CN103127166A - 一种治疗面部痤疮的药物 - Google Patents

一种治疗面部痤疮的药物 Download PDF

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CN103127166A
CN103127166A CN2011103728322A CN201110372832A CN103127166A CN 103127166 A CN103127166 A CN 103127166A CN 2011103728322 A CN2011103728322 A CN 2011103728322A CN 201110372832 A CN201110372832 A CN 201110372832A CN 103127166 A CN103127166 A CN 103127166A
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CN103127166B (zh
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张文龙
郭玉华
宋风莉
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Lanzhou Holyshine Pharmaceutical Co ltd
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JILIN SECOND RONGFU MILITARY HOSPITAL
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Abstract

本发明涉及一种治疗面部痤疮的药物，具体的说是一种治疗粉刺、脂溢性皮炎、酒渣鼻等痤疮疾病的“面痤净软膏”。该药物由甲硝唑、氯霉素、冰片、升华硫、硬脂酸、单硬脂酸甘油酯、卵磷脂、丙二醇、三乙醇胺、吐温、蒸馏水等根据工艺步骤制备而成，本发明药物具有抗痤疮丙酸杆菌、溶解皮肤角质和降低皮质游离脂及酸作用，对痤疮（粉刺）、脂溢性皮炎、酒渣鼻有显著的治疗效果。

Description

一种治疗面部痤疮的药物
技术领域
本发明涉及一种治疗面部痤疮的药物，具体的说是一种治疗粉刺、脂溢性皮炎、酒渣鼻等痤疮疾病的“面痤净软膏”。
背景技术
痤疮是多种因素导致的毛囊皮脂腺慢性炎症性皮肤病，目前治疗痤疮方法有：
1、内服的药物主要是抗生素，以抗菌消炎为主，但有些药物含有四环霉素。如果长期服用，无形中会加重肝、肾的负担，对孕妇尤其有禁忌。
2、维A酸类药物治疗，由于动物和人的皮肤结构差异及对维A酸刺激的敏感性不同所致。所以有关动物维A酸局部给药的安全性令人堪忧。
3、但上述方法在治疗上存在片面性的问题，而且有副作用。
发明内容
本发明的目的是克服现有技术的不足，提供一种治疗粉刺、脂溢性皮炎、酒渣鼻等痤疮疾病的药物，该药物治疗效果好、无副作用。
为了达到发明的上述目的，本发明的技术方案是：
本发明药物是由下列重量配比的原料药制成的：
甲硝唑3份       氯霉素1份         冰片0.1份     
升华硫6份       硬脂酸20份        单硬脂酸甘油酯4份   
卵磷脂1份       丙二醇10份        三乙醇胺2.5份             
吐温-802.5份      纯化水加至100份；
制备方法为：
①油相：取硬脂酸20份、单硬脂酸甘油酯4份、卵磷脂1份倒入油膏缸中，置于水浴锅中加热至70oC，混匀熔化备用；
②水相：取甲硝唑3份、氯霉素1份溶于适量纯化水中，并加入丙二醇10份、三乙醇胺2.5份、吐温-802.5份、50oC加热至溶，混匀，备用；
③将升华硫6份研细，过80目筛，备用；
④将冰片0.1份研细，过80目筛，备用；
⑤按等量递增法把研细后升华硫分次加入油相中，边加边搅拌，搅拌均匀后加入冰片细粉至溶，在搅拌下将水相缓缓加入油相中，继续搅拌至凝固，即得本发明产品。
本发明产品的剂型为软膏，性状为淡黄色，包装规格为每盒20g，仅供外用，涂于患处，一日1-2次。
本发明药物具有抗痤疮丙酸杆菌、溶解皮肤角质和降低皮质游离脂及酸作用，对痤疮（粉刺）、脂溢性皮炎、酒渣鼻有显著的治疗效果。
本发明药物的临床病例观察报告
    该治疗痤疮（粉刺）、脂溢性皮炎、酒渣鼻的药物面痤净乳膏是外用乳膏制剂，该药具有调节和控制上皮细胞分化与生长、促进基底细胞增生、抑制皮脂腺腺管上皮过度角化、降低皮脂分泌、抑制痤疮丙酸杆菌生长、调节病变皮肤免疫和炎症的作用。能溶解粉刺，并能减轻角质层的粘聚力，使粉刺松动，有利于粉刺排除。
一、病例选择
1.1  180例皮肤病患者，均来自我院门诊皮肤科，诊断标准符合临床皮肤病学有关寻常痤疮、脂溢性皮炎、酒渣鼻诊断。痤疮患者（且采取pillshurv分类法）、Ⅱ、Ⅲ、Ⅳ度痤疮患者列为对象。
100例痤疮患者；其中男性65例，年龄：14—32岁；女性55例， 年龄：14—30岁。
36例酒渣鼻患者：其中男性18例，年龄：26—42岁；女性18例，年龄：28—48岁。
 44例脂溢性皮炎患者，其中男性20例，年龄：22—40岁；女性24例，年龄：24—42岁。
1.2 治疗方法
采取随机开放式试验，不设对照组。使用本发明药面痤净软膏，一天2次，外用涂于患处。疗程8周，对治疗的患者于2周、4周、6周、8周各复诊随访1次，记录粉刺、丘疹脓疱、囊肿的变化，在第8周末评价疗效。 
二、诊断标准
     2.1痤疮分级，采用采取pillshurv分类法；皮损表现Ⅰ、Ⅱ、Ⅲ、Ⅳ。颜面部为主。
Ⅰ级主要皮损是粉刺，皮损总数在10—30个：
Ⅱ级主要皮损是粉刺，并有丘疹和脓包，皮损总数在31—50个：
Ⅲ级丘疹和脓包较多，皮损总数在51—100个：
Ⅳ级皮损数目>100个，并可见结节囊肿数目在3个以上。
2.2疗效判定标准
根据治疗前后皮损总数减少的百分率判定疗效标准：基本痊愈：皮肤损害消退率≥95%，无新发疹；显效：皮肤损害消退率≥70%—94%；
有效：皮肤损害消退率≥50%—69%；无效：皮肤损害消退率不足50%。
2.3疗效观察结果见表：
病种分类 例数 痊愈 显效 有效 无效 痊愈率 总有效率
痤疮 100 64 23 9   4 60.0% 87.0%
脂溢性皮炎   44 27 10 7   0 61.4% 84.1%
酒渣鼻 36 28 4 4 0 77.80% 89.6%
   从表中可以看出，①、该药对治疗痤疮治愈60例，治愈率64%；显效23例，显效率23%；有效9例，有效率9%；无效率4%。②、该药治疗脂溢性皮炎治愈27例，治愈率61.4%；总有效率84.1%；③、该药对治疗酒渣鼻治愈28例，治愈率77.80%，总有效率89.6%。该药是水包油型乳膏，性质稳定且易涂性、易洗性、无异味等优点。
 
