更新于：2024-12-04

Betamethasone Dipropionate/Clotrimazole

倍他米松二丙酸酯/克霉唑

更新于：2024-12-04

概要

概要

基本信息

药物类型

小分子化药

别名

Betamethasone Dipropionate/Clotrimazole/Gentamycin Sulfate Cream、CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM、Clotrimazole and Betamethasone Dipropionate Lotion

+ [5]

靶点

CYP51A1 x GR

作用机制

CYP51A1抑制剂(细胞色素P450家族成员51抑制剂)、GR激动剂(糖皮质激素受体激动剂)

治疗领域

感染皮肤和肌肉骨骼疾病泌尿生殖系统疾病

在研适应症

甲沟炎癣头癣+ [3]

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段批准上市

首次获批日期

美国 (1984-07-10),

体癣股癣足癣

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C28H37FO7

InChIKeyCIWBQSYVNNPZIQ-XYWKZLDCSA-N

CAS号5593-20-4

查看全部结构式(2)

关联

项与倍他米松二丙酸酯/克霉唑相关的临床试验

IRCT20231017059753N1 / Recruiting临床3期IIT

Comparison of the effect of Hypericum perforutum Vaginal gel and Clotrimazole Vaginal cream on Vaginal Candida albicans infection: A double-blind randomized clinical trial

开始日期2023-11-22

申办/合作机构-

IRCT20221002056076N1 / Suspended临床3期IIT

Investigating and comparing the effects of jujube vaginal cream and Clotrimazole cream on vaginal Candidiasis in women of reproductive age

开始日期2023-08-23

申办/合作机构

Mashhad University of Medical Sciences

IRCT20230521058245N1 / Recruiting早期临床1期IIT

Determining and comparing the effect of Clotrimazole vaginal cream and Prongus Fluorase vaginal cream (Jashir plant) on candidal vulvovaginitis

开始日期2023-06-25

申办/合作机构-

100 项与倍他米松二丙酸酯/克霉唑相关的临床结果

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100 项与倍他米松二丙酸酯/克霉唑相关的转化医学

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100 项与倍他米松二丙酸酯/克霉唑相关的专利（医药）

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106

项与倍他米松二丙酸酯/克霉唑相关的文献（医药）

2024-11-05·Military medicine

Efficacy of 1% Clotrimazole Powder Monotherapy for Treating Tinea Cruris: A Comparative Randomized Study

Article

作者: Ongsri, Punyawee ; Bangchang, Nanchaya Na ; Pattanaprichakul, Penvadee ; Bunyaratavej, Sumanas ; Saengthong-Aram, Phuwakorn ; Leeyaphan, Charussri

ABSTRACT:

Introduction:

A rise in tinea cruris among Thai Naval Cadets has been observed. Clotrimazole powder has been shown to be effective as an adjunct treatment for tinea cruris; however, its efficacy as a monotherapy is limited.

Objectives:

The aim is to determine the efficacy of 1% clotrimazole cream versus 1% clotrimazole powder in treating tinea cruris.

Material and Methods:

A randomized trial was conducted at the Thai Naval Rating School, Chonburi, Thailand. Naval rating cadets with suspected tinea cruris were randomly assigned to one of two groups: 1% clotrimazole cream or 1% clotrimazole powder, and they were instructed to apply the related medication to the affected lesion twice daily for 4 weeks. Clinical and symptomatic evaluations were carried out at 4 and 8 weeks.

Results:

All 17 and 14 participants who received 1% clotrimazole cream and powder, respectively, were included. After 4 weeks, the clinical cure rates were 76.5% in the cream group and 85.7% in the powder group (P = .664). All participants were clinically cured within 8 weeks. The self-evaluation of itch severity using a visual analog scale (VAS) revealed no significant difference between the two groups (P = .343). The dermatology quality of life index decreased as clinical improvement was achieved in both the clotrimazole cream and powder groups (6.0 vs. 7.5 score reductions, respectively; P = .765). The score for sweat reduction was higher in the 1% clotrimazole powder group compared to the cream group (5.0 vs. 4.0, respectively; P = .006).

