CN105998362A - 复方黄栌口服液及其制备方法 - Google Patents
复方黄栌口服液及其制备方法 Download PDFInfo
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- CN105998362A CN105998362A CN201610492867.2A CN201610492867A CN105998362A CN 105998362 A CN105998362 A CN 105998362A CN 201610492867 A CN201610492867 A CN 201610492867A CN 105998362 A CN105998362 A CN 105998362A
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- ramulus
- preparation
- fructus
- folium cotini
- oral liquid
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Abstract
本发明公开了一种复方黄栌口服液及其制备方法，所述复方黄栌口服液包括黄栌250‑350g、五味子150‑250g、垂盆草250‑350g、枸杞150‑250g、栀子200‑300g和大枣200‑300g。本发明的复方黄栌口服液中黄栌为君药，五味子、垂盆草共为臣药，枸杞、栀子为佐药，大枣为使药，诸药合用除湿清热，退黄降酶，用于急性黄疸型肝炎，慢性肝炎。经临床观察，复方黄栌口服液治疗黄疸型和无黄疸型肝炎有显著的疗效。本发明通过精制的生产工艺，提高了药物有效成分的提取，保证了制剂的稳定性，减少了由于制剂的质量差异引起的治疗效果降低及不良反应的发生。口服液的制剂形式，服用剂量小、吸收迅速、质量稳定。
Description
技术领域
本发明属于药物技术领域，具体地说，涉及一种复方黄栌口服液及其制备方法。
背景技术
肝炎(甲、乙、丙型)多因为感受外邪，饮食所伤，脾胃虚寒以及积聚转化而发病。其病机为湿邪阴滞中焦或瘀血等阴滞胆道，以致胆液不循常道，溢于肌肤而发黄。中医认为，湿热内蕴，不得外泄，郁久生热，伤津致肝阴亏损。目前治疗这方面病的药物很多，但效果均不够理想，西药虽见效快但副作用较大且复发率较高。
黄栌清热解毒，散瘀止痛，具有抗菌消炎、退热消肿等功效，广泛用于治疗黄疸型肝炎、干吗、齿龈炎等疾病。五味子味酸、甘，性温，归肺、心、肾经，具有敛肺止肾，生津敛汗，涩精止泻，宁心安神的功效，同时还能利胆降低血清转氨酶，对肝细胞有保护作用，能增加机体对非特异性刺激的防御能力，近代研究五味子治疗肝炎有良好的降酶作用。现代研究认为五味子能促进肝脏的解毒过程、保护肝脏免受毒害，并能再生因滥用酒精、药物或肝炎而受损的肝脏组织。人体测试结果显示，五味子对于患有因病毒所引起之慢性肝炎者尤其有效。根据中国的一项临床试验报告显示，它在治疗肝炎病人方面有76％成功率，而且没有副作用。垂盆草味甘、淡，性凉；归肝、胃、大肠经；具有清热解毒、清利湿热、降低谷丙转氨酶的功效，用于传染性肝炎。近年来，临床上单用本品治疗传染性肝炎(包括急性黄疸性肝炎，急性无黄疸性肝炎，以及迁延性肝炎，慢性肝炎的活动期)，对降低血清转氨脢有一定作用。枸杞味甘，性平。主要归肝、肾、肺经；能补血明目；润肺止咳。凡肝肾不足和肺肾阴虚所致诸症，均可应用。为滋阴助阳，益精补血之良药。现代研究报道，枸杞具有抗衰老、抗癌、降血脂与保肝作用。栀子味苦，性寒；归心、肝、肺、胃、三焦经。泻火除烦；清热利湿；凉血解毒。主热病心烦；肝火目赤；头痛；湿热黄疳；淋证；叶血衄血；血痢尿血；口舌生疮；疮疡肿毒；扭伤肿痛。大枣，性味甘温，归脾、胃经，具有补中益气，养血安神，缓和药性，有提高体内单核吞噬细胞系统的吞噬功能，保护肝脏等作用。
