CN105749103A - 一种治疗发作性睡病的药物制剂及其制备方法 - Google Patents
一种治疗发作性睡病的药物制剂及其制备方法 Download PDFInfo
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Abstract
本发明属于中医药领域,涉及一种治疗发作性睡病的药物制剂及其制备方法。该药物制剂由牛奶柴、小雪人参、枳壳、草豆蔻、千针万线草、黄芪、黄连、厚朴、茯苓、酸枣仁为药用原料精心组方研制而成,全方有机组合具有健脾利湿,利水泻热,兼有补脾益气,升阳益胃,能使中焦气机通畅,针对脾虚湿盛症研制,效果显著,随访复发率低。
Description
技术领域
本发明属于中医药领域,涉及一种治疗发作性睡病的药物制剂及其制备方法。
背景技术
睡眠是一个主动的生理过程,对于机体的精力与体力恢复有重要意义。发作性睡病是一种与神经系统功能有关的睡眠障碍,为较常见的睡眠障碍之一,主要表现为白天睡眠过多,多伴有一种或数种症状,包括摔倒症、睡瘫症和入睡幻觉。发作性睡病的病因目前还不十分明确,通常认为与遗传,感染,外伤等因素相关。
本病病因不明,目前西药治疗主要适用于症状严重、发作频繁的患者。传统的中枢兴奋药因不良反应明显,目前已较少应用。新型中枢兴奋药如莫达非尼,安全性良好,但存在头痛、恶心、焦虑、紧张、口干、腹泻等不良反应;羟丁酸钠适应症多,运用范围较广,但亦有眩晕、共济失调、体重减轻、抑郁、胃肠功能紊乱等不良反应。抗抑郁药作为临床常用抗猝倒药,对睡瘫症和入睡前幻觉有一定的效果,但不良反应较其他药更多。
中医古代文献对发作性睡病没有专门记载,根据本病的典型表现,发作性睡病归属于中医学“多寐”、“厥症”、“痫症”、“五软”、“梦魇”等范畴。中医方面关于对多寐病的治疗,古代医家多有阐述。如:《素问·六节藏象论》云:“心者,生之本,神之变也;……为阳中之太阳”。心阳宣发,气血通达,人则可应昼夜与四时之气,动静有节,寤寐有时;反之,则身体困倦,嗜卧多寐,或昼夜颠倒,精神不振。此病总的病机不外虚实两端,虚则因各脏腑之气及清阳之气不足,致使心阳不振,心神失养;实则因湿邪,痰浊或瘀血等实邪扰乱心神,致使寐寤失常。于具体而言,虚证多为脾气亏虚,而有神疲乏力,食少纳呆,便溏等症状;以及肾阳虚衰。于实证,痰湿困阻中焦则表现为头身困重,脘腹闷胀,口腻纳呆,舌苔白腻,脉濡或滑;痰热上扰心神,则昼日头昏欲寐,夜间心烦失眠,咳吐黄痰,舌红苔黄腻,脉滑数;瘀血阻窍多有外伤病史,而头昏头痛,多梦,舌黯,脉弦涩。中医的灵魂在于辨证论治,中医根据虚实寒热、标本先后的不同,采用辩证施治可以取得独特的疗效,有一定的优势。
发明内容
本发明的目的是提供一种治疗发作性睡病的药物制剂,尤其适用于依据中医理论辨证为脾虚湿盛症辨证用药,效果好。
为实现上述目的,本发明采用如下技术方案:
一种治疗发作性睡病的药物制剂,其特征在于由牛奶柴、小雪人参、枳壳、草豆蔻、千针万线草、黄芪、黄连、厚朴、茯苓、酸枣仁为药用原料精心组方研制而成。
本发明人经过长期、大量的筛选组方试验,进一步优选如下技术方案:一种治疗发作性睡病的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴30-35份、小雪人参15-20份、枳壳7-12份、草豆蔻4-7份、千针万线草15-20份、黄芪10-15份、黄连3-5份、厚朴5-9份、茯苓8-13份、酸枣仁7-12份。
进一步优选地,一种治疗发作性睡病的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴30份、小雪人参17份、枳壳8份、草豆蔻6份、千针万线草18份、黄芪12份、黄连3.5份、厚朴7份、茯苓10份、酸枣仁12份。
