CN105012336A - 一种用于治疗痛风的吸入式药物组合物及其制备方法 - Google Patents
一种用于治疗痛风的吸入式药物组合物及其制备方法 Download PDFInfo
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- CN105012336A CN105012336A CN201410336677.2A CN201410336677A CN105012336A CN 105012336 A CN105012336 A CN 105012336A CN 201410336677 A CN201410336677 A CN 201410336677A CN 105012336 A CN105012336 A CN 105012336A
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Abstract
本发明提供一种用于治疗痛风的吸入式药物组合物及其制备方法,包含第一气体及雾化药液。第一气体包含氢气,氢气占吸入式药物组合物的气体体积浓度在2%~96%之间。雾化药液包含选自秋水仙碱、别嘌呤醇、二丙苯磺胺以及苯磺唑酮所组成的组中之一或其组合。本发明吸入式药物组合物除了可以通过氢气去除患者体内的恶性自由基,并通过雾化药液以增加患者的药物吸收疗效,也因为使用少量雾化药液剂量,间接地降低药剂对人体产生的副作用。
Description
技术领域
本发明涉及一种吸入式药物组合物及其制备方法,特别涉及一种用于治疗痛风的吸入式药物组合物及其制备方法。
背景技术
痛风(Gout)又称高尿酸血症(Hyperuricemia),主要为一种嘌呤(Purine)代谢障碍。当人体无法将嘌呤从人体中代谢出时,体内的嘌呤会进一步氧化而形成尿酸,尿酸会以钠盐的形式沉积在关节部位,导致身体免疫系统过度反应而引发发炎现象。近年来,由于饮食结构的改变,高嘌呤食物以及啤酒饮品的摄入增加,导致痛风的发病率逐年上升,且发病年龄亦有下降的趋势。
目前用于治疗痛风的药物,分别有用于抑制尿酸产生的药,如别嘌呤醇(Allopurinol);促进尿酸排泄的药,如二丙苯磺胺(Probenecid)、苯磺唑酮(Sulfinpyrazone);以及用于减少痛风发作频率的药,如秋水仙碱(Colchicine)。然而,前述的药品已知具有发生副作用的风险,如造成皮肤过敏反应、肠胃不适、肾损害、肝损害、白细胞减少等副作用。
综上所述,目前缺乏一种能兼具治疗效果且降低对患者产生副作用的痛风药剂。
发明内容
因此,本发明提供一种用于治疗痛风的吸入式药物组合物,包含第一气体及雾化药液。第一气体包含氢气,氢气占吸入式药物组合物的气体体积浓度在2%~96%之间。雾化药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合。
根据本发明一实施例提供一种用于治疗痛风的吸入式药物组合物,第一气体是由电解水所产生的氢氧混合气体,其中氢气与氧气的体积比约为2:1。于一实施例中,氢气占吸入式药物组合物的气体体积浓度在2%~66.66%之间。此外,本发明吸入式药物组合物还包含第二气体,用于降低吸入式药物组合物中氢气的气体体积浓度,其中第二气体为选自由空气、水蒸汽、惰性气体、氧气及其组合所组成的组中的一种气体。于另一实施例中,氢气占吸入式药物组合物的气体体积浓度在4.7%~66.66%之间。
根据本发明的另一实施例提供一种用于治疗痛风的吸入式药物组合物,氢气占吸入式药物组合物的气体体积浓度在60%~66.66%之间。此外,于另一实施例提供一种用于治疗痛风的吸入式药物组合物,氢气占吸入式药物组合物的气体体积浓度大于66.66%。
此外,本发明另提供一种用于治疗痛风的吸入式药物组合物的制备方法,包含下列步骤:
(S1)制备第一气体,第一气体包含氢气;
(S2)雾化一药液以产生雾化药液,药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合;以及
(S3)混合第一气体以及雾化药液以产生该吸入式药物组合物,其中氢气占吸入式药物组合物的气体体积浓度在2%~96%之间。
根据本发明一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,本发明方法的步骤(S1)为电解水以产生第一气体,第一气体含氢氧混合气体,其中氢气与氧气的体积比约为2:1。