发明内容
有鉴于此，本发明所要解决的技术问题是提供一种质量稳定疗效确切，副作用小且轻的用于疗黄疸型或无黄疸型肝炎的复方黄栌口服液及其制备方法。
本发明公开了一种复方黄栌口服液，包括黄栌、五味子、垂盆草、枸杞、栀子和大枣。
进一步的，所述复方黄栌口服液包括黄栌250-350g、五味子150-250g、垂盆草250-350g、枸杞150-250g、栀子200-300g和大枣200-300g。
优选的，所述复方黄栌口服液包括黄栌300g、五味子200g、垂盆草300g、枸杞200g、栀子250g和大枣250g。
本发明还公开了上述复方黄栌口服液的制备方法，包括以下步骤：取黄栌、五味子、垂盆草、枸杞、栀子和大枣，加水煎煮，煎煮液过滤后合并，浓缩，浓缩液冷却至室温，边搅边加入乙醇，放置24h，取上清液回收至无醇味，加入矫味剂，调节pH值至5.0-7.0，再加水至1000ml，搅拌均匀后静置，滤过，取滤液灌装，灭菌即得。
进一步的，取黄栌300g、五味子200g、垂盆草300g、枸杞200g、栀子250g和大枣250g。
进一步的，所述煎液浓缩至80℃时相对密度为1.15-1.30。
进一步的，所述乙醇加入量为使乙醇含量为60％。
进一步的，所述矫味剂为单糖浆。
进一步的，所述单糖浆为80％浓度的蔗糖溶液。
进一步的，加入所述矫味剂同时还加入防腐剂。
进一步的，所述防腐剂为对羟基苯甲酸的乙醇溶液。
进一步的，所述灭菌条件为100℃灭菌30min。
进一步的，所述煎煮方法为加药材质量8倍水煎煮三次，每次煮沸40min。
与现有技术相比，本发明可以获得包括以下技术效果：
1)本发明的复方黄栌口服液通过精制的生产工艺，提高了药物有效成分的提取，保证了制剂的稳定性，减少了由于制剂的质量差异引起的治疗效果降低及不良反应的发生。
2)本发明采用口服液的制剂形式，服用剂量小、吸收迅速、质量稳定、方便携带、易保存，尤其适合工业化生产。
3)本发明的复方黄栌口服液由黄栌、五味子、垂盆草、栀子、枸杞、大枣等六味中药组成。黄栌为君药，五味子、垂盆草共为臣药，枸杞、栀子为佐药，大枣为使药，诸药合用除湿清热，退黄降酶，用于急性黄疸型肝炎，慢性肝炎。经临床观察，复方黄栌口服液治疗黄疸型和无黄疸型肝炎有显著的疗效，丰富了临床用药，是一个值得推广的药物。
当然，实施本发明的任一产品必不一定需要同时达到以上所述的所有技术效果。
具体实施方式
以下将配合实施例来详细说明本发明的实施方式，藉此对本发明如何应用技术手段来解决技术问题并达成技术功效的实现过程能充分理解并据以实施。
实施例1
取黄栌300g、五味子200g、垂盆草300g、枸杞200g、栀子250g和大枣250g，加8倍水煎煮三次，每次煮沸40min，煎煮液过滤后合并，浓缩至80℃时相对密度为1.25，浓缩液冷却至室温，边搅边加入乙醇，使乙醇含量为60％，放置24h，取上清液回收至无醇味，加入80％浓度的单糖浆和对羟基苯甲酸的乙醇溶液，调节pH值至7.0，再加水至1000ml，搅拌均匀后静置，滤过，取滤液灌装，100℃灭菌30min即得。
实施例2
取黄栌250g、五味子150g、垂盆草250g、枸杞150g、栀子200g和大枣200g，加8倍水煎煮三次，每次煮沸40min，煎煮液过滤后合并，浓缩至80℃时相对密度为1.13，浓缩液冷却至室温，边搅边加入乙醇，使乙醇含量为60％，放置24h，取上清液回收至无醇味，加入单糖浆(80％)和对羟基苯甲酸的乙醇溶液，调节pH值至5.0，再加水至1000ml，搅拌均匀后静置，滤过，取滤液灌装，100℃灭菌30min即得。
