CN109091580A - 改善紫癜的组合物、制剂及其制备方法与应用 - Google Patents
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Abstract
本发明公开了一种改善紫癜的组合物及其制剂，组合物包括主料和辅料，以重量份计，主料由1‑10份NMN、3‑8份人参皂苷PPD、1‑10份人参皂苷Rh2、2‑8份葡萄籽提取物、3‑7份燕窝酸和1‑8份s‑腺苷蛋氨酸组成。采用了适宜配伍比例的组分，各组分协同发挥作用，具有清热解毒、祛风止痒的效果，对紫癜具有显著疗效。各组分相辅相成，调整内分泌系统功能，改善机体内外环境，从而缓解紫癜的各种症状，药效温和，具有很好的应用前景和市场前景。还公开了制剂的制备工艺，所述工艺条件温和、步骤简单，适宜于工业化批量生产。
Description
技术领域
本发明属于药物制剂技术领域，具体地说涉及一种改善紫癜的组合物、制剂及其制备方法与应用。
背景技术
紫癜亦称紫斑，以血液溢于皮肤、粘膜之下，出现瘀点瘀斑，压之不退色为其临床特征，是常见的出血性疾病之一，多发于儿童及青年，该病的起因及机理至今尚未定论，但医学界普遍认为其是一种与人的免疫有关的过敏性疾病。过敏性疾病约占出血性疾病总数的三分之一，包括血管性紫癜和血小板性紫癜。其中，血管性紫癜由血管壁结构或功能异常所致，多见于内壁细胞或内壁下基质膜及胶原纤维等内皮下组织的病变，如遗传性出血性毛细管扩张症、获得性的过敏性紫癜、单纯性紫癜、老年型紫癜、感染性紫癜、坏血病等。血小板性紫癜由血小板疾病所致，如血小板减少，包括再生障碍性贫血、白血病、皮功能亢进、免疫性血小板减少性紫癜，和血栓性血小板减少性紫癜等；血小板功能异常，包括血小板病、血小板无力症、原发性血小板增多症、尿毒症、异常球蛋白血症，阿司匹林和双密达莫等引起的继发性血小板功能异常，临床上以皮肤、黏膜出血为主要表现。
我国作为传统中医药大国，在治疗上述紫癜也积累了丰富的经验，近年来传统的中医公开了多种配方，治疗紫癜的中药配方均各不相同，治疗效果也不尽相同，各有各的特点。目前，并没有对改善紫癜现象有任何高效的治疗方案。针对皮肤紫癜多为使用激素类药物，很少有有效的中西合成的方式存在，国内目前有少部分的中药外敷用品，对缓解紫癜有一定疗效，但是大多成分效果不明朗，有效成分也不确切，副作用也未经过调研。因此寻找一种有效成分确定，含量高，效果显著的减缓紫癜现象的药物，是本领域目前刻不容缓的事情。
发明内容
为此，本发明正是要解决上述技术问题，从而提出一种疗效优异、安全无毒副作用的改善紫癜的组合物、制剂及其制备方法与应用。
为解决上述技术问题，本发明的技术方案为：
本发明提供一种改善紫癜的组合物，其包括主料和辅料，以重量份计，所述主料由1-10份NMN、3-8份人参皂苷PPD、1-10份人参皂苷Rh2、2-8份葡萄籽提取物、3-7份燕窝酸和1-8份s-腺苷蛋氨酸组成。
作为优选，所述辅料以重量份计，包括如下组分中的至少十种：荆芥6-15份、浮萍4-10份、白芨0.5-10份、木蓝4-15份、车前子4-14份、秦皮3-7份、荨麻1.1-9.2份、栀子3-7份、连翘8-15份、虎杖8-15份、紫草10-15份、软蒺藜1-6份、香草精1.1-9.2份、马齿苋提取物3-5份、地榆提取物1-3份、大黄提取物0.5-1份。
作为优选，所述辅料以重量份计，还包括如下组分中的至少三种：尼泊金复合酯0.5-7份、富马酸2-6份、木糖醇3-6份、微晶纤维素2-5份、失水山梨醇脂肪酸酯1-4份、硬脂酸镁2-5份、交联羧甲基纤维素钠1-3份、氢氧化镁1-4份、预胶化淀粉1-3份、硫酸钙2-4份、气相二氧化硅2-4份、乳糖1-4份。
