪等水提取物与上述制成的清膏或辅料适量,制成颗粒,进行干燥后即得。
在本实施例中,辅料可以是蔗糖、糊精、乳糖、可溶性淀粉、甘露醇、麦芽糊精、羟丙基淀粉、甜菊糖苷、阿司巴甜中的任何一种或多种混合使用。
黄芪配当归:黄芪补脾肺之气,以益生血之源;当归养心肝之血,以补血和营,两药配伍,可增强益气生血的作用,适用于劳倦内伤、肌热面赤、烦渴、脉虚大乏力及疮疡、血虚发热、诸气血不足等。
当归配白芍:当归长于补血活血,止痛;白芍善于敛阴养血,柔肝止痛,两药伍用,有养血理血的作用,适用于心血不足的心悸不宁;肝血不足的头晕耳鸣,筋脉挛急;血虚血瘀之妇女月经不调、痛经等。
当归配川芎:当归长于补血活血,调经止痛;川芎善于活血行气,两药伍用,当归得川芎则祛瘀生新,补而不滞;川芎得当归,行血而不伤血,共奏补血活血之功,且为补血调经之要药,适用于血虚诸证及血虚兼血瘀所致的月经不调、痛经、经闭等。
当归配熟地黄:当归补血且能行血调经,熟地黄补血且能滋阴、填精益髓,两药伍用,可增强补血养阴的作用,适用于血虚兼有阴虚所致的月经不调、崩漏等。
川芎配白芍:川芎辛散温通,功能活血行气,为血中气药;白芍苦酸性凉,功善养血柔肝,敛阴止痛。两药配伍,具有活血行气止痛,养血柔肝调经之功,适用于血虚或阴虚有热之月经不调、痛经、经闭等。
熟地黄配白芍:熟地黄长于补血滋阴,填精益髓;白芍善于养血敛阴,柔肝止痛,两药伍用,可增强滋阴补肾,补血养血的作用,适用于肝血不足、肝肾亏虚所致的月经不调,两目昏花,视物不明等。
紫草配当归:紫草具有解毒,凉血活血之效;当归能养血活血,消肿散结,两药伍用,清热解毒,活血化瘀,消肿散结的作用增强。适用于痈疮肿毒及跌打损伤肿痛等证。
六味补血颗粒能够用于治疗血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭,其作用机制为:方中当归补血活血,养心肝之血,以补血和营,补血且能行血调经,调经止痛,熟地黄补血且能滋阴、填精益髓,二味为君药;黄芪补脾肺之气,以益生血之源;白芍善于敛阴养血,柔肝止痛;川芎辛散温通,功能活血行气,为血中气药;紫草具有解毒,凉血活血之效;诸药合用,共凑益气生血,养血理血,补血养阴,行气止痛,养血柔肝调经。适用于血虚诸证及血虚兼血瘀所致的月经不调、痛经、经闭,两目昏花,视物不明等。
本发明未详述部分为现有技术,尽管结合优选实施方案具体展示和介绍了本发明,具体实现该技术方案方法和途径很多,以上所述仅是本发明的优选实施方式,但所属领域的技术人员应该明白,在不脱离所附权利要求书所限定的本发明的精神和范围内,在形式上和细节上可以对本发明做出各种变化,均为本发明的保护范围。
Claims (3)
1.一种治疗血虚、血瘀或兼阴虚妇科疾病的中药组合物的质量控制方法,所述的中药组合物是由以下中药成分组成:当归、熟地黄、白芍、川芎、黄芪和紫草,其特征在于,所述的质量控制方法包括鉴别和含量测定;
鉴别:
(1)对当归药材的薄层色谱鉴别
取加工成品5g,研细,加乙醚30ml,浸渍30分钟,时时振摇,滤过,滤液挥干,残渣加无水乙醇1ml使溶解,作为供试品溶液,另取当归对照药材1g,同法制成对照药材溶液,照薄层色谱法试验,吸取上述两种溶液各5µl,分别点于同一硅胶G薄层板上,以正己烷和乙酸乙酯按9:1混合后为展开剂,展开,取出,晾干,置紫外光灯下检视,供试品色谱中,在与对照药材色谱相应的位置上,显相同的亮蓝白色荧光斑点;
(2)对黄芪药材的薄层色谱鉴别
取加工成品5g,研细,加甲醇30ml,置水浴上回流30分钟,滤过,滤液置水浴上蒸干,残渣加水30ml使溶解,用以水饱和的正丁醇提取3次,每次20ml,合并正丁醇溶液,用水洗涤3次,每次20ml,弃去水液,正丁醇液置水浴上蒸干,残渣加甲醇5ml使溶解,加于已处理好的中性氧化铝柱上,用40%甲醇50ml洗脱,收集洗脱液,置水浴上蒸干,残渣加甲醇0.5ml使溶解,作为供试品溶液,另取黄芪甲苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液,照薄层色谱法试验,吸取上述对照品溶液5μl、供试品溶液10μl,分别点于同一硅胶G薄层板上,以三氯甲烷和甲醇按照65:35的比例在10℃以下放置的下层溶液为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在105℃烘约5分钟,分别置日光及紫外光灯下检视,供试品色谱中,在与对照品色谱相应的位置上,显相同颜色的斑点或荧光斑点;
