Insulin liposome drug content determination method

• Main Authors: LIU YULING, MENG YINGYING, YANG YUQI, ZOU YUANYUAN, GUO YIYUE, XIA XUEJUN
• Format: Patent
• Language: Chinese; English
• Published: 25.11.2022
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

The present invention relates to the field of pharmaceutics, and discloses an insulin liposome drug content determination method, which is characterized by comprising: (1) membrane rupture: adding a membrane rupture agent composition to an insulin liposome, and uniformly mixing, and (2) detecting the insulin drug content by using a high performance liquid chromatography, the acid is selected from one or more of TFA, HCl and H2SO4, and the organic solvent is selected from one or more of methanol, ethanol and isopropanol. The method for determining the drug content of the insulin liposome is convenient and easy for quantitative analysis, has no damage to a chromatographic column and a liquid phase system, and lays a foundation for accurate determination of related preparations of hydrophilic protein polypeptide drugs. 本发明涉及药剂学领域，公开了一种胰岛素脂质体药物含量测定方法，其特征在于，所述方法包括(1)破膜：向所述胰岛素脂质体中加入破膜剂组合物，混匀，以及(2)采用高效液相法检测胰岛素药物含量，其中，所述破膜剂组合物包含酸和有机溶剂，所述酸选自TFA、HCl、H2SO4中的一种或一种以上，所述有机溶剂选自甲醇、乙醇、异丙醇中的一种或一种以上。本发明的胰岛素脂质体药物含量测定方法方便，易于定量分析，