Studies On The Preparation Process And Quality Standard Of Black Plaster A Pplication To Pediatric Dyspneic Cough

Objective: The application to pediatric dyspneic cough is a black plaster preparation which is prepared on the basis of years of clinical experience with the Pediatric Department of Wuhan Hospital of Traditional Chinese Medicine.It’s proved to have a good effect in the treatment of pediatric dyspneic cough and has been widely recognized in the society. However, the traditional preparation process tends to be decided by the experience of the veteran pharmaceutical workers, there is a serious lack of corresponding quantitative indicators in the process parameters, and research on the quality standard has lagged far behind. This research project aims at optimizing the preparation process of the application to pediatric dyspneic cough and formulating related quality standards in order to develop as early as possible such an application which is safe, effective, quality-stable and patient-friendly.Methods: ① