ABSTRACT
The Chinese Food and Drug Administration issued the new Good Laboratory Practice(GLP)for nonclinical safety studies in September 2017,which emphasizes the peer review during the pathology practice.Pathology peer review could verify and im?prove the accuracy and quality of pathology diagnoses and interpretations in discussion.Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies.The objectives of this review are to provide a unified interpretation of the new regulation and recommend compliant processes for organizations to implement.
ABSTRACT
In present study, a method for analyzing the absorbed ingredients of traditional Chinese medicine QinJiao has been developed. A rat everted gut sac (EGS) model has been established, and the transporting capacity of gut sacs was identified by histological examinations. The ingredients including loganic acid, sweroside, gentiopicroside, and swertiamarian in serosal solution absorbed by active transport of rat everted ileum and jejunum from Qinjiao extraction were determined using an HPLC method. Histological integrality of the gut sacs remains perfect and the active transport activity of them is normal within 45 min of the experiment. The HPLC method employed in this study presents high specificity and good correlation. The relative standard deviation of precision of this method is less than 5.5%. Extraction recovery of samples is more than 90%. And stability of the samples in room temperature is perfect. Eight ingredients of Qinjiao absorbed in serosal solution are identified. Furthermore, concentration of Qinjiao extraction significantly affects accumulated absorption and absorption coefficient of the ingredients. However, there is no significant impact on the accumulated absorption and absorption coefficient by diverse of everted gut sections. From above, the EGS techniques might be an efficient method, which can be employed for investigation of absorbed ingredients of Traditional Chinese Medicines.