实施例3
取黄栌350g、五味子250g、垂盆草350g、枸杞250g、栀子300g和大枣300g，加8倍水煎煮三次，每次煮沸40min，煎煮液过滤后合并，浓缩至80℃时相对密度为1.30，浓缩液冷却至室温，边搅边加入乙醇，使乙醇含量为60％，放置24h，取上清液回收至无醇味，加入单糖浆(80％)和对羟基苯甲酸的乙醇溶液，调节pH值至6.0，再加水至1000ml，搅拌均匀后静置，滤过，取滤液灌装，100℃灭菌30min即得。
实施例4
王XX，女，40岁，河南许昌人。该患者“恶心、呕吐、腹胀、眼黄半个月”为主诉，于2015-08-05入解放军371医院感染科。半个月前无明确诱因开始恶心，每日呕吐胃内容物1-2次，伴腹胀、乏力、眼黄、尿黄，无发热、寒战、皮疹，无心慌、胸闷，无呕血、黑便，食欲、睡眠差，尿色如茶水样，大便色如常，次数由每日1次减为2、3天一次。在当地诊所服用“胃药”(具体不详)1周，效果欠佳。今来我院，门诊查肝功能、胃镜异常以“急性肝炎”收入科。查体：皮肤、巩膜重度黄染，心肺听诊无异常。腹软，肝脾肋缘下未触及。腹水征阴性。双下肢无水肿。胃镜示反流性食管炎、慢性浅表性胃炎。肝功能：总胆红素98.5μmol/L、直接胆红素80.8μmol/L、谷草转氨酶992U/L、间接胆红素17.7μmol/L、谷丙转氨酶1123U/L。
考虑(1)病毒性肝炎(病原不清)急性黄疸型；(2)反流性食管炎；(3)慢性浅表性胃炎诊断成立。入院后完善相关检查：尿粪常规正常。RH-D血型阳性、ABO血型O型。血凝系列：D-二聚体0.089μg/ml、凝血酶原时间13.90S、部分凝血酶原时间37.60S、国际标准化比值1.24、纤维蛋白(原)降解产物1.18μg/ml、纤维蛋白原2.24g/L、活动度76.67％、凝血酶时间13.00S。肾功能：葡萄糖5.31mmol/L、二氧化碳18mmol/L、阴离子间隙18.50mmol/L，余正常。乙肝五项阴性、丁肝抗体阴性、抗核抗体阴性、戊肝抗体阴性、甲肝抗体阴性、抗M2型线粒体抗体阴性、抗核抗体阴性。血常规：红细胞4.17×1012/L、红细胞压积38.90％、单核细胞0.61×109/L、中性细胞数2.59×109/L、血小板264×109/L、白细胞4.71×109/L、血红蛋白128.0g/L。肝胆胰脾彩超未见异常。积极给予退黄、保肝、降酶、改善肝细胞代谢等综合治疗。复方黄栌口服液30ml，口服3/日，退黄；甘草酸二胺注射液150mg、静滴1/日保肝治疗；还原型谷胱甘肽1.8g、静滴1/日，降酶、辅助改善肝细胞代谢；维生素C 3.0g、静滴1/日，辅助肝脏解毒、缓解不适症状。复方铝酸铋、奥美拉唑肠溶胶囊、多潘立酮片口服对症。8天后(2015-08-13)患者恶心、乏力、腹胀、眼黄、尿黄明显减轻，无呕吐、腹痛、腹泻，无发热，食欲、睡眠可。复查肝功能：总胆红素76.7μmol/L、直接胆红素63.7μmol/L、白蛋白38.5g/L、总胆汁酸135.0μmol/L、谷丙转氨酶176U/L、谷草转氨酶103U/L、总蛋白57.6g/L、球蛋白19.1g/L、谷氨酰转肽酶92U/L，患者胆红素、谷丙转氨酶、谷草转氨酶均较前明显下降，治疗效果好。继续当前方案用药。于2015-08-25复查肝功能：总胆红素30.5μmol/L、胆碱酯酶6853U/L、直接胆红素25.5μmol/L、白蛋白41.4g/L、总胆汁酸28.9μmol/L、前白蛋白17.9mg/dl、腺苷脱氨酶17U/L、谷丙转氨酶48U/L、谷草转氨酶46U/L、总蛋白60.5g/L、球蛋白19.1g/L、间接胆红素5.0μmol/L、谷氨酰转肽酶85U/L。患者胆红素明显降低，转氨酶基本正常，各项指标较前明显好转。患者病情稳定，要求出院。出院后1个月内患者持续服用复方黄栌口服液30ml，3/日。1个月复查肝功能各项指标均正常。
