CN105664139A - 一种治疗尿道炎的胶囊剂及其制备方法 - Google Patents
一种治疗尿道炎的胶囊剂及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种治疗尿道炎的胶囊剂及其制备方法,所述的胶囊剂主要是由以下重量份的成分组成:木犀草素30-50份、阿魏酸26-42份、异鼠李素25-40份、梓醇22-38份、谷甾醇18-34份、蒙花甙18-30份、女娄菜素15-30份、混合氨基酸12-28份、维生素B6?12-25份、香草酸10-20份、桃叶珊瑚甙8-16份、D-甘露醇7-15份、三磷酸腺苷酶6-12份、胡萝卜素5-10份;所述的胶囊剂还包括辅料:稀释剂36-58份、崩解剂24-46份、助流剂20-38份、润湿剂18-35份。本发明的胶囊剂是将多种西药有效成分组合,综合作用,具有抗菌消炎、抑制尿道感染、利尿消痛的作用,有效调节患者肌体代谢的功能,合理增加排尿量来减轻尿道炎症带来的痛苦,本发明胶囊剂制备工艺简单,使用方便,有很好的临床意义。
Description
技术领域
本发明涉及泌尿疾病用药技术领域,具体是涉及一种治疗尿道炎的胶囊剂及其制备方法。
背景技术
尿道炎是一种临床常见的泌尿科疾病,主要是指尿道黏膜的炎症,多发为女性患者。临床上可分为急性和慢性、非特异性尿道炎和淋菌性尿道炎,后两种临床表现类似,必须根据病史和细菌学检查加以鉴别,多为致病菌逆行侵入尿道引起。其临床症状多表现为尿频、尿痛、尿急和血尿,急性期男性可有尿道分泌物,初始为黏液性,后多有量脓性分泌物;女性则少有分泌物,转为慢性时表现为尿道刺痛和排尿不适,尿道分泌物减少,呈稀薄浆液状,急性发作时耻骨上区和会阴部有钝痛,可见尿道口发红,有分泌物。男性患者的并发症有附睾炎、前列腺炎、精囊炎等;女性患者的并发症有子宫内膜炎、输卵管炎、盆腔炎、腹膜炎等。引起尿道炎常见的原因如下:尿道器械检查引起的尿道黏膜擦伤,可破坏尿道黏膜防御功能,导致细菌感染;自外界放入的异物或尿道内结石等,停顿稍久即可导致尿道感染;如包皮口狭窄,尿道外口狭窄,尿道狭窄,后尿道瓣膜,尿道肿瘤,女性处女膜伞,尿道口处女膜融合等,因排尿不畅,尿液积存于尿道内可继发尿道感染;邻近器官炎症,如前列腺炎、精囊炎、阴道炎或子宫颈炎等可蔓延到尿道,此常为慢性后尿道炎的顽固病灶;常与性生活有关,不洁性生活易引起尿道感染。
目前尿道炎的治疗主要是依赖抗生素,根据病原菌的种类及对药物的敏感性有针对性地选用多种药物联合应用,或者配合其他辅助治疗和局部治疗,如尿道扩张术、尿道内灌注药物、内镜电灼术等,虽能缓解症状,但是肌体长期使用抗生素所产生的耐药性和副作用却是不可避免的。
发明内容
本发明解决的技术问题是,提供一种治疗尿道炎的胶囊剂及其制备方法。
本发明的技术方案是:一种治疗尿道炎的胶囊剂,所述的胶囊剂主要是由以下重量份的成分组成:木犀草素30-50份、阿魏酸26-42份、异鼠李素25-40份、梓醇22-38份、谷甾醇18-34份、蒙花甙18-30份、女娄菜素15-30份、混合氨基酸12-28份、维生素B612-25份、香草酸10-20份、桃叶珊瑚甙8-16份、D-甘露醇7-15份、三磷酸腺苷酶6-12份、胡萝卜素5-10份;所述的胶囊剂还包括辅料:稀释剂36-58份、崩解剂24-46份、助流剂20-38份、润湿剂18-35份。
进一步的,所述的混合氨基酸由赖氨酸、组氨酸、精氨酸按照4:3:1的重量比混合组成的,赖氨酸是人体必需氨基酸之一,能促进人体发育、增强免疫功能,并有提高中枢神经组织功能的作用;组氨酸能降低胃液酸度,缓和疼痛,抑制由植物神经紧张而引起的消化道溃烂,从而减弱药物对肌体的副作用;精氨酸可以增加肝脏中精氨酸酶的活性,有助于将血液中的氨转变为尿素而排泄出去,精氨酸也是精子蛋白的主要成分,有促进精子的质量,提高精子运动能量的作用。
