[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-sequence, two-period crossover bioequivalence study of flunarizine hydrochloride capsules in healthy Chinese adult subjects

考察单次口服5mg（空腹/餐后）受试制剂盐酸氟桂利嗪胶囊（规格：5mg/粒，河南福森药业有限公司生产）与参比制剂盐酸氟桂利嗪胶囊（西比灵，规格：5mg/粒，西安杨森制药有限责任公司生产），在中国成年健康受试者体内的药代动力学特征，评价空腹与餐后状态分别口服两种制剂的生物等效性。

[Translation]

The pharmacokinetic characteristics of a single oral dose of 5 mg (fasting/fed) of the test preparation Flunarizine Hydrochloride Capsules (Specification: 5 mg/capsule, produced by Henan Fusen Pharmaceutical Co., Ltd.) and the reference preparation Flunarizine Hydrochloride Capsules (Sibelium, Specification: 5 mg/capsule, produced by Xi'an Janssen Pharmaceutical Co., Ltd.) in healthy adult Chinese subjects were investigated, and the bioequivalence of the two preparations when taken orally in the fasting and fed states was evaluated.

Start Date26 Feb 2021

Sponsor / Collaborator

He Nan Fu Sen Yao Ye You Xian Gong Si

CTR20190054 / Completed

盐酸二甲双胍缓释片在健康受试者中随机开放单剂量两制剂两序列两周期交叉空腹/餐后状态下的生物等效性试验

[Translation] A randomized open-label single-dose bioequivalence study of metformin hydrochloride extended-release tablets in healthy subjects with two formulations, two sequences, and two periods in a crossover fasting/fed state

健康受试者空腹/餐后状态下，口服单剂量盐酸二甲双胍缓释片与盐酸二甲双胍缓释片（GLUCOPHAGE XR ®）后，考察空腹/餐后条件下受试制剂与参比制剂在人体内的吸收速度和吸收程度，评价受试制剂与参比制剂是否具有生物等效性。研究次要研究目的：观察受试制剂盐酸二甲双胍缓释片和参比制剂盐酸二甲双胍缓释片（GLUCOPHAGE XR ®）在健康受试者中的安全性。

[Translation]

After a single oral dose of metformin hydrochloride extended-release tablets and metformin hydrochloride extended-release tablets (GLUCOPHAGE XR ®) was administered to healthy subjects in the fasting/postprandial state, the absorption rate and extent of the test preparation and the reference preparation in the human body were investigated to evaluate whether the test preparation and the reference preparation were bioequivalent. Secondary study objectives: To observe the safety of the test preparation metformin hydrochloride extended-release tablets and the reference preparation metformin hydrochloride extended-release tablets (GLUCOPHAGE XR ®) in healthy subjects.

Start Date11 Jan 2019

Sponsor / Collaborator

He Nan Fu Sen Yao Ye You Xian Gong Si

100 Clinical Results associated with He Nan Fu Sen Yao Ye You Xian Gong Si

0 Patents (Medical) associated with He Nan Fu Sen Yao Ye You Xian Gong Si

Literatures (Medical) associated with He Nan Fu Sen Yao Ye You Xian Gong Si

01 Sep 2024·Journal of Ethnopharmacology

Omics-based pharmacological evaluation reveals Yuanhu Zhitong oral liquid ameliorates arthritis by regulating PKC/ERK/NF-κB signaling pathway

Article

Author: Guan, Jianli ; Cao, Zhiming ; Chen, Chengyu ; Fan, Guanwei ; Zhang, Kai ; Chen, Feng ; Yin, Zhaorui ; Wang, Yi

ETHNOPHARMACOLOGICAL RELEVANCESuccessful use of herbal medicine in the treatment of rheumatoid arthritis (RA) creates opportunities for alternative therapies. Yuanhu Zhitong oral liquid (YZOL) is an herbal preparation known for its potent analgesic and anti-inflammatory properties in traditional use. However, the pharmacological mechanism of YZOL for treating RA remains unclear.AIM OF THE STUDYThe aim of this study was to evaluate the efficacy of YZOL in the treatment of RA and to explore its potential mechanisms through omics analysis.MATERIALS AND METHODSType II collagen was used to induce an arthritis rat model. The effects of YZOL on paw swelling, inflammatory cytokines, oxidative stress, and histopathological changes were systematically investigated. A pathway-driven transcriptomic analysis was performed to identify key signaling pathways associated with YZOL therapy. The key alterations were validated by qRT-PCR, Western blot, and immunohistochemistry assays.RESULTSYZOL significantly attenuated arthritis progression, reduced paw swelling rate, and lowered arthritis score in CIA rats. YZOL also inhibited systemic inflammation and associated oxidative stress during RA. Transcriptomic analysis identified 341 genes with significantly altered expression following YZOL treatment. These genes were enriched in inflammation-related pathways, particularly in the NF-κB and MAPK signaling pathways. In addition, we discovered that YZOL can alleviate inflammation in the local synovial tissue. The effect of YZOL was confirmed by the suppression of PKC/ERK/NF-κB p65 signaling at systemic and local levels.CONCLUSIONSThis study provides novel evidence that YZOL treatment ameliorates RA by suppressing the PKC/ERK/NF-κB pathway, suggesting its potential as an alternative therapy for RA.

