CN105687362A - 慢性痢疾活血止痢丸 - Google Patents
慢性痢疾活血止痢丸 Download PDFInfo
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- CN105687362A CN105687362A CN201610095590.XA CN201610095590A CN105687362A CN 105687362 A CN105687362 A CN 105687362A CN 201610095590 A CN201610095590 A CN 201610095590A CN 105687362 A CN105687362 A CN 105687362A
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Abstract
本发明公开了一种慢性痢疾活血止痢丸，取下述重量配比的主要原料药制备而成：黄连3-6，白头翁10-20，木香5-15，石莽草15-25，秋枫木6-12，黄芪12-20，当归6-10，桂枝8-15，马齿苋18-40，川芎6-12，盾果草6-15，草鞋青4-9。该制剂疗效显著、无毒副作用、疗程短、见效快、无复发。
Description
分案申请，原申请号2014105830371，申请日2014.10.28，名称慢性痢疾活血止痢制剂及制备方法。
技术领域
本发明涉及中医中药领域，特别是涉及一种慢性痢疾活血止痢制剂及其制备方法。
背景技术
痢疾是一种以腹痛、里急后重、下痢脓血为主要特点的常见病,好发于夏秋季节。《内经》称之为“肠癖”、“赤沃”，多由感受湿热、疫毒之邪以及饮食不节损伤脾胃肠腑所致。病程超过二个月以上者称为慢性痢疾。多由急性菌痢转变而来，以福氏菌感染者居多。有的病程可长达数月或数年，在此期间肠道病变此起彼伏，原有溃疡尚未愈合，新的溃疡又形成。因此新旧病灶同时存在。由于组织的损伤修复反复进行，慢性溃疡边缘不规则，粘膜常过度增生而形成息肉。肠壁各层有慢性炎症细胞浸润和纤维组织增生，乃至疤痕形成，从而使肠壁不规则增厚、变硬、严重的病例可致肠腔狭窄。
慢性痢疾的治疗：1.一般治疗。养成良好生活习惯，避免精神紧张，注意劳逸结合，提高机体的抵抗力和适应力。进食少渣、富于营养、易于消化的食物，避免寒冷刺激，积极治疗肠道寄生虫病。2.药物治疗。要根据药敏试验结果或以往的治疗经验选用有效抗菌药物，联合应用2种抗菌药物并延长疗程至10～15天，也可交替应用有效抗菌药物，必要时可进行保留灌肠：灌肠液200mL，加入抗菌药物如0.5%卡那霉素，1%～2%新霉素等与0.25%的普鲁卡因及20mg泼尼松，每晚一次，10～14天为一疗程。中医认为对阴虚痢的治疗是坚阴泄热，扶正止痢。用黄连阿胶汤合驻车丸加减。休息痢发作时以清化湿热为主，可用白头翁汤加减。休止时以健脾益气为主，可用健脾和胃汤合香连丸。对虚寒痢应温补脾肾，佐以固脱。用桃花汤合养脏汤加减。对湿热痢应清热化湿解毒，辅以调气行血。对疫毒痢应清热凉血解毒。
公开号CN1857460A（申请号2006100050998.1）的中国专利文献公开了一种治疗痢疾的药物组合物，主要成份为地蜂子、矮脚罗伞、算盘子、血见愁、大夜关门、十大功劳和蜂蜜。申请公布号CN104096159A（申请号201410343777.8）的中国专利文献公开了一种缓解慢性痢疾及肠功能紊乱的活菌合剂，取下述重量配比的主要原料制备而成：吴茱萸2-4份，栀子3-10份，建曲4-12份，五味子5-12份，茯神4-12份，山楂6-15份，石斛6-9份，砂仁5-12份，藕节3-10份，蜡样芽孢杆菌0.3-1.0份。申请公布号CN103405703A（申请号201310275325.6）的中国专利文献提供了一种治疗慢性痢疾的中药丸，包括以下重量比绢成中药组份：黄芩10-15份、白术12-18份、茯苓15份、神曲5份、木香8份、砂仁10-15份、山药15-20份、槐花10份、桔梗5份、奥椿皮20份、地榆10-15份、马齿苋20份、甘草6份；还提供了药丸的制备方法。