(3)对熟地黄药材的薄层色谱鉴别
取加工成品2.5g,研细,加水10ml使溶解,用水饱和正丁醇振摇提取3次,每次 10ml,合并正丁醇液,蒸干,残渣加甲醇1ml使溶解,作为供试品溶液;另取熟地黄对照药材1g,加水50ml,煎煮30分钟,滤过,滤液浓缩至10ml,同法制成对照药材溶液;再取毛蕊花糖苷对照品,加甲醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液和对照药材溶液各2~5μl、对照品溶液 2μl,分别点于同一聚酰胺薄膜上,以甲醇-冰醋酸-水按照2∶1∶7的比例混合后为展开剂,取出,晾干,置紫外光灯下检视;供试品色谱中,在与对照药材色谱和对照品色谱相应的位置上,显相同颜色的荧光斑点;
(4) 对川芎的的薄层色谱鉴别
取加工成品适量,研细,取 5g,加水 25ml,回流提取 30 分钟,放冷,滤过,滤液蒸干,残渣加甲醇 1ml 使溶解,作为供试品溶液;另取川芎对照药材1g,同法制成对照药材溶液;照薄层色谱法试验,吸取上述二种溶液各 4~10μl,分别点于同一硅胶 G 薄层板上,以环己烷-二氯甲烷-冰醋酸按照8∶8∶1混合为展开剂,展开,取出,晾干,喷以10%硫酸乙醇溶液,在 105℃加热至斑点显色清晰,置紫外光灯下检视;供试品色谱中,在与对照药材色谱相应的位置上,显相同颜色的荧光斑点;
(5) 对白芍的的薄层色谱鉴别
取加工成品5g,研细,加乙醇 20ml,超声处理 5 分钟,滤过,滤液浓缩至约 1ml,作为供试品溶液;另取白芍对照药材 2g,同法制成对照药材溶液;再取芍药苷对照品,加乙醇制成每1ml含1mg的溶液,作为对照品溶液;照薄层色谱法试验,吸取供试品溶液与对照药材溶液各 2µl、对照品溶液 5µl,分别点于同一硅胶G薄层板上,以三氯甲烷-乙酸乙酯-甲醇-甲酸按照40:5:10:0.2的比例混合后为展开剂,展开,取出,晾干,喷以5%香草醛硫酸溶液,加热至斑点显色清晰;供试品色谱中,在与对照药材和对照品色谱相应的位置上,显相同颜色的斑点;
(6)对紫草的的薄层色谱鉴别
取加工成品粉末2g,加60~90℃石油醚20ml,超声处理20分钟,滤过,滤液浓缩至1ml,作为供试品溶液;另取紫草对照药材0.5g,同法制成对照药材溶液;照薄层色谱法试验,吸取两种溶液各4μ1,分别点于同一硅胶G薄层板上,以环己烷-甲苯-乙酸乙酯-甲酸按照5:5:0.5:0.1混合为展开剂,展开,取出,晾干;
供试品色谱中,在与对照药材色谱相应的位置上,显相同的紫红色斑点;再喷以10%氢氧化钾甲醇溶液,斑点变为蓝色;
含量测定:
(1)色谱条件与系统适用性试验:用十八烷基硅烷键合硅胶为填充剂,乙腈和1%磷酸溶液按照15:85的比例混合后为流动相,检测波长为236nm,理论板数按芍药苷峰计算应不低于1000;
(2)对照品溶液的制备:精密称取经五氧化二磷干燥至恒重的芍药苷对照品适量,加甲醇制成每1ml含100μg的溶液,摇匀,即得;
(3)供试品溶液的制备:取本品2g,研细,精密称定,置50ml量瓶中,加甲醇40ml,超声处理30分钟,放冷至室温,加甲醇稀释至刻度,摇匀,滤过,弃去初滤液,精密量取续滤液25ml,置蒸发皿中,在水浴上蒸干,残渣加水适量使溶解,移至10ml量瓶中,加水稀释至刻度,摇匀,用微孔滤膜,滤过,即得;
(4)测定法:分别精密吸取对照品溶液与供试品溶液各10μl,注入液相色谱仪,测定,即得。
2.一种根据权利要求1的质量控制方法获得的中药组合物的应用,其特征在于,该中药组合物能够应用于治疗血虚、血瘀或兼阴虚妇科疾病。
3.根据权利要求2所述的中药组合物的应用,其特征在于,所述妇科疾病包括血虚诸证及血虚兼血瘀或兼阴虚所致的月经不调、痛经、经闭。
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