01 Sep 2024·Journal of Ethnopharmacology

Exploration on pharmacological mechanisms of YZP against neuropathic pain via inhibiting spinal inflammation and the rationality of its compatibility

Article

Author: Zhai, Baorong ; Cao, Zhiming ; Su, Jin ; Zhao, Chunhui ; Xu, Haiyu ; Yang, Hongjun ; Wu, Dan ; Wang, Ping ; Chen, Chengyu ; Li, Weijie ; Song, Naining ; Zhang, Yanqiong ; Guan, Jianli

ETHNOPHARMACOLOGICAL RELEVANCEYuanhu Zhitong Prescription (YZP) is a well-known traditional Chinese medicine (TCM) formula for neuropathic pain (NP) therapy with a satisfying clinical efficacy. However, the underlying pharmacological mechanism and its compatibility principle remain unclear.AIM OF THE STUDYThis study aims to investigate the analgesic and compatibility mechanisms of YZP on neuropathic pain (NP) at the gene and biological process levels.MATERIALS AND METHODSThe chronic constriction injury (CCI) rats were intragastrically administrated with extracts of YZP, YH and BZ separately, and then mechanical hypersensitivity were measured to evaluate the analgesic effects between YH and BZ before and after compatibility. Then, RNA-seq and bioinformatics analyses were performed to elucidate the potential mechanisms underlying YZP's analgesia and compatibility. Finally, the expression levels and significant differences of key genes were analyzed.RESULTSBehaviorally, both YZP and YH effectively alleviated mechanical allodynia in CCI rats, with YZP being superior to YH. In contrast, we did not observe an analgesic effect of BZ. Genetically, YZP, YH, and BZ reversed the expression levels of 52, 34, and 42 aberrant genes in the spinal cord of CCI rats, respectively. Mechanically, YZP was revealed to alleviate NP mainly by modulating the inflammatory response and neuropeptide signaling pathway, which are the dominant effective processes of YH. Interestingly, the effective targets of YZP were especially enriched in leukocyte activation and cytokine-mediated signaling pathways. Moreover, BZ was found to exert an adjunctive effect in enhancing the analgesic effect of YH by promoting skeletal muscle tissue regeneration and modulating calcium ion transport.CONCLUSIONSYH, as the monarch drug, plays a dominant role in the analgesic effect of YZP that effectively relieves NP by inhibiting the spinal inflammation and neuropeptide signaling pathway. BZ, as the minister drug, not only synergistically enhances analgesic processes of YH but also helps to alleviate the accompanying symptoms of NP. Consequently, YZP exerted a more potent analgesic effect than YH and BZ alone. In conclusion, our findings offer new insights into understanding the pharmacological mechanism and compatibility principle of YZP, which may support its clinical application in NP therapy.

01 Feb 2024·Journal of Pharmaceutical and Biomedical Analysis

Establishing an integrated, four-dimensional quality assessment system for traditional Chinese medicine: A case study of Shuanghuanglian oral liquid

Article

Author: Sun, GuoXiang ; Cao, Zhiming ; Sun, Wanyang ; He, Rongrong ; Fan, Jiajia ; Wang, Xinyi ; Wang, Pengyue ; Li, Yifang ; Lan, Lili ; Dai, Huiqing ; Gao, Jin ; Chen, Chengyu

The quality of traditional Chinese medicine (TCM) is the premise to ensure its safety and effectiveness in clinical application. In this study, a complete quality control system for four-dimensional fingerprinting of TCM was innovatively constructed based on multiple detection techniques, and the quality of Shuanghuanglian oral liquid (SHL) was evaluated. Electrochemical fingerprinting (ECFP) as an emerging method without pretreatment provides rich and quantifiable information for SHL samples. The first quantitative ECFP of SHL was developed by the B-Z oscillation system. Eight characteristic parameters were analyzed and a good linear relationship was found between the oscillation lifetime and sample volume, by which the calculated values of the added sample volume (VL) showed different fluctuations between samples. What is more, high-performance liquid chromatography five-wavelength fusion fingerprint (HPLC-FWFP), GC fingerprint (GC-FP), and UV quantum fingerprint (UV-QFP) was established. Meanwhile, the purity of the peaks of the HPLC-FWFP was verified by the dual-wavelength absorption coefficient ratio spectrum (DWAR). Equal weighted ratio quantitative fingerprinting method (EWRQFM) was successfully proposed to extract all potential features for the overall quality assessment of the samples. Finally, a comprehensive evaluation strategy was proposed, namely the variation coefficient weighting algorithm (VCWA). The results of qualitative and quantitative evaluation of HPLC-FWFP, GC-FP, electrochemical quantum fingerprints (EC-QFP), and UV-QFP were integrated by this method. The established evaluation system is also a suitable strategy to control the quality of other TCM preparations.

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