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苯巴比妥鈉亦称可溶性苯乙脲縮丙二酸鈉,其水溶液極易分解,随溫度的增高分解更速,分解后即生成苯基乙基醋酰脲而形成沉淀,特別是久貯和有游离酸存在时分解更速。为此常制成粉末安瓿,將一次剂量的苯巴比妥鈉粉末裝入安瓿中。抽出空气,吹入氮气,熔封,可防止久貯分解。亦有制成溶液的,可另外加适量的稳定剂,以增加苯巴比妥鈉的溶解度如:丙二醇(Glycol Propylnicum),三戊醉(Amyleni Hydras),三聚乙醛(Paraldehydum)。亦有文献記載用乙醇、水和甘油作稳定剂制成溶液的,但是成品不能用湿热或热压灭菌,須无菌操作,即或是無菌操作久貯后(約半个月)亦能水解形成沉淀,故須临时調配。綜合上述情况,我們認为粉末安瓿是比較理想的,但粉末安瓿在制造操作上如药品的提純(再结晶)、干燥,安瓿之充填等比較复杂,不适药房制造,而且成本較高,不合经济条件。为了克服上述缺点,我們經多次研究,改变了剂型和配制方法。現介紹如下:
Phenobarbital sodium, also known as soluble phenylurea sodium malonate, the aqueous solution is very easy to decompose, with the temperature increased decomposition faster, after the decomposition of phenylethyl ethyl urea formation of precipitation, especially long storage And with free acid in the presence of faster decomposition. For this purpose, powdered ampules are often prepared, and a single dose of sodium phenobarbital powder is filled into ampoules. Remove the air, blowing nitrogen, melted, to prevent long storage decomposition. Also made into solution, you can add an appropriate amount of stabilizer to increase the solubility of sodium phenobarbital such as: propylene glycol (Glycol Propylnicum), Amoxicillin (Amyleni Hydras), Paraldehyde (Paraldehydum). There are also documented using ethanol, water and glycerol as a stabilizer solution, but the finished product can not be hot or humidified sterilization, to be sterile operation, or aseptic storage for a long time (about half a month) can Hydrolysis to form a precipitate, it must be temporary deployment. In view of the above, we believe that powder ampoules are ideal, but the powder ampoules in the manufacturing operations such as drug purification (recrystallization), drying, ampoule filling more complicated, not suitable for pharmacy manufacturing, and the high cost, uneconomical condition. In order to overcome these shortcomings, we have studied many times, changed the formulation and formulation method. Now introduced as follows: