目的 優(yōu)化鹽酸消旋山莨菪堿注射液工藝處方，提高產(chǎn)品穩(wěn)定性。方法 鹽酸消旋山莨菪堿注射液工藝處方改為預(yù)先配制鹽酸溶液，再將消旋山莨菪堿緩緩加入鹽酸溶液中，成鹽時(shí)pH值控制在5.0～5.2。結(jié)果 工藝處方更改后，可降低產(chǎn)品的有關(guān)物質(zhì)，提高穩(wěn)定性。結(jié)論 經(jīng)處方優(yōu)化后，鹽酸消旋山莨菪堿注射液可在室溫條件下穩(wěn)定儲(chǔ)存。

Objective To optimize the prescription of raceanisodamine hydrochloride injection and increase the stability of the product. Methods The prescription of raceanisodamine hydrochloride injection was amended as described below. Hydrochloric acid solution was prepared in advance, raceanisodamine was slowly added into hydrochloric acid solution slowly, and pH value was controlled at 5.0 to 5.2. Results After the process beening changed, it could reduce the amount of the related substance and increase the stability of the product. Conclusion Raceanisodamine hydrochloride injection can be stored at room temperature after the process beening optimized.