总之，慢性菌痢病程长，反复发作或迁延不愈，目前临床以抗生素治疗为主，对于慢性痢疾疗效不好，毒副作用大。而中药治疗慢性痢疾疗程较长。
发明内容
针对现有技术的不足，本发明的目的是提供一种慢性痢疾活血止痢制剂及其制备方法。该制剂疗效显著、无毒副作用、疗程短、见效快、无复发。
本发明的技术方案是：
慢性痢疾活血止痢制剂，取下述重量配比的主要原料药制备而成：黄连3-6，白头翁10-20，木香5-15，石莽草15-25，秋枫木6-12，黄芪12-20，当归6-10，桂枝8-15，马齿苋18-40，川芎6-12，盾果草6-15，草鞋青4-9。
慢性痢疾活血止痢制剂，优选的方案是，取下述重量配比的主要原料药制备而成：黄连4-5.5，白头翁13-16，木香8-12，石莽草19-22，秋枫木8-11，黄芪15-18，当归7-9，桂枝11-13，马齿苋24-32，川芎9-11，盾果草8-11，草鞋青6-8。
慢性痢疾活血止痢制剂，更加优选的方案是，取下述重量配比的主要原料药制备而成：黄连5，白头翁14，木香10，石莽草21，秋枫木9，黄芪17，当归8，桂枝12，马齿苋29，川芎10，盾果草9，草鞋青7。
本发明还提供了将前述慢性痢疾活血止痢制剂制成药学上可接受的汤剂、散剂、稠膏剂和丸剂的制备方法。
所述汤剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15-35分钟（优选用水浸泡25分钟），捞入筐内，加盖湿布润4-8小时（优选加盖湿布润5小时），取出，切片，再用酒浸泡1.5-3.5小时（优选再用酒浸泡2.5小时），取出；
（2）将除白头翁和木香外的其余10味原药材置于砂锅中，加水，水的用量是加入的药材总重量的2.5-5.5倍（优选水的用量是加入的药材总重量的4.5倍），浸泡1.5-2.5小时（优选浸泡2小时）；
（3）将步骤（2）浸泡过的药材先用大火煮至沸腾，后转小火煎煮15-30分钟（优选后转小火煎煮22分钟），加水，水的用量是加入的药材总重量的2.2-4.5倍（优选水的用量是加入的药材总重量的3.2倍），然后加入木香以及步骤（1）所得白头翁，用大火煮至沸腾，后转小火煎煮35-55分钟（优选后转小火煎煮42分钟），滤出药液，即得。
所述散剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15-35分钟（优选用水浸泡25分钟），捞入筐内，加盖湿布润4-8小时（优选加盖湿布润5小时），取出，切片，再用酒浸泡1.5-3.5小时（优选再用酒浸泡2.5小时），取出，晒干，研成细粉，过130-170目筛（优选过150目筛）；
（2）将除白头翁外的其余原料药去除杂质，分别粉碎研磨成细粉，过140-180目筛（优选过150目筛）；
（3）将步骤（1）以及步骤（2）所得细粉充分混匀，无菌封装，每包5克。
所述稠膏剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15-35分钟（优选用水浸泡25分钟），捞入筐内，加盖湿布润4-8小时（优选加盖湿布润5小时），取出，切片，再用酒浸泡1.5-3.5小时（优选再用酒浸泡2.5小时），取出；