实施例5
桂XX，女，30岁，河南新乡人。该患者“反复乏力3个月，皮肤巩膜黄染1周”于2016-02-23入解放军371医院感染科。患者10年前发现乙肝，无不适症状，未在意未治疗。3个月前无明确诱因开始乏力，化验肝功能示谷草转氨酶、谷丙转氨酶高于正常，在门诊服用“保肝、降酶”药物，复查肝功能仍异常，近日来自觉乏力较前加重，同时出现皮肤、巩膜黄染，无恶心、呕吐、腹胀、纳差等不适，来我院查乙肝病毒载量高，乙肝五项定量显示大三阳。肝功能异常，为进一步治疗，门诊以“乙肝”收入科。此次发病以来，精神差，体力欠佳，食欲差，睡眠欠佳，大便正常，尿色偏黄，体重无明显变化。查体：皮肤、巩膜重度黄染，心肺听诊无异常。腹软，肝脾肋缘下未触及。肝区无压痛、叩击痛。腹水征阴性，双下肢无水肿。2016-02-19乙肝病毒定量3.187×107IU/ml，乙肝五项定量显示：乙肝表面抗原、乙肝e抗原、乙肝核心抗体阳性。肝功能：总胆红素114.3μmol/L、谷氨酰转肽酶85U/L、直接胆红素82.9μmol/L、白蛋白47.0g/L、谷草转氨酶118U/L、间接胆红素31.4μmol/L、谷丙转氨酶274U/L。肝脏彩超示肝内钙化灶。考虑病毒性肝炎乙型慢性(中度)诊断明确。入院后完善相关检查，血常规、尿常规、粪常规均正常。B型血，RH-D血型阳性。血凝系列、甲状腺系列、肾功能均正常。乙肝五项定量：乙肝表面抗原21981.43IU/ml，乙肝e抗原1102.249S/CO，核心抗体15.28S/CO。丙肝抗体阴性，免疫缺陷病毒抗体阴性，抗核抗体阴性，抗M2型线粒体抗体阴性。给予退黄、保肝、降酶、改善肝细胞代谢等综合治疗，使用核苷类似物抗病毒，情况允许可加用干扰素联合治疗。复方黄栌口服液30ml，口服，3/日退黄；复方甘草酸单铵160mg、静滴1/日保肝、降酶治疗；维生素C 2.0g、静滴1/日，辅助改善肝细胞代谢；香丹注射液30ml、静滴1/日，辅助肝脏解毒、缓解不适症状。拉米夫定片0.1g，口服，1/日，待胆红素下降可使用重组人干扰素60μg抗病毒。5天后复查肝功能：总胆红素97.5μmol/L、直接胆红素42.7μmol/L、谷氨酰转肽酶91U/L、白蛋白38.2g/L、谷草转氨酶70U/L、总蛋白59.6g/L、谷丙转氨酶157U/L。血常规：红细胞4.44×1012/L、中性细胞数1.45×109/L、血小板159×109/L、白细胞3.44×109/L、血红蛋白135.0g/L。2016-03-10复查肝功能总胆红素29.0μmol/L、直接胆红素15.6μmol/L、总胆汁酸65.4μmol/L、谷丙转氨酶41U/L、谷草转氨酶47U/L、谷氨酰转肽酶41U/L。继续。于2016-03-20好转出院，持续复方黄栌口服液、复方甘草酸单铵、维生素C、香丹退黄、保肝、降酶，拉米夫定口服抗病毒。出院后持续抗病毒治疗。每三个月复查肝功能、血常规均正常。
本发明的复方黄栌口服液由黄栌、五味子、垂盆草、栀子、枸杞、大枣等六味中药组成。黄栌为君药，五味子、垂盆草共为臣药，枸杞、栀子为佐药，大枣为使药，诸药合用除湿清热，退黄降酶，用于急性黄疸型肝炎，慢性肝炎。经临床观察，复方黄栌口服液治疗黄疸型和无黄疸型肝炎有显著的疗效，丰富了临床用药，是一个值得推广的药物。
