CN104800577B - 一种治疗偏头痛的药剂的制备方法 - Google Patents
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Abstract
本发明涉及一种治疗偏头痛的药剂的制备方法，该方法包括下列步骤：称取一箭球350克、二色内风消320克、十八症300克、山水芹菜300克、小地松280克、龙爪菜260克、巴掌草250克、甜茶藤270克、石见穿250克、白兰花260克、奶汁树230克、伞梗虎耳草210克、补血草180克、苦荬菜200克、狗肝菜170克和甘草150克，粉碎，过100目筛，然后称取糖粉250克，过80目筛，和上述原料混合，用3重量％的HPMC水溶液作粘合剂制软材，用16目尼龙筛制粒，在70℃下干燥3个小时，用16目的尼龙筛整粒，再加入430克的羧甲基淀粉钠和120克的硬脂酸镁，混匀，用直径14mm的冲头压片1000片，即得。本发明所述的治疗偏头痛的药剂的全部成分都是天然材料，安全性较好，适于在临床上大规模推广。
Description
技术领域
本发明涉及医药领域，具体来说涉及一种治疗偏头痛的药剂的制备方法。
背景技术
偏头痛多为一侧或两侧颞部反复发作的搏动性头痛，发作前可伴视觉、体觉先兆，发作时常伴呕吐；女性多发，约为男性的3～4倍，多在青春期起病，发病年龄25～34岁，少数发生于儿童期或中年后。引起偏头痛的病因很多，遗传、内分泌与代谢因素、饮食与药物、精神因素等都可以引发偏头痛，由于病情复杂而给治疗带来了不小的难度。
现有的技术，多采用西药镇痛的方法，这种治疗方法只能起到治标的作用，缓解头痛的困扰，不能从根本上解决问题容易反复发作，长期服用镇痛药物往往还会导致严重的药物依赖症，给患者身心造成严重的摧残。
发明内容
本发明的目的是提供一种治疗偏头痛的药剂的制备方法。
为了实现本发明的目的，本发明提供一种治疗偏头痛的药剂的制备方法，该方法包括下列步骤：称取一箭球350克、二色内风消320克、十八症300克、山水芹菜300克、小地松280克、龙爪菜260克、巴掌草250克、甜茶藤270克、石见穿250克、白兰花260克、奶汁树230克、伞梗虎耳草210克、补血草180克、苦荬菜200克、狗肝菜170克和甘草150克，粉碎，过100目筛，然后称取糖粉250克，过80目筛，和上述原料混合，用3重量％的HPMC水溶液作粘合剂制软材，用16目尼龙筛制粒，在70℃下干燥3个小时，用16目的尼龙筛整粒，再加入430克的羧甲基淀粉钠和120克的硬脂酸镁，混匀，用直径14mm的冲头压片1000片，即得。
本发明还提供组合物在制备治疗偏头痛的药剂中的用途，所述药剂是由下述重量配比的物质制成：一箭球350份、二色内风消320份、十八症300份、山水芹菜300份、小地松280份、龙爪菜260份、巴掌草250份、甜茶藤270份、石见穿250份、白兰花260份、奶汁树230份、伞梗虎耳草210份、补血草180份、苦荬菜200份、狗肝菜170份和甘草150份。
优选地，所述药剂是片剂、分散片、胶囊剂或汤剂。
在本发明的组合物中，一箭球、二色内风消为君药，十八症、山水芹菜、小地松、龙爪菜、巴掌草为臣药，甜茶藤、石见穿、白兰花、奶汁树、伞梗虎耳草、补血草、苦荬菜、狗肝菜为佐药，甘草调和诸药，为使药。
优选地，本发明的药剂可以为片剂、分散片、胶囊剂或汤剂。可以采用本领域技术人员熟知的方法来进行药剂的制备。根据需要，可以加入各种药学上可接受的载体。所述的载体包括药学领域常规的稀释剂、赋形剂、填充剂、粘合剂、湿润剂、崩解剂、吸收促进剂、表面活性剂、吸附载体、润滑剂等。本发明的药剂在制备时，可选择的填充剂有：淀粉、糖粉、磷酸钙、糊精、微晶纤维素、乳糖、预胶化淀粉、甘露醇等；可选择的粘合剂有：羧甲基纤维素钠、PVP-K30、羟丙基纤维素、淀粉浆、甲基纤维素、乙基纤维素、羟丙基甲基纤维素、胶化淀粉等；可选择的崩解剂有：干淀粉、交联聚维酮、交联羧甲基纤维素钠、羧甲基淀粉钠、低取代羟丙基纤维素等；可选择的润滑剂有：硬脂酸镁、滑石粉、十二烷基硫酸钠、微粉硅胶等。
