The improvement of formulation process and quality evaluation of coenzyme Q10 emulsion
10.12206/j.issn.2097-2024.202106117
- VernacularTitle:辅酶Q10乳剂的处方工艺改进与质量评价
- Author:
Yu WANG
1
;
Yihui DENG
2
;
Yanzhi SONG
2
;
Guangxuan LIU
1
Author Information
1. Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Shenyang 110042, China.
2. School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China.
- Keywords:
high oil content;
coenzyme Q10;
emulsion;
physicochemical property;
stability
- From:
Journal of Pharmaceutical Practice and Service
2022;40(6):526-531
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of coenzyme Q10 emulsion with improved formulation and technology and establish an assay method. Methods Coenzyme Q10 emulsion with a high oil concentration was prepared and analyzed by HPLC. The physical and chemical properties of the emulsion were characterized, and the entrapment efficiency was determined. The stability of sterilization, freeze-thaw and dilution was investigated. The photodegradation test as well as the influencing factors, acceleration and long-term stability tests were carried out. Results The particle size, Zeta potential, pH value, content and entrapment efficiency of coenzyme Q10 emulsion were (239.5±0.8) nm、(−32.28±2.04) mV、(5.86±0.02)、 (100.59±1.24) % and (98.5±1.1) %, respectively. The stability of sterilization, freeze-thaw and dilution was good. The photolysis rate was directly proportional to the dilution ratio and inversely proportional to the drug loading. Coenzyme Q10 emulsion should be prepared in light free environment and stored at a low temperature. The pH value dropped 0.61 when it was kept in darkness at (40±2) ℃ for 10 days. It exhibited good stability both in the accelerated and long-term test. Conclusion The physicochemical properties of coenzyme Q10 emulsion with a high oil concentration meet the quality requirements for intravenous injection with good stability.
