CN107929563A - 强力天麻杜仲胶囊及其成分检测方法 - Google Patents
强力天麻杜仲胶囊及其成分检测方法 Download PDFInfo
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- CN107929563A CN107929563A CN201711380905.6A CN201711380905A CN107929563A CN 107929563 A CN107929563 A CN 107929563A CN 201711380905 A CN201711380905 A CN 201711380905A CN 107929563 A CN107929563 A CN 107929563A
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- gastrodia elata
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Landscapes
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- Physics & Mathematics (AREA)
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- Analytical Chemistry (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Gastroenterology & Hepatology (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
本发明涉及一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各中药组份的含量为：天麻120～150g、盐制杜仲130～160g、制草乌12～22g、制附子12～22g、羌活150～185g、独活70～95g、藁本90～110g、当归150～185g、地黄250～285g、玄参90～110g、川牛膝90～110g、槲寄生90～110g。上述各中药组份通过特定的制备方法获得强力天麻杜仲胶囊，该胶囊通过成分鉴别和检测，重复性和稳定性都非常好。本发明强力天麻杜仲胶囊具有散风活血，舒筋止痛的功效；可用于中风引起的筋脉掣痛，肢体麻木，行走不便，腰腿酸痛，头痛头昏等。
Description
技术领域
本发明属于中医药领域，特别涉及一种强力天麻杜仲胶囊及其成分检测方法。
背景技术
天麻又名赤箭、离母、鬼督邮、神草、独摇芝等等，是著名的中药材，其富含天麻素，香荚兰素，蛋白质，氨基酸，微量元素，具有抗癫痫，抗悸厥，抗风湿；镇静，镇痉，镇痛，补虚，平肝息风的功效。天麻的药用价值和食用营养价值都很高。
杜仲又名胶木，其游离氨基酸极少，含有的少量蛋白质，是和绝大多数食品类似的完全蛋白，即能够水解晰出对人体必需的8种氨基酸。杜仲中含有15种矿物元素，其中有锌、铜、铁等微量元素，及钙、磷、钾、镁等宏量元素。
中药中所说的杜仲是指杜仲的干燥树皮，味甘，性温。有补益肝肾、强筋壮骨、调理冲任、固经安胎的功效。可治疗肾阳虚引起的腰腿痛或酸软无力，肝气虚引起的胞胎不固，阴囊湿痒等症，是一种名贵的滋补药材。
中医是中华民族的国粹，各种中药材都具有不同的功效，但怎样将不同的中药材组合在一起达到相应的疗效，则是非常有讲究的。
发明内容
本发明的目的是根据天麻和杜仲的医用疗效，提供一种疗效显著、服用方便的强力天麻杜仲胶囊及其成分检测方法。
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各中药组份的含量为：天麻 120～150g、盐制杜仲130～160g、制草乌12～22g、制附子12～22g、羌活150～185g、独活70～95g、藁本90～110g、当归150～185g、地黄 250～285g、玄参90～110g、川牛膝90～110g、槲寄生90～110g；
采用上述组份制备天麻杜仲胶囊的方法为：
（1）根据需要用量将各组份称量备用；
（2）将备好的天麻粉碎成细粉，过120目筛，备用；