进一步的,所述的稀释剂是微晶纤维素、乳糖、玉米淀粉其中的一种或者几种。
进一步的,所述的崩解剂是海藻酸、交联纤维素、甘氨酰基淀粉钠其中的一种或者几种。
进一步的,所述的助流剂是微粉硅胶和滑石粉其中的一种或者几种,助流剂的主要作用是增加颗粒的流动性,使药物分布均匀,可防止药粉出现分层、凝结等现象。
进一步的,所述的润湿剂是聚山梨酯80和十二烷基硫酸钠其中的一种或者几种。
一种治疗尿道炎的胶囊剂的制备方法为:
步骤一:按配比分别称取各组份:木犀草素、阿魏酸、异鼠李素、梓醇、谷甾醇、蒙花甙、女娄菜素、混合氨基酸、维生素B6、香草酸、桃叶珊瑚甙、D-甘露醇、三磷酸腺苷酶、胡萝卜素置于搅拌机机械搅拌均匀制得混合药粉,备用;
步骤二:将步骤一制备的混合药粉置于压力研磨滚式超细微粉碎机中粉碎,制得混合药物细粉,备用;
步骤三:给步骤二制备的混合药物细粉中加入适量乙醇溶液制粒,再加入所述重量组份的稀释剂、崩解剂、助流剂、润湿剂,通过干燥、整粒、筛分、填充、抛光、包装制成胶囊剂。
进一步的,步骤三所述的乙醇溶液重量为混合药物细粉的0.5-1倍,质量浓度为75-95%,高浓度的乙醇溶液在胶囊制粒过程中可以起到很好的粘合作用。
进一步的,步骤三所述的干燥是指温度为38-45℃的机械搅拌风干,所述温度范围可以使三磷酸腺苷酶保持活性,机械搅拌并风干不会促使所述混合药物之间发生反应,使所述药物能有更好的发挥药效。
本发明的有益效果是:本发明的胶囊剂是将多种西药有效成分组合,木犀草素、梓醇、女娄菜素、桃叶珊瑚甙联合使用可以起到抗菌消炎、消肿利尿的作用;阿魏酸、异鼠李素、蒙花甙联合使用可以起到镇静止痛、活血化瘀的功效;综合作用,具有抗菌消炎、抑制尿道感染、利尿消痛的作用,有效调节患者肌体代谢的功能,合理增加排尿量来减轻尿道炎症带来的痛苦,本发明胶囊剂制备工艺简单,使用方便,有很好的临床意义。
具体实施方式
实施例1:
一种治疗尿道炎的胶囊剂,所述的胶囊剂是由主要由以下重量份的成分组成:木犀草素30份、阿魏酸26份、异鼠李素25份、梓醇22份、谷甾醇18份、蒙花甙18份、女娄菜素15份、混合氨基酸12份、维生素B612份、香草酸10份、桃叶珊瑚甙8份、D-甘露醇7份、三磷酸腺苷酶6份、胡萝卜素5份;所述的胶囊剂还包括辅料:稀释剂36份、崩解剂24份、助流剂20份、润湿剂18份。
其中,所述的混合氨基酸由赖氨酸、组氨酸、精氨酸按照4:3:1的重量比混合组成的,赖氨酸是人体必需氨基酸之一,能促进人体发育、增强免疫功能,并有提高中枢神经组织功能的作用;组氨酸能降低胃液酸度,缓和疼痛,抑制由植物神经紧张而引起的消化道溃烂,从而减弱药物对肌体的副作用;精氨酸可以增加肝脏中精氨酸酶的活性,有助于将血液中的氨转变为尿素而排泄出去,精氨酸也是精子蛋白的主要成分,有促进精子的质量,提高精子运动能量的作用。所述的稀释剂是微晶纤维素。所述的崩解剂是海藻酸。所述的助流剂是微粉硅胶,助流剂的主要作用是增加颗粒的流动性,使药物分布均匀,可防止药粉出现分层、凝结等现象。所述的润湿剂是聚山梨酯80。
该胶囊剂的制备方法为:
步骤一:按配比分别称取各组份:木犀草素、阿魏酸、异鼠李素、梓醇、谷甾醇、蒙花甙、女娄菜素、混合氨基酸、维生素B6、香草酸、桃叶珊瑚甙、D-甘露醇、三磷酸腺苷酶、胡萝卜素置于搅拌机机械搅拌均匀制得混合药粉,备用;
步骤二:将步骤一制备的混合药粉置于压力研磨滚式超细微粉碎机中粉碎,制得混合药物细粉,备用;