    讨论：痤疮是青年人好发的一种常见皮肤病，痤疮的病因与激素代谢和皮脂腺分泌旺盛有关。在粉刺棒状杆菌等作用下引起局部炎症。酒渣鼻主要是毛囊蠕形螨在鼻皮脂腺内生长繁殖所致。脂溢性皮炎与脂肪代谢及局部感染有关。
 附图说明
图1是本发明药物的制备工艺流程图。
具体实施方式
按原料重量配比称取：
甲硝唑30g        氯霉素10g       冰片1g     
升华硫60g        硬脂酸200g       单硬脂酸甘油酯40g   
卵磷脂10g        丙二醇100g       三乙醇胺25g       
吐温-80 25g         纯化水加至1000g   
制备方法为：
①油相：取硬脂酸200g  、单硬脂酸甘油酯40g  、卵磷脂10g   倒入油膏缸中,置于水浴锅中加热至70oC，混匀熔化备用；
②水相：取甲硝唑30g、氯霉素10g  溶于适量纯化水中，并加入丙二醇100g、三乙醇胺25g、吐温-8025g、50oC加热至溶，混匀，备用；
③将升华硫60g研细，过80目筛，备用；
④将冰片1g研细，过80目筛，备用；
 ⑤按等量递增法把研细后升华硫分次加入油相中，边加边搅拌，搅拌均匀后加入冰片细粉至溶,在搅拌下将水相缓缓加入油相中，纯化水逐步加至足量(原料药和水的总量达到1000g)继续搅拌至凝固，即得本发明产品。
本发明的产品的剂型为软膏剂，性状为淡黄色软膏，包装规格为每盒20g，仅供外用，涂于患处，一日1-2次。

Claims (1)

1.一种治疗面部痤疮的药物，其特征在于：它是由下述重量配比的原料药制成：
甲硝唑3份        氯霉素1份       冰片0.1份    
升华硫6份        硬脂酸20份      单硬脂酸甘油酯4份   
卵磷脂1份        丙二醇10份      三乙醇胺2.5份         
吐温-802.5份      纯化水加至100份； 
制备方法为：
①油相：取硬脂酸20份、单硬脂酸甘油酯4份、卵磷脂1份倒入油膏缸中，置于水浴锅中加热至70oC，混匀熔化备用；
②水相：取甲硝唑3份、氯霉素1份溶于适量纯化水中，并加入丙二醇10份、三乙醇胺2.5份、吐温-802.5份、50oC加热至溶，混匀，备用；
③将升华硫6份研细，过80目筛，备用；
④将冰片0.1份研细，过80目筛，备用；
 ⑤按等量递增法把研细后升华硫分次加入油相中，边加边搅拌，搅拌均匀后加入冰片细粉至溶，在搅拌下将水相缓缓加入油相中，纯化水逐步加至足量继续搅拌至凝固，即得本发明产品。
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434956A (zh) * 2013-09-25 2015-03-25 重庆华邦制药有限公司 治疗痤疮、银屑病和酒糟鼻的复方制剂
CN105311058A (zh) * 2014-07-29 2016-02-10 上海百好博化工有限公司 一种杀灭痤疮杆菌的制剂
CN109528948A (zh) * 2017-09-21 2019-03-29 吴丽娟 一种祛痘膏及其制作方法
CN114796176A (zh) * 2022-06-09 2022-07-29 中南大学湘雅医院 一种用于治疗皮肤疾病的药物组合物及其制备方法

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
马锐等: "痤疮净乳膏的制备及临床应用", 《中国药师》 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104434956A (zh) * 2013-09-25 2015-03-25 重庆华邦制药有限公司 治疗痤疮、银屑病和酒糟鼻的复方制剂
CN104434956B (zh) * 2013-09-25 2018-10-19 重庆华邦制药有限公司 治疗痤疮、银屑病和酒糟鼻的复方制剂
CN105311058A (zh) * 2014-07-29 2016-02-10 上海百好博化工有限公司 一种杀灭痤疮杆菌的制剂
CN109528948A (zh) * 2017-09-21 2019-03-29 吴丽娟 一种祛痘膏及其制作方法
CN114796176A (zh) * 2022-06-09 2022-07-29 中南大学湘雅医院 一种用于治疗皮肤疾病的药物组合物及其制备方法

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