CN103054839A - 一种杀灭抗酸染色阳性（红色）杆菌的药物 - Google Patents
一种杀灭抗酸染色阳性（红色）杆菌的药物 Download PDFInfo
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- CN103054839A CN103054839A CN2013100113734A CN201310011373A CN103054839A CN 103054839 A CN103054839 A CN 103054839A CN 2013100113734 A CN2013100113734 A CN 2013100113734A CN 201310011373 A CN201310011373 A CN 201310011373A CN 103054839 A CN103054839 A CN 103054839A
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Abstract
本发明的目的在于提供一种杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物以碱性品红为活性成分，能够有效杀灭抗酸染色阳性（红色）杆菌。该药物由于使用无毒的碱性品红为活性成分，药物无毒副作用，患者服用后无不良发应，且其作用机理与现有药物不同，能够彻底清除人体内的结核杆菌以及麻风杆菌，从而治愈结核病以及麻风病。
Description
技术领域
本发明属于医药技术领域，特别提供一种杀灭抗酸染色阳性（红色）杆菌的药物以及碱性品红在医药方面的新用途。
背景技术
结核病是由结核分枝杆菌引起的疾病。结核杆菌是一种位于细胞内感染的病原体，它能适应酸性环境，同时可长时间对抗巨噬细胞的吞噬体，而避免环境的酸化，使细菌在体内长时间的生存，所以结核病是一种持久的、慢性感染性疾病。结核菌经呼吸道进入体内，经过血液循环可寄生在全身各个器官进行繁殖，甚至可以进入骨、淋巴结中。目前最常见的是肺结核，它通过空气传播，危害大，流传广，有隐蔽性，带菌者无明显特征，防范困难，是人类的一大难题，长时间危害人体健康。
由于耐药菌株的出现和免疫抑制剂的应用，使全球范围内结核病的疫情骤然恶化，据WHO统计，全球约每三个人中就有一个人感染了结核分枝杆菌，在某些发展中国家，成人中结核分枝杆菌携带率高达80%，其中约有5-8%携带者可发展为活动性结核病。
目前全世界每年约出现八百万结核的新病例，并导致约三百万人死亡，中国每年死于结核病的人约有二十五万之多，是各类传染病死亡人数总和的二倍多。因此结核病是危害人体健康的全球性的问题。
结核菌通过呼吸道侵入人体，细菌在肺胞巨噬细胞内存活和复制，进而扩散至邻近非活化的肺泡并形成早期的感染灶，在T淋巴细胞反映期，结核菌在巨噬细胞内的最初生长，形成中心呈固态干酪坏死的结核灶，它能限制结核杆菌继续复制。对于大部分感染者来说，结核菌与宿主处于共生存的状态，结核菌被纤维包裹在干酪坏死的病灶内，此时结核菌不能增值。但一旦人体免疫损害，机体抵抗力下降，便可引起受抑制的结核菌重新的活动与繁殖，大量的结核菌从液化干酪灶释放出来播散到全身。对于这些原发和继发的病人要实施用药治疗。
目前常规的一线用药：1异烟肼
2.利福平
3.链霉素
4.吡嗪酰胺
5.乙胺丁醇
这些药都有很大的毒副作用（如异烟肼和利福平易引起血清谷丙转氨酶升高，肝肿大和黄疸、恶心、呕吐，链霉素损伤听觉神经，乙胺丁醇损害视神经等），且在治疗的过程中，这些药物没有使细菌死掉，而是在体内终身存留，只是抑制细菌不繁殖了，其治疗效果只是痰结核杆菌转阴（查不到抗酸杆菌），使细菌在体内又被包裹隐藏起来。一旦机体抵抗力弱或感冒，细菌又会在体内繁殖发病，造成很大痛苦，唯一的办法只有再实施抗痨治疗。由于药物的毒副作用能使患者的肝脏、肾脏、神经胃肠及造血器官受损，如谷草转氨酶、谷丙转氨酶、尿素、肌酐、尿素氮等极度异常，有的可出现血尿，医生只好将治疗结核的方案转移到保肝肾上来。很多患者结核病没治好而肝、肾等器官受了很大的伤害。
麻风病：麻风分枝杆菌是麻风病的病原体，此菌与其他分枝杆菌的不同点在于不能在人工培育基上生长，因此麻风的诊断仅依靠涂片做抗酸染色的检查。