步骤三:给步骤二制备的混合药物细粉中加入适量乙醇溶液制粒,所述的乙醇溶液重量为混合药物细粉的0.5倍,质量浓度为75%,乙醇溶液在胶囊制粒过程中可以起到很好的粘合作用,再加入所述重量组份的稀释剂、崩解剂、助流剂、润湿剂,通过干燥、整粒、筛分、填充、抛光、包装制成胶囊剂,所述的干燥是指温度为38℃的机械搅拌风干,所述温度范围可以使三磷酸腺苷酶保持活性,机械搅拌并风干不会促使所述混合药物之间发生反应,使所述药物能有更好的发挥药效。
实施例2:
一种治疗尿道炎的胶囊剂,所述的胶囊剂是由主要由以下重量份的成分组成:木犀草素40份、阿魏酸34份、异鼠李素32.5份、梓醇30份、谷甾醇26份、蒙花甙24份、女娄菜素22.5份、混合氨基酸20份、维生素B618.5份、香草酸15份、桃叶珊瑚甙12份、D-甘露醇11份、三磷酸腺苷酶9份、胡萝卜素7.5份;所述的胶囊剂还包括辅料:稀释剂47份、崩解剂35份、助流剂29份、润湿剂26.5份。
其中,所述的混合氨基酸由赖氨酸、组氨酸、精氨酸按照4:3:1的重量比混合组成的,赖氨酸是人体必需氨基酸之一,能促进人体发育、增强免疫功能,并有提高中枢神经组织功能的作用;组氨酸能降低胃液酸度,缓和疼痛,抑制由植物神经紧张而引起的消化道溃烂,从而减弱药物对肌体的副作用;精氨酸可以增加肝脏中精氨酸酶的活性,有助于将血液中的氨转变为尿素而排泄出去,精氨酸也是精子蛋白的主要成分,有促进精子的质量,提高精子运动能量的作用。所述的稀释剂是乳糖。所述的崩解剂是交联纤维素。所述的助流剂是微粉硅胶,助流剂的主要作用是增加颗粒的流动性,使药物分布均匀,可防止药粉出现分层、凝结等现象。所述的润湿剂是聚山梨酯80。
该胶囊剂的制备方法为:
步骤一:按配比分别称取各组份:木犀草素、阿魏酸、异鼠李素、梓醇、谷甾醇、蒙花甙、女娄菜素、混合氨基酸、维生素B6、香草酸、桃叶珊瑚甙、D-甘露醇、三磷酸腺苷酶、胡萝卜素置于搅拌机机械搅拌均匀制得混合药粉,备用;
步骤二:将步骤一制备的混合药粉置于压力研磨滚式超细微粉碎机中粉碎,制得混合药物细粉,备用;
步骤三:给步骤二制备的混合药物细粉中加入适量乙醇溶液制粒,所述的乙醇溶液重量为混合药物细粉的0.75倍,质量浓度为85%,乙醇溶液在胶囊制粒过程中可以起到很好的粘合作用,再加入所述重量组份的稀释剂、崩解剂、助流剂、润湿剂,通过干燥、整粒、筛分、填充、抛光、包装制成胶囊剂,所述的干燥是指温度为41.5℃的机械搅拌风干,所述温度范围可以使三磷酸腺苷酶保持活性,机械搅拌并风干不会促使所述混合药物之间发生反应,使所述药物能有更好的发挥药效。
实施例3:
一种治疗尿道炎的胶囊剂,所述的胶囊剂是由主要由以下重量份的成分组成:木犀草素50份、阿魏酸42份、异鼠李素40份、梓醇38份、谷甾醇34份、蒙花甙30份、女娄菜素30份、混合氨基酸28份、维生素B625份、香草酸20份、桃叶珊瑚甙16份、D-甘露醇15份、三磷酸腺苷酶12份、胡萝卜素10份;所述的胶囊剂还包括辅料:稀释剂58份、崩解剂46份、助流剂38份、润湿剂35份。
其中,所述的混合氨基酸由赖氨酸、组氨酸、精氨酸按照4:3:1的重量比混合组成的,赖氨酸是人体必需氨基酸之一,能促进人体发育、增强免疫功能,并有提高中枢神经组织功能的作用;组氨酸能降低胃液酸度,缓和疼痛,抑制由植物神经紧张而引起的消化道溃烂,从而减弱药物对肌体的副作用;精氨酸可以增加肝脏中精氨酸酶的活性,有助于将血液中的氨转变为尿素而排泄出去,精氨酸也是精子蛋白的主要成分,有促进精子的质量,提高精子运动能量的作用。所述的稀释剂是玉米淀粉。所述的崩解剂是甘氨酰基淀粉钠。所述的助流剂是滑石粉,助流剂的主要作用是增加颗粒的流动性,使药物分布均匀,可防止药粉出现分层、凝结等现象。所述的润湿剂是十二烷基硫酸钠。
该胶囊剂的制备方法为:
