摘要
目的:对盐酸消旋山莨菪碱注射液的配制工艺及储藏方法进行优化,旨在提高该产品的稳定性。方法:将传统配制工艺修正为预先进行盐酸溶液配制、再缓慢加入消旋山莨菪碱、同时将成盐pH值控制在5.0~5.2范围内。结果:对于新工艺试制样品的试验结果表明,该工艺具有降低有关物质、提升产品稳定性的积极作用。结论:通过对配制工艺的优化,可于室温环境中实现盐酸消旋山莨菪碱注射液的稳定储存。
Objective: Preparation Raceanisodamide Hydrochloride Injection to optimize the stability of the product has been improved. Methods: The traditional preparation process correction hydrochloric acid solution was prepared in advance, then slowly add Raceanisodamide, and will become the salt pH control in the 5.0 to 5.2 range. Results: The trial of new technology to the test results of samples indicate that the process has reduced related substances, improve product stability positive role. Conclusion: Through the preparation process optimization can be achieved stable storage of hydrochloric acid racemic anisodamine injection at room temperature environment.
关键词
盐酸消旋山莨菪碱注射液
盐酸消旋山莨菪碱
工艺处方
Raceanisodamide hydrochloride injection
hydrochloride Raceanisodamide
process prescription
