Delving into the Latest Updates on Shanghai ZhongXi Pharmaceutical Co. Ltd. with Synapse

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Disease Domain	Count

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开放、随机、单次给药、双周期交叉设计，评价空腹和餐后状态下溴吡斯的明缓释片受试制剂（上海上药中西制药有限公司）与参比制剂（MESTINON®片，Valeant Pharmaceuticals International, Inc.）在中国健康成年受试者中的生物等效性试验

[Translation] An open-label, randomized, single-dose, two-period crossover design to evaluate the bioequivalence of the test formulation of pyridostigmine bromide extended-release tablets (Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd.) and the reference formulation (MESTINON® tablets, Valeant Pharmaceuticals International, Inc.) in healthy Chinese adult subjects under fasting and fed conditions

对上海上药中西制药有限公司生产的180 mg溴吡斯的明缓释片与Valeant Pharmaceuticals International, Inc.生产的180 mg MESTINON®片在空腹及餐后条件下进行生物等效性试验，评估两者之间是否具备生物等效性。

[Translation]

A bioequivalence study was conducted on 180 mg pyridostigmine bromide sustained-release tablets produced by Shanghai SPH Sino-Western Pharmaceutical Co., Ltd. and 180 mg MESTINON® tablets produced by Valeant Pharmaceuticals International, Inc. under fasting and fed conditions to evaluate whether the two are bioequivalent.

Start Date10 Jan 2022

Sponsor / Collaborator

Shanghai ZhongXi Pharmaceutical Co. Ltd.

CTR20200632 / CompletedNot Applicable

阿立哌唑片在空腹及餐后条件下的人体生物

[Translation] Biological characteristics of aripiprazole tablets in humans under fasting and fed conditions

本研究考察空腹及餐后条件下单次口服上海上药中西制药有限公司生产的受试制剂阿立哌唑片（10mg/片）或浙江大冢制药有限公司生产的参比制剂阿立哌唑片（商品名：安律凡®，10mg/片）的药动学特征，比较其相对生物利用度，评价两制剂间的生物等效性，为该受试制剂一致性评价提供依据。

[Translation]

This study investigated the pharmacokinetic characteristics of aripiprazole tablets (10 mg/tablet), a test preparation produced by Shanghai Shangyao Chinese and Western Pharmaceutical Co., Ltd., or a reference preparation produced by Zhejiang Otsuka Pharmaceutical Co., Ltd. (trade name: Anlufan®, 10 mg/tablet), under fasting and postprandial conditions, compared their relative bioavailability, evaluated the bioequivalence between the two preparations, and provided a basis for the consistency evaluation of the test preparation.

Start Date17 Apr 2020

Sponsor / Collaborator

Shanghai ZhongXi Pharmaceutical Co. Ltd.

CTR20200457 / CompletedNot Applicable

枸橼酸托法替布片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of tofacitinib citrate tablets in humans under fasting and fed conditions

本研究考察空腹及餐后条件下单次口服5mg由上海上药中西制药有限公司生产的枸橼酸托法替布片（受试制剂，规格：5mg）或5mg由Pfizer Manufacturing Deutschland GmbH生产的枸橼酸托法替布片（参比制剂，商品名：Xeljanz®，规格：5mg）的药动学特征，评价两制剂间的生物等效性，为该受试制剂注册申请提供依据。

[Translation]

This study investigated the pharmacokinetic characteristics of a single oral dose of 5 mg tofacitinib citrate tablets produced by Shanghai SPH Pharmaceuticals Co., Ltd. (test preparation, strength: 5 mg) or 5 mg tofacitinib citrate tablets produced by Pfizer Manufacturing Deutschland GmbH (reference preparation, trade name: Xeljanz®, strength: 5 mg) under fasting and postprandial conditions, evaluated the bioequivalence between the two preparations, and provided a basis for the registration application of the test preparation.

Start Date12 Apr 2020

Sponsor / Collaborator

Shanghai ZhongXi Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shanghai ZhongXi Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Shanghai ZhongXi Pharmaceutical Co. Ltd.

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3

Literatures (Medical) associated with Shanghai ZhongXi Pharmaceutical Co. Ltd.

Shanghai Huagong

Consistency Evaluation of the Dissolution of Generic and Original Drugs of Fluoxetine Hydrochloride Capsule

Author: Guo, Yanyan ; Zhang, Ting ; Ding, Yunhui ; Jin, Tuo

A method for determining the dissolution rate of fluoxetine hydrochloride capsules was established, and the consistency of the dissolution curves of the generic and original drugs was evaluated.The high-performance liquid chromatog.(HPLC) method was performed to detect the dissolution of generic and original preparations of fluoxetine hydrochloride tablet on the column of 227 nm, with dissolution medium of water, 0.1 mol/L hydrochloric acid solution, acetate buffer solution(pH=4.5) and phosphate buffer solution(pH=6.8), and the volume of dissolution medium was 500 m L, the rotation speed was 50 r/min. The linear range of fluoxetine hydrochloride was 9.04 ∼ 63.28 μg/mL, the relative standard deviations(RSD) of precision, stability and reproducibility tests were less than 2.0%, recoveries in 4 dissolution mediums were 100.24%(RSD=0.6%, n=9), 99.33%(RSD=0.7%, n=9), 100.11%(RSD=0.7%, n=9), 100.17%(RSD=0.6%, n=9).In the 4 dissolution mediums, the dissolution rate in 15 min of the three batches and the original were more than 80%.The HPLC method is suitable for the dissolution determination of fluoxetine hydrochloride capsules, meanwhile, the in vitro dissolution curves of generic and original preparations of fluoxetine hydrochloride capsules show similarity, so the quality consistency is good.

Zhongguo Yiyao Gongye Zazhi

Preparation of glipizide sustained-release tablets

Author: Zheng, Siji ; Zhang, Qi

Glipizide sustained-release tablets were prepared with high-viscosity HPMC and Carbopol as sustained release materials by wet granulation.The accumulated release of glipizide at 4, 8, 12, 16 and 24 h in 0.015 mol/L hydrochloric acid containing 0.25% sodium dodecyl sulfate were (29.9 ± 3.2)%, (55.0 ± 2.0)%, (78.9 ± 2.1)%, (89.6 ± 1.9)%, and (99.3 ± 1.5)%, resp.The correlation coefficient of in vitro release and in vivo absorption was 0.9833.The results showed that in vitro and in vivo correlation of the sustained-release tablets was good (P < 0.001).

Fenxi Ceshi Yiqi Tongxun

quantitative determination of piperaquine phosphate by reversed-phase ion-pair high performance liquid chromatography

Author: Tao, Hongying ; Chen, Wenliang ; Wu, Hui ; Chen, Minjuan

An ATTECH ODS (μm) was used as the fixed phase (column, θ4.6 mm × 150 mm), and the mobile phase consisted of a mixture of methanol-acetonitrile-water-triethylamine-sodium 1-pentanesulfonate (20 mL + 80 mL + 900 mL + 5 mL + 100 mg) which was adjusted to pH 3.0 with phosphoric acid.The flow rate was 1.0 mL/min.The detection wavelength was 240 nm.The RSD(n=10) for the determination of sample containing 99.59% piperaquine phosphate was 0.12% with an average recovery of 100.7%.

100 Deals associated with Shanghai ZhongXi Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Shanghai ZhongXi Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 08 Nov 2024

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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