本发明还提供一种改善紫癜的制剂，所述制剂包括所述的组合物。
本发明还提供一种制备所述的制剂的方法，其包括如下步骤：
S1、将原料与辅料分别过30-80目筛，使颗粒粒度均匀；
S2、按照比例将原料、辅料和水在25-40℃下充分搅拌均匀；
S3、将步骤S2得到的混合物升温至50℃后搅拌1h，即得改善紫癜的水剂。
本发明还提供一种制备所述的制剂的方法，其包括如下步骤：
S1、将干燥的主料和辅料各组分过60目筛，并按比例称重混合；
S2、将步骤S1得到的混合物烘干后进行整粒和压片处理，得到改善紫癜的片剂。
本发明还提供一种制备所述的制剂的方法，其包括如下步骤：
S1、将主料和辅料各组分过60目筛，并按比例称重混合；
S2、将步骤S1得到的混合物充填于软胶囊体中，并经过压丸、定型干燥、洗丸、晾丸、捡丸的步骤，得到改善紫癜的软胶囊。
本发明还提供一种制备所述的制剂的方法，其包括如下步骤：
S1、将辅料组分粉碎为颗粒，向颗粒中加入乙醇并加热回流提取2h，乙醇的添加量为组分颗粒质量的5倍，第一次过滤处理，得到药渣和药液，将药渣与3倍量的乙醇加热回流提取1h，第二次过滤处理，将第一次、第二次过滤得到的药液混合，并减压浓缩制得相对密度为1.35-1.4的稠膏备用；
S2、将步骤S1得到的稠膏加7倍量的水，加热回流提取4h，得到挥发油、药渣和药液的混合物，分取所述挥发油，并将药渣和药液过滤分离，得到上清液和固体药渣；
S3、将主料与步骤S2得到的挥发油和药渣混合，加18倍量的水煎煮提取2h，过滤得到滤液和滤渣，将滤液离心分离，得到第一上清液；将滤渣加12倍量的水煎煮提取1h，过滤得到滤液和滤渣，将滤液离心分离，得到第二上清液；将第一上清液、第二上清液与步骤S2中的上清液混合，减压浓缩制得相对密度为1.35-1.4的稠膏备用；
S4、将糊精、微粉硅胶混匀并与步骤S3制得的稠膏共同搅拌均匀，将得到的混合物干燥并粉碎后，加入糊精，喷入步骤S2得到的挥发油后过筛、混匀并装入胶囊壳，得到改善紫癜的胶囊。
作为优选，所述乙醇的体积浓度为70％。
本发明还提供一种所述的组合物在抗紫癜药物中的应用。
本发明的上述技术方案相比现有技术具有以下优点：
(1)本发明所述的改善紫癜的组合物，其包括主料和辅料，以重量份计，所述主料由1-10份NMN、3-8份人参皂苷PPD、1-10份人参皂苷Rh2、2-8份葡萄籽提取物、3-7份燕窝酸和1-8份s-腺苷蛋氨酸组成。所述改善紫癜的组合物中，采用了适宜配伍比例的组分，各组分协同发挥作用，成为了能够全方位改善紫癜的问题，组合物中主要组分均为有效提取物，纯度和溶出度高，有助于人体吸收，从而能够提高其生物利用度，而且患者长期服用后无毒副作用，安全性好。所述组合物具有清热解毒、祛风止痒的效果，对紫癜具有显著疗效。组合物中，NMN和葡萄籽提取物为君药，具有益肝清热化湿的作用；人参皂苷PPD、人参皂苷Rh2为臣药，具有祛风止痒、渗湿通淋的作用；所述s-腺苷蛋氨酸为佐药，具有补中益气的作用；所述燕窝酸为使药，可调和诸药药性，使得各组分相辅相成，调整内分泌系统功能，改善机体内外环境，从而缓解紫癜的各种症状，药效温和，具有很好的应用前景和市场前景。
所述改善紫癜的组合物首次提出了加用NMN和葡萄籽提取物、PPD、人参皂苷Rh2等明确的有效成分的理论，并以该理论为指导思想，通过大量药理实验。中西医理论相呼应，加入各类特定的辅料的引入能够显著提高方中其它药材对抗紫癜具有促进效果，以上几个组分发生了协同增效作用。现有报道中，NMN、葡萄籽提取物、PPD、Rh2四者仅仅单独作为原料被使用，目前尚未检索到任何将四者共同使用制备的针对改善紫癜的组合物，本发明通过调配得到了1+1+1+1＞4的技术效果。