Conclusion:

Monotherapy with 1% clotrimazole powder showed comparable efficacy to 1% clotrimazole cream. Furthermore, the powder treatment reduced sweat more effectively compared to the cream.

2024-01-01·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

A comprehensively validated IVRT method reliably discriminates sameness and differences between several topical clotrimazole creams

Article

作者: Rath, Seeprarani ; Kanfer, Isadore ; Wellington, Hannah

In vitro release testing (IVRT) has gained increasing acceptance for use as a biowaiver for topical products intended for local action. Whereas the United States Food and Drug Administration (US FDA) has issued product specific guidances (PSGs) recommending IVRT for several products, the PSG for clotrimazole cream does not include an IVRT option. However, an important requirement to include supplemental selectivity in the validation process as described in the recent FDA draft guidance on IVRT studies for topical drug products has generally been conspicuously absent in the published literature describing the application of IVRT as a biowaiver. Supplemental selectivity involves the comparison of a reference product and altered formulations containing the same strength of the active pharmaceutical ingredient (API). In order to demonstrate supplemental selectivity, cream formulation containing the same API (clotrimazole), at the same strength (1 %) and in the same dosage form (cream) but manufactured using different excipients were used. This will help assess the impact that excipients may have on the release rate of clotrimazole and whether the method is capable of identifying differences in the microstructure and arrangement of matter (Q3) as an important performance parameter. In addition, products containing <30 % or >40 % clotrimazole to serve as negative controls were also included for the discriminatory power assessment. Hence, the primary objective was to develop and validate a simple, reliable, reproducible, and cost-effective in vitro technique in accordance with the recent draft FDA guidance to assess the "sameness" of topical creams containing 1 % clotrimazole. An in vitro release testing (IVRT) system was used and an IVRT method was developed and accordingly validated. The validated IVRT method showed the potential to accurately measure the release from 1 % clotrimazole creams and demonstrated supplemental selectivity and appropriate discriminatory power to identify "sameness" and/ or differences.

2023-11-01·Explore (New York, N.Y.)

The efficacy of complementary treatment with marshmallow (Althaea officinalis L.) on vulvovaginal candidiasis: A randomized double-blinded controlled clinical trial

Article

作者: Zareshahrabadi, Zahra ; Jaladat, Amir Mohammad ; Namjooyan, Foroogh ; Zomorodian, Kamiar ; Hashempur, Mohammad Hashem ; Amini, Fatemeh ; Shojaei, Kobra

BACKGROUND:

Vulvovaginal candidiasis is a common gynecologic infection, and recurring cases are yet incurable. This trial was based on Persian medicine to compare how effective marshmallow aqueous extract 4% plus clotrimazole 1% (CLOT-M) is compared to clotrimazole 1% vaginal creams on VVC.

METHODS:

This study randomly assigned 100 women with VVC into two groups. The target group (n = 50) was treated with CLOT-M while controls (n = 50) with clotrimazole vaginal creams for seven consecutive nights. Different VVC symptoms and signs, and yeast culture from vaginal discharge were evaluated as the outcome measures before the intervention and 7 and 30 days after.

RESULTS:

The efficacy of CLOT-M vaginal cream was assessed during the 1st and 2nd follow-ups, indicating a significant decrease in mean itching (P = 0.001 for both comparisons) and dyspareunia score (P = 0.001 and P = 0.04, respectively) as compared to treatment with clotrimazole vaginal cream. Moreover, after 7 days of the intervention, patients in the CLOT-M group experienced significant improvement in mean dysuria score compared to those in the control group (P = 0.001). Neither cream caused any significant adverse events.

CONCLUSION:

It seems that CLOT-M vaginal cream had a significant effect on the VVC symptoms improvement, without any significant side effects. However, larger sample-sized trials are needed for more evidence-based judgment.