进一步优选地,一种治疗发作性睡病的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴35份、小雪人参18份、枳壳10份、草豆蔻5份、千针万线草20份、黄芪15份、黄连4.5份、厚朴8份、茯苓12份、酸枣仁10份。
《丹溪心法·中湿》曰:“脾胃受湿,沉困无力,倦怠嗜卧。”《脾胃论·肺之脾胃虚论》言:“脾胃之虚,怠惰嗜卧。”《血证论》云:“倦怠嗜卧者,乃脾经有湿也。”脾胃居于中焦,为气机升降之枢纽。气虚弱则易致湿邪困阻,痰浊壅盛,升降失调,进而导致清阳不展,不能达于头窍四末而出现倦怠嗜卧、头晕、神志不清等症状。方中:小雪人参甘微淡平,健脾补虚,利湿清热;草豆蔻辛温,温中燥湿,行气健脾,二药配伍使用为君药,温中健脾,利湿清热,温燥不伤阴。黄芪甘温,补气固表,利尿托毒,升举阳气;千针万线草善健脾益气,行气养血,补肝益肾;枳壳健脾开胃,调五脏,下气行滞消胀,为臣药,补气健脾,行滞消积,有升有降,水道通畅,脾胃湿热不存,中焦气机调畅。牛奶柴补中益气,健脾化湿,活血通络;黄连苦燥湿,寒胜热,能泄降一切有余之湿火,能平肝胃之火,通腹痛之滞下,厚朴苦辛温,行气消积,燥湿除满,降逆平喘;茯苓利水渗湿,益脾和胃,宁心安神,在泄不在补;酸枣仁平肝理气,润肺养阴,温中利湿,敛气,益志定呵,为佐使药。诸药伍用,相互作用,有健脾利湿,利水泻热,兼有补脾益气,升阳益胃,能使中焦气机通畅,针对湿阻中焦、脾虚湿困、清阳不展为发作性睡病的重要病因病机而研制,辨证用药,效果显著。
本发明所用各药材的药理学研究现状如下所述。
牛奶柴:【性味】甘;淡;性温。【归经】肺;脾;肾经。【功能主治】补中健脾;祛风湿;活血通络。主气虚乏力;四肢酸软;风湿痹痛;筋骨不利;跌打损伤;经闭;乳汁不通。【用法用量】内服:煎汤,30-60g。
小雪人参:【性味】甘;微淡;性平。【归经】脾经。【功能主治】健脾补虚;清热利湿;活血调经。主虚劳;血虚头晕;水肿;腹水;痢疾;经闭;痛经。【用法用量】内服:煎汤,15-30g。
枳壳:【性味】苦、辛、酸,温。【归经】归脾、胃经。【功能主治】理气宽中,行滞消胀。用于胸胁气滞,胀满疼痛,食积不化,痰饮内停;胃下垂,脱肛,子官脱垂。【用法用量】3~9g。
草豆蔻:【性味】味辛;性温。【归经】脾;胃经。【功能主治】温中燥湿;行气健脾。主寒湿阴滞脾胃之脘腹冷痛;痞满作胀,呕吐;泄泻;食谷不化;痰馀;脚气;阐疟;口臭。【用法用量】内服:煎汤,3-6g,宜后下;或入丸、散。
千针万线草:为石竹科植物云南繁缕的根。【性味】甘;性平。【归经】肝;脾;肾经。【功能主治】健脾养血;补肝益肾;消肿。主贫血;精神短少;头晕心慌;耳鸣眼花;潮热;遗精;月经不调;带下;骨折;乳腺炎。【用法用量】内服:煎汤,15-30g;或炖肉服。外用:适量,鲜品捣敷。
黄芪:【性味】甘,温。【归经】归肺、脾经。【功能主治】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。【用法用量】9~30g。
黄连:【性味】苦,寒。【归经】归心、脾、胃、肝、胆、大肠经。【功能主治】清热燥湿,泻火解毒。用于湿热痞满,呕吐吞酸,泻痢,黄疸,高热神昏,心火亢盛,心烦不寐,血热吐衄,目赤,牙痛,消渴,痈肿疔疮;外治湿疹,湿疮,耳道流脓。酒黄连善清上焦火热。用于目赤,口疮。姜黄连清胃和胃止呕。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。【用法用量】2~5g。外用适量。
