Quality Evaluation of Acetylspiramycin
- VernacularTitle:乙酰螺旋霉素的质量评价
- Author:
Zhuo CHEN
;
Liping WANG
- Publication Type:Journal Article
- Keywords:
Acetylspiramycin;
Quality evaluation;
Impurity profie;
Related substance;
Dissolution;
Consistency assessment
- From:
China Pharmacist
2016;19(9):1800-1803
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the quality condition and problems of acetylspiramycin at present. Methods:According to the standard described in Chinese Pharmacopoeia (2015 edition), acetylspiramycin and its preparations were determined, and the overall quality level of domestic acetylspiramycin was evaluated. The related substances, components and dissolution were analyzed to further explore the quality status. Results:In 258 batches of samples, the dissolution of only one batch did not meet the standard with the passing rate of 99. 6%. The results of exploratory research showed that the content of impurities in raw material was determined by the synthesis process, and the impurity profile of domestic and foreign formula was different. The dissolution behavior of domestic and for-eign formula in four kinds of media was not similar as well. Conclusion: The quality of domestic acetylspiramycin is promising. The research of related substances provides the reference for controlling the target impurities. The consistency assessment of dissolution pro-vides the reference for the formula process improvement and clinical application of acetylspiramycin tablets.