（2）将除白头翁和木香外的其余10味原药材置于砂锅中，加水，水的用量是加入的药材总重量的2.2-5.5倍（优选水的用量是加入的药材总重量的4.5倍），浸泡1.5-2.5小时（优选浸泡2小时）；
（3）将步骤（2）浸泡过的药材先用大火煮至沸腾，后转小火煎煮15-30分钟（优选后转小火煎煮22分钟），加水，水的用量是加入的药材总重量的2.2-4.5倍（优选水的用量是加入的药材总重量的3.2倍），然后加入木香以及步骤（1）所得白头翁，用大火煮至沸腾，后转小火煎煮35-55分钟（优选后转小火煎煮42分钟），滤出药液；
（4）将步骤（3）所得药液减压，浓缩至相对密度为1.2-1.4（优选相对密度为1.3）的清膏，然后加入辅料调匀，装无菌瓶中密封即得。
所述丸剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15-35分钟（优选用水浸泡25分钟），捞入筐内，加盖湿布润4-8小时（优选加盖湿布润5小时），取出，切片，再用酒浸泡1.5-3.5小时（优选再用酒浸泡2.5小时），取出，晒干，研成细粉，过110-140目筛（优选过130目筛）；
（2）将除白头翁外的其余原料药去除杂质，晒干之后，将这些药物一起混合并粉碎成细粉，过110-150目筛（优选过130目筛），然后与步骤（1）所得细粉充分混匀；
（3）将炼蜜加入到步骤（2）所得混匀细粉中，炼蜜的重量为药物总重量的0.9-1.8倍（优选炼蜜的重量为药物总重量的1.3倍），制成小丸粒，小丸粒的粒径为2-5mm（优选制成小丸粒的粒径为3mm）。
本发明所用主要中药原料的药理如下：
黄连：别名：味连、川连、鸡爪连，基原：为毛茛科植物黄连、三角叶黄连或云连的干燥根茎。药性：苦，寒。归心、脾、胃、肝、胆、大肠经。功用主治：清热燥湿，泻火解毒。用于寒热互结，湿热中阻，痞满呕吐。萸黄连舒肝和胃止呕。用于肝胃不和，呕吐吞酸。
白头翁：基原：本品为毛茛科植物白头翁的干燥根。药性：苦，寒。归胃、大肠经。功用主治：清热解毒，凉血止痢。用于热毒血痢，阴痒带下，阿米巴痢。
木香：基原：为菊科植物木香的干燥根。药性：辛、苦，温。归脾、胃、大肠、三焦、胆经。功用主治：行气止痛，健脾消食。用于胸脘胀痛，泻痢后重，食积不消，不思饮食。煨木香实肠止泻。用于泄泻腹痛。
石莽草：基原：为蓼科植物头花蓼的全草。中药化学成分：头花蓼全草含苯甲醛，乙酸，24-羟基二十四烷-3-酮，29-羟基二十九烷-3-酮，β-谷甾醇，没食子酸。《广西中草药》：“味苦，辛，性平，无毒。”功用主治：解毒，散瘀，利尿通淋。治痢疾，肾盂炎，膀胱炎，尿路结石，风湿痛，跌打损伤，疮疡湿疹。
秋枫木：基原：为大戟科植物秋枫木的根、树皮。中药化学成分：茎含β-谷甾醇，无羁萜，表无羁萜醇，无羁萜醇及β-谷甾醇-β-葡萄糖甙。种子含油25.5％，油的碘值159.0，皂化值194.5。脂肪酸组成：肉豆蔻酸0.3％，棕榈酸10.5％，硬脂酸5.0％，十六碳烯酸0.2％，油酸23.9％，亚油酸23.4％，亚麻酸36.7％。药性：辛、涩，凉。归心经。功用主治：祛风除湿，化瘀消积。主风湿骨痛，噎膈，反胃，痢疾。
黄芪：基原：为豆科植物蒙古黄芪或膜荚黄芪的干燥根。药性：甘，温。归肺、脾经。功用主治：补气固表，利尿托毒，排脓，敛疮生肌。用于气虚乏力，食少便溏，中气下陷，久泻脱肛，便血崩漏，表虚自汗，气虚水肿，痈疽难溃，久溃不敛，血虚痿黄，内热消渴，慢性肾炎蛋白尿，糖尿病。
当归：基原：为伞形科植物当归的干燥根。药性：甘、辛，温。归肝、心、脾经。功用主治：补血活血，调经止痛，润肠通便。用于血虚萎黄，眩晕心悸，月经不调，经闭痛经，虚寒腹痛，肠燥便秘，风湿痹痛，跌扑损伤，痈疽疮疡。酒当归活血通经。用于经闭痛经，风湿痹痛，跌扑损伤。
