CN108771702A - 一种用于人体肛周皮肤的外用熏洗抑菌剂 - Google Patents
一种用于人体肛周皮肤的外用熏洗抑菌剂 Download PDFInfo
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Abstract
本发明公开了一种用于人体肛周皮肤的外用熏洗抑菌剂,该外用熏洗抑菌剂由玄明粉、枯矾、金银花提取物、荆芥提取物、马齿苋提取物和抑菌活性成分组成。本发明的外用熏洗抑菌剂对大肠杆菌、金黄色葡萄球菌、真菌、绿脓杆菌、变形杆菌等有明显的抑制作用,对肛门术后并发症、肛周湿疹、炎性外痔以及人体肛周皮肤感染可起到预防和治疗作用,应用前景广阔。
Description
技术领域
本发明属于药物制备技术领域,具体涉及一种用于人体肛周皮肤的外用熏洗抑菌剂,特别适合肛肠病患者肛周皮肤的抗菌、消炎、止血、止痛。
背景技术
祖国医学认为,肛肠病的发病以风、湿、热、瘀为主。中药熏洗疗法是祖国医学用以治疗肛肠病术前术后的一种独特方法,疗效已获肯定,相对于口服、外用膏栓剂等方法具有明显优势,可缩短疗程,减轻患者痛苦,先熏后洗,药物双管齐下,直接作用于肛肠病变部位,使患处腠理舒畅,气血流通,疾病得治。
方中君药玄明粉清热消肿,臣药马齿苋、金银花清热解毒、凉血消肿,佐药枯矾、荆芥收湿敛疮、止血化腐、祛风胜湿,诸药合用,共奏清热解毒、消肿止痛、祛风燥湿之功。该药为纯中药制剂加入抑菌活性成分,不同于一般熏洗药物需煎煮草药,此剂型仅需将粉末状抑菌剂溶于适量沸水中,待水温合适后即可使用,具有使用方便、疗效好、不良反应少等优点。
发明目的
本发明的目的在于提供一种用于人体肛周皮肤的外用熏洗抑菌剂,该外用熏洗抑菌剂具有抗炎、镇痛、抑菌和止血之功效,对肛门术后并发症、肛周湿疹和炎性外痔等症状具有明显的治疗作用。
为实现上述目的,本发明所采取的技术方案为:
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
优选的,由如下原料制成:
优选的,由如下原料制成:
优选的,由如下原料制成:
优选的,所述抑菌活性成分有聚六亚甲基双胍、苯扎溴铵、苄索氯铵、醋酸氯已定、葡萄糖酸氯已定或溴硝丙二醇。
另外,本发明还要求保护该用于人体肛周皮肤的外用熏洗抑菌剂的制备方法,具体步骤为:
(1)取玄明粉、枯矾粉碎,过7号筛后混匀;
(2)取金银花、荆芥加5倍量的水浸泡0.5小时,然后水蒸汽蒸馏6小时提取挥发油,蒸馏后的水溶液另器收集;
(3)取马齿苋加15倍量的水浸泡0.5小时,与步骤(2)水蒸汽蒸馏后的残渣合并煎煮3次,每次加15倍量水煎煮1.5小时,之后与步骤(2)水蒸汽蒸馏后的水溶液合并,过滤,滤液于60℃减压浓缩至相对密度为1.17的清膏,喷雾干燥(进风170℃,出风80℃)得干浸膏粉;
(4)分别将干浸膏粉、活性抑菌成分粉碎后过80目筛备用;将步骤(2)得到的挥发油用无水乙醇溶解后喷入玄明粉、枯矾的细粉中,混匀,再与干浸膏粉、抑菌活性成分混合均匀即得。
优选的,所述外用熏洗抑菌剂的剂型可选择颗粒剂、散剂、洗剂和粉剂,以方便患者的使用。
在本发明中,玄明粉(Natrii Sulfas Exsiccatus)泻热通便、软坚散结、清热解毒、清肺解暑、消积和胃。由朴硝脱水制成,由于产地及提炼方法不同,所含夹杂物亦异,常见者为硫酸钙、硫酸铁、硫酸钾。枯矾(Alumen)主要适用于消痰、燥湿、止泻、止血、解毒、杀虫。取拣净的白矾,置砂锅内加热溶化并煅至枯干,取出,为不规则的结晶体,大小不一。金银花(Lonicerae japonicae Flos)自古被誉为清热解毒的良药。它性甘寒,气芳香,甘寒清热而不伤胃,芳香透达又可祛邪。金银花既能宣散风热,还善清解血毒,用于各种热性病,如身热、发疹、发斑、热毒疮痈、咽喉肿痛等症,均效果显著。荆芥(Schizonepetae Herba)祛风解表、透疹、消疮。用于外感表证、风疹瘙痒和疮疡等症。马齿苋(Portulacae Herba)清热解毒,凉血止血。用于热痢脓血,热淋,带下病,痈肿恶疮,丹毒。
与现有技术相比,本发明的有益效果为:传统中药制剂虽然对肛门术后并发症、肛周湿疹和炎性外痔等症状起到一定的治疗作用,但抑菌消炎作用比较弱。本发明在传统中药制剂的基础上加入了抑菌活性成分,使得药物抗菌消炎效果更强,作用更为持久,从而有效地解除患者的痛苦。同时,该抑菌剂仅需溶于适量沸水中,待水温合适后即可使用,具有使用方便、疗效好、不良反应少等优点。
具体实施方式
实施例1
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例2
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例3
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例4
