清宣止咳颗粒(Qingxuan Zhike Granules) - 在研适应症：咳嗽_专利_临床

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

非在研机构-

最高研发阶段批准上市

首次获批日期

中国 (2020-07-28),

咳嗽

最高研发阶段(中国)批准上市

特殊审评-

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关联

2

项与清宣止咳颗粒相关的临床试验

ChiCTR2300070500 / Suspended临床4期IIT

A randomized controlled clinical trial on the efficacy and safety of Qingxuan Zhike Granule combined with oseltamivir phosphate granules in the treatment of children with influenza (wind heat invading the lung syndrome)

开始日期2023-04-28

申办/合作机构

云南省中医医院

CTR20130346 / Completed临床2期

清宣止咳颗粒与安慰剂对照治疗急性气管-支气管炎，评价其有效性和安全性的多中心临床研究。

1.初步评价清宣止咳颗粒对急性气管-支气管炎的止咳作用。 2.初步评价清宣止咳颗粒对外感咳嗽·风热犯肺证的改善作用。 3.探索清宣止咳颗粒治疗急性气管-支气管炎的合理剂量。 4.观察清宣止咳颗粒临床应用的安全性。

开始日期2014-08-29

申办/合作机构

苏中药业集团股份有限公司

100 项与清宣止咳颗粒相关的临床结果

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100 项与清宣止咳颗粒相关的转化医学

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100 项与清宣止咳颗粒相关的专利（医药）

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5

项与清宣止咳颗粒相关的文献（医药）

2024-06-01·Biomedical Chromatography

Integrated network pharmacology, molecular docking, and lipidomics to reveal the regulatory effect of Qingxuan Zhike granules on lipid metabolism in lipopolysaccharide‐induced acute lung injury

Article

作者: Feng, Lu ; Lin, Lili ; Shao, Hua ; Chen, Jiabin ; Shan, Jinjun ; Chen, Hui ; Ye, Jin ; Zhou, Yang ; Wang, Shouchuan

AbstractQingxuan Zhike granules (QXZKG), a traditional Chinese patent medication, has shown therapeutic potential against acute lung injury (ALI). However, the precise mechanism underlying its lung‐protective effects requires further investigation. In this study, integrated network pharmacology, molecular docking, and lipidomics were used to elucidate QXZKG's regulatory effect on lipid metabolism in lipopolysaccharide‐induced ALI. Animal experiments were conducted to substantiate the efficacy of QXZKG in reducing pro‐inflammatory cytokines and mitigating pulmonary pathology. Network pharmacology analysis identified 145 active compounds that directly targeted 119 primary targets of QXZKG against ALI. Gene Ontology function analysis emphasized the roles of lipid metabolism and mitogen‐activated protein kinase (MAPK) cascade as crucial biological processes. The MAPK1 protein exhibited promising affinities for naringenin, luteolin, and kaempferol. Lipidomic analysis revealed that 12 lipids showed significant restoration following QXZKG treatment (p < 0.05, FC >1.2 or <0.83). Specifically, DG 38:4, DG 40:7, PC O‐40:8, TG 18:1_18:3_22:6, PI 18:2_20:4, FA 16:3, FA 20:3, FA 20:4, FA 22:5, and FA 24:5 were downregulated, while Cer 18:0;2O/24:0 and SM 36:1;2O/34:5 were upregulated in the QXZKG versus model groups. This study enhances our understanding of the active compounds and targets of QXZKG, as well as the potential of lipid metabolism in the treatment of ALI.

2023-12-01·Phytomedicine

Effectiveness and safety of Xingbei Zhike granules in patients with postinfectious cough: A multicenter, randomized, double-blinded, placebo-controlled trial

Article

作者: Xue, Hanrong ; Yu, Changli ; Wu, Zhenhu ; Zhao, Zhiying ; Zhen, Hui ; Han, Yun ; Guo, Xin ; Gu, Dongwei ; Lin, Lin ; Li, Suyun ; Chen, Yuanbin ; Fan, Feiting ; Chen, Hongping ; Zhou, Mingjuan ; Liu, Lei ; Ma, Xiao ; Zhao, Xianping ; Xiao, Jingmin ; Pang, Jianguo ; Wu, Lei ; Chi, Yihe ; Wang, Jincheng ; Wang, Guangen ; Wang, Yaoyong ; Guo, Dongwei ; Ding, Junping