(2)本发明所述的制剂的制备工艺，条件温和、步骤简单，适宜于工业化批量生产。
具体实施方式
为了使本发明的内容更容易被清楚的理解，下面根据本发明的具体实施例对本发明作进一步详细的说明，
实施例1
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由1份NMN、3份人参皂苷PPD、1份人参皂苷Rh2、2份葡萄籽提取物、3份燕窝酸和1份s-腺苷蛋氨酸组成。其中，葡萄籽提取物是从葡萄籽中提取分离得到的一类多酚类物质,主要由原花青素,儿茶素,表儿茶素,没食子酸,表儿茶素没食子酸酯等多酚类物质组成。
所述辅料以重量份计，包括荆芥6份、浮萍4份、白芨0.5份、木蓝4份、车前子4份、秦皮3份、荨麻1.1份、栀子3份、连翘8份、虎杖8份。
本实施例还提供一种改善紫癜的水剂，其包括上述组合物，其通过如下工艺制备：
S1、将原料与辅料分别过30目筛，使颗粒粒度均匀。
S2、按照比例将原料、辅料和水在25℃下充分搅拌均匀。
S3、将步骤S2得到的混合物升温至50℃后搅拌1h，即得改善紫癜的水剂。
所述NMN采用如下工艺制备：
以烟酰胺、ATP和木糖为原料，在烟酰胺磷酸核糖转移酶核糖磷酸焦磷酸激酶、核糖-5-磷酸异构酶、核酮糖-3-磷酸异构酶、木酮糖激酶以及木糖异构酶的催化作用下发生反应，制得烟酰胺单核苷酸。
具体为：向反应釜中加入底物溶液，含30mM的ATP、30mM的木糖、20mM的MgCl2、10mM的KC1以及l00mM的Tris-HCl缓冲液，调pH至7.5-8.0。然后加入以下催化用酶：核糖磷酸焦磷酸激酶6g/L底物溶液，核糖-5-磷酸异构酶10g/L底物溶液，核酮糖-3-磷酸异构酶l lg/L底物溶液，木酮糖激酶10g/L底物溶液，木糖异构酶10g/L底物溶液。搅拌均匀后进行反应，反应过程中持续搅拌(搅拌速度50rpm)，控制反应温度为35℃，维持pH值为7.5-8.0。
待上述反应进行4h后，分离出反应液，并将反应液送入另一反应釜中，再向反应液中加入60mM的烟酰胺、30mM的ZnCl2、l00mM的Tris-HCl缓冲液以及烟酰胺磷酸核糖转移酶15g/L底物溶液，搅拌均匀后继续反应，反应过程中持续搅拌(搅拌速度50rpm)，控制反应温度为35℃，维持pH值为7.5-8.0，再反应4h后即得烟酰胺单核苷酸粗产品溶液(含NMN12mM)，再经过滤、纯化、干燥后即得烟酰胺单核苷酸成品。
实施例2
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由10份NMN、8份人参皂苷PPD、10份人参皂苷Rh2、8份葡萄籽提取物、7份燕窝酸和8份s-腺苷蛋氨酸组成。
所述辅料以重量份计，包括如下组分：荆芥15份、浮萍10份、白芨10份、木蓝15份、车前子14份、秦皮7份、荨麻9.2份、栀子7份、连翘15份、虎杖15份、紫草15份、软蒺藜6份、香草精9.2份、尼泊金复合酯7份、富马酸6份、木糖醇6份、微晶纤维素5份、失水山梨醇脂肪酸酯4份、硬脂酸镁5份、交联羧甲基纤维素钠3份。
本实施例还提供一种改善紫癜的片剂，所述片剂包括上述组合物，其通过如下工艺制备：
S1、将干燥的主料和辅料各组分过60目筛，使颗粒粒度分布均匀，流动性更好，并按比例称重混合。
