[Translation] A randomized, open-label, single-dose, fasting, two-formulation, two-sequence, two-period crossover bioequivalence study of epalrestat tablets in healthy adult Chinese subjects

主要研究目的：单次口服50mg（空腹）受试制剂依帕司他片T（规格：50mg/片，湖南千金湘江药业股份有限公司生产）与参比制剂依帕司他片R（KINEDAK®，规格：50mg/片，小野药品工业株式会社生产），观察两种制剂在受试者体内的药代动力学特征，评估空腹状态下分别口服两种制剂的生物等效性次要研究目的：观察受试制剂T和参比制剂R单次口服50mg（空腹）在中国成年健康受试者中的安全性。

[Translation]

Main study objectives: A single oral administration of 50 mg (fasting) of the test preparation epalrestat tablets T (specification: 50 mg/tablet, produced by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.) and the reference preparation epalrestat tablets R (KINEDAK®, specification: 50 mg/tablet, produced by Ono Pharmaceutical Co., Ltd.) was conducted to observe the pharmacokinetic characteristics of the two preparations in the subjects and to evaluate the bioequivalence of the two preparations when taken orally in the fasting state Secondary study objectives: Observe the safety of a single oral administration of 50 mg (fasting) of the test preparation T and the reference preparation R in healthy adult Chinese subjects.

Start Date10 Sep 2024

Sponsor / Collaborator

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

CTR20242419 / Active, not recruitingNot Applicable

苯磺酸左氨氯地平片在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of levamlodipine besylate tablets in healthy Chinese subjects: two-formulation, two-sequence, two-period, crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂苯磺酸左氨氯地平片（规格：5mg（按左氨氯地平计）；生产企业：湖南千金湘江药业股份有限公司）和参比制剂苯磺酸氨氯地平片（商品名：络活喜®；规格：10mg；持证商和生产企业：辉瑞制药有限公司）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂苯磺酸左氨氯地平片和参比制剂苯磺酸氨氯地平片（络活喜®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation levamlodipine besylate tablets (specification: 5 mg (calculated as levamlodipine); manufacturer: Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.) and the reference preparation amlodipine besylate tablets (trade name: Norvasc®; specification: 10 mg; licensee and manufacturer: Pfizer Pharmaceuticals Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation levamlodipine besylate tablets and the reference preparation amlodipine besylate tablets (Norvasc®) in healthy Chinese subjects.

Start Date06 Aug 2024

Sponsor / Collaborator

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

CTR20241886 / CompletedNot Applicable

达格列净片（10mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of dapagliflozin tablets (10 mg) in healthy Chinese subjects under fasting and fed conditions

主要研究目的：选择AstraZeneca AB为持证商的达格列净片（商品名：安达唐®（FORXIGA®），规格：10mg）为参比制剂，对湖南千金湘江药业股份有限公司持证的受试制剂达格列净片（规格：10mg）进行空腹和餐后条件下给药的人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂达格列净片（规格：10mg）和参比制剂达格列净片（商品名：安达唐®（FORXIGA®），规格：10mg）的安全性。

[Translation]

Main research purpose: To select Dapagliflozin Tablets (trade name: FORXIGA®, specification: 10 mg) licensed by AstraZeneca AB as the reference preparation, and conduct human bioequivalence test of Dapagliflozin Tablets (specification: 10 mg) licensed by Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd. under fasting and postprandial conditions, to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Dapagliflozin Tablets (specification: 10 mg) and the reference preparation Dapagliflozin Tablets (trade name: FORXIGA®, specification: 10 mg) in healthy subjects.

Start Date02 Jul 2024

Sponsor / Collaborator

Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhuzhou Qianjin Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Zhuzhou Qianjin Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Zhuzhou Qianjin Pharmaceutical Co., Ltd.

01 Jul 2024·Journal of Ethnopharmacology

Exploring the therapeutic potential of tonic Chinese herbal medicine for gynecological disorders: An updated review

Review

Author: Jiang, Mingli ; Wu, Mengyao ; Li, Wei ; Zou, Liang ; He, Qizhi ; Hu, Yingfan ; Lin, Jie ; Zhang, Yan ; Wan, Shun ; Zhang, Lele