项与倍他米松二丙酸酯/克霉唑相关的新闻（医药）

2023-05-06

·蒲公英Ouryao

参比制剂目录（第67批）正式发布！

‍‍‍‍转自：国家药监局编辑：wangxinglai20042023年05月06日，国家药监局发布了第67批次仿制药一致性评价参比制剂目录，其中新增品种50个、变更及增加持证商品种28个。通知原文经国家药品监督管理局仿制药质量和疗效一致性评价专家委员会审核确定，现发布仿制药参比制剂目录（第六十七批）。涉及品种：依托考昔片、苯磺酸氨氯地平口崩片、普瑞巴林缓释片、盐酸氨溴索口服溶液、吸入用一氧化氮、舒林酸片、头孢地尼干混悬剂、左乙拉西坦片、普瑞巴林口服溶液、复方奥美拉唑干混悬剂/奥美拉唑碳酸氢钠干混悬剂、非那雄胺片、二巯丁二酸胶囊、复方电解质注射液（Ⅴ）、克林霉素磷酸酯阴道凝胶、铜[64Cu]氧奥曲肽注射液、注射用亚锡二巯丁二钠、甘油磷酸钠注射液、复方克霉唑乳膏（Ⅱ）、黄素腺嘌呤二核苷酸钠糖浆、丙酸交沙霉素干糖浆剂、甘油灌肠剂、门冬氨酸钾镁注射液、来特莫韦片、来特莫韦注射液、氨吡啶缓释片、乌帕替尼缓释片、钆塞酸二钠注射液、黄体酮阴道缓释凝胶、盐酸布比卡因注射液、左卡尼汀口服溶液、碳酸氢钠血滤置换液（钾4mmol/L）、碳酸氢钠血滤置换液（钾4mmolL无钙）、酮咯酸氨丁三醇片、蔗糖铁注射液、头孢氨苄胶囊、注射用双羟萘酸曲普瑞林、枸橼酸莫沙必利片、度他雄胺软胶囊、复方聚乙二醇电解质散（儿童型）、碘[131I]苄胍注射液等；仿制药参比制剂目录（第67批）（扫描二维码下载附件）仿制药参比制剂目录（第67批）1.目录中所列尚未在国内上市品种的通用名、剂型等，以药典委核准的为准。2.参比制剂目录公示后，未正式发布的品种将进行专题研究，根据研究结果另行发布。3.欧盟上市的参比制剂包括其在英国上市的同一药品。4.选择未进口参比制剂开展仿制药研究除满足其质量要求外，还需满足现行版《中国药典》和相关指导原则要求。5.放射性药物不同于普通化学药物，具有一定的特殊性如放射性、时效性、按放射性活度给药等特点，参比制剂主要用于明确其研发目标和基本要求，可根据其药物特性同时结合参比制剂的可获得性进行研究。‍‍