桂枝：基原：为樟科植物肉桂的嫩枝。桂枝含挥发油0.69%，油中主要成分为桂皮醛64.75%，还有苯甲酸苄酯，乙酸肉桂酯，β-荜澄茄烯，菖莆烯，香豆精等。药性：辛、甘，温。归膀胱、心、肺经。功用主治：散寒解表，温通经脉。用于通阳化气风寒表证，寒湿痹痛，四肢厥冷，经闭痛经，癥瘕结块，胸痹，心悸，痰饮，小便不利。
马齿苋：基原：为马齿苋科植物马齿苋的全草。中药化学成分：全草含大量去甲肾上腺素和多量钾盐（包括硝酸钾、氯化钾、硫酸钾和其他钾盐)。还含多巴，多巴胺，甜菜素，异甜菜素，异甜菜甙，草酸，苹果酸，柠檬酸，谷氨酸，天冬氨酸，丙氨酸以及葡萄糖，果糖，蔗糖等。另据报道全草显生物碱，香豆精，黄酮，强心甙和蒽甙的反应。并含大量的聚ω-3不饱和脂肪酸。药性：酸，寒。归大肠、肝经。功用主治：清热解毒，凉血止血。用于热毒血痢，痈肿疔疮，湿疹，丹毒，蛇虫咬伤，便血，痔血，崩漏下血。
川芎：基原：为伞形科植物川穹的干燥根茎。药性：辛，温。归肝、胆、心包经。功用主治：活血行气，祛风止痛。用于月经不调，经闭痛经，癥瘕腹痛，胸胁刺痛，跌扑肿痛，头痛，风湿痹痛。
盾果草：基原：为紫草科盾果草属植物盾果草的全草。药性：苦，凉。功用主治：清热解毒消肿。主治痈肿，疔疮，咽喉疼痛，泄泻，痢疾。
草鞋青：基原：为金星蕨科金星蕨属植物单叶新月蕨的全草。药性：甘、微涩，凉。功用主治：清热解毒。主治咽喉肿痛，痢疾，毒蛇咬伤。
本发明提供的慢性痢疾活血止痢制剂组方科学，各种剂型的制备方法简单，所得产品服用方便。除此之外，本发明的优良效果还表现在：
1、安全可靠，无毒副作用；
2、疗程短、见效快；
3、疗效显著，无复发；
4、具有清热解毒、润肠通便、活血止痢的功效；
5、原料价廉易得，治疗成本低，减轻患者经济负担。
具体实施方式
下面结合实施例和实验例详细说明本发明的技术方案，但保护范围不限于此。
实施例1慢性痢疾活血止痢制剂，取下述重量的主要原料药制备而成：黄连3g，白头翁10g，木香5g，石莽草15g，秋枫木6g，黄芪12g，当归6g，桂枝8g，马齿苋18g，川芎6g，盾果草6g，草鞋青4g。
慢性痢疾活血止痢制剂汤剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15分钟，捞入筐内，加盖湿布润4小时，取出，切片，再用酒浸泡1.5小时，取出；
（2）将除白头翁和木香外的其余10味原药材置于砂锅中，加水，水的用量是加入的药材总重量的2.5倍，浸泡2小时；
（3）将步骤（2）浸泡过的药材先用大火煮至沸腾，后转小火煎煮15分钟，加水，水的用量是加入的药材总重量的2.2倍，然后加入木香以及步骤（1）所得白头翁，用大火煮至沸腾，后转小火煎煮35分钟，滤出药液，即得。
服用方法：每日两次，每次280mL（温服）。
实施例2慢性痢疾活血止痢制剂，取下述重量的主要原料药制备而成：黄连6g，白头翁20g，木香15g，石莽草25g，秋枫木12g，黄芪20g，当归10g，桂枝15g，马齿苋40g，川芎12g，盾果草15g，草鞋青9g。
慢性痢疾活血止痢制剂散剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡25分钟，捞入筐内，加盖湿布润5小时，取出，切片，再用酒浸泡2.5小时，取出，晒干，研成细粉，过150目筛；
（2）将除白头翁外的其余原料药去除杂质，分别粉碎研磨成细粉，过150目筛；
（3）将步骤（1）以及步骤（2）所得细粉充分混匀，无菌封装，每包5克。