根据本发明的另一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,本发明方法的步骤包含:
(S21)制备第一气体,第一气体包含氢气;
(S22)雾化一药液以产生雾化药液,药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合;
(S23)准备第二气体;以及
(S24)混合第一气体、第二气体以及雾化药液以产生吸入式药物组合物,其中第二气体用于降低吸入式药物组合物中氢气的气体体积浓度。于此实施例中,本发明用于治疗痛风的吸入式药物组合物中氢气占吸入式药物组合物的气体体积浓度,可因第二气体加入而降低吸入式药物组合物中氢气的气体体积浓度。
此外,根据本发明的另一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,其中氢气占吸入式药物组合物的气体体积浓度在60%~66.66%之间。于另一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,其中氢气占吸入式药物组合物的气体体积浓度大于66.66%。
相比于现有技术,本发明提供一种用于治疗痛风的吸入式药物组合物及其制备方法,本发明吸入式药物组合物除了可以提供患者直接吸入的服用便利性外,并可以通过氢气去除患者体内的恶性自由基,并通过雾化药液以增加患者的药物吸收疗效。
附图说明
图1是本发明用于治疗痛风的吸入式药物组合物的制备方法于一具体实施例的方法流程图。
图2是本发明用于治疗痛风的吸入式药物组合物的制备方法于另一具体实施例的方法流程图。
图3是本发明用于治疗痛风的吸入式药物组合物的制备方法中步骤(S1)于一具体实施例的电解装置示意图。
图4是本发明用于治疗痛风的吸入式药物组合物的制备方法中步骤(S2)及(S3)于一具体实施例的气体混合系统示意图。
具体实施方式
为了让本发明的优点,精神与特征可以更容易且明确地了解,后续将以实施例并参照所附附图进行详述与讨论。值得注意的是,这些实施例仅为本发明代表性的实施例,其中所举例的特定方法、装置、条件、材质等并非用以限定本发明或对应的实施例。
本发明提出一种用于治疗痛风的吸入式药物组合物,包含第一气体及雾化药液。第一气体包含氢气,氢气占吸入式药物组合物的气体体积浓度在2%~96%之间。雾化药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合。
于本发明的实施例中,第一气体还包含氧气,而第一气体是由电解水所产生的氢氧混合气体,其中氢气与氧气的体积比约为2:1。于实际应用时,氢气与氧气的体积比原则是2:1,但是有时在收集电极的氢气或氧气会有些许误差,但仍约为2:1。而雾化药液则是由针对一药液进行雾化或挥发所产生,其中药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合,且上述药物应用于痛风治疗上已为本领域的技术人员所熟知,故在此不多加赘述。于本实施例中,氢气占吸入式药物组合物的气体体积浓度在2%~66.66%之间。
本发明吸入式药物组合物还包含第二气体,第二气体用于降低吸入式药物组合物中氢气的气体体积浓度,其中第二气体为选自由空气、水蒸汽、惰性气体、氧气及其组合所组成的组中的一种气体。于本实施例中,氢气占吸入式药物组合物的气体体积浓度可在4.7%~66.66%之间,惟不以此范围为限。
于另一具体实施例中,本发明吸入式药物组合物可以通过混合第一气体以及雾化一体积为40c.c.的药液所产生的雾化药液所制备,而氢气占吸入式药物组合物的气体体积浓度在60%~66.66%之间。于另一实施例中,也可以用氢气瓶提供所需氢气,并与雾化药液进行混合,此时氢气占吸入式药物组合物的气体体积浓度将可能会高于66.66%,例如67%~96%之间。于另一实施例中,也可直接收集电解水中所产生的氢气(而非氢氧混合气)直接与雾化药液进行混合,此时氢气占吸入式药物组合物的气体体积浓度将也会高于66.66%。
请参阅图1,图1是本发明用于治疗痛风的吸入式药物组合物的制备方法于一具体实施例的方法流程图。如图所示,本发明吸入式药物组合物的制备方法包含下列步骤:
(S1)制备第一气体,第一气体包含有氢气;
(S2)雾化一药液以产生雾化药液,药液包含有选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合;以及
