当代医药论丛
噹代醫藥論叢
당대의약론총
Contemporary Medicine Forum
2014年
15期
13-13,14
,共2页
盐酸消旋山莨菪碱注射液%盐酸消旋山莨菪碱%工艺处方
鹽痠消鏇山莨菪堿註射液%鹽痠消鏇山莨菪堿%工藝處方
염산소선산랑탕감주사액%염산소선산랑탕감%공예처방
Raceanisodamide hydrochloride injection%hydrochloride Raceanisodamide%process prescription
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。
目的：對鹽痠消鏇山莨菪堿註射液的配製工藝及儲藏方法進行優化，旨在提高該產品的穩定性。方法：將傳統配製工藝脩正為預先進行鹽痠溶液配製、再緩慢加入消鏇山莨菪堿、同時將成鹽pH值控製在5.0～5.2範圍內。結果：對于新工藝試製樣品的試驗結果錶明，該工藝具有降低有關物質、提升產品穩定性的積極作用。結論：通過對配製工藝的優化，可于室溫環境中實現鹽痠消鏇山莨菪堿註射液的穩定儲存。
목적：대염산소선산랑탕감주사액적배제공예급저장방법진행우화，지재제고해산품적은정성。방법：장전통배제공예수정위예선진행염산용액배제、재완만가입소선산랑탕감、동시장성염pH치공제재5.0～5.2범위내。결과：대우신공예시제양품적시험결과표명，해공예구유강저유관물질、제승산품은정성적적겁작용。결론：통과대배제공예적우화，가우실온배경중실현염산소선산랑탕감주사액적은정저존。
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.
