Analysis on the expression of drug standards and related issues in the newly revised Drug Administration Law / 中国药房

OBJECTIVE To sort out and analyze the expression and provisions of drug standards in the text of the newly revised Drug Administration Law ，and to explore the connotation and legal positioning of drug registration standards so as to provide reference for the rational application and interpretation of relevant provisions of drug standards in Drug Administration Law . METHODS Through the review of the evolution of drug standard management in China ，the legal provisions of drug standard in the Drug Administration Law were analyzed. Comparative study and literature research methods were used to analyze the legal expression and connotation of drug standards. RESULTS & CONCLUSIONS There were different expressions about “national drug standards ”“drug standards ”and“quality standards ”in the current provisions of the newly revised Drug Administration Law ； the legal position of the provincial-level standard for the preparation of Chinese herbal pieces was not clear ，and there may be insufficient legal regulation in the enforcement of drug administration. It is necessary to make an administrative interpretation for the content of relevant drug standards and provisions ，and further clarify the legal attributes of drug standards in the processing of provincial Chinese herbal pieces in order to promote the standardized management of Chinese herbal pieces.

Optimization of Extraction Process for Polysaccharide from Fermented Cordyceps Sinensis Powder by Response Surface Methodology / 广州中医药大学学报

Objective To optimize the extraction process for the polysaccharide from fermented Cordyceps Sinensis powder with response surface methodology.Methods We selected the factors and levels on the basis of single factor experiment,and then designed the experiment with 3 factors and 3 levels based on the principle of Box-Behnken's design.Results The effect of the factors of extraction temperature,time and solid-liquid ratio on extraction ratio was in decreasing sequence.The optimal extraction technology obtained through the classical analysis was as follows:extraction temperature at 95 ℃,the ratio of solid to liquid being 1 ∶ 21,and extraction for 73 min.Under this condition the theoretical extraction rate was 4.31％ and the actual extraction rate was (4.20 ± 0.1)％.Conclusion The obtained values agree with the predicted values of the mathematic models,and the Box-Behnken experimental design is suitable for optimizing the extraction of the polysaccharide from fermented Cordyceps Sinensis powder.