(S3)混合第一气体以及雾化药液以产生吸入式药物组合物,其中氢气占吸入式药物组合物的气体体积浓度在2%~96%之间。
根据本发明一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,本发明方法的步骤(S1)为电解水以产生第一气体,第一气体含氢氧混合气体,其中氢气与氧气的体积比约为2:1。于实际应用时,氢气与氧气的体积比原则是2:1,但是有时在搜集电极的氢气或氧气会有些许误差,但仍约为2:1。于一实施例中,氢气占吸入式药物组合物的气体体积浓度在2%~66.66%之间,惟不以此范围为限。
请参阅图2,图2是本发明的用于治疗痛风的吸入式药物组合物的制备方法于另一具体实施例的方法流程图。如图所示,本发明吸入式药物组合物的另一制备方法,包含下列步骤:
(S21)制备第一气体,第一气体包含有氢气;
(S22)雾化一药液以产生雾化药液,药液包含有选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合;以及
(S23)准备第二气体;以及
(S24)混合第一气体、第二气体以及雾化药液以产生吸入式药物组合物。
根据本发明一实施例提供一种用于治疗痛风的吸入式药物组合物的制备方法,本发明方法的步骤(S21)为电解水以产生第一气体,第一气体含氢氧混合气体,其中氢气与氧气的体积比约为2:1。于实际应用时,氢气与氧气的体积比原则是2:1,但是有时在收集电极的氢气或氧气会有些许误差,但仍约为2:1。此外,本发明用于治疗痛风的吸入式药物组合物中氢气占吸入式药物组合物的气体体积浓度,可因第二气体加入而降低吸入式药物组合物中氢气的气体体积浓度,于本实施例中,氢气占吸入式药物组合物的气体体积浓度可在4.7%~66.66%之间,惟不以此范围为限。
当然,于另一实施例中,也可以用氢气瓶提供所需氢气,并与雾化药液进行混合,此时氢气占吸入式药物组合物的气体体积浓度将可能会高于66.66%,例如67%~96%之间。但因吸入气体中氢气体积浓度太高(如高于96%)可能使氧气体积浓度太低而对人体产生缺氧的不良影响,因此此时需注意控制氢气体积浓度不要高于96%,如在67%~90%之间。于另一实施例中,也可直接收集电解水中所产生的氢气(而非氢氧混合气)直接与雾化药液进行混合,此时氢气占吸入式药物组合物的气体体积浓度将也会高于66.66%。
请参阅图3,图3是本发明用于治疗痛风的吸入式药物组合物的制备方法中步骤(S1)于一具体实施例的电解装置示意图。于本实施例中,本发明能够通过电解水以产生含有氢氧混合气体的第一气体,其中电解装置100包含电解槽102、电解水104、电极106A、106B以及一电源。
首先,电解槽102用以容纳电解水104,其中电解水104主要成份为纯水,惟不以此为限,于实际应用时,电解水能够视需要以添加少量的电解质,如氢氧化钠、碳酸钙、氯化钠等。再者,电解槽102中包含电极106A、106B,电极106A、106B分别为一阴极电极及一阳极电极,并耦接至一电源(未绘示于图中),藉以提供电解水所需的电能。于一具体实施例中,电极106A、106B能够是固定的极性,如电极106A为阴极,电极106B为阳极,惟电极的极性不以固定为限。于另一具体实施例中,电极106A、106B能够是交替变换的极性,如在某一时间点,电极106A为阴极,电极106B为阳极;经过一预定时间后,在另一时间点,电极106A切换为阳极,电极106B切换为阴极,其后依此类推。
接着,电解槽102中的电解水104经过电极106A、106B通电后会开始电解,而在阴极(负极)产生氢气,阳极(正极)产生氧气,且释出于电解槽102的上部,以形成第一气体108,其中第一气体108由电解槽102的第一气体管路110输出,以作为后续的使用,惟不以此为限。于另一个实施例中,本发明亦能够将阴极产生的氢气与阳极产生的氧气,分别以一气体导管导引出电解槽102,之后再进行混合而产生第一气体108。
由于电解水104经过电解后所产生的氢气及氧气的体积比约为2:1。于一具体实施例中,本发明能够再添加第二气体112,以降低吸入式药物组合物中氢气的气体体积浓度,例如氢气占吸入式药物组合物的气体体积浓度可以控制在4.7%~66.66%之间,其中第二气体为选自由空气、水蒸汽、惰性气体、氧气及其组合所组成的组中的一种气体。
