Quality evaluation and specification research of transfer factor injections / 中国药学杂志

ABSTRACT

OBJECTIVE: To understand the quality status and problems of domestic transfer factor injections and evaluate the suitability of statutory standard and additional explorative researches. METHODS: Fifty-seven batches of transfer factor injections were analyzed according to the legal quality standard and the results were statistically analyzed to assess the overall level of quality. The qualities of the products form different manufacturing enterprises were compared. According to the explorative researches, the overall situation of product quality and standard condition were then comprehensively evaluated. RESULTS: The qualified rate of the 57 batches of samples was 91.2%. Four samples failed due to visible foreign substances and one sample failed due to unqualified content of ribose. There were obvious differences between the results of legal test and exploratory research. The results reflected some defects and problems of the legal quality standard which was greatly improved and revised in our research. CONCLUSION: The overall quality status of transfer factor injections is not ideal. The results of exploratory research demonstrate that many defects exist in the legal quality standard and a series of exclusive, accurate and sensitive methods should be established to fully control the quality of transfer factor injections.