主要研究目的: 本研究考察空腹及餐后条件下单次口服由天津天药药业股份有限公司生产的QKH（受试制剂，规格：20mg）或由ShireServicesBVBA持证的参比制剂( 商品名：Plenadren®，规格：20mg）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，为受试制剂的注册申请提供依据。次要研究目的: 观察空腹及餐后条件下单次口服受试制剂QKH（规格：20mg）或参比制剂（商品名：Plenadren®，规格：20mg）在中国健康受试者中的安全性。

[Translation]

Main study purpose: This study investigates the pharmacokinetic characteristics of QKH (test preparation, specification: 20 mg) produced by Tianjin Tianyao Pharmaceutical Co., Ltd. or the reference preparation (trade name: Plenadren®, specification: 20 mg) certified by Shire Services BVBA under fasting and postprandial conditions, compares their relative bioavailability, evaluates the bioequivalence between the two preparations, and provides a basis for the registration application of the test preparation. Secondary study purpose: Observe the safety of single oral administration of the test preparation QKH (specification: 20 mg) or the reference preparation (trade name: Plenadren®, specification: 20 mg) under fasting and postprandial conditions in healthy Chinese subjects.

Start Date14 Jun 2021

Sponsor / Collaborator

Tianjin Tianyao Pharmaceuticals Co., Ltd.

CTR20211107 / CompletedNot Applicable

活性炭阻断条件下BUD在中国健康受试者中随机、开放、两制剂、单次给药、两周期交叉的生物等效性试验

[Translation] A randomized, open-label, two-dose, single-dose, two-period crossover bioequivalence study of BUD in Chinese healthy subjects under activated carbon blockage

要研究目的：考察健康受试者在活性炭阻断条件下，空腹吸入天津金耀药业有限公司生产的吸入用布地奈德混悬液（受试制剂；规格：2ml:1mg；2ml/支）与AstraZeneca公司生产的吸入用布地奈德混悬液（参比制剂；规格：2ml:1mg；2ml/支；英文商品名：Pulmicort®，中文商品名：普米克令舒），比较两制剂在人体内的药代动力学参数，评价活性炭阻断条件下两种制剂在健康受试者体内的生物等效性。次要研究目的：观察受试制剂（T）和参比制剂（R）在健康受试者中的安全性。

[Translation]

Primary study purpose: To investigate the pharmacokinetic parameters of the two preparations in humans by inhaling budesonide suspension for inhalation produced by Tianjin Jinyao Pharmaceutical Co., Ltd. (test preparation; specification: 2ml:1mg; 2ml/tube) and budesonide suspension for inhalation produced by AstraZeneca (reference preparation; specification: 2ml:1mg; 2ml/tube; English trade name: Pulmicort®, Chinese trade name: Pulmicort®) under activated carbon blocking conditions in healthy subjects on an empty stomach, and to evaluate the bioequivalence of the two preparations in healthy subjects under activated carbon blocking conditions. Secondary study purpose: To observe the safety of the test preparation (T) and the reference preparation (R) in healthy subjects.

Start Date31 May 2021

Sponsor / Collaborator

Tianjin Jinyao Pharmaceutical Co., Ltd.

CTR20210253 / CompletedNot Applicable

BUD在中国健康受试者中随机、开放、两制剂、单次给药、两周期交叉的生物等效性试验

[Translation] BUD: A randomized, open-label, two-drug, single-dose, two-period crossover bioequivalence study in Chinese healthy subjects

主要目的：评价天津金耀药业有限公司生产的受试制剂吸入用布地奈德混悬液（规格：2ml:1mg；2ml/支）与Astrazeneca Pty Ltd生产的参比制剂吸入用布地奈德混悬液（规格：2ml:1mg；2ml/支；英文商品名：Pulmicort®，中文商品名：普米克令舒®）在中国健康成人受试者中经口腔单次雾化吸入时的生物等效性。次要目的：评价中国健康成人受试者经口腔单次雾化吸入吸入用布地奈德混悬液受试制剂和参比制剂的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the test preparation of budesonide suspension for inhalation (specification: 2ml:1mg; 2ml/vial) produced by Tianjin Jinyao Pharmaceutical Co., Ltd. and the reference preparation of budesonide suspension for inhalation (specification: 2ml:1mg; 2ml/vial; English trade name: Pulmicort®, Chinese trade name: Pulmicort®) produced by Astrazeneca Pty Ltd in Chinese healthy adult subjects after single oral aerosol inhalation. Secondary objective: To evaluate the safety of the test preparation and reference preparation of budesonide suspension for inhalation in Chinese healthy adult subjects after single oral aerosol inhalation.

Start Date11 Mar 2021

Sponsor / Collaborator

Tianjin Jinyao Pharmaceutical Co., Ltd.

100 Clinical Results associated with Tianjin Tianyao Pharmaceuticals Co., Ltd.

0 Patents (Medical) associated with Tianjin Tianyao Pharmaceuticals Co., Ltd.

Literatures (Medical) associated with Tianjin Tianyao Pharmaceuticals Co., Ltd.

Huaxue Gongye Yu Gongcheng (Tianjin, China)

Treatment of high content aniline wastewater by extraction

Author: Li, Guo-bing ; Chen, Song ; Jiang, Xiao-yun

By comparing of several kinds of methods for treatment of aniline wastewater, an extracting method using methylbenzene as extracting agent was proposed for the treatment of 40 g/L aniline wastewater produced in the manufacture of rubber antioxidant (RD).Based on the technol. parameters obtained from experiment, a production facility whose capacity was 20 m³/d was designed.The production showed that 98.5% of aniline was recovered.Compared with other means, the proposed extraction method has advantages such as low equipment investment, easy operation and low consumption.

