主要目的：以持证商为Otsuka Pharmaceutical Co Ltd的布瑞哌唑片（商品名：Rexulti，规格：2mg）为参比制剂，以马应龙药业集团股份有限公司研发的布瑞哌唑片（规格：2mg）为受试制剂，通过单中心、随机、开放、单次给药、两制剂、两周期、两序列、交叉设计的临床试验来评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：观察受试制剂和参比制剂在中国健康受试者中的安全性。

[Translation]

Main purpose: Using the brepirazole tablets (trade name: Rexulti, specification: 2mg) of the license holder Otsuka Pharmaceutical Co Ltd as the reference preparation and the brepirazole tablets (specification: 2mg) developed by Mayinglong Pharmaceutical Group Co., Ltd. as the test preparation, a single-center, randomized, open, single-dose, two-preparation, two-cycle, two-sequence, crossover clinical trial was conducted to evaluate the bioequivalence of the two preparations in fasting and fed states in healthy Chinese subjects. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date08 Mar 2024

Sponsor / Collaborator

Mayinglong Pharmaceutical Group Co., Ltd.

CTR20233534 / CompletedNot Applicable

氢溴酸伏硫西汀片人体生物等效性研究

[Translation] Study on the bioequivalence of vortioxetine hydrobromide tablets in healthy volunteers

主要目的：本试验旨在研究单次空腹和餐后口服马应龙药业集团股份有限公司研制、生产的氢溴酸伏硫西汀片（10 mg）的药代动力学特征；以H. Lundbeck A/S生产的氢溴酸伏硫西汀片（心达悦®，10 mg）为参比制剂，比较两制剂中药动学参数Cmax和AUC0-72，评价两制剂的人体生物等效性。次要目的：观察受试制剂氢溴酸伏硫西汀片和参比制剂氢溴酸伏硫西汀片（心达悦®）在健康受试者中的安全性。

[Translation]

Main purpose: This study aims to study the pharmacokinetic characteristics of vortioxetine hydrobromide tablets (10 mg) developed and produced by Mayinglong Pharmaceutical Group Co., Ltd. after single fasting and postprandial oral administration; using vortioxetine hydrobromide tablets (Xindayue®, 10 mg) produced by H. Lundbeck A/S as the reference preparation, compare the pharmacokinetic parameters Cmax and AUC0-72 of the two preparations, and evaluate the human bioequivalence of the two preparations. Secondary purpose: Observe the safety of the test preparation vortioxetine hydrobromide tablets and the reference preparation vortioxetine hydrobromide tablets (Xindayue®) in healthy subjects.

Start Date22 Nov 2023

Sponsor / Collaborator

Mayinglong Pharmaceutical Group Co., Ltd.

CTR20160427 / RecruitingNot Applicable

洛芬待因缓释胶囊与洛芬待因片在健康受试者中的单中心、随机、开放、两周期、自身交叉药代动力学对比研究

[Translation] A single-center, randomized, open-label, two-period, self-crossover pharmacokinetic comparison study of rofencodeine sustained-release capsules and rofencodeine tablets in healthy subjects

以马应龙药业集团股份有限公司研制的洛芬待因缓释胶囊为受试制剂，以Reckitt Benckiser Healthcare (UK) Ltd生产的洛芬待因片为参比制剂，比较两者在空腹、餐后条件下单次给药的药代动力学特点，同时比较两者在空腹条件下多次给药的药代动力学特点，以验证洛芬待因缓释胶囊的缓释作用。观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The fencodeine sustained-release capsules developed by Mayinglong Pharmaceutical Group Co., Ltd. were used as the test preparation, and the fencodeine tablets produced by Reckitt Benckiser Healthcare (UK) Ltd were used as the reference preparation. The pharmacokinetic characteristics of the two were compared after single administration under fasting and postprandial conditions, and the pharmacokinetic characteristics of the two were compared after multiple administration under fasting conditions to verify the sustained-release effect of the fencodeine sustained-release capsules. The safety of the test preparation and the reference preparation in healthy subjects was observed.

Start Date08 Jun 2022

Sponsor / Collaborator

Mayinglong Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Mayinglong Pharmaceutical Group Co., Ltd.

0 Patents (Medical) associated with Mayinglong Pharmaceutical Group Co., Ltd.

Literatures (Medical) associated with Mayinglong Pharmaceutical Group Co., Ltd.