典型病例一：曾XX，男，46岁。慢性痢疾已3年。初因饮食不洁致急性中毒性痢疾，经抢救而愈。3个月后，因饮酒及食生冷复患痢疾，大便日8-9次，里急后重，便带脓血，曾服泻痢停及输液等，诸症已消，但此后稍有饮食不慎即复发。近1年来，痢无休止，遍服中西药物，痢终未瘥现大便每日数次，便带脓血，伴里急后重，虚坐努责，手足心热，烦渴，少腹持续绵绵作痛，喜暖熨温食，但食量甚少，腰部酸软发凉，面色萎黄发暗，神情倦怠，语声低微，舌质淡苔白，脉细数无力。服用本实施例所得慢性痢疾活血止痢制剂散剂，每日两次，每次5克，开水冲服。服用两天，大便每日2次，略有成形，脓性粘液量减，血液几乎不见，腹痛、里急后重、手足心热等症均有不同程度减轻。服用4天，大便每日1次，成形，便中带血及腹痛里急已失，饮食增加，精神好转，但大便中仍有少量粘液，时感口渴。服用6天后，诸症消失，病告痊愈。随访未复发。
实施例3慢性痢疾活血止痢制剂，取下述重量的主要原料药制备而成：黄连4g，白头翁13g，木香8g，石莽草19g，秋枫木8g，黄芪15g，当归7g，桂枝11g，马齿苋24g，川芎9g，盾果草8g，草鞋青6g。
慢性痢疾活血止痢制剂的稠膏剂制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡25分钟，捞入筐内，加盖湿布润5小时，取出，切片，再用酒浸泡2.5小时，取出；
（2）将除白头翁和木香外的其余10味原药材置于砂锅中，加水，水的用量是加入的药材总重量的4.5倍，浸泡2小时；
（3）将步骤（2）浸泡过的药材先用大火煮至沸腾，后转小火煎煮22分钟，加水，水的用量是加入的药材总重量的3.2倍，然后加入木香以及步骤（1）所得白头翁，用大火煮至沸腾，后转小火煎煮42分钟，滤出药液；
（4）将步骤（3）所得药液减压，浓缩至相对密度为1.3的清膏，然后加入辅料调匀，装无菌瓶中密封即得。
典型病例二：高XX，女，40岁。患痢疾2年，服西药、中成药及中药汤剂终未能愈。现每日粘液便5-7次，便带脓血，少腹部隐痛，喜温喜暖，遇寒冷腹痛痢重，里急后重，大便不畅，便意未尽，口苦，舌质红，苔黄腻，脉濡数。服用本实施例所得慢性痢疾活血止痢制剂稠膏剂，每日三次，每次25克。服药2天，大便每日3次，不成形，粘液减少，血液几乎不见，症状减轻，舌质稍红，苔薄黄，仍感腹中稍凉。服用4天，大便基本成形，粘液几乎不见，食量增加，诸症基本消失。服用6天，痊愈。随访未见复发。
实施例4慢性痢疾活血止痢制剂，取下述重量的主要原料药制备而成：黄连5.5g，白头翁16g，木香12g，石莽草22g，秋枫木11g，黄芪18g，当归9g，桂枝13g，马齿苋32g，川芎11g，盾果草11g，草鞋青8g。
慢性痢疾活血止痢制剂丸剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡25分钟，捞入筐内，加盖湿布润5小时，取出，切片，再用酒浸泡2.5小时，取出，晒干，研成细粉，过130目筛；
（2）将除白头翁外的其余原料药去除杂质，晒干之后，将这些药物一起混合并粉碎成细粉，过130目筛，然后与步骤（1）所得细粉充分混匀；
（3）将炼蜜加入到步骤（2）所得混匀细粉中，炼蜜的重量为药物总重量的1.3倍，制成小丸粒，小丸粒的粒径为3mm。
典型病例三：林XX，女，60岁。2009年4月25日初诊。患痢疾6月余，痢下不止，下粘液样便，带血丝，伴里急后重，口干乏力，舌红、苔薄黄，脉细数。曾用静脉点滴菌必治、丁胺卡那霉素等治疗多日，初用时有好转，后渐无效，大便仍日痢下数次。服用本实施例所得慢性痢疾活血止痢制剂丸剂，每日三次，每次15粒。连用4天，病告痊愈。血丝不见。随访2年，病未再发。
实施例5慢性痢疾活血止痢制剂，取下述重量的主要原料药制备而成：黄连5g，白头翁14g，木香10g，石莽草21g，秋枫木9g，黄芪17g，当归8g，桂枝12g，马齿苋29g，川芎10g，盾果草9g，草鞋青7g。
慢性痢疾活血止痢制剂汤剂的制备方法是：