厚朴:【性味】苦;辛;性温。【归经】脾;胃;大肠经。【功能主治】行气消积;燥湿除满;降逆平喘。主食积气滞;腹胀便秘;湿阻中焦,脘痞吐泻;痰壅气逆;胸满喘咳。【用法用量】内服:煎汤,3-10g;或入丸、散。
茯苓:【性味】甘、淡,平。【归经】归心、肺、脾、肾经。【功能主治】利水渗湿,健脾宁心。用于水肿尿少,痰饮眩悸,脾虚食少,便溏泄泻,心神不安,惊悸失眠。【用法用量】9~15g。
酸枣仁:【性味】甘、酸,平。【归经】归肝、胆、心经。【功能主治】补肝,宁心,敛汗,生津。用于虚烦不眠,惊悸多梦,体虚多汗,津伤口渴。【用法用量】9~15g。
为了更好地表达本发明的药物制剂,本发明的药物制剂可由牛奶柴、小雪人参、枳壳、草豆蔻、千针万线草、黄芪、黄连、厚朴、茯苓、酸枣仁或其水或其有机溶剂提取物为活性成分,该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成。
所述的药学上可接受的载体,如甘露醇、山梨醇、焦亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、盐酸半胱氨酸、巯基乙酸、蛋氨酸、维生素C、EDTA二钠、EDTA钙钠,一价碱金属的碳酸盐、醋酸盐、磷酸盐或其水溶液、盐酸、醋酸、硫酸、磷酸、氨基酸、氯化钠、氯化钾、乳酸钠、木糖醇、麦芽糖、葡萄糖、果糖、右旋糖苷、甘氨酸、淀粉、蔗糖、乳糖、甘露糖醇、硅衍生物、纤维素及其衍生物、藻酸盐、明胶、聚乙烯吡咯烷酮、甘油、土温80、琼脂、碳酸钙、碳酸氢钙、表面活性剂、聚乙二醇、环糊精、β-环糊精、磷脂类材料、高岭土、滑石粉、硬脂酸钙、硬脂酸镁等等。
本发明药物制剂优选制成为口服剂型,如:片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂等。进一步优选的是本发明所述药物制剂的口服剂型为片剂、胶囊剂或颗粒剂,最优选为胶囊剂。
本发明还提供了上述所述药物制剂的制备方法,本发明的发明人在研究中发现,通过优化制备方法,能够在保持有效药物的情况下,去除杂质或无药效的部分,减少杂质对治疗效果的干扰,使得该药物制剂更加有效,并且由此减少药物的用量。
本发明提供的一种治疗发作性睡病的药物制剂的制备方法,主要包括以下步骤:
(1)取草豆蔻、黄连、厚朴,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.0-2.0小时,趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
(2)取牛奶柴、小雪人参、枳壳、千针万线草、黄芪、茯苓、酸枣仁连同草豆蔻、黄连、厚朴乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为35%,静置24小时后,离心20分钟(转速为1000-3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,浓缩成稠膏得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成本发明的药物制剂。
本发明还请求保护上述所述药物制剂在制备治疗发作性睡病药物中的用途。通过临床观察试验实施例8可知:与西药常规疗法相比,使用本发明药物制剂胶囊治疗发作性睡病有较好的疗效,疗效总有效率达97.4%,尤其是在控制白天嗜睡方面,症状有效率达97.4%,在减少嗜睡、控制体重、减少猝倒方面疗效显著,有效率在85%以上;而且对于其他一些症状,也有较佳的效果,如睡眠瘫痪、幻觉症状有效率>70%;有效患者随访并发率低,安全无毒副作用。
