ABSTRACT
OBJECTIVE: To understand the quality status and problems of human albumin. METHODS: A total of 153 batchs human albumin samples from 33 manufacturers were analyzed according to the legal quality standard. Three exploratory researches on human parvovirus B19 screening, protein impurity and influencing factors of alum inumion content were conducted. RESULTS: The qualified rate of the 153 batches of samples was 100.0%. The positive rate of B19 DNA in 60 batches from 33 manufacturers was zero. Twenty-three types of other plasma protein were identified in 28 batches of samples from 27 manufacturers. The increase in aluminum contents was related with glass bottle and citrate ion content.CONCLUSION: The overall quality of human albumin is good. However, the content of aluminium ion increases significantly during storage. It is suggested to conduct further study on the influencing factors of aluminium ion content.
ABSTRACT
OBJECTIVE: To analyze and evaluate the quality status of Yigan Jiedu Capsules for providing evidence for its standard improvement and standardized production. METHODS: According to the problems found in the standard test, combined with the quality status of the original medicinal materials, exploratory research was carried out from the aspects of authenticity, safety, consistency and effectiveness of the drug, and a number of detection methods were established to analyze the quality of the preparations and the original medicinal materials. RESULTS: The qualified rate of inspection was 99.2%. The results of exploratory research indicated that some manufacturers may have problems such as false material feeding and insufficient material feeding. CONCLUSION: The overall quality of Yigan Jiedu Capsules is generally good, and the quality standard needs to be improved.
ABSTRACT
OBJECTIVE: To evaluate the quality status of Sanqi Shangyao tablets. METHODS: Based on the results of statutory inspection and exploratory research, the quality evaluation regarding authenticity, effectiveness, and safety, was carried out. RESULTS: The qualified rate of inspection was 98.8%. Some problems, such as inconsistency of preparation process of standards and illegal dying, were discovered in some samples. CONCLUSION: In general, the overall quality of Sanqi Shangyao tablets is good. Some deficiency in the quality standards deserves further concern.