CN104474195A - 一种治疗白癜风的中药复方制剂及其制备方法 - Google Patents
一种治疗白癜风的中药复方制剂及其制备方法 Download PDFInfo
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Abstract
本发明提供一种治疗白癜风的中药复方制剂。其中制成活性成分的中药原料组成为下列重量份配比：当归10-15份、黄芪15-20份、川芎5-10份、红花5-10份、盐补骨脂10-15份、制香附10-15份、炒蒺藜10-15份、丹参10-15份。中药原料为加工后的中药粉末或中药提取物本发明的中药复方制剂为粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂等。本发明提供了制备方法。本发明的中药复方制剂疗效确切，且无明显不良反应。使用、携带方便。有很好的临床应用前景。本发明提供的制备方法，原料易得，操作简便，宜于工业化生产，有较大的应用价值。
Description
技术领域
本发明涉及中药制备，具体涉及中药复方制剂及其制备方法，尤其涉及一种治疗白癜风的中药复方制剂(中药八味补白制剂)及其制备方法。
背景技术
白癜风是一种后天性色素减退性皮肤病，表现为局部性或泛发行色素脱失，是皮肤科的常见病、多发病、疑难病。由于该病程长、治疗效果差和发病率高而被称为皮肤病之王。据统计，该疾病在世界各地均有发生，世界发病率为0.5％到4％，中国白癜风发病近年来呈上升趋势，发病率约达1％。白癜风不仅影响美观，还给患者精神上带来巨大的压力。最新研究证实，由于白癜风患者紫外线防御能力弱，皮肤癌的发病率比正常人要高很多，同时还可诱发多种疾病，如恶性贫血、斑秃、银屑病、恶性肿瘤、支气管哮喘、类风湿关节炎、白内障以及甲亢等。中医认为，白癜风主要因先天禀赋不足，惊恐伤肾，郁怒伤肝，日久耗伤阴血，使肝肾精血亏虚，复外感风邪，阻滞经脉，使局部气血瘀滞，致腠理气血失和，肌肤不得濡养所致。现代医学有关白癜风病因及发病机制学说众多，有自身免疫学说、黑素细胞自身破坏学说、神经化学因子学说、黑素细胞生长因子缺乏学说、遗传因素等，其中，黑素细胞生成缺乏和自身破坏学说占主导地位。通过近十几年的研究国内外运用中医药治疗白癜风大量实验和临床研究结果发现，中医药对白癜风病的治疗有减少和缩小白斑有很好的疗效；改善患者的症状体征；提高生活质量，延长生命等方面有极大的作用。
发明内容
本发明所要解决的技术问题在于研究设计治疗白癜风的中药复方制剂。本发明提供一种治疗白癜风的中药复方制剂。
本发明中药复方制剂由黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附8味中药组成。
本发明中药复方制剂，其中当归、黄芪柔肝养血，健脾益气，补后天之本以充气血生化之源；补骨脂益肾填精，“乙癸同源,肝肾同治”；川芎、红花、丹参行气活血；白蒺藜、香附疏风祛邪以通络，共奏调和气血，活血化瘀之效。诸药合用可以调和气血，活血化瘀，补益肝肾，祛风散邪。补骨脂含有呋喃香豆素类物质，有提高皮肤对紫外线光敏感作用，刺激黑色素细胞的形成。业已证实，酪氨酸酶的活性直接与黑素含量有关，上调酪氨酸酶的活性，加速黑素生成的药物可提高白癜风的治疗效果。现代医学认为，丹参、当归中含有有机酸类及其他多种微量元素，因此具有活血补血的作用；黄芪中含有的主要化学成分为黄酮类、皂苷类和多糖等，具有增强机体免疫功能和应激力的作用。盐补骨脂含有呋喃香豆素类物质，有提高皮肤对紫外线敏感作用，刺激黑色素细胞的形成，对酪氨酸酶的活性也有较强的激活作用。
本发明的一种治疗白癜风的中药复方制剂，由下列重量份的中药原料与药用辅料组成：
