天麻首乌片

天麻首乌片 使用说明书 请仔细阅读说明书并按说明使用或在药师指导下购买和使用。 【标准来源】中国药典2000 【药品名称】通用名称:天麻首乌片 汉语拼音:tian ma shou wu pian 【作用类别】本品为虚证类非处方药药品。 【成 份】见本书中药典同名品种。 【性 状】本品为糖衣片或薄膜衣片，除去包衣后显棕褐色;气香，味微苦。 【功能主治】滋阴补肾，养血息风。用于肝肾阴虚所致的头晕目眩、头痛耳鸣、口苦咽干、腰膝痠软、脱发、白发;血管神经性头痛、脂溢性脱发见上述证候者。 【用法用量】口服，一次6片，一日3次。 【不良反应】 【禁 忌】 【注意事项】 1.忌不易消化食物。 2.感冒发热病人不宜服用。 3.有高血压、心脏病、肝病、糖尿病、肾病等慢性病严重者应在医师指导下服用。 4.儿童、孕妇、哺乳期妇女应在医师指导下服用。 5.服药4周症状无缓解，应去医院就诊。 6.对本品过敏者禁用，过敏体质者慎用。 7.本品性状发生改变时禁止使用。 8.儿童必须在成人监护下使用。 9.请将本品放在儿童不能接触的地方。 10.如正在使用其他药品，使用本品前请咨询医师或药师。 【药物相互作用】如与其他药物同时使用可能会发生药物相互作用，详情请咨询医师或药师。 如有问题可与生产企业联系 Instruction of Tianma Shouwu Tablets Please read the instruction carefully and take the drug according it or buy and take the drug under pharmacist’ guidance. [The source of criteria] Chinese Pharmacopeia (Edition 2000) [Drug name] Generic name: Tianma Shouwu Tablets Pinyin:Tianma Shouwu Pian [Effect classification]OTC drug for deficiency syndrome. [Ingredients]See the homonym species in pharmacopeia. [Description]Sugar or film coated tablets with brown core; odor, fragrant; taste, slightly bitter. [Action and indications]To nourish yin and tonify the kidney, to nourish blood and quench wind, it is indicated for dizziness, blurred vision, headache, tinnitus, feeling bitter of the mouth, dry throat, aching and limpness of the loins, trichomadesis and white hair due to yin-deficiency of the liver and the kidney; nervous vascular headache and seborrheic alopecia marked by above symptoms. [Administration and dosage]Orally, 6 tablets, 3 times a day. [Adverse reaction] [Contraindication] [Precaution] 1. It is incompatible with hard-to-digest foods. 2. Patients with fever due to common cold should not take it. 3. Patients with severe chronic disease such as hypertension, heart disease, hepatopathy, diabetes mellitus and renopathy should take the drug under doctor’s advice. 4. Children, pregnant and lactating women should take it under physician’s guidance. 5. Go to the hospital for treatment if symptoms have no improvement 4 weeks after administration. 6. The drug is contraindicated for patient allergic to this drug, and should be administrated with caution for patients with allergic constitution. 7. The drug should not be used when its character has changed. 8. Children should take the drug under adults’ surveillance. 9. Put the drug where children cannot reach. 10. Please consult physician or pharmacist if other drugs are taken. [Drug interaction] Drug interaction may occur when taking with other drugs, please consult physician or pharmacist for details. Please directly contact the manufacturer if there is any problem 天麻首乌片 拼音名:Tianma Shouwu Pian 书页号:2000年版一部-38 【处方】天麻 白芷 何首乌 熟地黄 丹参 川芎 当归 制蒺藜 桑叶 墨旱莲 女 贞子 白芍 黄精 甘草 【制法】以上十四味，取天麻、川芎、何首乌粉碎成细粉，过筛，混匀;取白 芷、当归提取挥发油，备用;药渣与其余各药加水煎煮二次，每次2小时，合并煎液，滤过，滤液浓缩成清膏(相对密度1.28,1.30，热测)，加入上述药粉，混匀，干燥，粉碎，过筛，制成颗粒，喷入上述白芷、当归挥发油，密闭，压制成1000片，包糖衣或薄膜衣，即得。 【性状】本品为糖衣片或薄膜衣片，除去包衣后显棕褐色;气香，味微苦。 【鉴别】(1)取本品20片，除去包衣，研碎，加乙醚20ml，振摇10分钟，放置20分钟，滤过，滤液呈黄色，取滤液10ml，置分液漏斗中，加氢氧化钠试液5ml，轻轻振摇，水层显红色，再加稀盐酸5ml，使水层呈酸性，振摇后水层由红色变为无色。 (2)取[鉴别](1)项下剩余的乙醚提取液，置蒸发皿中，挥干乙醚，残渣滴加1%香草醛硫酸溶液，显紫红色。 (3)取本品10片，除去包衣，研细，加水10ml，振摇5分钟，滤过，取药渣，加75%乙醇10ml，超声处理30分钟，滤过，滤液作为供试品溶液。另取天麻素对照品适量，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(附录?B)试验，吸取上述两种溶液各3,5μl，分别点于同一硅胶G薄层板上，以氯仿-甲醇(7:3)为展开剂，展开，取出，晾干，喷以10%磷钼酸乙醇溶液，在105?加热约10分钟。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。 【检查】应符合片剂项下有关的各项规定(附录?D)。 【含量测定】取本品40片，除去包衣，精密称定，研细，取粉末适量(约相当于15片的重量)，精密称定，加5mol/L硫酸溶液30ml，加热回流1.5小时，放冷，加氯仿80ml，加热回流1.5小时，放冷，分取氯仿层，酸水层用氯仿提 取3次，每次30ml，合并氯仿提取液，通过装有无水硫酸钠的漏斗，滤器用少 量氯仿洗涤，洗液并入滤液中，置水浴上蒸干，残渣加甲醇适量使溶解，置5ml 量瓶中，并加甲醇至刻度，摇匀，作为供试品溶液。另取大黄素对照品，加甲 醇制成每1ml含0.1mg的溶液，作为对照品溶液。照薄层色谱法(附录?B) 试验，吸取供试品溶液8μl、对照品溶液2μl与6μl，交叉点于同一硅胶G薄层 板上，以正己烷-醋酸乙酯-甲酸(6:2:0.1)为展开剂，展开，取出，晾干。照 薄层色谱法(附录?B薄层扫描法)进行扫描，波长λs=445nm，λR=700nm， 测量供试品吸收度积分值与对照品吸收度积分值，计算，即得。 本品每片含何首乌以大黄素(C15H10O5)计，不得少于10μg。 【功能与治】养血息风、滋补肝肾。用于肝肾阴虚所致的头痛，头晕，目眩， 口苦咽干，舌红苔少，脉弦，视力、听力减退，腰酸乏力，脱发，白发;脑动 脉硬化，早期高血压，血管神经性头痛，脂溢性脱发等病见以上证候者。 【用法与用量】口服，一次6片，一日3次。 【贮藏】密封，置干燥处。 Tianma Shouwu Tablets Pinyin: Tianma Shouwu Pian page number: Edition2000，Volume 1, Page 383 [Ingredients] Rhizoma Gastrodiae; Radix Angelicae Dahuricae; Radix Polygoni Multiflori; Radix Rehmanniae preparata; Radix Salviae Miltiorrhiae; Rhizoma Chuanxiong; Radix Angelicae Sinensis; Fructus Tribuli(stir-baked); Folium Mori; Herba Ecliptae; Fructus Ligustri Lucidi; Raidix Paeoniae Alba; Rhizoma Polygonati; Radix Glycyrrhizae. [Procedure]Pulverize Rhizoma Gastrodiae, Rhizoma Chuanxiong and Radix Polygoni Multiflori to fine powder respectively, sift and mix thoroughly; Extract volatile oil from Radix Angelicae Dahuricae and Radix Angelicae Sinensis by distillation; decoct the drug residue together with other 9 ingredients with water twice, each for 2 hours, combine the decoctions, filter, concentrate to a thin extract with a relative density of 1.28,1.30(measured in warm condition). Add the above fine powder, mix thoroughly, dry, pulverize, sift and make granules. Spray the volatile oils of Angelicae Dahuricae and Radix Angelicae Sinensis, and close tightly. Compress into 1000 tablets, and coat with sugar or film. [Description]Sugar or film coated tablets with brown core; odor, fragrant; taste, slightly bitter. [Identification](1)Triturate 20 tablets with coating removed to powder, add 20 ml of ether, shake for 10 minutes, allow to stand for 20 minutes, filter, the filtrate show a yellow color. Transfer 10 ml of the filtrate to a separator, add 5 ml of sodium hydroxide TS, shake slightly, the aqueous layer shows a red color. Acidify the aqueous layer with 5 ml of dilute hydrochloric acid, shake, the red aqueous layer turns to colorless. (2)Transfer the rest of ether extract obtained under the test for Identification (1) to an evaporating dish, expel ether, add several drops of 1% solution of vanillin in sulfuric acid, a purplish-red color is produced. (3)Triturate 10 tablets with coating removed to fine powder, add 10 ml of water, shake for 5 minutes and filter. Add 10 ml of 75% ethanol to the drug residue, ultrasonicate for 30 minutes, filter, using