步骤一:按配比分别称取各组份:木犀草素、阿魏酸、异鼠李素、梓醇、谷甾醇、蒙花甙、女娄菜素、混合氨基酸、维生素B6、香草酸、桃叶珊瑚甙、D-甘露醇、三磷酸腺苷酶、胡萝卜素置于搅拌机机械搅拌均匀制得混合药粉,备用;
步骤二:将步骤一制备的混合药粉置于压力研磨滚式超细微粉碎机中粉碎,制得混合药物细粉,备用;
步骤三:给步骤二制备的混合药物细粉中加入适量乙醇溶液制粒,所述的乙醇溶液重量为混合药物细粉的1倍,质量浓度为95%,乙醇溶液在胶囊制粒过程中可以起到很好的粘合作用,再加入所述重量组份的稀释剂、崩解剂、助流剂、润湿剂,通过干燥、整粒、筛分、填充、抛光、包装制成胶囊剂,所述的干燥是指温度为45℃的机械搅拌风干,所述温度范围可以使三磷酸腺苷酶保持活性,机械搅拌并风干不会促使所述混合药物之间发生反应,使所述药物能有更好的发挥药效。
本发明胶囊剂在治疗尿道炎中的应用:
一、动物毒性试验:
急性毒性试验:
试验方法:健康雄性SD大鼠30只,体重220~260g,平均(236±20)g,分成三个组,经检疫后确定各组大鼠生命体征正常且无个体差异。将本发明所述的胶囊剂配成15g/kg、20g/kg、25g/kg三个剂量组,以1ml/10g,灌胃,每隔3h给药一次,观察24h内大鼠的体征变化情况。
试验结果:小鼠无任何异常反应,也无死亡,说明本发明所述的胶囊剂无明显的毒性。
最大耐药量试验:
试验方法:健康雄性SD大鼠30只,体重220~260g,平均(236±20)g,将本发明所述的胶囊剂以25g/kg灌胃,每隔2h给药一次,即口服总量50g/kg,给药后连续观察一周,观察大鼠有无明显异常表现。
试验结果:小鼠无任何异常表现,亦无死亡,最后全部称重,皆比给药前体重有所增加,平均增加3g,为正常体重增长,因此,大鼠的最大耐受量为25g/kg。本发明所述的药物成人每日口服限量为15g,按成人平均体重65kg计,15g/65kg计成人剂量为0.23g/kg,小鼠的最大耐受量25g/kg/d,是成人剂量的108倍多,体重还有所增加,因此判定此胶囊剂无明显毒性,用药安全。
二、临床试验:
1、病例诊断标准:出现尿道刺激,尿道口红肿、有脓性分泌物、沿尿道可有压痛,尿中有多量红细胞、白细胞,尿道分泌物涂片染色检查或细菌培养有致病菌。
2、病例选取要求:依据就诊病历,在十所医院筛选尿道炎的患者300例,年龄25-68岁,,病程2天-1年,男性患者182例,女性患者118例。试验前,将患者随机分为两组,实验组150例和对照组150例,两组在性别、年龄、病程、病情等方面无显著差异。
3、服药方法:实验组随机服用本发明实施例1、2、3所制备的胶囊剂,每次5mg,一天两次,口服,七天为一个疗程;对照组按照说明服用利君沙片。服药期间对两组患者进行连续观察,记录症状及变化。
4、疗效判定标准:
(1)治愈:症状消失,排尿通畅,尿常规检查完全正常;
(2)显效:症状基本消失,尿常规化验基本正常;
(3)无效:治疗前后症状无明显改善。
5、临床结果:经三个疗程的服药后,两组的治疗结果如下表所示:
组别 | 病例总数 | 治愈 | 显效 | 无效 | 不良反应 | 有效率 |
实验组 | 150 | 69 | 78 | 3 | 0 | 98.0 |
对照组 | 150 | 42 | 93 | 6 | 9 | 90.0 |
综上所述可见,本发明制备的胶囊剂对治疗尿道炎的有效率为98%,且暂未见任不良反应,因此在临床上有很好的效果。
病例1:段某某,女,48岁,近半年常有尿频、尿疼、尿道刺疼、尿道白肿,检查为尿道炎,服用本发明实施例1制备的胶囊剂1个疗程后,效果明显,尿频、尿痛明显缓解,继续服用2个疗程,痊愈,半年后随访无复发。