Huaxue Gongye Yu Gongcheng (Tianjin, China)

Optimization of fluorination reaction in the preparation of dexamethasone acetate

Author: Lu, Yan-chang ; Wang, Fu-jun ; Zhu, Cui-hong ; Wen, Jian-ping

Fluorination reaction, a key process in the preparation of dexamethasone acetate, is optimized and the optimum conditions are obtained.The ratio of raw material to HF-DMF is 5.5:1.0, the concentration of HF-DMF is 0.6 g/mL, reaction temperature is -3° - -5° and recrystallization solvent is acetone.Under the above optimum reaction conditions, the yields of crude and purified products reach 101.0% and 75.6% resp.The purity of dexamethasone acetate is above 98.5%.

Shandong Huagong

Summary of reaction of introducing 9-fluorine atoms into steroid hormones

Author: Zhang, Jie

A review with references summary of reaction of introducing 9-fluorine atoms into steroid hormones is presented.The methods of introducing 9-fluorine atoms into steroid hormones using HF/H₂O solution, HF/THF solution, HF/Py solution and HF/DMF solution as fluorinating reagents were described, and the advantages and disadvantages of various methods were compared.It is believed that the HF/DMF solution is used as a fluorinating reagent to introduce fluorine atoms, which has the characteristics of high yield, easy operation, relatively mild reaction, and safety.

News (Medical) associated with Tianjin Tianyao Pharmaceuticals Co., Ltd.

04 Jan 2023

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Amino Acids China E-News 2022: Real-Time Reporting, Expert Commentary and Market Trend Analysis - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Amino Acids China E-News 2022" newsletter has been added to ResearchAndMarkets.com's offering. This newsletter will help you stay ahead of the game in this fast-changing market with real-time reporting on the entire amino acid industry chain, from raw materials to end consumption. It includes breaking news from China and abroad, the latest market data (price, import & export, production, consumption, operating rates, etc.), in-depth analysis of market trends, and expert commentary from industry insiders. Key Topics Covered: Headline Editor's Note Governmental Direction Two amino acid-related draft standards open for comments Market Analysis Developments in two amino acid projects Hubei Trisun & Pingdingshan Heshengyuan: developments in glycine projects Company Dynamics Fufeng Group: rises in sales and prices of main products lead to surging H1 2022 performance Feed raw material project of Shandong Highvarve and food additives & feed additives project of Hongda Biotech Delekang Food's 120 t/a theanine project and Tianyao Holdings' amino acid project Shanghai Ajinomoto's amino acid project and Tongliao Meihua's threonine project Jirong Pharmaceutical's compound amino acids project and Jianye Amino Acid's amino acid food additives project (Phase I) Price Update The prices of major amino acid varieties in China, September 2022 Ex-works price of methionine drops for seven consecutive months Import and Export Import and export data of five amino acid varieties in China, July 2022 Import volume of methionine in Jan.-July drops YoY whereas export volume climbs YoY News in Brief Tianyao Holdings: revenue of amino acid segment for H1 2022 falls Novus International to transform its business model in China Adisseo's 180,000 t/a liquid methionine (BANC2) project goes into production First-time EIA publication of Lanzhou Jinli's 20,000 t/a sodium sarcosinate project Qinhuangdao Huaheng: first-time EIA publication of organic acids project Wilmar High Polymer Material (Lianyungang): EI report of 22,000 t/a amino acid surfactant project publicised EIA of Shandong Deep Sea's 5-ALA project publicised LHG: dual increases in operating revenue and net profit for H1 2022 Deyang Xuwei's 8,000 t/a amino acid complex compound (chelate) feed additive project MARA advocates reducing amount of soybean meal in feed and using alternatives Companies Mentioned Zhejiang Tianshun Biotechnology Co., Ltd. E'meishan Longteng Biotechnology Co., Ltd. Hubei Trisun Chemicals Co., Ltd. Pingdingshan Heshengyuan Environmental Protection New Material Co., Ltd. Shandong Asia-Pacific Highvarve Organisms Science and Technology Co., Ltd. Shandong Hongda Biotechnology Co., Ltd. Zhejiang Delekang Food Co., Ltd. Tianjin Tianyao Pharmaceuticals Co., Ltd. Shanghai Ajinomoto Amino Acid Co., Ltd. Tongliao Meihua Biological Sci-tech Co., Ltd. Shijiazhuang Jirong Pharmaceutical Co., Ltd. Shijiazhuang Jianye Amino Acid Co., Ltd. Shijiazhuang Haitian Amino Acid Co., Ltd. Zhejiang NHU Co., Ltd. Bluestar Adisseo Co., Ltd. Jinli Chemical Wool Spinning Co., Ltd. Qinhuangdao Huaheng Bioengineering Co., Ltd. Qinhuangdao Huaheng Bioengineering Co., Ltd. Anhui Huaheng Biotechnology Co., Ltd. Wilmar High Polymer Material (Lianyungang) Co., Ltd. Shandong Deep Sea Biotechnology Co., Ltd. Deyang Xuwei Biotechnology Co., Ltd. For more information about this newsletter visit https://www.researchandmarkets.com/r/t7qjmz About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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100 Translational Medicine associated with Tianjin Tianyao Pharmaceuticals Co., Ltd.

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