盐酸赖氨酸注射液的研制

Preparation of Lysine Hydrochloride Injection

目的研究开发盐酸赖氨酸注射液,建立其质量控制方法,考察其稳定性,并进行其血管刺激性、溶血性及全身过敏性试验,以此评价药品的安全性。方法优化处方组成与制备工艺,进行性状、鉴别、pH值、其他氨基酸检查等质量研究,用电位滴定法测定盐酸赖氨酸含量,通过影响因素试验、加速试验和长期试验考察其稳定性。结果按照优化出来的最佳处方及工艺制备3批中试样品,其质量均合格。结论制剂处方合理,制备工艺简便可行,质量可控,稳定性良好,用药安全。

Objective To research and develop lysine hydrochloride injection in order to meet the clinical requirement, to investigate the stability, to build up the methods of the quality control, and to evaluate their safety by blood vessel stimulus, haemolyticus, systemic sensitivity test. Methods The formula and preparation technique were optimized. Their property, identification, pH value, the other amino acids were studied and the content of lysine hydrochloride was determined by electric titration, the stability was investigated by influencing factor test, accelerated test and long-term test. Results According to the optimized formula and preparation technique, the three batches of lysine hydrochloride injection were prepared and their qualities of the products were investigated. It showed that the results were qualified. Conclusion The design of the formula and preparation technique are rational. The quality can be controlled. The stability is achieved and the use of lysine hydrochloride injection is safety.