一致性评价上市批准

2022-08-13

·CPhI制药在线

金笔奖 | 经皮给药制剂的产品开发进展

点击上方蓝字关注并星标我们经皮给药系统是在皮肤表面给药，通过皮肤以固定剂量和可调节速率递送药物，经毛细血管吸收进入体循环，产生全身或局部治疗作用的给药系统，是一种改良的药物递送系统。1979年，FDA批准了首个经皮给药贴片Transderm-Scop，用于预防晕车引起的恶心呕吐。此后，经皮给药系统因其独特的优势，成为继口服、注射后的第三大给药系统，在防治疾病上发挥着越来越重要的作用。相较于口服、注射等给药方式，经皮给药可以避免肝脏的首过效应和胃肠道的影响，维持恒定的有效血药浓度，给药方便，安全性高，患者顺应性好。近年来，经皮给药制剂有多种新产品上市，包括贴剂、凝胶剂、乳膏剂、软膏剂、泡沫剂、洗剂等剂型。 1.贴剂贴剂是原料药物与适宜的材料制成的供粘贴在皮肤上的可产生全身性或局部作用的一种薄片状制剂。贴剂可分为黏胶分散型、周边黏胶骨架型、储库型。目前国外已上市的贴剂有丁丙诺啡透皮贴剂（Butrans）、奥昔布宁透皮贴剂（Oxytrol）、利多卡因局部给药贴剂（Ztlido）等。以奥昔布宁透皮贴剂为例，它是单剂量独立包装，外观为长方形圆角形状，每贴面积为39cm2，含盐酸奥昔布宁36mg。每贴可使用3~4d。奥昔布宁属抗胆碱能类药物，可使过度活动的膀胱肌肉松弛，缓解患者的尿频、尿急和尿失禁等症状。奥昔布宁贴剂为尿失禁患者提供了一种新的选择。 2.凝胶剂凝胶剂是指药物与凝胶的辅料制成溶液、混悬或乳状型的稠厚液体或半固体制剂，具有膨胀性、脱水收缩性、触变性、黏合性的特点，还具有易涂展、舒适感、无油腻易洗除、保湿且促进药物透皮作用。目前国外已上市的凝胶剂有2%盐酸萘替芬凝胶（Naftin）、0.33%溴莫尼定局部凝胶（Mirvaso）等。其中Naftin凝胶是一种黄色凝胶，每克含有20mg盐酸萘替芬，该产品在趾间足癣部位及距健康皮肤边缘约1.27cm的部分涂上一层薄膜，每天1次，持续2周。目前，用于治疗足癣的药物有复方酮康唑乳膏、克霉唑倍他米松乳膏等，但都含有激素，长期用药可能引起皮质功能亢进症，因此不易长期使用。Naftin是一种属于烯丙胺类的抗真菌药，具有广谱抗真菌活性，毒性较低，临床研究表明，受试者被随机分配至Naftin凝胶组和安慰剂组，每天使用1次，持续2周，在治疗结束时，Naftin凝胶组和安慰剂组相比瘙痒明显改善且红斑和鳞屑也显著改善，其治疗效果和完全治愈率更明显。 3.乳膏剂乳膏剂是指药物溶解或分散于乳状型基质中形成的均匀半固体制剂。主要由水相、油相及乳化剂组成。该剂型具有油腻感小、稠度适宜、易于涂抹、易于清洗、易于经皮吸收的优点，目前国外已上市的乳膏剂有1%卢立康唑乳膏（Luzu）、1%伊维菌素乳膏（Soolantra）、1%盐酸羟甲唑啉乳膏（Rhofade）等。以Rhofade为例，它是一种白色乳膏，每克乳膏含有10mg（1%）盐酸羟甲唑啉。每天1次，薄膜状覆盖患部，2017年FDA批准盐酸羟甲唑啉乳膏上市用于治疗红斑痤疮，临床研究表明，该制剂每天使用1次，持续用药29d、364d，可改善中度至重度红斑痤疮的红斑症状，且安全、耐受性好。 4.软膏剂软膏剂是指药物与油脂性或水溶性基质均匀混合制成的半固体外用制剂，由药物、基质和附加剂组成，具有润滑皮肤、保护创面和局部治疗作用，广泛应用于皮肤科和外科疾病的治疗。目前国外已上市的软膏剂有1%瑞他莫林软膏（Altabax）、骨化三醇软膏（Vectical）、2%克立硼罗软膏（Eucrisa）等，以Eucrisa软膏为例，它是一种白色软膏，每克含有20mg的克立硼罗。使用时将Eucrisa软膏薄膜状涂于患处，每日2次。Eucrisa的活性成分克立硼罗是一种磷酸二酯酶4（PDE-4）抑制剂，是一种含硼的小分子抗炎药，在Eucrisa上市前，特应性皮炎的治疗药物为皮质类固醇和钙调神经磷酸酶抑制剂，其较强的全身反应限制了其应用。