BACKGROUNDPostinfectious cough (PIC) is a common symptom following a respiratory tract infection. Xingbei Zhike (XBZK) granules, a Chinese patent medicine, has been widely used for PIC in clinics. However, there is a lack of evidence on the effectiveness.PURPOSETo investigate whether treatment with XBZK granules is effective for PIC.STUDY DESIGNA multicenter, randomized, double-blinded, placebo-controlled trial.METHODSEligible participants from fourteen hospitals were randomly assigned in 3:1 ratio to receive either XBZK granules or placebo for 14 days. The primary outcome was the area under the curve (AUC) of a visual analogue scale (VAS) for cough symptoms. Secondary outcomes included cough symptom score (CSS), time and probability of recovery from cough, traditional Chinese medicine (TCM) syndrome score, relief rates of individual symptoms, Leicester Cough Questionnaire (LCQ) score, and the use of reliever drug.RESULTSA total of 235 patients (176 in XBZK and 59 in placebo groups) were included in the analysis. The AUC for cough VAS scores was lower in the XBZK than placebo group (-8.10, 95 % CI -14.12 to -2.07, p = 0.009), indicating superiority. XBZK decreased CSS (-0.68 points, 95 % CI -1.13 to -0.22, p = 0.01), shortened time to cough recovery (-2 days, hazard ratio [HR] 1.48, 95 % CI 1.03 to 2.13, p = 0.02), enhanced the probability of cough recovery (risk ratio [RR] 1.66, 95 % CI 1.07 to 2.58, p = 0.03), lowered TCM syndrome score (-0.99 points, 95 % CI -1.58 to -0.40, p = 0.004), increased the rate of daytime (RR 1.84, 95 % CI 1.07 to 3.15, p = 0.02) and nighttime (RR 2.07, 95 % CI 1.29 to 3.35, p = 0.004) cough recovery, and reduced the viscosity of sputum (RR 2.92, 95 % CI 1.66 to 5.13, p < 0.001) compared to placebo. There were no significant differences in LCQ scores and taking reliever drugs between groups. No severe adverse events were reported in either group.CONCLUSIONSXBZK granules are a promising therapy against PIC, effective in lowering the overall severity of cough, shortening the time to cough recovery, and reducing the viscosity of sputum.

2022-12-01·Biomedical Chromatography

Determination of six core components from Mahuang Xuanfei Zhike syrup in rat plasma and tissues by UPLC–MS/MS: Application to a pharmacokinetics and tissue distribution study

Article

作者: Yang, Yang ; He, Na ; Mei, Quan‐xi ; Yao, Chang‐liang ; Feng, Guang‐jun ; Chen, Qin‐hua ; Guo, De‐an ; Zhu, Jing ; Yang, Guang‐yi

AbstractMahuang Xuanfei Zhike (MXZ) syrup, a Chinese patent medicine, has been widely used in the clinical treatment of cough. However, there is no reported method for the quantitative analysis of the effective components of MXZ syrup in biological samples. In this study, the effective components of MXZ syrup were screened by network pharmacology and molecular docking technology. A sensitive and rapid ultra‐performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS) method was established to test the active components of MXZ syrup in rat plasma and tissue homogenates, including ephedrine, amygdalin, chlorogenic acid, harpagoside, forsythin and forsythoside A. Chromatographic separation was performed on a Waters Acquity UPLC HSS T3 column (2.1 × 50 mm, 1.8 μm) and the mass analysis was conducted using a Waters Xevo TQ mass spectrometer using multiple reaction positive and negative ion simultaneous monitoring mode. The results showed that the linearity ranged from 0.3 to 409.4 ng/ml. The extraction recoveries were all <8.33%, and the matrix effects were all <8.45, which met the requirements. The pharmacokinetic and tissue distribution results indicated that the main active components of MXZ syrup were absorbed quickly and eliminated slowly in vivo, and there may be a reabsorption process.

100 项与清宣止咳颗粒相关的药物交易

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