ETHNOPHARMACOLOGICAL RELEVANCEGynecological disorders have the characteristics of high incidence and recurrence rate, which sorely affects female's health. Since ancient times, traditional Chinese medicine (TCM), especially tonic medicine (TM), has been used to deal with gynecological disorders and has unique advantages in effectiveness and safety.AIM OF THE REVIEWIn this article, we aim to summarize the research progress of TMs in-vivo and in-vitro, including their formulas, single herbs, and compounds, for gynecological disorders treatment in recent years, and to offer a reference for further research on the treatment of gynecological disorders and their clinical application in the treatment of TMs.MATERIALS AND METHODSRelevant information on the therapeutic potential of TMs against gynecological disorders was collected from several scientific databases including Web of Science, PubMed, CNKI, Google Scholar and other literature sources.RESULTSSo far, there are 46 different formulas, 3 single herbs, and 24 compounds used in the treatment of various gynecological disorders such as premature ovarian failure, endometriosis breast cancer, and so on. Many experimental results have shown that TMs can regulate apoptosis, invasion, migration, oxidative stress, and the immune system. In addition, the effect of TMs in gynecological disorders treatment may be due to the regulation of VEGF, PI3K-AKT, MAPK, NF-κB, and other signaling pathways. Apparently, TMs play an active role in the treatment of gynecological disorders by regulating these signaling pathways.CONCLUSIONTMs have a curative effect on the prevention and treatment of gynecological disorders. It could relieve and treat gynecological disorders through a variety of pathways. Therefore, the appropriate TM treatment program makes it more possible to treat gynecological disorders.

01 Jun 2024·Journal of Pharmaceutical and Biomedical Analysis

Pharmacokinetic and tissue distribution analysis of bioactive compounds from Fuke Qianjin capsules in rats by a validated UPLC MS/MS method

Article

Author: Zhang, Peng ; Guo, Xiujie ; Wu, Mengyao ; Yang, Jiaying ; Gong, Yun ; Wang, Chaoran ; Zheng, Yuanqing ; Wang, Wei

Fuke Qianjin capsules (FKQJ) exhibit obvious advantages and characteristics in the treatment of pelvic inflammatory disease. At present, information regarding the in vivo process of FKQJ is lacking, which has become a bottleneck in further determining the therapeutic effect of this traditional Chinese medicine. In the present study, a sensitive, simple and reliable method was developed and validated for the simultaneous quantification of 12 main components (4 flavonoids, 4 alkaloids, 2 phthalides and 2 diterpene lactones) in plasma and seven tissues of rats to study the pharmacokinetic and distribution characteristics of these components in vivo by using ultra performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for the first time. Plasma and tissue were prepared by protein precipitation with acetonitrile and methanol, followed by its separation on a Waters Acquity UPLC BEH C₁₈ column. The quantification was performed via multiple reaction monitoring (MRM) by a triple quadrupole mass spectrometer under positive electrospray ionization (ESI) mode. The method was validated to demonstrate its selectivity, linearity, accuracy, precision, recovery, matrix effect and stability. For 12 analytes, the low limit of quantification (LLOQs) reached 0.005-2.44 ng/mL, and all calibration curves showed good linearity (r² ≥ 0.990) in linear ranges. The intra-day and inter-day precision (relative standard deviation) for all analytes was less than 14.96%, and the accuracies were in the range of 85.29%-114.97%. Extraction recoveries and matrix effects of analytes were acceptable. The pharmacokinetic results showed that the main components could be absorbed quickly, had a short residence time, and were eliminated quickly in vivo. At different time points, the 12 components were widely distributed with uneven characteristics in the body, which tended to be distributed in the liver, kidney and lung and to a lesser extent in the uterus, brain and heart. The pharmacokinetic process and tissue distribution characteristics of FKQJ were expounded in this study, which can provide a scientific theory for in-depth development of FKQJ and guide FKQJ use in the clinic.

01 Dec 2023·Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy

A NIR ratiometric fluorescence probe for rapid, sensitive detection and bioimaging of hypochlorous acid

Article

Author: Qin, Xin ; Liu, Xiu ; Lei, Jieni ; Zhou, Yi ; Li, Yaqian ; Yang, Zi ; Li, Guangyi

Hypochlorous acid (HClO) is a condition where there is not enough oxygen in body tissues due to an imbalance between oxygen supply and consumption for cellular functions. In order to comprehend the biological functions of HClO within cells, the development of an effective and selective detection method is of great crucial. In this paper, a near-infrared ratiometric fluorescent probe (YQ-1) for detecting HClO was exploited based on a benzothiazole derivative. YQ-1's fluorescence shifted from red to green with a large blue shift (165 nm) in the presence of HClO, and the solution's color changed from pink to yellow. YQ-1 quickly detected HClO (within 40 s) with a low detection limit (4.47 × 10^-7 mol/L) and was not affected by other interferences. The mechanism of YQ-1's response to HClO was confirmed by HRMS, ¹H NMR and density functional theory (DFT) calculations. Moreover, due to its low toxicity, YQ-1 successfully utilized for fluorescence imaging for HClO both endogenous and exogenous in cells.

100 Deals associated with Zhuzhou Qianjin Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Zhuzhou Qianjin Pharmaceutical Co., Ltd.

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Fuke Qianjin Tablets	Uterine Cervicitis More	Approved
Fuke Qianjin Capsule	Endometritis More	Approved
Zolpidem Tartrate ( GABAA receptor )	Sleep Initiation and Maintenance Disorders More	Approved
Trepibutone	Cholecystitis More	Approved
Buxue Yimu Pill	Abdominal Pain More	Approved

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