（1）将白头翁除去杂质，洗净灰尘，用水浸泡25分钟，捞入筐内，加盖湿布润5小时，取出，切片，再用酒浸泡2.5小时，取出；
（2）将除白头翁和木香外的其余10味原药材置于砂锅中，加水，水的用量是加入的药材总重量的4.5倍，浸泡2小时；
（3）将步骤（2）浸泡过的药材先用大火煮至沸腾，后转小火煎煮22分钟，加水，水的用量是加入的药材总重量的3.2倍，然后加入木香以及步骤（1）所得白头翁，用大火煮至沸腾，后转小火煎煮42分钟，滤出药液，即得。
试验例1：为了验证实施例5所得慢性痢疾活血止痢制剂的药效，我们进行了对比试验。实验筛选慢性痢疾患者248人，随机地分为对照组和实验组，每小组人数相同，各为124人。实验组：服用实施例5所得慢性痢疾活血止痢制剂汤剂，服用方法：每日两次，每次280mL（温服）。对照组：使用诺氟沙星、复方新诺明、黄连素片等常规治疗慢性痢疾的药物。疗效情况判定标准：治愈：临床症状、体征消失，大便常规、血常规等实验室检查均转正常；显效：临床症状、体征基本消失，血常规、大便常规等指标大部分正常；好转：临床症状、体征好转，血常规、大便常规部分正常；无效：临床症状及体征，血和大便常规检查无改善。结果如下表所示：
表1：实施例5所得慢性痢疾活血止痢制剂汤剂效果验证
治疗效果：治愈76例（61.29%），显效45例（36.29%），好转3例（2.42%），总有效率97.58%。效果明显优于对照组。
本发明选择黄连、白头翁、木香、石莽草等进行配伍，使得这些药物产生协同作用，能够更有效地治疗慢性痢疾。方中白头翁清热解毒，凉血止痢。黄连苦寒有清热燥湿、坚阴泻火解毒的作用。木香行气止痛，健脾消食。石莽草解毒，散瘀，利尿通淋。秋枫木祛风除湿，化瘀消积。黄芪补气固表，利尿托毒，排脓，敛疮生肌。当归补血活血，调经止痛，润肠通便。桂枝散寒解表，温通经脉。马齿苋清热解毒，凉血止血。川芎活血行气，祛风止痛。盾果草清热解毒消肿。草鞋青清热解毒。诸药配伍，共奏清热解毒、润肠通便、活血止痢之效。本发明慢性痢疾活血止痢制剂疗效显著。
应当指出的是，具体实施方式只是本发明比较有代表性的例子，显然本发明的技术方案不限于上述实施例，还可以有很多变形。本领域的普通技术人员，以本发明所明确公开的或根据文件的书面描述毫无异议的得到的，均应认为是本专利所要保护的范围。
Claims (4)
1.慢性痢疾活血止痢制剂，其特征在于，取下述重量配比的主要原料药制备而成：黄连5.5，白头翁16，木香12，石莽草22，秋枫木11，黄芪18，当归9，桂枝13，马齿苋32，川芎11，盾果草11，草鞋青8。
2.根据权利要求1所述的慢性痢疾活血止痢制剂丸剂的制备方法，其特征在于，
（1）将白头翁除去杂质，洗净灰尘，用水浸泡15-35分钟（优选用水浸泡25分钟），捞入筐内，加盖湿布润4-8小时（优选加盖湿布润5小时），取出，切片，再用酒浸泡1.5-3.5小时（优选再用酒浸泡2.5小时），取出，晒干，研成细粉，过110-140目筛（优选过130目筛）；
（2）将除白头翁外的其余原料药去除杂质，晒干之后，将这些药物一起混合并粉碎成细粉，过110-150目筛（优选过130目筛），然后与步骤（1）所得细粉充分混匀；
（3）将炼蜜加入到步骤（2）所得混匀细粉中，炼蜜的重量为药物总重量的0.9-1.8倍（优选炼蜜的重量为药物总重量的1.3倍），制成小丸粒。
3.根据权利要求2所述的制备方法，其特征在于，步骤（2）中过110-150目筛（优选过130目筛）。
4.根据权利要求2所述的制备方法，其特征在于，步骤（3）中小丸粒的粒径为2-5mm（优选小丸粒的粒径为3mm）。
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