01 Jan 2023·Evidence-Based Complementary and Alternative Medicine

Angelica Yinzi Alleviates Pruritus‐Related Atopic Dermatitis through Skin Repair, Antioxidation, and Balancing Peripheral μ‐ and κ‐opioid Receptors

Article

Author: Luo, Yang ; Li, Li ; Song, Wanci ; Dan, Hanxiong ; Liu, Wei ; Zhou, Daonian ; You, Pengtao

Background. Angelica Yinzi (AYZ) is a Chinese traditional herbal formula reported to attenuate itches and inflammation caused by atopic dermatitis (AD). However, the underlying mechanism of AYZ in the attenuation of itchiness and inflammation remains unknown. Objective. This study investigated the mechanism of AYZ in reducing itchiness in mice with 1‐chloro‐2,4‐dinitrobenzene‐ (DNCB‐)‐induced atopic dermatitis. Methods. Hematoxylin and eosin (H&E) and toluidine blue staining were used to evaluate pathological changes in skin tissue, while an enzyme‐linked immunosorbent assay (ELISA) was used to assess the cytokine levels in the skin. After that, qRT‐PCR was performed to determine the mRNA levels of cytokines in the skin. Immunofluorescence and western blotting analysis were further used to assess µ‐opioid receptor (MOR) expression and immunohistochemistry to assess the p‐ERK, p‐AKT, and κ‐opioid receptor (KOR). Results. The AYZ treatment alleviated the AD clinical symptoms, including decreasing the scratching frequency, the ear thickness, and the infiltration of mast cells, lymphocytes, inflammatory cells, and mononuclear cells. In addition, AYZ inhibited the expression of interleukin (IL)‐13, thymic stromal lymphopoietin (TSLP), and reduced neuraminidase (NA), corticotropin‐releasing factor (CRF), and reactive oxygen species (ROS) expression. Markers involved in itches, such as p‐ERK and p‐AKT, were significantly downregulated following AYZ treatment. Besides, AYZ significantly increased MOR expression and downregulated KOR in the epidermis and spinal cord. Conclusion. Our findings imply that AYZ ameliorates pruritus‐related AD through skin repair, antioxidation, and balancing peripheral MOR and KOR. The findings in this study lay a theoretical foundation for the control mechanism of peripheral itch.

01 Dec 2014·Food and Chemical ToxicologyQ2 · MEDICINE

Characterization and hepatoprotective effect of polysaccharides from Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou sarcocarp

Q2 · MEDICINE

Article

Author: Ding, Hong ; Huang, Fuwei ; Cao, Xiaoqin ; Niu, Yunhui ; Wu, Shuangchan ; Zhang, Xuyan ; Yue, Yuan ; Zhang, Huifang

The polysaccharides from Ziziphus jujuba Mill. var. spinosa (Bunge) Hu ex H. F. Chou sarcocarp (PWJS) is evaluated for the chemical composition, antioxidant activity and hepatoprotective effect. The characteristics of PWJS were determined by FT-IR spectral and HPLC analysis. The antioxidant activity was investigated using in vitro systems. An in vivo study of PWJS against CCl4 induced liver injury was also conducted. HPLC analysis showed that PWJS is an acidic heteropolysaccharide, rich in glucose (38.59%), arabinose (23.16%), galacturonic acid (17.64%) and galactose (10.44%). PWJS displayed strong antioxidant activity in vitro. In the in vivo study, PWJS treatment lowered the serum levels of ALT and AST in CCl4-intoxicated mice. Additionally, levels of antioxidant enzymes (SOD and CAT) and GSH were elevated in liver damage mice by PWJS intervention, while content of MDA was lessened. Meanwhile, PWJS reverses the suppression of Nrf2 nuclear translocation, and increases the protein expression of HO-1, GSTα and NQO1 in liver damage mice. Hematoxylin-eosin staining showed that the condition of liver damage was mitigated. This study demonstrates that PWJS reverses hepatotoxicity in CCl4-intoxicated mice through the mechanisms of antioxidant activity, as well as an augmentation of the Nrf2 pathway in liver tissue.

Zhongguo Yaoshi (Wuhan, China)

Purification of total flavonoids from Pericarpium Citri Reticulatae Viride with macroporous resin

Author: Huang, Fuwei ; Sun, Jinlong ; Song, Aihua ; Qin, Jinling

The purification process parameters of total flavonoids from Pericarpium Citri Reticulatae Viride with macroporous resin were investigated.With the content of total flavonoids as the evaluation index, the optimum purification process parameters were screened by the exptl. study of dynamic adsorption and desorption.The conditions of adsorption process were as follows: the herbal concentration was 0.25 g·ml^-1, the sample quantity was 1.1 g·g^-1 resin, and the ratio of diameter to height was 1:8.The desorption process was as follows: 10 BV and 50% alc. eluted the macro porous resin column after removing the impurities with 5 BV water.The content of total flavonoids in the extracts was above 90%.Macroporous resin shows application value in the purification of total flavonoids from Pericarpium Citri Reticulatae Viride.

100 Deals associated with Mayinglong Pharmaceutical Group Co., Ltd.

100 Translational Medicine associated with Mayinglong Pharmaceutical Group Co., Ltd.

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