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Characterization of butaselen-2, 6-dimethyl-β-cyclodextrin inclusion complexes and preparation of injectable solutions
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Jin CHANG1, 2, Meng LI2, Yuan-hao CHANG3, Kui LU1, *, Ai-ping ZHENG2, *
Acta Pharmaceutica Sinica | 2022, 57(9) : 2851 - 2856
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Acta Pharmaceutica Sinica | 2022, 57(9): 2851-2856
• Original Articles •
Characterization of butaselen-2, 6-dimethyl-β-cyclodextrin inclusion complexes and preparation of injectable solutions
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Jin CHANG1, 2, Meng LI2, Yuan-hao CHANG3, Kui LU1, *, Ai-ping ZHENG2, *
Affiliations
  • 1. School of Bioengineering, Tianjin University of Science and Technology, Tianjin 300457, China
  • 2. China Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Academy of Military Sciences, Beijing 100850, China
  • 3. Beijing Institute of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
Published: 2022-09-12 doi: 10.16438/j.0513-4870.2022-0316
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In this study, butaselen-2, 6-dimethyl-β-cyclodextrin inclusion complexes were prepared by saturated aqueous solution method to improve the solubility of butaselen, so as to obtain its injection solutions. The content of butaselen in the inclusions was determined by high performance liquid chromatography (HPLC), and then the preparation process was optimized by orthogonal design using the inclusion ratio as an indicator. X-ray diffraction (XRD), Fourier-transform infrared spectroscopy (FTIR) and scanning electron microscope (SEM) were used to verify the structure of the inclusions. The effects of the inclusions on the solubility and stability of butaselen were also investigated. The results showed that the optimized preparation process with a mass ratio of 1:340, an encapsulation time of 3 h and an encapsulation temperature of 70 ℃ resulted in an encapsulation ratio of (91.24 ± 0.42) %, and the results of XRD, FTIR and SEM demonstrated the formation of inclusion complexes. The developed HPLC method is rapid, simple, accurate, applicable, specific and reproducible for the determination of butaselen content in butaselen cyclodextrin inclusion complexes, which can lay the foundation for the development of new butaselen dosage forms and clinical applications and provide technical support.

butaselen  /  inclusion complex  /  orthogonal test  /  2  /  6-dimethyl-β-cyclodextrin  /  method validation
Jin CHANG, Meng LI, Yuan-hao CHANG, Kui LU, Ai-ping ZHENG. Characterization of butaselen-2, 6-dimethyl-β-cyclodextrin inclusion complexes and preparation of injectable solutions[J]. Acta Pharmaceutica Sinica, 2022 , 57 (9) : 2851 -2856 . DOI: 10.16438/j.0513-4870.2022-0316
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Article Info
doi: 10.16438/j.0513-4870.2022-0316
  • Receive Date：2022-03-15
  • Online Date：2025-12-24
  • Published：2022-09-12
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History
  • Received：2022-03-15
  • Revised：2022-04-11
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Affiliations
    1. School of Bioengineering, Tianjin University of Science and Technology, Tianjin 300457, China
    2. China Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences, Academy of Military Sciences, Beijing 100850, China
    3. Beijing Institute of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing 100070, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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