氨酪酸氯化钠注射液的研制

目的根据临床需要,研究开发氨酪酸氯化钠注射液,建立其质量控制方法,考察其稳定性和用药的安全性。方法优化处方组成与制备工艺,并进行性状、鉴别、pH值、有关物质检查等质量研究,氨酪酸含量采用非水滴定法测定,氯化钠含量采用银量法测定,影响因素试验、加速试验和长期试验考察其稳定性。结果按照优化出来的最佳处方及工艺,制备3批中试样品,并对其产品质量进行检测,结果均合格。结论该制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。

Preparation of aminobutyric acid and sodium chloride injection

Objective To develop aminobutyric acid and sodium chloride injection to meet the clinical requirements,to establish the methods of quality control,to investigate the stability,and to evaluate its safety.Methods The formula and preparation techniques were optimized.The property,identification,pH value,and related materials were studied and the content of aminobutyric acid and sodium chloride was determined by non-aqueous titration and argentometry respectively.The stability was investigated by influence factor test,acceleration test and long-term test.Results According to the optimized formula and preparation technique,the 3 batches of aminobutyric acid and sodium chloride injection were prepared and the quality of the products was investigated.They were qualified. Conclusion The design of the formula and the preparation technique is rational.The quality can be controlled and the stability is achieved.