S2、将步骤S1得到的混合物烘干后在制粒机中进行制粒，烘干后进行整粒处理，随后放到压片机中，进行压片，得到理论片重为500mg的改善紫癜的片剂。
实施例3
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由6份NMN、5份人参皂苷PPD、6份人参皂苷Rh2、5份葡萄籽提取物、6份燕窝酸和5份s-腺苷蛋氨酸组成。
所述辅料以重量份计，包括如下组分：荆芥10份、浮萍7份、白芨5份、木蓝11份、车前子9份、秦皮5份、荨麻5份、栀子5份、连翘12份、虎杖12份、紫草10份、软蒺藜1份、香草精1.1份、马齿苋提取物3份、地榆提取物1份、大黄提取物0.5份、尼泊金复合酯0.5份、富马酸2份、木糖醇3份、微晶纤维素2份、失水山梨醇脂肪酸酯1份、硬脂酸镁2份、交联羧甲基纤维素钠1份、氢氧化镁1份、预胶化淀粉1份、气相二氧化硅2份。
本实施例还提供一种改善紫癜的软胶囊，所述软胶囊包括上述组合物，其通过如下工艺制备：
S1、将干燥的主料和辅料各组分分别过60目筛，并按比例称重混合均匀。
S2、将步骤S1得到的混合物充填于软胶囊体中，并经过常规压丸、定型干燥、洗丸、晾丸、捡丸的步骤，得到改善紫癜的软胶囊；所述软胶囊体通过以下步骤制备：首先将甘油和水加入溶胶罐中，然后加入明胶和相关辅料，搅拌并真空脱气，即得。
实施例4
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由4份NMN、6份人参皂苷PPD、7份人参皂苷Rh2、6份葡萄籽提取物、4.5份燕窝酸和6份s-腺苷蛋氨酸组成。
所述辅料以重量份计，包括如下组分：荆芥12份、浮萍8.5份、白芨7份、木蓝8份、车前子7份、秦皮6份、荨麻7份、栀子6份、连翘10份、虎杖13份、紫草12份、软蒺藜4份、香草精6份、马齿苋提取物5份、地榆提取物3份、大黄提取物1份、尼泊金复合酯7份、富马酸6份、木糖醇6份、微晶纤维素5份、失水山梨醇脂肪酸酯4份、硬脂酸镁5份、交联羧甲基纤维素钠3份、氢氧化镁4份、预胶化淀粉3份、硫酸钙2份、气相二氧化硅4份、乳糖1份。
本实施例还提供一种改善紫癜的胶囊，所述胶囊包括上述组合物，其通过如下工艺制备：
S1、将辅料组分粉碎为颗粒，向颗粒中加入体积浓度为70％的乙醇并加热回流提取2h，乙醇的添加量为组分颗粒质量的5倍，第一次过滤处理，得到药渣和药液，将药渣与3倍量的乙醇加热回流提取1h，第二次过滤处理，将第一次、第二次过滤得到的药液混合，并减压浓缩制得相对密度为1.35-1.4的稠膏备用。
S2、将步骤S1得到的稠膏加7倍量的水，加热回流提取4h，得到挥发油、药渣和药液的混合物，分取所述挥发油，并将药渣和药液过滤分离，得到上清液和固体药渣。
S3、将主料与步骤S2得到的挥发油和药渣混合，加18倍量的水煎煮提取2h，过滤得到滤液和滤渣，将滤液离心分离，得到第一上清液；将滤渣加12倍量的水煎煮提取1h，过滤得到滤液和滤渣，将滤液离心分离，得到第二上清液；将第一上清液、第二上清液与步骤S2中的上清液混合，减压浓缩制得相对密度为1.35-1.4的稠膏备用。
S4、将糊精、微粉硅胶混匀并与步骤S3制得的稠膏共同搅拌均匀，将得到的混合物干燥并粉碎后，加入糊精，喷入步骤S2得到的挥发油后过筛、混匀并装入胶囊壳，得到改善紫癜的胶囊。
实施例5
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由6.5份NMN、4.5份人参皂苷PPD、9份人参皂苷Rh2、6.5份葡萄籽提取物、6份燕窝酸和3份s-腺苷蛋氨酸组成。