Eucrisa是FDA在过去十几年首次批准治疗特应性皮炎的新药，为特异性皮炎患者提供了一种重要的非类固醇替代疗法。 5.泡沫剂泡沫剂是指药物溶液与抛射剂共同装封于具有特制阀门系统的耐压容器中，使用时借助抛射剂的压力将内容物呈雾状喷出。该剂型具有速效、定位、方便、准确控制剂量、创面刺激性小的优点。目前国外已上市的泡沫剂有1%硝酸益康唑局部泡沫剂（Ecoza）、0.005%/0.064%卡泊三烯和倍他米松二丙酸酯泡沫剂（Enstilar）等。例如Enstilar泡沫剂是一种白色液体，给药时为白色泡沫，每克含50μg卡泊三烯和0.643mg倍他米松二丙酸酯。每天1次涂抹于皮肤患处，最多使用4周，用于局部治疗寻常型银屑病。Enstilar泡沫剂能够在全身大部分皮肤使用，为患者提供了一种便利且易于使用的剂型。 6.洗剂洗剂是含药物溶液、乳状液、混悬液，供清洗或涂抹无损伤皮肤的外用液体制剂。使用时，轻涂或用纱布蘸取本品敷于皮肤的疾患处，发挥消毒、消炎、止痒、收敛保护等局部作用。目前国外已上市的洗剂有0.05%卤倍他索丙酸酯洗剂（Ultravate）、0.01%/0.045%卤倍他索丙酸酯和他扎罗汀乳液洗剂（Duobrii）等。以Duobrii洗剂为例，它是一种白色液体，每克含有0.1mg（0.01%）卤倍他索丙酸酯（HP）和0.45mg（0.045%）他扎罗汀（TZA），使用时，将本品擦拭于患处，每天1次，用于成人斑块状银屑病的局部治疗。HP/TAZ是将2种药物合用，组合成一种具有双重作用机制的单一洗剂，前者是一类皮质类固醇，能结合皮质类固醇受体，起到抗炎症的作用，后者是一种维甲酸的前体药物，其已获批治疗痤疮和银屑病等皮肤疾病，具有见效快、安全性高、药效持久等优点。由于银屑病是一种慢性皮肤病，患者需要持续治疗以达到最佳效果，HP/TAZ解决了在治疗效果和治疗持久性方面银屑病患者的需求。经皮给药系统可以通过皮肤给药用于治疗局部或全身疾病，可以克服传统给药方式的弊端，目前已广泛应用于临床治疗，取得了一定的效果。经皮药物制剂递送的最大屏障是角质层，开发安全有效的方法和技术解决经皮吸收的屏障，使大分子药物（蛋白质、多肽等）、难溶性药物进行递送，是目前需要解决的问题。在未来可以将经皮给药制剂与微针技术相结合应用于临床中，开发出更安全、有效的产品用于疾病的诊断、预防和治疗。参考文献： [1]韩佳琦,刘哲鹏.经皮给药系统的研究进展[J].生物医学工程学进展,2022,43(01):24-28. [2]姚明杰,赵锋,马银玲,刘红星,杜青.上市新型经皮递药系统的研究进展[J].中国医院药学杂志,2020,40(12):1390-1395. 作者简介：沙罗，中药研发工作者，现就职于国内某大型药物研发公司，致力于中药新药的研究开发。智药研习社8月培训会报名来源：CPhI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPhI制药在线▼点击阅读原文，进入智药研习社~

免疫疗法小分子药物

100 项与倍他米松二丙酸酯/克霉唑相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	S01CA05 D07CC01 S03CA06	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
体癣	美国	Organon & Co.	1984-07-10
股癣	美国	Organon & Co.	1984-07-10
足癣	美国	Organon & Co.	1984-07-10
甲沟炎	中国	津药和平（天津）制药有限公司	-
癣	中国	津药和平（天津）制药有限公司	-
头癣	中国	津药和平（天津）制药有限公司	-
花斑癣	中国	津药和平（天津）制药有限公司	-
外阴阴道炎	中国	津药和平（天津）制药有限公司	-