请参阅图4,图4是本发明用于治疗痛风的吸入式药物组合物的制备方法中步骤(S2)及(S3)于一具体实施例的气体混合系统示意图。本发明吸入式药物组合物的制备方法中步骤(S2)及(S3)可以通过气体混合系统200,以雾化药液220并混合第一气体108进而产生吸入式药物组合物214。
气体混合系统200包含雾化/挥发气体混合槽210,雾化/挥发气体混合槽210通过第一气体管路110与电解装置100(如图3所示)耦接,以接收第一气体108,并与雾化药液212混合,以形成吸入式药物组合物214。雾化/挥发气体混合槽210还包括震荡器216(例如超音波震荡器),适于对雾化/挥发气体混合槽210中药液220进行雾化,以产生雾化药液212。药液220可以为秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合,且上述药物应用于痛风治疗上已为本领域的技术人员所熟知,故在此不多加赘述。
于另一具体实施例中,雾化/挥发气体混合槽210中可容纳的药液约40~100c.c的范围,预估以60分钟内雾化完毕,故雾化药液本身产气量约0.67cc/min~1.67cc/min之间,而电解槽102控制每分钟产气量约2,000cc/min~3,000cc/min之间,其中如电解槽产气的结果仅仅是氢氧混合气(氢气及氧气的体积比约为2:1),则氢气占吸入式药物组合物的气体体积浓度在66.61%~66.65%之间。但有时因电解槽电解的热能,会蒸发电解水而使电解槽产气的结果除氢氧混合气外,还可能含有少量些许的水蒸气,因此氢气占吸入式药物组合物的气体体积浓度会低于66.61%,例如在60%~66.61%之间,当然上述的少量些许水蒸气可以通过降温而减少。本发明吸入式药物组合物的制备方法可以通过混合氢氧混合气以及雾化药液所制备,一般而言氢气占吸入式药物组合物的气体体积浓度在60%~66.66%之间。
于另一具体实施例中,第一气体及雾化药液在吸入式药物组合物中的组成含量比例依气体体积百分比浓度计得分别为35.33~99.99%及0.01~64.67%,但并不以此比例为限,于实际应用时,第一气体、雾化药液在吸入式药物组合物中的组成含量比例得视病人情况进行调整。于实际应用时,本发明的吸入式药物组合物得通过吸入并每天施用至少30~60分钟,每天为一次至三次。
此外,于另一具体实施例中,第一气体、雾化药液及第二气体在吸入式药物组合物中的组成含量比例依气体体积百分比浓度计得分别为33~97%、0.01~64%及2~66%,但并不以此比例为限,于实际应用时,第一气体、雾化药液及第二气体在吸入式药物组合物中的组成含量比例得视病人情况进行调整。于实际应用时,本发明的吸入式药物组合物得通过吸入并每天施用至少30~60分钟,每天为一次至三次。
由上述实施例可知,本发明吸入式药物组合物包含氢气与雾化药液,以提供患者(未绘示)吸入。人体因各种原因,(比如疾病、饮食、所处环境或生活习惯)引生的恶性自由基,亦称有害自由基,可以与吸入的氢气还原成部份的水,而排出体外。间接减少人体自由基的数量,达到酸性体质还原至健康的碱性体质,可以抗氧化进而也达到消除慢性疾病效果。另外,液态药液于一实施例中经过雾化后形成1~5微米的药水粒子,经由吸入的方式,而透过鼻粘膜或肺泡直接吸收,可以更有利于人体吸收,也就是说较少雾化药液剂量即可达到原先一般口服或注射所需要药剂量的治疗效果,也因为使用少量雾化药液剂量,也间接降低药剂对人体产生的副作用。当然药液也可以是口服药溶于水后的混合液。因此,本发明通过具有氢氧与雾化药液的吸入式药物组合物,供人体吸入后可以达到更好的治疗或医疗效果。
相比于现有技术,本发明提供一种用于治疗痛风的吸入式药物组合物及其制备方法,本发明吸入式药物组合物除了可以通过氢气去除患者体内的恶性自由基,并通过雾化药液以增加患者的药物吸收疗效,通过较少雾化药液剂量即可达到原先一般口服或注射所需要药剂量的治疗效果,因而能使用少量雾化药液剂量,间接地降低药剂对人体产生的副作用。
通过以上较佳具体实施例的详述,希望能更加清楚描述本发明的特征与精神,而并非以上述所揭露的较佳具体实施例来对本发明的范畴加以限制。相反地,其目的是希望能涵盖各种改变及具相等性的安排于本发明所欲申请的专利范围的范畴内。因此,本发明所申请的专利范围的范畴应根据上述的说明作最宽广的解释,以致使其涵盖所有可能的改变以及具相等性的安排。
Claims (20)