中药原料：
加工后的中药粉末或中药提取物 50-95份
药用辅料：
本发明的一种治疗白癜风的中药复方制剂，其中制成活性成分的中药原料组成为下列重量份配比：
当归10-15份、黄芪15-20份、川芎5-10份、红花5-10份、盐补骨脂10-15份、制香附10-15份、炒蒺藜10-15份、丹参10-15份。
所述薄膜包衣预混剂为新菲尔胃溶型薄膜包衣预混剂。
中药原料通过下列方法预加工：
(1)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片分别切断，长度约为0.5-8cm；或粉碎打粉，或超细微粉；或纳米微粉，细粉的目数范围在10目至200目；干燥得中药原料干燥粉备用；或
(2)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片混合后加水或乙醇煎煮1-3次，加水或乙醇量每次为中药原料的5-18倍量W/W，每次煎煮1-4小时，循环煎煮，(0.5-5h)；最大蒸汽压力≤0.3Mpa,边浓缩边提取，浓缩时的蒸发水冷凝后作为煎煮水自然流入提取罐，煎液自然流出，滤过(80-200目)放出煎液；
(3)放出的煎液浓缩或减压浓缩，减压浓缩至相对密度为1.08～1.24(60-90℃测)，最大蒸汽压力≤0.3Mpa；或真空减压浓缩，真空度为(≥-0.1Mpa)，最大蒸汽压力≤0.3Mp，浓缩至液体相对密度为1.08～1.24(60-90℃测)，得浸膏粉，备用。
本发明的又一目的是提供所述一种治疗白癜风的中药复方制剂的制备方法。
本发明方法所采用的详细技术方案包括以下步骤：
(一)预加工中药：
(1)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片分别切断，长度约为0.5-8cm；或粉碎打粉，或超细微粉；或纳米微粉，细粉的目数范围在10目至200目；干燥得中药原料干燥粉，备用；或
(2)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片混合后加水或乙醇煎煮1-3次，加水或乙醇量每次为中药原料的5-18倍量W/W，每次煎煮1-4小时，循环煎煮，(0.5-5h)；最大蒸汽压力≤0.3Mpa,边浓缩边提取，浓缩时的蒸发水冷凝后作为煎煮水自然流入提取罐，煎液自然流出，滤过(80-200目)放出煎液；
(3)放出的煎液浓缩或减压浓缩，减压浓缩至相对密度为1.08～1.24(60-90℃测)，最大蒸汽压力≤0.3Mpa；或真空减压浓缩，真空度为(≥-0.1Mpa)，最大蒸汽压力≤0.3Mp，浓缩至液体相对密度为1.08～1.24(60-90℃测)，得浸膏粉，备用。
(二)制备制剂：
(1)上述步骤(一)(3)制得的浸膏粉，真空减压干燥或喷雾干燥至干燥粉含水量2-8％，得干燥粉；
(2)干燥粉加入药用辅料制成制剂；或
上述步骤(一)(1)粉碎的中药原料干燥粉，加药用辅料制成制剂，即得。
本发明提供粉碎、提取、干燥、制粒等制备技术。
所述粉碎：除了具有一般的粉末的特点外，还在于超细微粉的中药饮片制成的药品，小分子可直接被人体吸收，提高物质的利用度。
所述提取：除了具有一般的中药饮片提取含量高的有效成分外，还在于采用了循环提取的方法，让浓缩过程中冷凝的热溶媒，返回至提取罐中，减少了溶媒的用量，节约了加热能源,在循环过程中完成了提取和浓缩。
所述干燥：除了具有一般的烘箱干燥、减压低温等干燥的特点外，还在于采用了喷雾干燥的方法，将中药的提取液，在短时间内瞬间干燥，使物料的受热时间大大的缩短，同时缩短了中药制剂的工时，而且使用的特殊的雾化制粒盘，(实施例5)干燥粉的粒径大小可以用以后续工序的压片、颗粒剂的包装等。