所述辅料以重量份计，包括如下组分：荆芥13.5份、浮萍6.5份、白芨8份、木蓝13份、车前子12份、秦皮4份、荨麻6.5份、栀子4.5份、连翘12.5份、虎杖9.5份、紫草14份、软蒺藜3.5份、香草精7.5份、马齿苋提取物4份、地榆提取物2份、大黄提取物0.8份、尼泊金复合酯5份、富马酸4份、木糖醇5份、微晶纤维素4份、失水山梨醇脂肪酸酯3份、硬脂酸镁3.5份、交联羧甲基纤维素钠2份、氢氧化镁2.5份、预胶化淀粉2份、硫酸钙4份、气相二氧化硅3份、乳糖3份。
本实施例还提供一种改善紫癜的片剂，所述片剂包括上述组合物，其通过如下工艺制备：
S1、将干燥的主料和辅料各组分过60目筛，使颗粒粒度分布均匀，流动性更好，并按比例称重混合。
S2、将步骤S1得到的混合物烘干后在制粒机中进行制粒，烘干后进行整粒处理，随后放到压片机中，进行压片，得到理论片重为500mg的改善紫癜的片剂。
实施例6
本实施例提供一种改善紫癜的组合物，所述组合物可用于抗紫癜药物中，其包括主料和辅料，以重量份计，所述主料由2份NMN、6.5份人参皂苷PPD、3份人参皂苷Rh2、3份葡萄籽提取物、4.8份燕窝酸和6.8份s-腺苷蛋氨酸组成。
所述辅料以重量份计，包括如下组分：白芨2份、木蓝6份、车前子11份、秦皮4.5份、荨麻8份、栀子6.2份、连翘9.5份、虎杖12份、紫草12份、软蒺藜5份、香草精2.5份、马齿苋提取物3.5份、地榆提取物2.5份、木糖醇4份、微晶纤维素3.3份、硬脂酸镁4.2份、交联羧甲基纤维素钠2.4份、氢氧化镁3份、预胶化淀粉2.5份、硫酸钙3份、气相二氧化硅3.5份、乳糖2.5份。
实验例
本发明所用试剂和原料均市售可得或可按文献方法制备。下列实施例中未注明具体条件的实验方法，通常按照常规条件，或按照制造厂商所建议的条件。
1、对照试验，将具有紫癜症状的病例随机分成7组：
治疗组1：280例，其中女性153例，男性127例，年龄1-82岁，病程3日-36年，对治疗组1采用实施例1所述的组合物制成的水剂进行治疗，根据年龄每次3-10ml片，日3次口服。
治疗组2：242例，其中女性153例，男性127例，年龄1-80岁，病程10日-30年，对治疗组2采用实施例2所述的组合物制成的片剂进行治疗,根据年龄每次1-5片，日3次口服。
治疗组3：280例，其中女性162例，男性118例，年龄3-75岁，病程5日-25年，对治疗组3采用实施例3所述的组合物制成的软胶囊进行治疗，根据年龄每次1-4粒，日3次口服。
治疗组4：255例，其中女性150例，男性105例，年龄5-70岁，病程3日-30年，对治疗组4采用实施例4所述的组合物制成的胶囊进行治疗，根据年龄每次1-4粒，日3次口服。
治疗组5：300例，其中女性183例，男性117例，年龄6-75岁，病程15日-20年，对治疗组5采用实施例5所述的组合物制成的片剂进行治疗，根据年龄每次1-5片，日3次口服。
对照组1：100例，其中女性58例，男性42例，年龄5-70岁，病程5日-20年，对对照组1采用断血流胶囊进行治疗，根据年龄每次1-6片，日3次口服。
对照组2：120例，其中女性65例，男性55例，年龄6-75岁，病程2日-24年，对对照组2采用升血小板胶囊进行治疗，根据年龄每次2-5粒，日3次口服。
全部患者均符合急慢性过敏性紫癜、血小板减少性紫癜的诊断标准，七组患者在性别、年龄、病程等方面差异无显著性意义(P>0.05)，具有可比性。
入选标准：中医诊断标准参照1994年国家中医药管理局制定的《中医病证诊断疗效标准》中过敏性紫癜、血小板减少性紫癜的诊断标准。西医诊断标准参照《临床疾病诊断依据治愈好转标准》，包括急性、慢性过敏性紫癜、血小板减少性紫癜。
