Formulation Studies on Stable Vitamin B-C Complex Parenteral Solution by Accelerated Stability Analysis

CNU IR > Chna Nan Annual Bulletin > Vol.8 (1982) > Item 310902800/27053

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Title:	Formulation Studies on Stable Vitamin B-C Complex Parenteral Solution by Accelerated Stability Analysis 維生素乙、丙複合注射之安定化研究
Authors:	Hsu, Hsingchu
Contributors:	私立嘉南藥學專科學校藥劑學研究室
Date:	1982
Issue Date:	2013-10-25 09:22:23 (UTC+8)
Abstract:	A systematic study by employing accelerated stability analysis was carried out to formulate stable parenteral solution for vitamin B complex and vitamin C. The approaches were centered to stabilize thiamine HCl, riboflavin and I-ascorbic acid in the solution. Pyridoxine HCl and niacinamide were found quite stable in the solution. The complicated effects of tryptophan, cysteine, polyoxyethylene hydrogenated castor oil, propylene glycol and pH on the stability of thiamine, riboflavin and 1-ascorbic acid in vitamin B-C complex parenteral solution were demonstrated and discussed. A stable formulation was proposed which contained thiamine HCl, riboflavin, pyridoxine HCl, niacinamide and 1-ascorbic acid, stabilized by EDTA, tryptophan, 0.5% polyoxyethylene hydrogenated castor oil, 0.01% cysteine HCl and 10% propylene glycol at pH 5.30 in amber glass vials. The estimated shelf-life at 25℃ by accelerated stability analysis was 2.3 years. The parenteral solution was examined by i.v. injection and i.v. infusion to rabbit and there was no appreciable difference between the simple aqueous solution of vitamins and stabilized preparation on the recording observation of blood pressure and respiratory rate before, during and after injection. 利於加速分解法，研討維生素乙、丙複合注射液之安定化方法及影響維生素安定性因子之定量效應。在含有維生素B1、B2、B6，菸鹼胺及維生素C之複合注射液中，B6及菸鹼胺之安定性頗佳。但維生素B1、B2及C之安定性極差。B 2之分解，主要是光分解，在常溫至70℃間，其安定性和溫度無關。B1及C之安定性大受pH及各種添加劑之共存影響。本研究利用安定性快速解析法經系統追查，擬定一安定性良好之安定化處方。在維生素乙、丙複合成分中，配合適量之EDTA，tryptophan，0.5% polyoxyethylenehydrogenated castor oil，0.01% cysteine HCl及10% propylene glycol. Ph 5.30，以氮氣充填於茶色注射用玻璃容器，保存在25℃時，可獲得2年之有效安定度。各種添加劑對維生素安定性之影響及相互效應，均經實驗闡明。對維生素B1及C顯著之分解速度之差異，也利用動力學方法選擇其同步化之最適條件。該製劑經家兔靜脈注射，記錄其血壓及呼吸之變動，證實此ㄧ安定性良好的注射液並無任何急性毒性。
Relation:	嘉南學報 8, (轉載論文) 台灣藥學雜誌第三十三卷第二期
Appears in Collections:	[Chna Nan Annual Bulletin] Vol.8 (1982) [Dept. of Pharmacy] Periodical Articles

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