CN1108940A - 乳酸软膏 - Google Patents

乳酸软膏 Download PDF

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CN1108940A
CN1108940A CN94111688A CN94111688A CN1108940A CN 1108940 A CN1108940 A CN 1108940A CN 94111688 A CN94111688 A CN 94111688A CN 94111688 A CN94111688 A CN 94111688A CN 1108940 A CN1108940 A CN 1108940A
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lactic acid
ointment
xeroderma
carbamide
cholesterol
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CN1063631C (zh
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陈立中
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Fujian Pacific Pharmaceutical Co ltd
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NO 1 HOSPITAL ATTACHED TO HUAX
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Abstract

本发明提供一种疗效确切持久,安全无刺激,使 用方便舒适,易为患者皆接受的治疗鱼鳞病等皮肤干 燥症的外用乳酸软膏。本软膏以乳酸为主药,加适量 氨水使成盐、尿素为助渗剂,胆固醇等为乳化剂、稳定 剂,掺以抗氧剂及其他辅料组成一个稳定的油包水型 软膏基质。本发明处方设计合理,制剂工艺成熟,拟 定的质量标准能控制产品质量,临床使用效果极佳, 对皮肤无毒性、刺激性和致敏反应,是一种治疗皮肤 干燥症安全有效的制剂,有极好的社会效益和经济效 益。

Description

本发明属皮肤干燥症外用治疗药,具体的说是一种乳酸盐脂。
皮肤干燥症是临床常见的皮肤病的一组症状,可由鱼鳞病,异位性皮炎,皮肤浅部真菌感染及某些工农职业性皮肤病等多种原因引起,中老年人多发。其症状为皮肤干燥,严重者引起皲裂,出血和继发感染。本症疗法较多,但疗效不尽如意。国外文献:“12%乳酸盐洗剂治疗皮肤干燥症-一种双盲临床评价”和“12%乳酸胺洗剂与5%乳酸洗剂治疗中度,重度皮肤干燥的疗效比较”的报道。处方中以乳酸盐为主药,制成洗剂,但洗剂疗效不如软膏持久,用药易流失,造成浪费,并且影响治疗效果。国内对皮肤干燥症的治疗研究多以尿素为主药的霜剂,为水包油型,缺点是尿素不稳定,也有用尿素加凡士林混合,虽解决了尿素不稳定的问题,但油腻性太重,污染衣物,尚未见乳酸制剂的研制报道。
本发明的目的在于提供一种疗效确切持久,安全无刺激,使用方便舒适,易被患者接受的治疗鱼鳞病等皮肤干燥症的优良制剂-乳酸软膏。
乳酸软膏是以乳酸为主药,加适量氨水中和部分乳酸使成盐。尿素为助渗剂,能降低皮肤阻力,使角质层肿胀,因而增加了皮肤的穿透性,增强乳酸疗效,同时尿素可增加角质层含水量,两者配合,临床疗效更佳,而尿素易分解,故选用一些辅料组成油包水型软膏基质,有易洗除,对皮肤表面分泌物有亲和力,不妨碍皮肤功能,润滑作用好,久用无干燥感等特点。选用胆固醇等作乳化剂,稳定剂,二丁基羟基甲苯为抗氧剂,掺以其他辅料组成一个稳定的油包水型的软膏基质。
该乳酸软膏配方是:(重量配比)
乳酸        5-15%,        浓氨水        适量(达到PH4.5-5.5),
尿素        8-12%,        胆固醇        3-5%,
单硬脂酸甘油酯        10-15%,    白凡士林        30-40%,
甘油        8-12%,    油酸        2-4%,
对羟基苯甲酸乙酯        0.01-0.05%,
聚氧乙烯(40)单硬脂酸酯        0.6-1.0%,
二丁基羟基甲苯        0.005-0.05%,
蒸馏水        加至100%。
工艺流程见附图。
本发明的主要优点:本药品处方设计合理,制剂工艺成熟,拟定的质量标准能控制产品质量,经留样观察24个月产品稳定,经动物皮肤毒性试验,刺激性试验及过敏性试验,未见皮肤毒性,刺激性及致敏反应。成品PH值4.5-5.5。临床采用随机双盲研究195例中度和重度皮肤干燥症患者治疗两周,疗效肯定。其中治疗组100例,有效率93%,软膏基质组(对照组1)50例,有效率36%;10%尿素霜组(对照组2)46例,有效率71%。检验具有显著性差异,特别是冬季皮肤、手、足干燥皲裂有特效。故本品是一种治疗皮肤干燥症安全有效的制剂。预期可望有较好的社会效益和经济效益。
附图1    乳酸软膏工艺流程。
实施例:乳酸    100克
浓氨水    适量(达到PH值为4.5)
尿素    100克
胆固醇    30克
单硬脂酸甘油酯    70克
白凡士林    320克
油酸    20克
聚氧乙烯(40)单硬脂酸酯    8克
甘油    100克
对羟基苯甲酸乙酯    1克
蒸馏水    加至1000克

Claims (2)

1、一种治疗鱼鳞病及皮肤干燥症的外用药,乳酸软膏其特征是:以乳酸为主药,加适量氨水使成盐,尿素为助渗剂,胆固醇为乳化剂,稳定剂,二丁基羟基甲苯为抗氧剂,掺以其他辅料组成一个稳定的油包水型软膏基质复方制剂。
2、按权利要求1所说的乳酸软膏其特征是:所述制剂中含乳酸5-15%,浓氨水(调节PH值为4.5-5.5),尿素8-12%,胆固醇3-5%,单硬脂酸甘油酯10-15%,白凡士林30-40%,聚氧乙烯(40)单硬脂酸酯0.6-1.0%,甘油8-12%,对羟基苯甲酸乙酯0.05-0.2%,二丁基羟基甲苯0.005-0.05%,蒸馏水加至100%。
CN94111688A 1994-03-23 1994-03-23 乳酸软膏 Expired - Fee Related CN1063631C (zh)

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CN94111688A CN1063631C (zh) 1994-03-23 1994-03-23 乳酸软膏

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CN94111688A CN1063631C (zh) 1994-03-23 1994-03-23 乳酸软膏

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CN1108940A true CN1108940A (zh) 1995-09-27
CN1063631C CN1063631C (zh) 2001-03-28

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1058866C (zh) * 1996-09-23 2000-11-29 牛德英 一种治疗鳞屑、角化型手足癣、甲癣的药物组合物
CN102657601A (zh) * 2012-05-18 2012-09-12 乔风敏 一种主治鱼鳞病和皮肤干燥症的外用药配方和工艺
CN105832657A (zh) * 2016-05-27 2016-08-10 湖北丽益医药科技有限公司 一种复方乳酸乳膏、制备方法及应用

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1063820A (zh) * 1991-01-30 1992-08-26 樊芝芹 灰指甲溶解膏的制造方法
CN1069651A (zh) * 1991-12-09 1993-03-10 贺建龙 速效伤口愈的生产方法

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1058866C (zh) * 1996-09-23 2000-11-29 牛德英 一种治疗鳞屑、角化型手足癣、甲癣的药物组合物
CN102657601A (zh) * 2012-05-18 2012-09-12 乔风敏 一种主治鱼鳞病和皮肤干燥症的外用药配方和工艺
CN105832657A (zh) * 2016-05-27 2016-08-10 湖北丽益医药科技有限公司 一种复方乳酸乳膏、制备方法及应用

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