所述制粒：除了具有一般的湿法制粒特点外，还在于采用了一步制粒的方法，减少了制粒的工序，减少了粉尘，颗粒可塑性好等特点，并可以在封闭环境的条件下生产，极大的优化了中药制剂生产的工艺。
本发明的中药复方制剂可制成粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆(或无糖型糖浆)、胶囊剂、注射液、粉针等药物制剂(如有剂型实施例可以增加)，添加的药用辅料按不同的剂型选择相应的糊精、微晶纤维素、低取代羟丙基纤维素或淀粉中的一种或多种及其用量。
本发明的中药复方制剂经加速留样6个月和24个月室温考察，结果表明各项指标均符合规定，无明显变化，稳定性好。
本发明的中药复方制剂在上海徐汇区中心医院临床应用多年，疗效确切，具有充分的临床实践依据。本发明人对2008年1月-2009年6月就诊于我院，采用祛白方治疗的白癜风患者进行了分析，观察了祛白方对白癜风的临床疗效及安全性，结果显示，本发明的临床疗效与NB-UVB照射作用相当，疗效确切，且无明显不良反应。
本发明中药复方制剂与现有药物相比，具有下列特征：①纯中药制剂；②将补益肝肾、调气和血的治本之法与祛风散邪的治标之法结合起来，从而达到标本兼治。特别体现消斑止痒的用意。③组方严谨，君臣佐使之职能分明。④临床运用疗效肯定，还能调节机体的增强机体免疫功能和应激力的作用。⑤使用、携带方便。有很好的临床应用前景。
本发明提供的中药复方制剂制备方法，原料易得，操作简便，宜于工业化生产，有较大的应用价值。
具体实施方式
以下实施例所用中药原料以及药用辅料市售得到。
本发明的中药复方制剂(以下简称八味补白制剂)
实施例1、本发明的中药复方制剂-八味补白颗粒剂
中药原料配方：
提取：在1M3多功能提取罐中加入上述中药饮片，并加纯化水煎煮二次,第一次加水约100L煮沸3小时，并过滤,得滤液，第二次提取加水92L，煮沸1.5小时，每次放出煎液，备用；
浓缩与干燥：合并放出煎液，滤过(200目)，浓缩,最大蒸汽压力0.2±0.1.3Mpa；或真空减压浓缩，真空度为(-0.4±0.2Mpa)，最大蒸汽压力为0.2±0.1Mpa，浓缩至液体相对密度为1.12±0.02(60-90℃测)，YC-015型喷雾干燥机喷雾干燥实验操作数据：工作参数设定，具体参数是进风温度160±5℃，出风温度115±2℃进料蠕动泵流动速度55±3ml/min，喷雾干燥。得浸膏粉2265g，流动性好，得率为14.9％，备用；
制粒：将配物料浸膏粉2265g，糊精700g，淀粉35g；分别于制粒机(HLsy-10湿法混合制粒机)中，一边混匀，一边加入水适量喷入制粒机中制成颗粒，并于70±3℃干燥成含水量为小于6％的干颗粒，经过ZL-300整粒机20目筛整粒，备用；
包装：用颗粒包装机(XFL-K300)分包装成10g/包，即得。
实施例2、本发明的中药复方制剂-八味补白胶囊
中药原料配方：
提取：在1M3多功能提取罐中加入上述中药原料饮片，加70％乙醇提取(1M3多功能提取罐)二次，第一次加溶剂(70％乙醇)320L，第二次加水280L，加热，回流合并提取液，每次2小时，滤过，收集滤液，备用；
浓缩与干燥：滤液回收乙醇，浓缩至相对密度为1.22±0.02(60℃)的稠膏，加入淀粉10％，减压干燥(真空度-0.1Mpa，温度60±2℃，DZF-6210D真空减压干燥箱)，得干燥干浸膏粉7.2kg，粉碎，过60目，备用；
制粒：干浸膏粉中加入微晶纤维素240g，硬脂酸镁20g混合均匀(HD-100多项运动混合机)，以水制粒(HLsy-10混合制粒机)，颗粒在CTC-II热风循环烘箱80±2℃干燥，至颗粒含水量4％，备用；
