Neostigmine methylsulfate injection and its preparation method
By using a carbon dioxide dissolved oxygen controlled preparation method, the problem of impurity I growth in neostigmine methylsulfate injection was solved, thereby improving product stability and medication safety.
CN116650412BActive Publication Date: 2026-05-26宝利化(南京)制药有限公司
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Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- 宝利化(南京)制药有限公司
- Filing Date
- 2023-06-20
- Publication Date
- 2026-05-26
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Figure CN116650412B_ABST
Abstract
This invention relates to the field of pharmaceutical injection technology, specifically to a neostigmine methylsulfate injection and its preparation method. The preparation method of the neostigmine methylsulfate injection of this invention includes the following steps: S1 pretreatment of water for injection, S2 preparation, S3 filtration, S4 filling and sealing, and S5 sterilization. This invention features a simple process, high yield, and low cost. It effectively reduces the generation of impurity I in the neostigmine methylsulfate injection, improves the storage stability of the product, reduces potential medication safety hazards caused by impurities, and ensures drug quality and medication safety.
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