OBJECTIVE To observe the toxic effects of single administration and repeated administration of Qingzi granules for 13 weeks on rats, and to evaluate their preclinical safety. METHODS For the single dose toxicity experiment, SD rats were randomly divided into two groups, vehicle control group(deionized water) and Qingzi group(18 g·kg-1), which were given in a volume of 30 mL·kg-1 per time, twice in 24 h(interval more than 4 h), and observation was performed for 14 d after administration. The toxicity reaction was evaluated through observation of body weight change and pathological anatomy. For the repeated dose toxicity experiment, juvenile SD rats(postnatal day, PND 4) were randomly divided into vehicle control group (deionized water) and low, medium and high dose of Qingzi groups(1, 2 and 4 g·kg-1). The rats were orally administered twice daily with vehicle or Qingzi for 13 weeks in a volume of 10 mL·kg-1 per time. A recovery period of 4 weeks was followed. Test items included clinical observations, body weight measurement, food intake measurement, hematology test, biochemical test, urinalysis, sex hormone level determination, cellular immune function assay, growth indexes and histopathology test. RESULTS For the single dose toxicity experiment, Qingzi granules were orally administered to SD rats without significant toxicity, and the maximum-tolerated dose was greater than 18 g·kg-1. In the repeated dose toxicity test, juvenile SD rats were given Qingzi granules by gavage and repeated administration for 13 weeks, the no observed adverse effect level was 2 g·kg-1. The target organ of toxicity was the liver and the main toxic effect was inflammatory necrosis of hepatocytes, no dose-dependent relationship. CONCLUSION No overt toxicity of Qingzi granules was observed on the tested animals within the intended clinical dosage range.

ABSTRACT Taste is an important factor influencing the efficacy of oral formulations and patient compliance. Children have unique pathological and physiological characteristics and poor tolerance to adverse taste, which leads to inaccurate dosing and high risk of medication administration. Therefore, the establishment of an objective and scientific taste evaluation method is an important part of the research and development of drugs for children, which has important clinical significance and scientific value. This research group organized experts in the field of taste design and evaluation of pediatric drugs from five dimensions: instrumentation, research and development, clinical, review, and regulation, to clarify the current situation, discuss problems, and propose strategies for improvement, so as to provide reference for the development of suitable oral formulations for children.

Objective    To investigate the diagnostic value and the best criteria of multiplanar reconstruction (MPR) of spiral CT in recurrent laryngeal nerve lymph node metastasis. Methods    We performed multiplanar reconstruction of the spiral CT data of 138 esophageal carcinoma patients admitted to our hospital between December 2016 and June 2019, including 113 males and 25 females with an average age of 47-85 (63.03±15.58) years. The short and long diameters of recurrent laryngeal nerve lymph nodes were measured respectively, and then ratio of short to long diameter was calculated. The three parameters were contrasted with the pathological results and the receiver operating characteristic (ROC) curves for the parameters were drawn. Results    Of the 138 patients, 291 left recurrent laryngeal nerve lymph nodes were dissected with an average number of 0-14 (2.11±0.41) per patient and the metastasis rate was 16.70%; while 436 right ones were dissected with the average number of 0-17 (3.16±0.45) per patient and the metastasis rate was 21.00%. The total metastasis rate was 29.70%. In the diagnosis of lymph node metastasis, the areas under ROC curve for short and long diameters as well as the ratio of short to long diameter of left recurrent laryngeal nerve lymph nodes were 0.808, 0.779, 0.621, respectively, while those for the right ones were 0.865, 0.807, 0.637, respectively. Conclusion    The metastasis rate of recurrent laryngeal nerve lymph nodes is high and the short diameter has a higher diagnostic value for recurrent laryngeal nerve lymph node metastasis.