the filtrate as the test solution. Dissolve a quantity of gastrodin CRS in ethanol to produce a solution containing 1 mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix ?B), using silica gel G as the coating substance and a mixture of chloroform-methanol(7:3)as the mobile phase. Apply separately to the plate 3,5ul each of the test solution and reference solution. After developing and removal of the plate, dry it in air, spray with 10% solution of phosphomolybdic acid in ethanol and heat at 105? for about 10 minutes. The spot in the chromatogram obtained with the test solution corresponds in position and color to the spot in the chromatogram obtained with the reference solution. [Other requirements]Comply with the general requirements for tablets (Appendix ?D). [Assay]Triturate 40 tablets with coating removed, accurately weighed, to fine powder. Weigh accurately a quantity of powder (equivalent to the weight of 15 tablets), heat under reflux with 30 ml of 5mol/L solution of sulfuric acid for 1.5 hours, and allow it to cool. Add 80 ml of chloroform and heat under reflux again for 1.5 hours, allow it to cool and separate the chloroform layer. Extract the acidified water layer with three 30-ml quantities of chloroform, combine the chloroform extract, pass through a funnel packed with anhydrous sodium sulfate. Wash the filter with a little quantity of chloroform, combine the washings with the filtrate, evaporate to dryness on a water bath. Dissolve the residue with a quantity of methanol in a 5 ml of volumetric flask, dilute with methanol to volume and mix well as the test solution. Dissolve emodin CRS in methanol to produce a solution containing 0.1mg per ml as the reference solution. Carry out the method for thin layer chromatography (Appendix ?B), using silica gel G as the coating substance and a mixture of n-hexane-ethyl acetate-formic acid(6:2:0.1) as the mobile phase. Apply separately to the plate 8ul of the test solution, 2ul and 6ul of the reference solution. After developing and removal of the plate, dry it in air. Carry out the method for thin layer chromatography (Appendix ?B, thin layer chromatographic scanning method), scan at the wavelength: λs=445nm，λR=700nm. Measure separately the integration values of absorbance of the test solution and the reference solution and calculate. It contains not less than 10ug of emodin(CHO) per tablet, referred to 15105 Radix Polygoni Multiflori. [Action and indications]To nourish blood and quench wind, to tonify the liver and the kidney, it is indicated for headache, dizziness, blurred vision, feeling dry and bitter of the mouth, red tongue with little fur, wiry pulse, hypopsia and hypoacusis, aching and limpness of the loins, trichomadesis and white hair due to yin-deficiency of the liver and the kidney; cerebral arteriosclerosis, the early stage the hypertension, nervous vascular headache and seborrheic alopecia, etc. marked by above symptoms. [Administration and dosage]Orally, 6 tablets, 3 times a day.