（3）将备好的独活、藁本、当归、羌活提取挥发油，药渣留存备用；
（4）将步骤（3）所得药渣与杜仲、制草乌、附子、地黄、玄参、川牛膝、槲寄生混合均匀，加水煎煮2次，第一次3小时，第二次2小时，合并煎液，滤过，滤液浓缩成膏，备用；
（5）将步骤（2）所得天麻细粉与步骤（4）所得中药膏混合均匀干燥，粉碎，过筛，制成颗粒；
（6）将所得颗粒喷入步骤（3）制得的挥发油，混匀后装入胶囊，即得强力天麻杜仲胶囊。
进一步，按1000粒胶囊量计算，各中药组份的含量为：天麻139g、盐制杜仲147g、制草乌17g、制附子17g、羌活174g、独活86g、藁本102g、当归174g、地黄278g、玄参102g、川牛膝102g、槲寄生102g 。
强力天麻杜仲胶囊的成分可采用以下一种或一种以上方法进行鉴别：
（1）取本品内容物0.4克，以水浸渍3次，每次约2ml，浸渍10分钟；残渣置显微镜下，再以水洗除有色残液，见棕色组织碎块，加碘液0.02mol/L染色3～5分钟，染成茶棕色，再用水洗除碘液，则部分组织碎块边缘或部分菲薄组织碎块呈紫堇色或茶紫色；
（2）取本品内容物3.2g加约15ml乙醚及约1ml氨试液，充分搅拌或者振摇5分钟，静置10分钟，取上层醚液，挥干，加稀硫酸0.5ml、水2ml使溶解，滤过，取滤液1ml加碘化铋钾试液1滴，生成橙色沉淀；另取滤液1ml加碘-碘化钾试液1滴，生成棕色沉淀；
（3）取本品内容物4g,加饱和的正丁醇30ml，超声处理30分钟，滤过，滤液蒸干，残渣加水2ml使溶解，加在已处理好的D-101型大孔吸附树脂柱上，用10%乙醇25ml洗脱，蒸干，残渣加甲醇1ml使溶解，作为供试品溶液；另取天麻素对照品，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，吸取上述溶液2～3ul,分别点于同一羧甲基纤维素钠为粘合剂的硅胶G薄层板上，以氯仿-醋酸乙酯-甲醇-甲酸8：1:3:0.1为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在110摄氏度烘至斑点显色清晰，供试品色谱中，在与对照品色谱相应的位置上，显示相同颜色斑点。
强力天麻杜仲胶囊可采用以下方法进行含量测定：
色谱条件与系统适用性试验以十八烷基硅烷键合硅胶为填充剂，乙腈—0.05%磷酸溶液2:98；检测波长：210nm；柱温：室温；流速：1.0ml/min，理论塔板数按梓醇峰计算应不低于5000；
对照品溶液的制备：精密称取梓醇对照品适量，精密称定，用流动相溶解并稀释，制成1ml含50ug梓醇的对照溶液；
供试品溶液的制备：取本品内容物1g，精密称定，置于具塞锥形瓶中，精密加甲醇50ml，精密称定重量，密塞，加热回流提取1.5小时，放冷，加甲醇补足减失重量，摇匀，滤过，取续滤液10ml，蒸干，残渣用流动相溶解，转移至10ml量瓶中，并用流动相稀释至刻度，摇匀，滤过，取续滤液，即得供试品溶液；
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。
本发明强力天麻杜仲胶囊具有散风活血，舒筋止痛的功效。可用于中风引起的筋脉掣痛，肢体麻木，行走不便，腰腿酸痛，头痛头昏等。
具体实施方式
以下结合实施例对本发明进行描述，所举实施例只用于解释发明，并非用于限定本发明的范围。
实施例1
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各组份的含量为：天麻 120g、杜仲（盐制）130g、制草乌12g、附子（制）12g、羌活150g、独活70g、藁本190g、当归150g、地黄 250g、玄参90g、川牛膝90g、槲寄生 90g。
采用上述组份制备天麻杜仲胶囊的方法为：
（1）根据需要用量将各组份称量备用；
（2）将备好的天麻粉碎成细粉，过120目筛，备用；
（3）将备好的独活、藁本、当归、羌活提取挥发油，药渣留存备用；
（4）将步骤（3）所得药渣与杜仲、制草乌、附子、地黄、玄参、川牛膝、槲寄生混合均匀，加水煎煮2次，第一次3小时，第二次2小时，合并煎液，滤过，滤液浓缩成膏，备用；
（5）将步骤（2）所得天麻细粉与步骤（4）所得中药膏混合均匀干燥，粉碎，过筛，制成颗粒；
（6）将所得颗粒喷入步骤（3）制得的挥发油，混匀后装入胶囊，即得强力天麻杜仲胶囊。
实施例2
