Comparison of Statistical Analysis of Biological Assays of Anticoagulation Activity of Leeches between European and Chinese Pharmacopeias / 中国药学杂志

OBJECTIVE: To compare two biological standardization calculation methods for evaluating the anticoagulation activity of different leeches in the same measure. METHODS: Heparin was used as the reference substance. The APTT values of W. pigra, H. nipponica and P. manillensis were used as the anticoagulant activity evaluation potency. The slope ratio model of European Pharmacopoeia 7.0 and the parallel reaction model of Ch.P 2015 were used to calculate the activity and the results were compared. RESULTS: The logarithm dose response curves of three kinds of leeches displayed linear relationship. Both of biological standardization statistical methods could be used for the calculation. The slope ratio model complete randomized design(0, 3, 3) of European Pharmacopoeia 7.0 was suitable to calculate the activity potency of different leeches, but the parallel reaction model of Chinese Pharmacopoeia 2015 was only suitable for P. manillensis. CONCLUSION: Taking the anticoagulation potency of heparin sodium as the reference, the slope ratio model complete randomized design(0, 3, 3) of European Pharmacopoeia 7.0 can be used as a standard method to evaluate the anticoagulation activity of different leeches.

Orthologous Allergens and Diagnostic Utility of Major Allergen Alt a 1

PURPOSE: Hypersensitivity to fungi is associated with rhinoconjunctivitis and asthma. For some fungi, such as Alternaria alternata (A. alternata), the symptoms of asthma are persistent, increasing disease severity and the risk of fatal outcomes. There are a large number of species of fungi but knowledge of them remains limited. This, together with the difficulties in obtaining adequate standardized extracts, means that there remain significant challenges in the diagnosis and immunotherapy of allergy associated with fungi. The type of indoor fungi related to asthma/allergy varies according to geographic, climatic, and seasonal factors, making their study difficult. The aim of this study was to determine hypersensitivity to indoor fungi in a population from Cuenca, Spain. METHODS: Thirty-five patients with symptoms compatible with rhinitis or asthma who showed clear worsening of their symptoms in their homes or workplace were included. In vivo and in vitro tests were made with a battery of fungal allergens, including the species isolated in the home or workplace. RESULTS: Ulocladium botrytis (U. botrytis) and A. alternata were the most representative species as a source of home sensitization. These species showed very high concordance in skin tests, specific IgE, and histamine release. The allergen Alt a 1, which was recognized in all patients, was detected in A. alternata, U. botrytis, and Stemphylium botryosum (S. botryosum). CONCLUSIONS: U. botrytis and A. alternata were the most representative species as a source of home sensitization. Alt a 1 was recognized in all patients and may be considered a non-species-specific allergen that could be used as a diagnostic source of sensitization to some species of the Pleosporaceae family.

Assay of anticoagulation activity of leeches by using biological standardization method / 中国药学杂志

OBJECTIVE: To assay the anticoagulant activity of leeches by using biological standardization method with the aim to explore the quality control method which can reflect the biological activity. METHODS: Heparin was used as the reference substance, and APTT value was used as the index of anticoagulant activity evaluation. Four species of leeches were determined, including Hirudo nipponia Whitman, Poecilobdella manillensis Lesson, Poecilobdella javanica Wahlberg, and Whitmania pigra Whitman. The determination results were calculated with standard curve and bioassay statistics. RESULTS: The concentration-response curves of APTT of the four species of leeches were similar to that of heparin, and their variation ranges were parallel. CONCLUSION: APTT values can reflect the comprehensive anticoagulant activity of different species of leeches, which may have more clinical significance. Biological standardization is a good supplement to the current quality control methods, also a proper technology for the quality control of TCM.