[Translation] A single-center, single-dose, randomized, open-label, two-dose, partially repeated crossover, three-period bioequivalence study of diclofenac diethylamine emulsion in healthy subjects

主要目的:以丽彩甘肃西峰制药有限公司生产的双氯芬酸二乙胺乳胶剂(规格:2.32%(30g:0.696g，以CI8HClN202计))为受试制剂，以GlaxoSmithKline Consumer Healthcare(UK)Trading Limited的双氯芬酸二乙胺乳胶剂(规格:2.32%(30g:0.696g，以CI8H2ClN20计))为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的:观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Diclofenac diethylamine emulsion (specification: 2.32% (30g: 0.696g, calculated as CI8HClN202)) produced by Licai Gansu Xifeng Pharmaceutical Co., Ltd. was used as the test preparation, and diclofenac diethylamine emulsion (specification: 2.32% (30g: 0.696g, calculated as CI8H2ClN20)) produced by GlaxoSmithKline Consumer Healthcare (UK) Trading Limited was used as the reference preparation. According to the relevant provisions of the bioequivalence test, the bioequivalence of the two preparations in healthy subjects was investigated. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

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Gansu Xifeng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Gansu Xifeng Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Gansu Xifeng Pharmaceutical Co., Ltd.

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Zhongshouyi Yiyao Zazhi

Effects of different doses of sulfur fumigation on the tissue structures, pH and ferulic acid of Angelica sinensis

Author: Li, Long ; Ma, Dongni ; Wang, Xiaoli ; Zhang, Lijun ; Li, Yun

Objective: To explore the effects of different doses of sulfur fumigation on the tissue structures, pH and ferulic acid of Angelica sinensis, and provide scientific basis for ensuring the quality of authentic Chinese medicinal materials in Gansu.Methods: Fresh and com. available samples of sulfur fumigation and Angelica sinensis were collected sep., and the fresh Angelica sinensis medicinal materials were subjected to fumigant processing in three doses of high (5%), medium (1%) and low (0.2%), resp.The tissue structures were observed and the content of ferulic acid in different sulfur dosages of Angelica sinensis were determined by microscope and high performance liquid chromatog.Results: After sulfur fumigation, the color gradually became lighter of Angelica sinensis.Tissue structures have also been changed.After sulfur fumigation, the diameter of the oil chamber became larger, the number of oil chambers per unit mm² were reduced, and the oil chamber were ruptured more.After sulfur fumigation of Angelica sinensis, the pH of extract was lowered, especially with 5% sulfur smoked dose most significant (21.98%).The content of ferulic acid in Angelica sinensis increased firstly with increase of the dose of sulfur fumigation, and the dose of 1%sulfur was the most obvious (11.88%).Conclusion: Sulfur fumigation had certain influence on Angelica sinensis.In order to ensure the quality of Angelica sinensis and the safety of clin. medication, the processing of production should strictly control the dose of sulfur fumigation.

100 Deals associated with Gansu Xifeng Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Gansu Xifeng Pharmaceutical Co., Ltd.

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