排除标准：
(1)治疗期间随意终止或更换治疗药物及方法者；
(2)妊娠期、哺乳期妇女；
(3)有神经精神疾病及严重内分泌疾病患者；
(4)有严重心、肝、肾等内脏疾患及恶性肿瘤者。
疗效判定标准：参照《中药新药临床研究指导原则》制定。疗效指数(％)＝(治疗前积分-治疗后积分)/治疗前总积分×100％。临床痊愈：皮肤紫癜全部消退，无出血点，血尿常规正常，症状消失，无鼻、牙龈及其他部位出血、血小板升至10万以上。积分值减少≥95％。显效：皮肤紫癜大部分消退，偶见出血点，尿常规潜血十～±。症状明显减轻，无鼻、牙龈及其他部位出血，血小板升至7万-9万，积分值减少≥70％；有效：皮肤紫癜部分消退，尿Rt有所改善，偶见鼻、牙龈及其他部位出血，症状有所改善，血小板有上升，呈较低水平(3-53)，积分值减少≥50％。无效：皮肤紫癜及出血点改善不明显，尿常规无明显改善，血小板症状未见减轻或加重，积分值减少不足50％。
统计学处理，采用SPSS10.0软件统计学处理，组间积分和治疗前后积分比较用配对t检验；有效率的比较用X2检验.
结果：
七组患者治疗后疗效比较：七组患者治疗一周前后疗效见表1。
表1
七组患者治疗后疗效比较：七组患者治疗一周前后疗效见表2.
表2
| 组别 | 例数 | 痊愈 | 显效 | 有效 | 无效 | 有效率 |
| 治疗组1 | 280 | 143 | 68 | 60 | 9 | 96.8％ |
| 治疗组2 | 242 | 123 | 59 | 52 | 8 | 96.7％ |
| 治疗组3 | 280 | 146 | 62 | 60 | 12 | 95.7％ |
| 治疗组4 | 255 | 134 | 68 | 48 | 5 | 98％ |
| 治疗组5 | 300 | 163 | 79 | 52 | 6 | 98％ |
| 对照组1 | 100 | 22 | 23 | 39 | 16 | 84％ |
| 对照组2 | 120 | 42 | 39 | 26 | 15 | 87.5％ |
从上述结果可看出，采用实施例1-5所述的组合物制得的药剂有效性明显高于对照组采用的药剂，治疗组疗效明显优于对照组，P<0.05。
另外，七组患者在治疗过程中，耐受性良好，无不良事件发生，均能顺利完成全程治疗，从中发现，断血流胶囊组功能上偏于止血，升血小板胶囊组偏于凉血解毒，由以上临床结果可知，本发明所述的组合物配方可用于治疗急慢性过敏性紫癜、血小板减少性紫癜，起效快、疗效确切、不易反复、无毒副作用。
2、典型病例
(1)李某，男，26岁，患过敏性紫癜，发病时皮肤出现瘀点，服用一个疗程后，病症消除，一年后经过电话回访，无复发现象。
(2)张某，女，12岁，患过敏性紫癜，发病时皮肤出现瘀斑，服用一个疗程后，治愈，一年后经过电话回访，无复发现象。
(3)王某，男，8岁，患过敏性紫癜，发病时皮肤出现瘀斑，服用三周程后，治愈，一年后经过电话回访，无复发现象。
(4)秦某，男，15岁，患过敏性紫癜，发病时皮肤出现瘀斑，服用一个疗程后，治愈，一年后经过电话回访，无复发现象。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。
Claims (10)
1.一种改善紫癜的组合物，其特征在于，包括主料和辅料，以重量份计，所述主料由1-10份NMN、3-8份人参皂苷PPD、1-10份人参皂苷Rh2、2-8份葡萄籽提取物、3-7份燕窝酸和1-8份s-腺苷蛋氨酸组成。