本发明所述的治疗偏头痛的药剂的全部成分都是天然材料，安全性较好，适于在临床上大规模推广。
具体实施方式
下面通过实施例进一步说明本发明。应该理解的是，本发明的实施例是用于说明本发明而不是对本发明的限制。根据本发明的实质对本发明进行的简单改进都属于本发明要求保护的范围。除非另有说明，否则本发明中的百分数是重量百分数。
实施例
称取一箭球350克、二色内风消320克、十八症300克、山水芹菜300克、小地松280克、龙爪菜260克、巴掌草250克、甜茶藤270克、石见穿250克、白兰花260克、奶汁树230克、伞梗虎耳草210克、补血草180克、苦荬菜200克、狗肝菜170克和甘草150克，粉碎，过100目筛，然后称取糖粉250克，过80目筛，和上述原料混合，用3重量％的HPMC水溶液作粘合剂制软材，用16目尼龙筛制粒，在70℃下干燥3个小时，用16目的尼龙筛整粒，再加入430克的羧甲基淀粉钠和120克的硬脂酸镁，混匀，用直径14mm的冲头压片1000片，即得。
实验例
诊断标准
偏头痛西医诊断标准参照《偏头痛诊断与防治专家共识》制定的头痛分类及诊断标准(偏头痛诊断与防治专家共识组.偏头痛诊断与防治专家共识[J]·中华内科杂志，2006,45(8)；694-696.)拟定及《中医新药临床研究指导原则》头痛诊断标准(郑筱萸.中医新药临床研究指导原则[S].北京:中国医药科技出版社,2002；105-109.)拟定：(1)偏头痛以精神紧张、躯体疲劳、情绪因素、外界刺激、月经来潮、环境改变等为诱因；(2)头痛表现为阵发性发作的偏侧搏动性疼痛、昏痛、胀痛等，持续时间为数分钟或数小时不等，一般不超过24h，偶有持续长达1周者，间歇期如常人，经一段间歇期后再次发病，病程多迁延数年；(3)偏头痛发作时可伴恶心、呕吐、耳鸣或失眠、心烦等症状；(4)神经系统等理化检查无特殊。
选取符合上述标准的患者100例，其中男20例，女80例，年龄为26岁-37岁，平均年龄33岁，平均病程半年。全部患者治疗前全部检查血常规、脑血流图，部分检查脑电图、脑地形图，重者作头颅CT和MRI检查。
治疗方法
使用实施例中制备片剂对于上述患者进行治疗，一日三次，每次口服一片。以15天为一个疗程，连续进行两个疗程。
疗效标准
痊愈：头痛及伴随症状消失，随访6个月无复发，脑血流图正常；
显效：头痛及伴随症状消失，随访6个月有复发现象，脑血流图基本上正常；
好转：头痛发作程度及伴随症状减轻，脑血流图有改善；
无效：治疗2个疗程后头痛及伴随症状无改善。
结果
经过治疗，发现全部患者的头痛及伴随症状消失，随访6个月无复发，脑血流图正常，因此全部符合痊愈标准，并且治疗过程中未发现明显的不良反应。
Claims (1)
1.一种治疗偏头痛的药剂的制备方法，该方法包括下列步骤：称取一箭球350克、二色内风消320克、十八症300克、山水芹菜300克、小地松280克、龙爪菜260克、巴掌草250克、甜茶藤270克、石见穿250克、白兰花260克、奶汁树230克、伞梗虎耳草210克、补血草180克、苦荬菜200克、狗肝菜170克和甘草150克，粉碎，过100目筛，然后称取糖粉250克，过80目筛，和上述原料混合，用3重量％的HPMC水溶液作粘合剂制软材，用16目尼龙筛制粒，在70℃下干燥3个小时，用16目的尼龙筛整粒，再加入430克的羧甲基淀粉钠和120克的硬脂酸镁，混匀，用直径14mm的冲头压片1000片，即得。
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