灌装与包装：加入硬脂酸镁50g将上述颗粒用800型胶囊充填机灌装，0.4g/粒，抛光，挑粒，每瓶装100粒，封口，即得。
实施例3、本发明的中药复方制剂-八味补白丸
中药原料配方：
将上述饮片混合，用万能粉碎机(型号GF300AZX)进行粉碎成80目以上的粉,再用贝利粉碎机粉碎成120目以上的细粉，备用；
制粒：超细粉中加入低取代羟丙基纤维素30g，混合均匀(HD-300多项运动混合机)，以水制小丸(LSH-200湿法混合制粒机)，小丸在CTC-II热风循环烘箱)60±2℃干燥，至小丸含水量8％，备用；
包装：将上述小丸，抛光，挑粒，每瓶装150粒，封口，即得。
实施例4、本发明的中药复方制剂-八味补白片
中药原料配方：
提取：加水提取(3M3多功能提取罐)一次，加水800L，提取1h，滤过(200目)，最大蒸汽压力为0.2±0.1Mpa，边浓缩边提取，温度为98±2℃浓缩时的蒸发水冷凝后作为煎煮水自然流入提取罐，煎液自然流出，滤过(200目)，放出煎液，循环煎煮,平衡(0.5h)；滤过，滤液浓缩至相对密度为1.12±0.02(60℃)的浸膏，备用；
干燥：上述浸膏喷雾干燥，(DIS-100喷雾干燥机)，雾化盘速度30±2Hz，进风温度控制在170±3℃，出风温度控制在135±5℃至含水量5％干燥干浸膏粉，备用；
制粒：上述干浸膏粉中加入淀粉4％，微晶纤维素15％，混合均匀(HD-600多项运动混合机)，以95％乙醇(2％的混合粉量)制粒(ZL-300制粒机)，加混合粉总量的0.5％硬脂酸镁，混合均匀(HD-600多项运动混合机)10分钟，得总混颗粒，备用；
压片和包衣：将颗粒用GZPY-32A全自动高速压片机，压制成片，包市售新菲尔薄膜衣(4％片重量)(BGB-150D高效包衣机)，包装，即得。
实施例5本发明的中药复方制剂-八味补白片
提取：第一次加75％乙醇提取(3M3多功能提取罐)一次，加600L，提取1h，滤过(200目)，蒸汽压力为0.2±0.1Mpa，边浓缩边提取，温度为98±2℃浓缩时的蒸发溶液冷凝后作为煎煮自然流入提取罐，煎液自然流出，滤过(200目)，放出煎液，循环煎煮,平衡(0.5h)；滤过，滤液浓缩至相对密度为1.18±0.02(80℃)的浸膏，备用；
干燥：上述浸膏喷雾干燥，(DIS-100喷雾干燥机)，雾化(制粒)盘速度28±2Hz，进风温度控制在175±3℃，出风温度控制在140±5℃至含水量4％干燥干浸膏粉，备用；
混合：加干浸膏粉总量的0.4％硬脂酸镁，混合均匀(HD-600多项运动混合机)10分钟，得总混物，备用；
压片和包衣：将总混物GZPY-32A全自动高速压片机，直接压制成片，包市售新菲尔薄膜衣(5％片重量)(BGB-150D高效包衣机)，包装，即得。
实施例6本发明一种治疗白癜风的中药复方制剂稳定性的研究
为保证药品贮藏及使用期间的质量、保证临床疗效及确定药品使用期限，进行了该药稳定性的研究。
①本发明实施例4的制剂与市售样品，(八味补白片，上海百岁行药业有限公司生产，批号X110401、X110402、X110403)用高密度聚乙烯瓶密封包装，在温度40±2℃，相对湿度75±5％的恒温恒湿培养箱内放置6个月。
②本发明实施例4的制剂与市售样品，(八味补白片，上海百岁行药业有限公司生产，批号X110401、X110402、X110403)，用高密度聚乙烯瓶密封包装，室温25±2℃，相对湿度60±10％下，放置24个月。按八味止白片质量标准(上海市食品药品监督管理局医疗机构制剂注册批件，批件号YP140002)要求进行检查，对其内在质量进行全面考察，同时进行卫生学检查。具体考察项目为性状、外观、鉴别、检查(片重差异、崩解时限)、含量测定、微生物检查。