总之,与现有技术相比,本发明具有以下有益效果:
本发明依据中医理论,按照君臣佐使原则配伍组方,针对发作性睡病脾虚湿盛症型辨证用药,全方伍用健脾利湿,利水泻热,兼有补脾益气,升阳益胃,能使中焦气机通畅,效果显著,随访复发率低。
本发明采用纯天然中草药,药源丰富,无毒副作用,且制备方法简单,服用方便。
具体实施方式
以下通过具体实施例进一步描述本发明,本发明不仅仅限于以下实施例。在本发明的范围内或者在不脱离本发明的内容、精神和范围内,对本发明进行的变更、组合或替换,对于本领域的技术人员来说是显而易见的,且包含在本发明的范围之内。
实施例1胶囊剂
处方:牛奶柴30份、小雪人参17份、枳壳8份、草豆蔻6份、千针万线草18份、黄芪12份、黄连3.5份、厚朴7份、茯苓10份、酸枣仁12份。
制备方法:(1)取草豆蔻、黄连、厚朴,加药材量6倍的50%的乙醇溶液,提取二次,每次1.5小时,趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
(2)取牛奶柴、小雪人参、枳壳、千针万线草、黄芪、茯苓、酸枣仁连同草豆蔻、黄连、厚朴乙醇提取后滤渣,加7倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.07(60℃测得),加乙醇使含醇量为35%,静置24小时后,离心20分钟(转速为1000-3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.08(60℃测得)后与上述乙醇提取物浓缩液混合,浓缩成稠膏得到药物活性成分,依照制剂学常规技术制成胶囊剂,本实施例胶囊每粒重0.35g,相当于生药1.2g。
实施例2胶囊剂
牛奶柴35份、小雪人参18份、枳壳10份、草豆蔻5份、千针万线草20份、黄芪15份、黄连4.5份、厚朴8份、茯苓12份、酸枣仁10份。
制备方法:(1)取草豆蔻、黄连、厚朴,加药材量5倍的50%的乙醇溶液,提取二次,每次1.5小时,趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
(2)取牛奶柴、小雪人参、枳壳、千针万线草、黄芪、茯苓、酸枣仁连同草豆蔻、黄连、厚朴乙醇提取后滤渣,加7倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.06(60℃测得),加乙醇使含醇量为35%,静置24小时后,离心20分钟(转速为1000-3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.08(60℃测得)后与上述乙醇提取物浓缩液混合,浓缩成稠膏得到药物活性成分,依照制剂学常规技术制成胶囊剂。
实施例3胶囊剂
处方:牛奶柴33份、小雪人参17份、枳壳12份、草豆蔻4份、千针万线草20份、黄芪10份、黄连3份、厚朴6份、茯苓12份、酸枣仁8份。
制备方法:(1)取草豆蔻、黄连、厚朴,加药材量8倍的50%的乙醇溶液,提取二次,每次1.0小时,趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
(2)取牛奶柴、小雪人参、枳壳、千针万线草、黄芪、茯苓、酸枣仁连同草豆蔻、黄连、厚朴乙醇提取后滤渣,加10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.10(60℃测得),加乙醇使含醇量为35%,静置24小时后,离心20分钟(转速为1000-3000r/min),弃去下层沉淀物,得到上清液,浓缩至相对密度1.05(60℃测得)后与上述乙醇提取物浓缩液混合,浓缩成稠膏得到药物活性成分,依照制剂学常规技术制成胶囊剂。