2.根据权利要求1所述的改善紫癜的组合物，其特征在于，所述辅料以重量份计，包括如下组分中的至少十种：荆芥6-15份、浮萍4-10份、白芨0.5-10份、木蓝4-15份、车前子4-14份、秦皮3-7份、荨麻1.1-9.2份、栀子3-7份、连翘8-15份、虎杖8-15份、紫草10-15份、软蒺藜1-6份、香草精1.1-9.2份、马齿苋提取物3-5份、地榆提取物1-3份、大黄提取物0.5-1份。
3.根据权利要求2所述的改善紫癜的组合物，其特征在于，所述辅料以重量份计，还包括如下组分中的至少三种：尼泊金复合酯0.5-7份、富马酸2-6份、木糖醇3-6份、微晶纤维素2-5份、失水山梨醇脂肪酸酯1-4份、硬脂酸镁2-5份、交联羧甲基纤维素钠1-3份、氢氧化镁1-4份、预胶化淀粉1-3份、硫酸钙2-4份、气相二氧化硅2-4份、乳糖1-4份。
4.一种改善紫癜的制剂，其特征在于，所述制剂包括如权利要求1-3任一项所述的组合物。
5.一种制备如权利要求4所述的制剂的方法，其特征在于，包括如下步骤：
S1、将原料与辅料分别过30-80目筛，使颗粒粒度均匀；
S2、按照比例将原料、辅料和水在25-40℃下充分搅拌均匀；
S3、将步骤S2得到的混合物升温至50℃后搅拌1h，即得改善紫癜的水剂。
6.一种制备如权利要求4所述的制剂的方法，其特征在于，包括如下步骤：
S1、将干燥的主料和辅料各组分过60目筛，并按比例称重混合；
S2、将步骤S1得到的混合物烘干后进行整粒和压片处理，得到改善紫癜的片剂。
7.一种制备如权利要求4所述的制剂的方法，其特征在于，包括如下步骤：
S1、将主料和辅料各组分过60目筛，并按比例称重混合；
S2、将步骤S1得到的混合物充填于软胶囊体中，并经过压丸、定型干燥、洗丸、晾丸、捡丸的步骤，得到改善紫癜的软胶囊。
8.一种制备如权利要求4所述的制剂的方法，其特征在于，包括如下步骤：
S1、将辅料组分粉碎为颗粒，向颗粒中加入乙醇并加热回流提取2h，乙醇的添加量为组分颗粒质量的5倍，第一次过滤处理，得到药渣和药液，将药渣与3倍量的乙醇加热回流提取1h，第二次过滤处理，将第一次、第二次过滤得到的药液混合，并减压浓缩制得相对密度为1.35-1.4的稠膏备用；
S2、将步骤S1得到的稠膏加7倍量的水，加热回流提取4h，得到挥发油、药渣和药液的混合物，分取所述挥发油，并将药渣和药液过滤分离，得到上清液和固体药渣；
S3、将主料与步骤S2得到的挥发油和药渣混合，加18倍量的水煎煮提取2h，过滤得到滤液和滤渣，将滤液离心分离，得到第一上清液；将滤渣加12倍量的水煎煮提取1h，过滤得到滤液和滤渣，将滤液离心分离，得到第二上清液；将第一上清液、第二上清液与步骤S2中的上清液混合，减压浓缩制得相对密度为1.35-1.4的稠膏备用；
S4、将糊精、微粉硅胶混匀并与步骤S3制得的稠膏共同搅拌均匀，将得到的混合物干燥并粉碎后，加入糊精，喷入步骤S2得到的挥发油后过筛、混匀并装入胶囊壳，得到改善紫癜的胶囊。
9.根据权利要求8所述的制剂的制备工艺，其特征在于，所述乙醇的体积浓度为70％。
10.一种如权利要求1-3任一项所述的组合物在抗紫癜药物中的应用。
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| CN105535930A (zh) * | 2015-12-21 | 2016-05-04 | 天津中津药业股份有限公司 | 一种药物保健组合物 |
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