CN Patent

CN112129844A — 一种乙酰半胱氨酸降解产物及其制备方法和用途

Assigned to Wuhan Xinghua Wisdom Medicine Technology Co ltd · Expires 2020-12-25 · 5y expired

What this patent protects

本发明属于医药技术领域，涉及一种乙酰半胱氨酸降解产物，所述降解产物为N,N‑二乙酰基羊毛硫氨酸；本发明还提供制备N,N‑二乙酰基羊毛硫氨酸的方法为：(1)乙酰半胱氨酸水溶液在高温和碱性双重条件下降解得到降解产物溶液；(2)将降解产物溶液用液相色谱法纯化，收集降解产物洗脱液，洗脱液冷冻干燥得到降解产物N,N‑二乙酰基羊毛硫氨酸。本发明还提供N,N‑二乙酰基羊毛硫氨酸的用途。本发明制备的N,N‑二乙酰基羊毛硫氨酸纯度高，可作为乙酰半胱氨酸及相关制剂定性和定量检测用对照品，能使乙酰半胱氨酸制剂中杂质谱更为清晰和明确，以提高制剂的安全性和可控性。

USPTO Abstract

本发明属于医药技术领域，涉及一种乙酰半胱氨酸降解产物，所述降解产物为N,N‑二乙酰基羊毛硫氨酸；本发明还提供制备N,N‑二乙酰基羊毛硫氨酸的方法为：(1)乙酰半胱氨酸水溶液在高温和碱性双重条件下降解得到降解产物溶液；(2)将降解产物溶液用液相色谱法纯化，收集降解产物洗脱液，洗脱液冷冻干燥得到降解产物N,N‑二乙酰基羊毛硫氨酸。本发明还提供N,N‑二乙酰基羊毛硫氨酸的用途。本发明制备的N,N‑二乙酰基羊毛硫氨酸纯度高，可作为乙酰半胱氨酸及相关制剂定性和定量检测用对照品，能使乙酰半胱氨酸制剂中杂质谱更为清晰和明确，以提高制剂的安全性和可控性。

Drugs covered by this patent

Patent Metadata

Patent number
CN112129844A
Jurisdiction
CN
Classification
—
Expires
2020-12-25
Drug substance claim
No
Drug product claim
No
Assignee
Wuhan Xinghua Wisdom Medicine Technology Co ltd
Source
FDA Orange Book + USPTO grounding via Google Patents

Bibliographic data sourced from FDA Orange Book + USPTO public records. Plain-English summary generated by AI grounded in source text. Patent term extensions (PTR, SPC, pediatric) may shift the effective expiry. Not legal advice.

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