实施例4胶囊剂
处方:牛奶柴30份、小雪人参15份、枳壳12份、草豆蔻4份、千针万线草18份、黄芪10份、黄连4份、厚朴5份、茯苓12份、酸枣仁9份。
制备方法:参照实施例1-3的操作。
实施例5胶囊剂
处方:牛奶柴35份、小雪人参15份、枳壳10份、草豆蔻5份、千针万线草15份、黄芪15份、黄连3.5份、厚朴8份、茯苓13份、酸枣仁8份。
制备方法:参照实施例1-3的操作。
实施例6胶囊剂
牛奶柴35份、小雪人参15份、枳壳7份、草豆蔻7份、千针万线草18份、黄芪12份、黄连4.5份、厚朴8份、茯苓12份、酸枣仁10份。
制备方法:参照实施例1-3的操作。
实施例7胶囊剂
处方:牛奶柴33份、小雪人参18份、枳壳9份、草豆蔻5份、千针万线草18份、黄芪12份、黄连3份、厚朴9份、茯苓13份、酸枣仁9份。
制备方法:参照实施例1-3的操作。
实施例8临床观察试验
1资料与方法
1.1一般资料:76例研究对象来自2014年1-12月我院睡眠医学专题门诊的发作性睡病患者。其中男50例,女26例;年龄9~57岁,平均(24.4±10.7)岁;病程3个月~15年,平均(37.1±42.3)个月;平均体重指数(BMI)为(26.1±4.3);有家族史8例;四联征中,嗜睡76例,猝倒28例,幻觉21例,睡瘫12例。随机分为治疗组和对照组,两组一般资料对比无显著性差异(P>0.05),具有可比性。
1.2诊断标准:
1.2.1发作性睡病诊断标准:①嗜睡或突然感觉肌无力。②白天频繁小睡或突然进入睡眠的症状持续至少3个月。③猝倒发作。④相关症状还包括睡眠瘫痪、睡眠幻觉、自动行为、夜间频繁觉醒。⑤多导睡眠图证实下述一项以上:睡眠潜伏期<10min;REM睡眠潜伏期<20min;多次小睡潜伏期试验(MSLT)平均潜伏期<5min;出现2次或2次以上睡眠始发的REM睡眠。⑥HLA检测证实DQB1*0602或DR2阳性。⑦临床症状不能用躯体和精神方面疾病解释。⑧可以伴有其他睡眠障碍,如周期性肢体运动障碍或中枢性或外周性睡眠呼吸暂停,但不是引起以上症状的主要原因。上述8项中如符合②和③两项或符合①、④、⑤和⑦项均可诊断。
1.2.2中医诊断标准:参照《中药新药临床研究指导原则》并结合临床症状,制定脾虚湿盛症:卧嗜睡、不欲动、体型肥胖、自感身体重着,头目昏沉纳差、、口黏而干或大便溏泄,苔白腻,脉濡或细滑。
1.3纳入及排除标准:纳入符合上述诊断标准且数据完整者。排除因自身免疫性疾病、脑部肿瘤、头部外伤、神经变性疾病等引起的继发性发作性睡病者。
1.4治疗方法
治疗组:口服本发明实施例1制备的胶囊,每日2次,每次3-6粒,饭后半小时服用,
对照组:口服苯丙胺,每次5mg,每日早晨服1次。以上两组病例治疗1个月为1个疗程,治疗3个疗程后评定疗效。治疗期间不用其他方法治疗。
1.5观察指标及方法:观察治疗前后患者症状,包括白天嗜睡、体重增加、猝倒、睡瘫、多梦、幻觉、睡语、吐舌的发生例数,计算各症状有效率。症状有效率=(治疗前例数-治疗后例数)/治疗前例数×100%。
1.6疗效判定标准:参照贾建平第6版《神经病学》拟定。疗效标准:痊愈:瞌睡消失,能正常生活、工作、学习;显效:偶有瞌睡,但不影响生活、工作、学习。有效:瞌睡减少,仍影响生活、工作、学习;无效:仍旧磕睡,影响生活、工作、学习。停药3个月后,通过现场、电话或电子邮件进行随访。根据末次就诊情况评价近期疗效,停药3个月后情况评价远期疗效。
1.7统计学方法:采用SPSS15.0统计软件进行计算。各数值以表示,计量资料采用t检验,计数资料采用χ2检验,以P<0.05为差异有统计学意义。