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各组份的含量为：天麻130g，杜仲（盐制）135g、制草乌15g、附子（制）15g、羌活160g、独活80g、藁本95g、当归165g、地黄265g、玄参95g、川牛膝95g、槲寄生95g。采用上述组份制备强力天麻杜仲胶囊的方法与实施例1相同。
实施例3
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各组份的含量为：天麻139g、杜仲（盐制）147g、制草乌17g、附子（制）17g、羌活174g、独活86g、藁本102g、当归174g、地黄278g、玄参102g、川牛膝102g、槲寄生102g 。采用上述组份制备强力天麻杜仲胶囊的方法与实施例1相同。
实施例4
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各组份的含量为：天麻145g、杜仲（盐制）155g、制草乌20g、附子（制）20g、羌活180g、独活90g、藁本105g、当归180g、地黄280g、玄参105、川牛膝105g、槲寄生105g。采用上述组份制备强力天麻杜仲胶囊的方法与实施例1相同。
实施例5
一种强力天麻杜仲胶囊，按1000粒胶囊量计算，各组份的含量为：天麻150g、杜仲（盐制）160g、制草乌22g、附子（制）22g、羌活185g、独活95g、藁本110g、当归185g、地黄285g、玄参110g、川牛膝110g、槲寄生110g。采用上述组份制备强力天麻杜仲胶囊的方法与实施例1相同。
对本发明强力天麻杜仲胶囊进行鉴别的方法如下：
（1）取本品内容物0.4克，以水浸渍3次，每次约2ml，浸渍10分钟。残渣置显微镜下，再以水洗除有色残液，见棕色组织碎块，加碘液(0.02mol/L)染色3～5分钟，染成茶棕色，再用水洗除碘液，则部分组织碎块边缘或部分菲薄组织碎块呈紫堇色或茶紫色。
（2）取本品内容物3.2g加约15ml乙醚及约1ml氨试液，充分搅拌或者振摇5分钟，静置10分钟，取上层醚液，挥干，加稀硫酸0.5ml、水2ml使溶解，滤过，取滤液1ml加碘化铋钾试液1滴，生成橙色沉淀；另取滤液1ml加碘-碘化钾试液1滴，生成棕色沉淀。
（3）取本品内容物4g,加饱和的正丁醇30ml，超声处理30分钟，滤过，滤液蒸干，残渣加水2ml使溶解，加在已处理好的D-101型大孔吸附树脂柱（柱长16cm,内径1cm）上，用10%乙醇25ml洗脱，蒸干，残渣加甲醇1ml使溶解，作为供试品溶液。另取天麻素对照品，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（《中国药典》2015年版四部通则0502）试验，吸取上述溶液2～3ul,分别点于同一羧甲基纤维素钠为粘合剂的硅胶G薄层板上，以氯仿-醋酸乙酯-甲醇-甲酸（8：1:3:0.1）为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在110摄氏度烘至斑点显色清晰，供试品色谱中，在与对照品色谱相应的位置上，显示相同颜色斑点。
对本发明强力天麻杜仲胶囊进行含量测定，确保强力天麻杜仲胶囊每粒（0.4g）含梓醇不低于0.12mg，采用照液相色谱法（《中国药典》2015年版四部通则0512）测定。
色谱条件与系统适用性试验以十八烷基硅烷键合硅胶为填充剂，乙腈—0.05%磷酸溶液（2:：98）；检测波长：210nm；柱温：室温；流速：1.0ml/min，理论塔板数按梓醇峰计算应不低于5000；
（1）对照品溶液的制备：精密称取梓醇对照品适量，精密称定，用流动相溶解并稀释，制成1ml含50ug梓醇的对照溶液；
（2）供试品溶液的制备：取本品内容物1g，精密称定，置于具塞锥形瓶中，精密加甲醇50ml，精密称定重量，密塞，加热回流提取1.5小时，放冷，加甲醇补足减失重量，摇匀，滤过，取续滤液10ml，蒸干，残渣用流动相溶解，转移至10ml量瓶中，并用流动相稀释至刻度，摇匀，滤过，取续滤液，即得供试品溶液。
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。
测定时将6份供试品溶液各10μl，注入液相色谱仪，测定峰面积，计算结果如下表，梓醇的平均含量为0.2764mg/g，RSD为1.54%。
