ABSTRACT
Quality control of Chinese materia medica (CMM) is an effective measure to ensure the safety and effectiveness of CMM in clinical practice, which is also a bottleneck to restrict the modernization process of CMM. Regarding the current quality evaluation model of CMM, we reviewed the research strategies of quality control for CMM at the present stage from the perspectives of "discrimination of authenticity" and "assessment of superiority" to state the research status and development tendency of quality standard of CMM. What's more, we put forward a new quality control pattern of CMM based on "identification of herbal origin, study on material basis, discrimination of quality markers (Q-markers), and development of quality control method". An in-depth study of material basis based on authentic CMM was implemented to discriminate "Q-markers", and further developed a quality control method to control the quality of CMM. Finally, a quality control standard has been established to meet the characteristic of CMM.
ABSTRACT
OBJECTIVE:To correct the standard of bismuth content in Weishusan.METHODS:The contents of effective bismuth in Weishusan and other three reference substances were detected by compleximetry.After adjusting the dosage of Weishusan,clinical rank sum test was carried out.RESULTS:The content of bismuth in original formula of Weishusan was rather high,therefore the inventory of bismuth subcarbonate in preparation technic of Weishusan should be reduced to7.0kg.CONCLUSION:The quality standard should be reformulated as bismuth subcarbonate0.1g(?10%)in per gram of Weishusan.