2结果
2.1两组临床疗效的比较:治疗组与对照组总有效率分别为97.4%和84.2%,两组总有效率比较差异有统计学意义(P<0.05),治疗组的疗效明显优于对照组。见表1。
表1两组临床综合疗效的比较
注:与对照组比较,*P<0.05。
2.2两组患者症状有效率分析:两组治疗后各症状病例数均有减少,其中白天嗜睡、体重增加、猝倒、睡瘫、幻觉症状有效率均高于50.0%,而治疗组明显高与对照组,差异有统计学意义(P<0.05)。
表2两组患者症状有效率分析
注:与对照组比较,*P<0.05。
2.3安全性及随访情况:各组患者在治疗前后进行肝肾功能、血尿常规检查均未见明显异常,亦未见明显不良反应。治疗组治疗有效的37例患者中,1例失访,2例复发,其余患者均有效,而对照组治疗有效的33例患者中,1例失访,7例复发,其余患者均有效,治疗组的远期效果明显优于对照组,差异有统计学意义(P<0.05)。
Claims (10)
1.一种治疗发作性睡病的药物制剂,其特征在于由牛奶柴、小雪人参、枳壳、草豆蔻、千针万线草、黄芪、黄连、厚朴、茯苓、酸枣仁为药用原料制成。
2.如权利要求1所述的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴30-35份、小雪人参15-20份、枳壳7-12份、草豆蔻4-7份、千针万线草15-20份、黄芪10-15份、黄连3-5份、厚朴5-9份、茯苓8-13份、酸枣仁7-12份。
3.如权利要求2所述的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴30份、小雪人参17份、枳壳8份、草豆蔻6份、千针万线草18份、黄芪12份、黄连3.5份、厚朴7份、茯苓10份、酸枣仁12份。
4.如权利要求2所述的药物制剂,其特征在于由下述重量份的药用原料制成:牛奶柴35份、小雪人参18份、枳壳10份、草豆蔻5份、千针万线草20份、黄芪15份、黄连4.5份、厚朴8份、茯苓12份、酸枣仁10份。
5.如权利要求1-4任一所述的药物制剂,其特征在于制备方法主要包括以下步骤:
(1)取草豆蔻、黄连、厚朴,加药材量4-8倍的50%的乙醇溶液,提取二次,每次1.0-2.0小时,趁热过滤,浓缩至无醇味得乙醇提取物浓缩液;
(2)取牛奶柴、小雪人参、枳壳、千针万线草、黄芪、茯苓、酸枣仁连同草豆蔻、黄连、厚朴乙醇提取后滤渣,加5-10倍水浸泡3-4小时,煎煮提取两次,每次1.5-2.0小时(从沸腾时开始计时);趁热过滤,浓缩至相对密度1.05-1.10(60℃测得),加乙醇使含醇量为35%,静置24小时后,离心20分钟,弃去下层沉淀物,得到上清液,浓缩至相对密度1.05-1.10(60℃测得)后与上述乙醇提取物浓缩液混合,浓缩成稠膏得到药物活性成分;该成分单独或与药物可接受的载体混合,依照制剂学常规技术制成本发明的药物制剂。
6.如权利要求1-5任一所述的药物制剂,其特征在于所述药物制剂优选制成为口服剂型。
7.如如权利要求6所述的药物制剂,其特征在于所述口服剂型为片剂、糖衣片剂、薄膜衣片剂、肠溶衣片剂、胶囊剂、硬胶囊剂、软胶囊剂、口服液、口含剂、颗粒剂、冲剂、蜜丸剂、散剂、丹剂、溶液剂或硬膏剂。
8.如如权利要求7所述的药物制剂,其特征在于所述口服剂型优选为片剂、胶囊剂或颗粒剂。
9.如如权利要求8所述的药物制剂,其特征在于所述口服剂型优选为胶囊剂。
10.权利要求1-4任一所述的药物制剂在制备治疗发作性睡病药物中的用途。
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