通过上表可看出，每粒强力天麻杜仲胶囊（0.4g/粒）中梓醇的含量均不低于0.12mg,试品之间梓醇的含量偏差小于2%，重复性良好。本发明强力天麻杜仲胶囊具有散风活血，舒筋止痛的功效。可用于治疗中风引起的筋脉掣痛，肢体麻木，行走不便，腰腿酸痛，头痛头昏等。本发明采用口服形式，一次2～3粒，一日两次；须密封保存。
Claims (4)
1.一种强力天麻杜仲胶囊，其特征在于：按1000粒胶囊量计算，各中药组份的含量为：天麻 120～150g、盐制杜仲130～160g、制草乌12～22g、制附子12～22g、羌活150～185g、独活70～95g、藁本90～110g、当归150～185g、地黄 250～285g、玄参90～110g、川牛膝90～110g、槲寄生 90～110g；
采用上述组份制备天麻杜仲胶囊的方法为：
（1）根据需要用量将各组份称量备用；
（2）将备好的天麻粉碎成细粉，过120目筛，备用；
（3）将备好的独活、藁本、当归、羌活提取挥发油，药渣留存备用；
（4）将步骤（3）所得药渣与杜仲、制草乌、附子、地黄、玄参、川牛膝、槲寄生混合均匀，加水煎煮2次，第一次3小时，第二次2小时，合并煎液，滤过，滤液浓缩成膏，备用；
（5）将步骤（2）所得天麻细粉与步骤（4）所得中药膏混合均匀干燥，粉碎，过筛，制成颗粒；
（6）将所得颗粒喷入步骤（3）制得的挥发油，混匀后装入胶囊，即得强力天麻杜仲胶囊。
2.如权利要求1所述强力天麻杜仲胶囊，其特征在于：按1000粒胶囊量计算，各中药组份的含量为：天麻139g、盐制杜仲147g、制草乌17g、制附子17g、羌活174g、独活86g、藁本102g、当归174g、地黄278g、玄参102g、川牛膝102g、槲寄生102g 。
3.如权利要求1或2所述强力天麻杜仲胶囊的成分检测方法，其特征在于：采用以下一种或一种以上方法进行鉴别：
（1）取本品内容物0.4克，以水浸渍3次，每次约2ml，浸渍10分钟；残渣置显微镜下，再以水洗除有色残液，见棕色组织碎块，加碘液0.02mol/L染色3～5分钟，染成茶棕色，再用水洗除碘液，则部分组织碎块边缘或部分菲薄组织碎块呈紫堇色或茶紫色；
（2）取本品内容物3.2g加约15ml乙醚及约1ml氨试液，充分搅拌或者振摇5分钟，静置10分钟，取上层醚液，挥干，加稀硫酸0.5ml、水2ml使溶解，滤过，取滤液1ml加碘化铋钾试液1滴，生成橙色沉淀；另取滤液1ml加碘-碘化钾试液1滴，生成棕色沉淀；
（3）取本品内容物4g,加饱和的正丁醇30ml，超声处理30分钟，滤过，滤液蒸干，残渣加水2ml使溶解，加在已处理好的D-101型大孔吸附树脂柱上，用10%乙醇25ml洗脱，蒸干，残渣加甲醇1ml使溶解，作为供试品溶液；另取天麻素对照品，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，吸取上述溶液2～3ul,分别点于同一羧甲基纤维素钠为粘合剂的硅胶G薄层板上，以氯仿-醋酸乙酯-甲醇-甲酸8：1:3:0.1为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在110℃烘至斑点显色清晰，供试品色谱中，在与对照品色谱相应的位置上，显示相同颜色斑点。
4.如权利要求3所述强力天麻杜仲胶囊的成分检测方法，其特征在于：采用以下方法进行含量测定：
色谱条件与系统适用性试验以十八烷基硅烷键合硅胶为填充剂，乙腈—0.05%磷酸溶液2:98；检测波长：210nm；柱温：室温；流速：1.0ml/min，理论塔板数按梓醇峰计算应不低于5000；
对照品溶液的制备：精密称取梓醇对照品适量，精密称定，用流动相溶解并稀释，制成1ml含50ug梓醇的对照溶液；
供试品溶液的制备：取本品内容物1g，精密称定，置于具塞锥形瓶中，精密加甲醇50ml，精密称定重量，密塞，加热回流提取1.5小时，放冷，加甲醇补足减失重量，摇匀，滤过，取续滤液10ml，蒸干，残渣用流动相溶解，转移至10ml量瓶中，并用流动相稀释至刻度，摇匀，滤过，取续滤液，即得供试品溶液；
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。
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