结果表明加速留样6个月和24个月室温考察，各项指标均符合规定，无明显变化，说明稳定性良好。
稳定性试验数据表
样品：八味补白片
Claims (7)
1.一种治疗白癜风的中药复方制剂，其特征在于，所述中药复方制剂由下列重量份的中药原料与药用辅料组成：
中药原料：
加工后的中药粉末或中药提取物 50-95份；
药用辅料：
2.根据权利要求1所述的一种治疗白癜风的中药复方制剂，其特征在于，其中制成活性成分的中药原料组成为下列重量份配比：
当归10-15份、黄芪15-20份、川芎5-10份、红花5-10份、盐补骨脂10-15份、制香附10-15份、炒蒺藜10-15份、丹参10-15份。
3.根据权利要求1或2所述的一种治疗白癜风的中药复方制剂，其特征在于，所述中药原料通过下列方法预加工：
(1)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片分别切断，长度约为0.5-8cm；或粉碎打粉，或超细微粉；或纳米微粉，细粉的目数范围在10目至200目；干燥得中药原料干燥粉备用；或
(2)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片混合后加水或乙醇煎煮1-3次，加水或乙醇量每次为中药原料的5-18倍量W/W，每次煎煮1-4小时，循环煎煮，0.5-5h；最大蒸汽压力≤0.3Mpa,边浓缩边提取，浓缩时的蒸发水冷凝后作为煎煮水自然流入提取罐，煎液自然流出，滤过80-200目，放出煎液；
(3)放出的煎液浓缩或减压浓缩，减压浓缩至相对密度为1.08～1.2460-90℃测，最大蒸汽压力≤0.3Mpa；或真空减压浓缩，真空度为≥-0.1Mpa，最大蒸汽压力≤0.3Mp，浓缩至液体相对密度为1.08～1.2460-90℃测，得浸膏粉，备用。
4.根据权利要求1所述的一种治疗白癜风的中药复方制剂，其特征在于，所述薄膜包衣预混剂为新菲尔胃溶型薄膜包衣预混剂。
5.如权利要求1所述的一种治疗白癜风的中药复方制剂的制备方法，其特征在于，该方法包括下列步骤：
(1)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片分别切断，长度约为0.5-8cm；或粉碎打粉，或超细微粉；或纳米微粉，细粉的目数范围在10目至200目；干燥得中药原料干燥粉备用；或
(a)中药黄芪、蒺藜、川芎、当归、丹参、补骨脂、红花、香附药材或饮片混合后加水或乙醇煎煮1-3次，加水或乙醇量每次为中药原料的5-18倍量W/W，每次煎煮1-4小时，循环煎煮，0.5-5h；最大蒸汽压力≤0.3Mpa,边浓缩边提取，浓缩时的蒸发水冷凝后作为煎煮水自然流入提取罐，煎液自然流出，滤过80-200目放出煎液；
(b)放出的煎液浓缩或减压浓缩，减压浓缩至相对密度为1.08～1.2460-90℃测，蒸汽压力≤0.3Mpa；或真空减压浓缩，真空度为≥-0.1Mpa，蒸汽压力≤0.3Mp，浓缩至液体相对密度为1.08～1.2460-90℃测，得浸膏粉，备用；
(二)制备制剂：
(1)上述步骤(一)(3)制得的浸膏粉，真空减压干燥或喷雾干燥至干燥粉含水量2-8％，得干燥粉；
(2)干燥粉加入药用辅料制成制剂；或
上述步骤(一)(1)粉碎的中药原料干燥粉，加药用辅料制成制剂，即得。
6.根据权利要求1所述的一种治疗白癜风的中药复方制剂，其特征在于，所述制剂为粉状制剂、散剂、丸剂、丹剂、膏剂、颗粒剂、口服液、糖浆、胶囊剂或注射液。
7.根据权利要求6所述的一种治疗白癜风的中药复方制剂，其特征在于，所述制剂为无糖型糖浆或粉针剂。
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