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例5
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例6
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
实施例7
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
对比例1
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
对比例2
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
对比例3
一种用于人体肛周皮肤的外用熏洗抑菌剂,按质量百分数计,由如下原料制成:
对本发明实施例1制备的外用熏洗抑菌剂以及对比例1-3所制备的外用熏洗抑菌剂进行抑菌实验,结果如下:
结论:本发明实施例1的外用熏洗抑菌剂的微生物指标检测结果符合GB15979-2002的规定。
对本发明实施例1制备的外用熏洗抑菌剂以及对比例1-3所制备的外用熏洗抑菌剂进行抑菌环实验,结果如下:
结论:本发明的外用熏洗抑菌剂对大肠杆菌、金黄色葡萄球菌的抑菌环均>7mm,结果符合《消毒技术规范》(2002年版)2.1.8.2的要求。
根据《消毒技术规范(2002年版)》所述方法,本发明的外用熏洗抑菌剂进行多次皮肤刺激实验及对家兔急性眼刺激反应试验研究,结果如下:
本发明的外用熏洗抑菌剂对家兔多次皮肤刺激性试验结果
结论:本发明的外用熏洗抑菌剂多次皮肤刺激试验检测结果表明,本品无刺激性。
本发明的外用熏洗抑菌剂对家兔急性眼刺激反应试验结果
结论:本发明的外用熏洗抑菌剂在0.1425g/ml浓度时(相当于临床使用浓度的5倍)对家兔眼睛无急性刺激性。
本发明的外用熏洗抑菌剂的临床使用结果如下:
本发明的外用熏洗抑菌剂治疗肛门术后并发症71例,结果表明,经本发明的外用熏洗抑菌剂治疗后,肛门部水肿、疼痛均有明显改善,对出血也有较好的治疗作用。同时,用本发明的外用熏洗抑菌剂的治疗组中无肛周湿疹的病例发生。对照组中有5例发生肛周湿疹,说明本发明的外用熏洗抑菌剂具有清热解毒、消肿止痛、祛风燥湿之功效。
本发明的外用熏洗抑菌剂治疗肛周湿疹37例,结果表明,治疗4周后,治疗组与对照组总有效率分别为86.5%和77.5%。治疗组综合疗效和对照组比较,经Ridit分析差异有显著性(P<0.05),治疗组优于对照组。
本发明的外用熏洗抑菌剂治疗炎性外痔65例,治疗方法:将1袋本发明的外用熏洗抑菌剂加入1000ml沸水冲化后趁热熏蒸肛门,可根据热气温度相应调整肛门与药液平面高低,以肛门皮肤感到温度适度为宜;待药液温度降至40℃,予以坐浴,每次约30min,每日2次,先熏后洗,尤以排便后及睡前为宜,疗程7d。治愈48例,好转16例,无效1例,总有效率98.5%。
以上所述,仅为本发明的具体实施方式,但本发明的保护范围并不局限于此,任何熟悉本技术领域的技术人员在本发明揭露的技术范围内,可轻易想到变化或替换,都应涵盖在本发明的保护范围之内。因此,本发明的保护范围应以所述权利要求的保护范围为准。
Claims (7)
1.一种用于人体肛周皮肤的外用熏洗抑菌剂,其特征在于,按质量百分数计,由如下原料制成:
2.根据权利要求1所述的用于人体肛周皮肤的外用熏洗抑菌剂,其特征在于,由如下原料制成:
3.根据权利要求2所述的用于人体肛周皮肤的外用熏洗抑菌剂,其特征在于,由如下原料制成:
4.根据权利要求3所述的用于人体肛周皮肤的外用熏洗抑菌剂,其特征在于,由如下原料制成:
5.根据权利要求1-4任一项所述的用于人体肛周皮肤的外用熏洗抑菌剂,其特征在于,所述菌活性成分为聚六亚甲基双胍、苯扎溴铵、苄索氯铵、醋酸氯已定、葡萄糖酸氯已定或溴硝丙二醇。
6.根据权利要求1-5所述的用于人体肛周皮肤的外用熏洗抑菌剂的制备方法,其特征在于,具体步骤为:
(1)取玄明粉、枯矾粉碎,过7号筛后混匀;
(2)取金银花、荆芥加5倍量的水浸泡0.5小时,然后水蒸汽蒸馏6小时提取挥发油,蒸馏后的水溶液另器收集;
(3)取马齿苋加15倍量的水浸泡0.5小时,与步骤(2)水蒸汽蒸馏后的残渣合并煎煮3次,每次加15倍量水煎煮1.5小时,之后与步骤(2)水蒸汽蒸馏后的水溶液合并,过滤,滤液于60℃减压浓缩至相对密度为1.17的清膏,喷雾干燥得干浸膏粉;
(4)分别将干浸膏粉、活性抑菌成分粉碎后过80目筛备用;将步骤(2)得到的挥发油用无水乙醇溶解后喷入玄明粉、枯矾的细粉中,混匀,再与干浸膏粉、抑菌活性成分混合均匀即得。
7.根据权利要求6所述的用于人体肛周皮肤的外用熏洗抑菌剂的制备方法,其特征在于,所述外用熏洗抑菌剂的剂型可选择颗粒剂、散剂、洗剂和粉剂,以方便患者的使用。
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