麻风分枝杆菌和结核分枝杆菌的共同特点，都不易着色，一旦着色后，又不能为酸，酒精所褪色，故又称为抗酸杆菌。两者均为无鞭毛，无芽胞，无荚膜的革兰氏（G+）阳性杆菌。（经抗酸染色后都为红色（+））
麻风分枝杆菌和结核分枝杆菌在分类学上都属于裂殖菌纲，放线菌目，分枝杆菌科。麻风分枝杆菌和结核分枝杆菌区别如表1：
表1 麻风分枝杆菌和结核分枝杆菌区别
目前治疗麻风病的用药与治疗结核病的药物相同，只是剂量更大、疗程更长，常用药有利福平、氯苯酚嗪、硫酰胺等，都是毒性极强的药物，对肝脏、肾脏、神经、胃肠、及造血功能都有严重的损害。
发明内容
本发明的目的在于提供一种杀灭抗酸染色阳性（红色）杆菌的药物，该药物能够有效杀灭抗酸染色阳性（红色）杆菌，该药物能够彻底清除人体内的结核杆菌以及麻风杆菌，从而治愈结核病以及麻风病。
本发明具体提供了一种杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物以碱性品红为活性成分。
1、碱性品红的原用途：
碱性品红（别称：碱性新品红、盐基品红、玫瑰苯胺盐酸盐）为最强的核染料，能使粘朊弹性组织和嗜品红的颗粒染色，中枢神经的核染色剂，细菌学用于鉴别结核杆菌，分析化学中配制席夫试剂检验醛类，用溴酸盐滴定的氧化还原指示剂，用于染棉、麻、人造纤维麦秆、皮革羽毛、脂肪等，也用于制造色淀。
2、制备来源：
由苯胺、邻甲苯胺，对甲苯胺的盐酸盐在铁和氯化锌存在下与硝基苯熔融缩合，再经酸提，中和结晶而制成。
3、化学结构式：NH2CH3C6H3C:C6H4(NH2)(CL)C6H4-NH2
NH2C6H4C:C6H4(NH2)(CL)C6H4NH2
4、分子式及分子量：C20H20N3CL=337.84
C19H18N3CL=323.82
5、性状：为绿色金属光泽结晶，溶于乙醇和戊醇，微溶于水，在水溶液呈红色，不溶于乙醚。
6、治疗的原理：
（1）、因为T、B淋巴细胞/或称吞噬细胞中的结核杆菌之膜蛋白，可以维持细菌体内的pH值而生存在宿主体内。而蛋白质有两性电离的性质，在酸碱的环境中都会改变他的pH值，同时也改变了所带正负电荷的量。各物质蛋白质有不同的等电点。DNA有两条链的磷酸基向外，带负电荷，显酸性，很容易与带正电荷的碱性品红（碱性）染料结合着色，所以结核菌体的膜蛋白更容易与碱性品红作用，使菌体膜蛋白的pH值改变。而菌体失去调节pH值的功能，无法抑制吞噬体兴溶酶的分泌，使被细胞吞噬的结核菌被吞噬细胞所产生的兴融酶体消化，导致细菌无法生存。
（2）、在快速鉴别抗酸杆菌的检验中，抗酸染色的染色液中其主要染料为碱性品红，它使结核分枝杆菌和麻风分枝杆菌体着色成红色，不易脱色，染料进入菌体，而其他组织细胞不被碱性品红染成红色，被结晶紫（天青）染成蓝色。故称为万木丛中一点红，因此我认为抗酸杆菌的着色是杀死细菌的所在。此着色给细菌做了标记，增强免疫细胞的识别力，这样免疫细胞能识别攻击目标，使机体免疫功能被起动，是消灭细菌的主要原因。
（3）、因为碱性品红无毒，在作药敏时，将碱性品红加入到罗琴培养基中，只能使颜色有所变化，不会给培养基带来毒性，也不会改变罗-琴培养基的营养条件，所以细菌应正常在此培养基中生长。更证明了碱性品红的无毒性，也证明了不是碱性品红本身具有杀灭抗酸染色阳性（红色）杆菌的作用，而是因为碱性品红给细菌菌体着上了颜色，使人体内强大的免疫功能被起动，来彻底清除细菌，这是此药的极大优点。
如果在罗--琴培养基中加入常规药物，等于给细菌的食物下了毒，使细菌因中毒而不能繁殖，从而导致培养结果为细菌不能生长（称敏感）。即常规药物只能起到抑制细菌的作用，并不能彻底消灭细菌。且会带来严重的毒副作用，伤害人体的解毒器官。
总之：碱性品红治疗结核杆菌的要点在于：
①、因菌体的着色，使细菌膜蛋白的pH值有改变，而使菌体失去了自身调节pH值的作用，无法抑制吞噬细胞分秘兴溶酶，使细菌被兴溶酶清除。
②、因碱性品红给菌体着色，即给细菌本身做了标记，使吞噬细胞能识别目标，进而消灭。
③、因碱性品红无毒，其作用机理与现有药物不同，无法用毒性抑制或杀灭细菌，所以在体外做药敏时因没有体细胞的环境，所以细菌不能被消灭，应该正常在培养基中生长。
本发明提供的杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物含有碱性品红药学上可接受的辅料或辅助性成分。其中药学上可接受的辅料或辅助性成分优选为米粞、小麦胚芽或五谷类辅料，最优选为米粞，选取米粞为辅料时，药物组成优选为重量百分比碱性品红55-65%、米粞35-45%。
其中，米粞的营养成分：富含有纤维素和大量的VB、VE族的维生素和矿物质，如钙、磷、铁等，俗称为肠道的清道夫，改善胃肠功能，增加肠的蠕动，清肠毒，及时将垃圾排出体外，解除便秘，促进营养的吸收，促进血液循环，提高免疫力，增强体质，米粞富含的膳食纤维还能与胆汁中的胆固醇结合，促进胆固醇的排出，有净化血液、调节血脂等作用。
小麦胚芽：含有高浓度的维持生命运动的各种营养成分，如脂肪、蛋白质及各种酵素、维生素、矿物质等，所含的维生素B1为每天人体需要的3.5倍。此外还含有大量的维生素E和罂酸，以及在其它食品中很少存在的维生素B6。
本发明提供的杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述的药物是口服制剂，注射制剂或外用制剂。
本发明提供的杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物是片剂、口服液、胶囊剂、注射剂、膏剂、酊剂、散剂、冲剂、栓剂、霜剂、透皮制剂或保健食品。
本发明还提供了碱性品红在制备抑制或/和杀灭抗酸染色阳性（红色）杆菌的药物中的用途。
经我们的研究发现，碱性品红可以用于制备治疗结核病和麻风病的药物。且目前我们发现用碱性品红治疗结核病优于现有技术治疗结核病。其治疗优点如下：
（1）、无毒：用于口服两年的患者其肝、肾无损伤。
（2）、取材方便，有利于推广。
（3）、价格廉，给国家和个人减轻负担。
（4）、治疗彻底：治愈后的患者，无一例复发，体症消失一切结核病的症状。
（5）、无不良发应：在治疗过程中，无一例有副作用。
（6）、治疗方便：口服即可，不用住院。
（7）、药物不在体内存留，并使体液一时性有改善，服药后尿液的pH值变化如表2所示：
尿：约4-6小时排出体外（表2）
便：约12-24小时排出体外，肉眼观察。
表2 服药后患者（素食）在不同时间尿液pH值的变化
注：尿液pH值都在2-3小时达到高峰，且pH值在6.0-7.5（5.5-7.0）区间可持续3-4小时，并在2-3小时后恢复正常。
附图说明
图1服药后患者尿液pH值随时间变化曲线。
具体实施方式
实施例1
药敏的检查培育：
（一）、药物：碱性品红
（二）、培养方法：罗琴二氏培养基（改良法）
（三）、罗-琴二氏培养基的成分：
KH2PO4：2.4g、MgSO4·7H2O：0.24g、枸橼酸镁：0.6g、天门冬素：3.6g、甘油：12ml、蒸馏水：600ml、马铃薯粉：30g、新鲜全卵液：1000ml、2%孔雀绿水溶液：20ml。
（四）、仪器
1.电热恒温培育箱（黄石市恒丰医疗器械有限公司）：36℃(特殊定制)；
2.生物安全柜：BIOBASE BIOTEOH
规格型号:BSC-1500IZB2-Χ
生产厂家：济南鑫久西生物技术有限公司
3.蒸汽恒温箱：85℃
生产厂家：北京新中大业代表有限公司
4.药品：2%碱性品红水溶液，100ml备用。
（五）、培养基的制备：
将KH2PO4，MgSO4·7H2O，枸橼酸镁，天门冬素及甘油加水后，置于沸水浴中加热使之溶解，再加上马铃薯粉，继续在沸水中加热30分钟，不断搅拌，使其成均匀糊状。待冷却到60℃左右，加入新鲜全卵液1000ml，及2%孔雀绿水溶液20ml，充分混合后，用双层纱布过滤，分装于螺旋盖的试管中，每管加入7ml，此时将2%的碱性品红溶液按比例加入试管中（加入量见表3)，将试管置于85%蒸汽恒温箱中90分钟，待冷至60℃以下时将试管倾斜放置在生物安全柜内（也称净化台），使培养基冷至凝固，并形成斜面，将菌液的浓度为10-2/mg/ml的结核杆菌活菌液冲盈在培育基的斜面上。每管冲盈菌液为0.1ml。在培育基中菌液的浓度为10-3mg/ml，放入电热恒温培养箱中培养。培养五周后无菌生长。（见表3）
表3 实验结果
实施例2
碱性品红治疗结核病：
患者用药量：胶囊500mg/粒，其中重量配比为碱性品红：米粞=3：2；每人口服1~2粒/日。
