[Translation] A single-center, randomized, open-label, single-dose, two-drug, self-crossover bioequivalence study of Al-Mg-Pirine Tablets (II) in healthy volunteers

本次试验以广州大光制药有限公司研发的铝镁匹林片（Ⅱ）为受试制剂，按生物等效性研究的有关规定，以铝镁匹林片（Ⅱ）（Lion Corporation生产，商品名：BUFFERIN）为参比制剂，考察两种制剂的相关药代动力学参数和相对生物利用度，评价两者在单次给药后（空腹和餐后）是否具有生物等效性。

[Translation]

In this trial, Aluminum Magnesium Aspirin Tablets (II) developed by Guangzhou Daguang Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant regulations of bioequivalence studies, Aluminum Magnesium Aspirin Tablets (II) (produced by Lion Corporation, trade name: BUFFERIN) was used as the reference preparation. The relevant pharmacokinetic parameters and relative bioavailability of the two preparations were investigated, and whether the two preparations were bioequivalent after a single dose (fasting and postprandial) was evaluated.

Start Date-

Sponsor / Collaborator

Guangzhou Daguang Pharmaceutical Co., Ltd.

CTR20232710 / CompletedNot Applicable

铝镁匹林片（II）在健康人体进行的单中心、随机、开放、单次给药、两制剂、两周期、自身交叉、餐后生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, self-crossover, postprandial bioequivalence study of Al-Mg-Pirine Tablets (II) in healthy volunteers

本次试验以广州大光制药有限公司研发的铝镁匹林片（Ⅱ）为受试制剂，按生物等效性研究的有关规定，以铝镁匹林片（Ⅱ）（Lion Corporation生产，商品名：BUFFERIN）为参比制剂，考察两种制剂的阿司匹林及水杨酸药代动力学参数和相对生物利用度，评价两者在单次给药后（餐后）是否具有生物等效性。

[Translation]

In this trial, Aluminum Magnesium Aspirin Tablets (II) developed by Guangzhou Daguang Pharmaceutical Co., Ltd. was used as the test preparation. According to the relevant regulations of bioequivalence studies, Aluminum Magnesium Aspirin Tablets (II) (produced by Lion Corporation, trade name: BUFFERIN) was used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of aspirin and salicylic acid in the two preparations were investigated to evaluate whether the two preparations were bioequivalent after a single dose (after meal).

Start Date10 Sep 2023

Sponsor / Collaborator

Guangzhou Daguang Pharmaceutical Co., Ltd.

CTR20230970 / CompletedNot Applicable

铝镁匹林片（Ⅱ）在健康人体进行的单中心、随机、开放、单次给药、两制剂、两周期、自身交叉生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose, two-drug, two-period, self-crossover bioequivalence study of Al-Mg-Pirine Tablets (II) in healthy volunteers

[Translation]

Start Date19 Apr 2023

Sponsor / Collaborator

Guangzhou Daguang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Guangzhou Daguang Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Guangzhou Daguang Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Guangzhou Daguang Pharmaceutical Co., Ltd.

Jinri Yaoxue

Research progress on anti-cancer activity of cordycepin in cordyceps militaris

Author: Chen, Weihan ; Huang, Weijing ; Li, Jiajia

Cordycepin is the first nucleoside antibiotic isolated from Cordyceps militaris and it has significant anti-cancer activity.Cordycepin can also be used to control the growth and metastasis of cancer, and to assist cancer patients after surgery or chemotherapy.Cordycepin plays an increasingly important role in cancer treatment as a natural anticancer drug.In this study, the progress of anti-cancer effects of cordycepin is highlighted and the future study of cordycepin is prospected.

Zhongguo Yaoshi (Wuhan, China)

Simultaneous Determination of Triethyl Phosphate and Diethyl Phosphite in Incadronate Disodium by LC-MS/MS

Author: Huang Weijing ; Huang Weimin ; Chen Weihan

Objective: To develop and validate an LC-MS/MS method for the simultaneous determination of tri-Et phosphate and di-Et phosphite in incadronate disodium.Methods: A WATERS ACQUITY♂UPLC HSS C_(18) column(30 mmx2. 1 mm, 1. 8 μm) was used, and the column temperature was set at 35 °C .The mobile phase consisted of 0. 1% formic acid water solution and acetonitrile(7: 3, V/V), the flow rate was 0. 5 mL·min∼(-1), and the injection volume was 1 μl.By an MRM scanning mode, the quant. ion of tri-Et phosphate and di-Et phosphite was m/z 127. 1 and m/z 111. 1, resp.Results: The linear range of tri-Et phosphate and di-Et phosphite was 1. 00-200. 00 ng·ml∼(-1)(r= 0. 999 7) and 3. 30-200. 00 ng·ml∼(-1)(r= 0. 999 9), resp.All the validation parameters for the method including specificity, repeatability, intermediate precision, accuracy, solution stability and durability were within the rangs of the corresponding guidelines in Chinese Pharmacopoeia(2020 edition).Conclusion: The LC-MS/MS method has the advantages of high accuracy, good repeatability and promising durability.It can be used for the simultaneous determination of tri-Et phosphate and di-Et phosphite in incadronate disodium.

Jinri Yaoxue

Advances in study of polyquaternium-1 as A new type of ophthalmic preservative

Author: Huang, Hongzhang ; Chen, Weihan ; Huang, Weijing ; Wen, You ; Tan, Jiajia ; Wen, Lin

Polyquaternium-1 is a kind of strong cationic polymer with low toxicity and irritability.In this paper, the mechanism of action, bacteriostatic effect, toxic effect and clin. studies of polyquaternium-1 were summarized by consulting domestic and foreign literatures, and its application prospect was also discussed.

100 Deals associated with Guangzhou Daguang Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Guangzhou Daguang Pharmaceutical Co., Ltd.

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