注射用氨酪酸的研制

Preparation of Aminobutyric Acid for Injection

目的研制注射用氨酪酸并建立其质量控制方法,考察其稳定性和安全性。方法拟订处方组成与制备工艺,进行性状、鉴别、pH值、有关物质检查等研究,采用非水滴定法测定氨酪酸含量,通过影响因素试验、加速试验和长期试验考察其稳定性,以其血管刺激性、溶血性及全身过敏性试验评价用药安全性。结果确定了不加赋形剂的处方,以及将氨酪酸直接冻干的工艺;影响因素试验(10d)、恒温加速试验(6个月)和长期留样试验(24个月)表明,主药含量及其他氨基酸无明显改变。结论处方工艺合理可行,制剂质量可控、稳定性良好、安全。

Objective To research and develop Aminobutyric Acid for Injection for building up the methods of the quality control and to investigate the stability and the safety. Methods The formula and preparation technique were optimized. Their property, identification, pH value, the related materials were studied and the content was determined by non- aqueous titration. The stability was investigated by influencing factor test, accelerated test and long-term test. The safety was evaluated by blood vessel stimulus, haemolytic and systemic sensitivity test. Results The formula without excipient was established. Then the aminobutyric acid was freezed to be dry directly. No changes were observed after 10 d of influencing factor test, 6 months of accelerated test and 24 months of long- term test. Conclusion The design of the preparation and manufacturing technique is rational. The quality can be controlled. The stability is achieved and the use of Aminobutyric Acid for Injection is safe.