服用方法：每天早饭前服用碱性品红胶囊后即可用餐，正常饭水，三个月为一个疗程，患者病历见表4，治疗结果见表5。
病历说明：
1.此病历患者都是经过正规结核病医院或结核病防治所确诊的，且所有患者均经常规用药治疗后病情反复发作。
2.患者经正规治疗后有不同程度的肝脏、肾脏受损，而无法再服用常规药物。
3.在服药前都有明显的结核症状：周身无力，不适，发热，咳嗽，盗汗等（胸椎骨结核患者有疼痛，也有月经闭经的）。
4.大多数患者服药一个月后症状明显减轻，三个月基本消除结核症状，六个月经拍片确认痊愈。
5.服药后患者肝脏、肾脏抽血检查结果都在正常范围内。
6.服药一个月后在痰中找不到结核肝菌（即未找到抗酸杆菌）。服药六个月后可以停药，能够恢复正常生活并参加体力劳动。
表4 结核病患者个体病历表
表5 结核病患者治疗效果
实施例3
一、药物的种类：1.口服药胶囊：患者用药量：胶囊500mg/粒，其中重量配比为碱性品红：米粞=3：2；每人口服1~2粒/日；2.外用酊剂，涂抹溃疡面。
二、碱性品红酊剂的制备：
材料：1.碱性品红结晶（市售）
2.医用酒精（75%乙醇溶液）
制备过程：
1.在玻璃烧杯内倒入100g碱性品红以及800ml75%的酒精，用玻璃棒搅拌均匀。
2.用镊子夹取酒精棉球，用打火机点燃后放在装有碱性品红和75%的酒精的烧杯表面，点燃混合液，燃烧时用玻璃棒搅拌，直至火焰燃尽。
3.待温度达到60℃时用漏斗将烧好的药液倒入磨口瓶中备用。
4.将制备好的酊剂浸入到有脱脂棉球的辅料缸中备用。
三.使用方法：
外用：先将麻风病人的溃疡面用盐水清洗干净，再用制备好的碱性品红酊剂脱脂棉球涂抹伤口，反复涂抹后用纱布遮盖包扎好，3天一换药，直至伤口愈合为止。
内服：每日早饭前用温开水口服1粒胶囊，直至痊愈，一个疗程为3个月，治疗效果见表6。
病历说明：对象为山东滕州市麻风村的麻风病患者以及广东省无川市普光医院麻风病康复中心的患者。
表6 麻风个体病历
上述实施例只为说明本发明的技术构思及特点，其目的在于让熟悉此项技术的人士能够了解本发明的内容并据以实施，并不能以此限制本发明的保护范围。凡根据本发明精神实质所作的等效变化或修饰，都应涵盖在本发明的保护范围之内。
Claims (10)
1.一种杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物以碱性品红为活性成分。
2.按照权利要求1所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物含有碱性品红药学上可接受的辅料或辅助性成分。
3.按照权利要求1所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药学上可接受的辅料或辅助性成分为米粞、小麦胚芽或五谷类辅料。
4.按照权利要求3所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药学上可接受的辅料或辅助性成分为米粞。
5.按照权利要求4所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述药物其组成为重量百分比碱性品红55-65％、米粞35-45%。
6.按照权利要求1~5所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述的药物是口服制剂，注射制剂或外用制剂。
7.按照权利要求6所述杀灭抗酸染色阳性（红色）杆菌的药物，其特征在于：所述的药物是片剂、口服液、胶囊剂、注射剂、膏剂、酊剂、散剂、冲剂、栓剂、霜剂、透皮制剂或保健食品。
8.碱性品红在制备抑制或/和杀灭抗酸染色阳性（红色）杆菌的药物中的用途。
9.碱性品红在制备治疗结核病的药物中的用途。
10.碱性品红在制备治疗麻风病的药物中的用途。
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| CN105963285A (zh) * | 2016-04-11 | 2016-09-28 | 胡淑贤 | 一种治疗布氏杆菌病的药物 |
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