1.一种用于治疗痛风的吸入式药物组合物,包含第一气体及雾化药液,其中该第一气体包含氢气,氢气占该吸入式药物组合物的气体体积浓度在2%~96%之间,该雾化药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合。
2.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,该第一气体还包含氧气。
3.如权利要求2所述的用于治疗痛风的吸入式药物组合物,其特征在于,该第一气体是由电解水所产生的氢氧混合气体,其中氢气与氧气的体积比约为2:1。
4.如权利要求2所述的用于治疗痛风的吸入式药物组合物,其特征在于,还包含第二气体,用于降低该吸入式药物组合物中氢气的气体体积浓度,其中该第二气体为选自由空气、水蒸汽、惰性气体、氧气及其组合所组成的组中的一种气体。
5.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在2%~66.66%之间。
6.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在4.7%~66.66%之间。
7.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在60%~66.66%之间。
8.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,氢气占该吸入式药物组合物的气体体积浓度大于66.66%。
9.如权利要求1所述的用于治疗痛风的吸入式药物组合物,其特征在于,该雾化药液是由针对一药液进行雾化或挥发所产生。
10.如权利要求9所述的用于治疗痛风的吸入式药物组合物,其特征在于,该药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合。
11.一种用于治疗痛风的吸入式药物组合物的制备方法,包含下列步骤:
(S1)制备第一气体,该第一气体包含氢气;
(S2)雾化一药液以产生雾化药液,该药液包含选自秋水仙碱(Colchicine)、别嘌呤醇(Allopurinol)、二丙苯磺胺(Probenecid)以及苯磺唑酮(Sulfinpyrazone)所组成的组中之一或其组合;以及
(S3)混合该第一气体以及该雾化药液以产生该吸入式药物组合物,其中氢气占该吸入式药物组合物的气体体积浓度在2%~96%之间。
12.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,于步骤(S2)之后还包含下列步骤:
(S23)准备第二气体。
13.如权利要求12所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,该步骤(S3)为混合该第一气体、该第二气体以及该雾化药液以产生该吸入式药物组合物。
14.如权利要求12所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,该第二气体用于降低该吸入式药物组合物中氢气的气体体积浓度。
15.如权利要求12所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,该第二气体为选自由空气、水蒸汽、惰性气体、氧气及其组合所组成的组中的一种气体。
16.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其其特征在于,步骤(S1)为电解水以产生该第一气体,该第一气体含氢氧混合气体,其中氢气与氧气的体积比约为2:1。
17.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在2%~66.66%之间。
18.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在4.7%~66.66%之间。
19.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,氢气占该吸入式药物组合物的气体体积浓度在60%~66.66%之间。
20.如权利要求11所述的用于治疗痛风的吸入式药物组合物的制备方法,其特征在于,氢气占该吸入式药物组合物的气体体积浓度大于66.66%。
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