复方黄栌口服液通过精制的生产工艺，提高了药物有效成分的提取，保证了制剂的稳定性，减少了由于制剂的质量差异引起的治疗效果降低及不良反应的发生。本发明采用口服液的制剂形式，服用剂量小、吸收迅速、质量稳定、方便携带、易保存，尤其适合工业化生产。
如在说明书及权利要求当中使用了某些词汇来指称特定成分或方法。本领域技术人员应可理解，不同地区可能会用不同名词来称呼同一个成分。本说明书及权利要求并不以名称的差异来作为区分成分的方式。如在通篇说明书及权利要求当中所提及的“包含”为一开放式用语，故应解释成“包含但不限定于”。“大致”是指在可接收的误差范围内，本领域技术人员能够在一定误差范围内解决所述技术问题，基本达到所述技术效果。说明书后续描述为实施本发明的较佳实施方式，然所述描述乃以说明本发明的一般原则为目的，并非用以限定本发明的范围。本发明的保护范围当视所附权利要求所界定者为准。
还需要说明的是，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的商品或者系统不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种商品或者系统所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的商品或者系统中还存在另外的相同要素。
上述说明示出并描述了本发明的若干优选实施例，但如前所述，应当理解本发明并非局限于本文所披露的形式，不应看作是对其他实施例的排除，而可用于各种其他组合、修改和环境，并能够在本文所述发明构想范围内，通过上述教导或相关领域的技术或知识进行改动。而本领域人员所进行的改动和变化不脱离本发明的精神和范围，则都应在本发明所附权利要求的保护范围内。
Claims (10)
1.复方黄栌口服液，其特征在于，包括黄栌250-350g、五味子150-250g、垂盆草250-350g、枸杞150-250g、栀子200-300g和大枣200-300g。
2.如权利要求1所述的复方黄栌口服液，其特征在于，包括黄栌300g、五味子200g、垂盆草300g、枸杞200g、栀子250g和大枣250g。
3.一种复方黄栌口服液的制备方法，其特征在于，包括以下步骤：取黄栌、五味子、垂盆草、枸杞、栀子和大枣，加水煎煮，煎煮液过滤后合并，浓缩，浓缩液冷却至室温，边搅边加入乙醇，放置24h，取上清液回收至无醇味，加入矫味剂，调节pH值至5.0-7.0，再加水至1000ml，搅拌均匀后静置，滤过，取滤液灌装，灭菌即得。
4.如权利要求3所述的复方黄栌口服液的制备方法，其特征在于，取黄栌300g、五味子200g、垂盆草300g、枸杞200g、栀子250g和大枣250g。
5.如权利要求4所述的复方黄栌口服液的制备方法，其特征在于，所述煎液浓缩至80℃时相对密度为1.15-1.30。
6.如权利要求5所述的复方黄栌口服液的制备方法，其特征在于，所述乙醇加入量为使乙醇含量为60％。
7.如权利要求6所述的复方黄栌口服液的制备方法，其特征在于，所述矫味剂为单糖浆。
8.如权利要求7所述的复方黄栌口服液的制备方法，其特征在于，加入所述矫味剂同时还加入防腐剂，所述防腐剂为对羟基苯甲酸的乙醇溶液。
9.如权利要求8所述的复方黄栌口服液的制备方法，其特征在于所述灭菌条件为100℃灭菌30min。
10.如权利要求9所述的复方黄栌口服液的制备方法，其特征在于，所述煎煮方法为加药材质量8倍水煎煮三次，每次煮沸40min。
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