病例2:张某,男,54岁,尿道口红肿痒感,尿频、尿急、排尿困难,小便时灼痛,患者包皮过长,龟头红肿,确诊为急性淋菌性尿道炎,服用本发明实施例2制备的胶囊剂1个疗程后,症状明显好转,继续服用3个疗程,症状消失,痊愈,一年,后随访无复发。
病例3:王某,女,36岁,尿道灼痛,伴有腰酸,尿道分泌物涂片检验后,诊断为非淋菌性尿道炎,服用本发明实施例3制备的胶囊剂1个疗程后,症状明显好转,继续服用3个疗程,治愈,至今未复发。
尽管已参照其具体实施方案描述和阐明了本发明,但本领域技术人员会认识到,可以在不背离本发明的精神和范围的情况下对其作出各种改变、修改和取代。例如,由于被治疗特定病症的人的响应能力的变化,如上阐述的优选剂量以外的有效剂量可能适用。同样地,观察到的药理学响应可能根据和依赖所选特定活性化合物或是否存在药用载体以及制剂类型和所用给药模式而变,根据本发明的目的和实践预想到结果中的这类预期变化或差异。因此,本发明意在仅受下列权利要求的范围限制且这些权利要求应在合理的程度上尽可能广义地解释。
Claims (9)
1.一种治疗尿道炎的胶囊剂,其特征在于,所述的胶囊剂是由主要由以下重量份的成分组成:木犀草素30-50份、阿魏酸26-42份、异鼠李素25-40份、梓醇22-38份、谷甾醇18-34份、蒙花甙18-30份、女娄菜素15-30份、混合氨基酸12-28份、维生素B612-25份、香草酸10-20份、桃叶珊瑚甙8-16份、D-甘露醇7-15份、三磷酸腺苷酶6-12份、胡萝卜素5-10份;所述的胶囊剂还包括辅料:稀释剂36-58份、崩解剂24-46份、助流剂20-38份、润湿剂18-35份。
2.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于,所述的混合氨基酸由赖氨酸、组氨酸、精氨酸组成。
3.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于,所述的稀释剂是微晶纤维素、乳糖、玉米淀粉其中的一种或者几种。
4.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于,所述的崩解剂是海藻酸、交联纤维素、甘氨酰基淀粉钠其中的一种或者几种。
5.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于,所述的助流剂是微粉硅胶和滑石粉其中的一种或者几种。
6.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于,所述的润湿剂是聚山梨酯80和十二烷基硫酸钠其中的一种或者几种。
7.如权利要求1所述的一种治疗尿道炎的胶囊剂,其特征在于制备方法为:
步骤一:按配比分别称取各组份:木犀草素、阿魏酸、异鼠李素、梓醇、谷甾醇、蒙花甙、女娄菜素、混合氨基酸、维生素B6、香草酸、桃叶珊瑚甙、D-甘露醇、三磷酸腺苷酶、胡萝卜素置于搅拌机机械搅拌均匀制得混合药粉,备用;
步骤二:将步骤一制备的混合药粉置于压力研磨滚式超细微粉碎机中粉碎,制得混合药物细粉,备用;
步骤三:给步骤二制备的混合药物细粉中加入适量乙醇溶液制粒,再加入所术重量组份的稀释剂、崩解剂、助流剂、润湿剂,通过干燥、整粒、筛分、填充、抛光、包装制成胶囊剂。
8.如权利要求7所述的一种治疗尿道炎的胶囊剂,其特征在于步骤三所述的乙醇溶液重量为混合药物细粉的0.5-1倍,质量浓度为75-95%。
9.如权利要求8所述的一种治疗尿道炎的胶囊剂,其特征在于步骤三所述的干燥是指温度为38-45℃的机械搅拌风干。
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