[Reflections on supervision strategies of new Tibetan drug registration].

Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.

[Development and evaluation of an inquiry scale for diagnosis of heart system syndromes in traditional Chinese medicine].

OBJECTIVE: To develop an inquiry scale for diagnosis of heart system syndromes, and to discuss the provisional standardization of the inquiry method in traditional Chinese medicine (TCM). METHODS: Based on scale-making method, Chinese medicine theory and literature searching, an inquiry scale for diagnosis of heart system syndromes in TCM was developed. Statistics method, frequency counting and Delphi method were used for analysis. The inquiry scale was revised and tested repeatedly to check the test reliability, internal consistency reliability, and content validity, etc. RESULTS: The inquiry scale for diagnosis of heart system syndromes mainly covered basic data, chief complaint, history of present illness (accompanying symptoms) and past history, with appendix of inspection and palpation information as well as diagnosis made according to traditional Chinese and Western medicine. Among them, general inquiries covered fever and chills, sweating, head-body and chest-belly symptoms, taste and diet, stool and urine, sleep, mood, and gynecologic symptoms, which were scaled in 8 dimensions. And 66 symptom variables were screened finally. The scale had a good content validity and its coefficient alpha was 0.82. For the results of test-retest reliability, the Kappa values of using the scale for diagnosis of heart-qi deficiency, heart-yang deficiency, turbid phlegm, and cold coagulation twice by the same doctor ranged from 0.74 to 1, showing that the consistency of the scale was relatively high. The Kappa values of evaluation of scorer reliability in diagnosis of heart-qi deficiency, heart-yang deficiency, and heart-yin deficiency were also high, which were 0.63, 0.72, 1 and 0.48 respectively. Other results of diagnosis had low-consistency or even no diagnostic agreement. CONCLUSION: The research on the scale for inquiry in TCM indicates that it is feasible for the standardization of inquiry scale for diagnosis of heart system syndromes in TCM, offering a reference for research on the inquiry scales for other systems.

[Eutrophication and pollution level of microcystin in Dianshan Lake].

A survey was conducted in Dianshan Lake to study the eutrophication indexes including total phosphorus (TP), total nitrogen (TN), pH, temperature, diaphaneity and chlorophyll-a level and dominant algae in seasons. The impacts of temperature, light, nitrogen and phosphorus on growth of and microcystin LR production by Microcystis aeraginosa strain under laboratory conditions were studied. Relationship between algal cell density and concentration of microcystin LR were studied. Results suggest that water in Dianshan Lake was eutrophicated. The suitable seasons for algae growth are the end of spring and summer. The annual average of TP and TN were 1.93 mg/L and 0.18 mg/L respectively. And 93.5 and 92.2 percent of TP and TN were higher than the criteria for the third class water body. Significant impact from agriculture was indicated since the peak of algae laged one month after the maxium use of fertilizer. The dominant algae in Dianshan Lake were cyanobacteria, bacillariophyta, cryptophyta and euglenophyta. Microcystis, anabaena and synedra, which excrete toxins and indicate water pollution, and are dominant algae species in summer. M. aeraginosa strain had a biggest growth rate at temperature of 25 degrees C and light intensity of 3 0001x, while microcystin LR production contents reached maximum at 20 degrees C and 5000lx respectively. The optimum TP and TN concentrations for growth of and toxin production by M. aeraginosa were found to be 650 micromol/L and 6.5 micromol/L respectively. TP is suspected to be the limiting factor for the growth of algae both in field and laboratory conditions. Positive correlations between total microcystin LR concentrations and algae cell density or M. aeraginosa cell densities are found. The algae cell density can be used to predict the level of algal toxins in water.