更新于：2024-11-01

Zhike Cataplasm

止咳巴布贴膏

更新于：2024-11-01

概要

概要

基本信息

药物类型

中药

别名-

靶点-

作用机制-

治疗领域-

在研适应症-

非在研适应症-

原研机构-

在研机构

南通华夏中医药科技开发有限公司

南京中医药大学

非在研机构-

最高研发阶段临床3期

首次获批日期-

最高研发阶段(中国)临床3期

特殊审评-

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关联

项与止咳巴布贴膏相关的临床试验

CTR20132007 / Recruiting临床3期

止咳巴布贴膏治疗急性气管-支气管炎的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验

1.进一步观察止咳巴布贴膏的安全性及不良反应。 2.进一步评价止咳巴布贴膏治疗急性气管-支气管炎（表寒肺热证）的临床疗效。

开始日期2012-12-31

申办/合作机构

南通华夏中医药科技开发有限公司

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100 项与止咳巴布贴膏相关的临床结果

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100 项与止咳巴布贴膏相关的转化医学

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100 项与止咳巴布贴膏相关的专利（医药）

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项与止咳巴布贴膏相关的文献（医药）

2023-05-04·Pharmaceutics

Topical Delivery of Ketorolac Tromethamine via Cataplasm for Inflammatory Pain Therapy.

Article

作者: Wen, Qiang ; Yan, Peng ; Hou, Zhiyuan ; Ding, Jinsong ; Zhang, Hailong ; Zhou, Wenhu

Nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely used in the treatment of inflammatory pain, such as in osteoarthritis. Ketorolac tromethamine is considered to be an NSAID with strong anti-inflammatory and analgesic potency, however, traditional applications, such as oral administration and injections, often induce high systemic exposure, leading to adverse events such as gastric ulceration and bleeding. To address this key limitation, herein we designed and fabricated a topical delivery system for ketorolac tromethamine via cataplasm, which is based on a three-dimensional mesh structure formed by the cross-linking of dihydroxyaluminum aminoacetate (DAAA) and sodium polyacrylate. The viscoelasticity of the cataplasm was characterized by rheological methods and exhibited a "gel-like" elastic property. The release behavior showed a Higuchi model characteristic with a dose dependence. To enhance the skin permeation, permeation enhancers were added and screened utilizing ex vivo pig skin, in which 1,2-propanediol was found to have the optimal permeation-promoting effect. The cataplasm was further applied to a rat carrageenan-induced inflammatory pain model, which showed comparable anti-inflammatory and analgesic effects with oral administration. Finally, the biosafety of the cataplasm was tested in healthy human volunteers, and reduced side effects were achieved as compared to the tablet formulation, which can be ascribed to less systemic drug exposure and lower blood drug concentrations. Therefore, the constructed cataplasm can reduce the risk of adverse events while maintaining efficacy, thus serving as a better alternative for the treatment of inflammatory pain, including osteoarthritis.

2023-04-01·Biomedical Chromatography

QbD‐based stability‐indicating liquid chromatography (RP‐HPLC) method for the determination of flurbiprofen in cataplasm

Article

作者: Nathi, Rathnakar ; Konduru, Naresh ; Kowtharapu, Leela Prasad ; Muchakayala, Siva Krishna

AbstractA nonsteroidal drug called flurbiprofen (FBN) has analgesic, anti‐inflammatory and antipyretic activity. Currently the determination of FBN in cataplasm does not have any pharmacopeial method. However, the drug substance, tablet and ophthalmic solution formulations do have pharmacopeial methods. The development and validation of an accurate, precise and stability‐indicating analytical method for the determination of FBN in cataplasm formulations is reported. The gradient method was employed for the quantification of FBN in the presence of internal standards such as biphenyl. A nonpolar separation phase (C18, 250 × 4.6 mm, 5 μm Inertsil column; GL Sciences) was used. The optimal flow rate, column oven temperature, injection volume and detector wavelengths were 1.0 ml/min, 40°C, 20 μl and 245 nm, respectively. Mobile phase A was a mixture of water and glacial acetic acid (30:1 v/v) pH adjusted to 2.20 with glacial acetic acid or 1 m NaOH; mobile phase B was methanol (100%). The gradient elution program was [time (min)/% B]: 5/60, 20/70, 25/70, 30/60 and 40/60. The obtained RSDs for the precision and intermediate precision were 0.7 and 0.5%. The percentage recovery ranged from 99.2 to 100.4%. The linear regression coefficient >0.9996 indicates that all peak responses were linear with the concentration. The sample and standard solutions were stable for up to 24 h on the benchtop and in the refrigerator. The critical peaks were well separated from the generated peaks owing to forced degradation, including diluent and placebo peaks. The method validation data and quality by design‐based robustness study results indicate that the developed method is robust and fit for routine use in the quality control laboratory. The proposed method is specific, accurate and precise, and the quality by design utilized the first method for the determination of FBN in cataplasm formulations. Transdermal patches and gels have low extraction capacity and this method is applicable for quantification.

2021-11-26·Pharmaceutical Development and Technology4区 · 医学

Improved transdermal permeability of tanshinone IIA from cataplasms by loading onto nanocrystals and porous silica

4区 · 医学

Article

作者: Chen, Jing ; Niu, Yang ; Guo, Jueshuo ; Mai, Yaping ; Yang, Jianhong ; Zhao, Qipeng ; Gu, Xiangshuai

Novel transdermal cataplasms have been designed to improve permeability of poorly soluble drugs by different pretreatments. Nanocrystal and porous silica solid dispersions were loaded with Tanshinone IIA and incorporated into a cross-linked hydrogel matrix of cataplasm. It was shown that the small particle size and improved dissolution would increase dermal bioavailability. The adhesion, rheological properties, drug release, skin permeation, skin deposition and in vivo skin absorption of the different formulations were investigated. In an in vitro experiment using mouse skin, cumulative amount of drug permeated within 24 h was 7.32 ± 0.98 μg/cm² from conventional cataplasm, 13.14 ± 0.70 μg/cm² from nanocrystal-loaded cataplasm and 11.40 ± 0.13 μg/cm² from porous silica solid dispersion-loaded cataplasm. In vitro dissolution profiles showed that drug release was 76.5% and 74.9% from two optimized cataplasms within 24 h, while conventional cataplasm was 55.0%. The cross-linking characteristics of the cataplasms were preserved after incorporation of different drug forms, while the elastic and viscous behaviors of the hydrogel layers increased. In vivo evaluation by CLSM showed the more favorable skin permeation for two optimized cataplasms. These findings suggest that applications of nanocrystal and porous silica systems on cataplasms enable effective transdermal delivery of poorly soluble drugs. The resulting drug delivery and rheological properties are desirable for transdermal application.AbbreviationAll the abbreviations that appear in this article are shown in Table 1.

100 项与止咳巴布贴膏相关的药物交易

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