随机、开放、两制剂、两序列、两周期、自身交叉对照设计,评价中国健康受试者在空腹状态下单次雾化吸入丙酸氟替卡松雾化吸入用混悬液后的生物等效性正式试验
[Translation] A randomized, open-label, two-drug, two-sequence, two-period, self-crossover controlled study to evaluate the bioequivalence of a single nebulized inhalation of fluticasone propionate suspension for inhalation in Chinese healthy subjects in the fasting state
以深圳大佛药业股份有限公司提供的丙酸氟替卡松雾化吸入用混悬液为受试制剂;并以Eddingpharm B.V.持证的丙酸氟替卡松雾化吸入用混悬液为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] The fluticasone propionate suspension for nebulized inhalation provided by Shenzhen Dafo Pharmaceutical Co., Ltd. was used as the test preparation, and the fluticasone propionate suspension for nebulized inhalation certified by Eddingpharm B.V. was used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.
黄体酮阴道缓释凝胶随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验
[Translation] A formal bioequivalence trial of progesterone sustained-release vaginal gel in Chinese healthy subjects in a randomized, open-label, crossover design
主要目的:以深圳大佛药业股份有限公司的黄体酮阴道缓释凝胶为受试制剂;并以Merck Serono Limited的黄体酮阴道缓释凝胶为参比制剂,进行人体相对生物利用度和生物等效性评价。
[Translation] Main purpose: Use the progesterone vaginal sustained-release gel of Shenzhen Dafo Pharmaceutical Co., Ltd. as the test preparation; and use the progesterone vaginal sustained-release gel of Merck Serono Limited as the reference preparation to conduct human body relative bioavailability and biological evaluation. Equivalence evaluation.
100 Clinical Results associated with Shenzhen Daphne Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shenzhen Daphne Pharmaceutical Co., Ltd.
18 Feb 1999·Zhongguo Yiyuan Yaoxue Zazhi
Studies on determination of pilocarpine nitrate in eye drops and its stability by HPLC
Author: Xiao, Yang ; Shang, Suqin
The content of pilocarpine nitrate in eye drops and its degradation products were determined by HPLC and the stability of pilocarpine eye drops was examined A Shim-pack Clc-Phenye column (0.15 m x 6.0 mm) was used and the detection was at 230 nm. O-Phthalic acid was used as the internal standard The mobile phase was MeCN-5% KH2PO4 (6:100) and the pH was adjusted by H3PO4 to 3.0. The influence of light and pH on the stability of pilocarpine nitrate eye drops was studied, and pH 4.5 was the optimum one. The average recovery was 100.5 with RSD 0.6. The method was simple and specific.
100 Deals associated with Shenzhen Daphne Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shenzhen Daphne Pharmaceutical Co., Ltd.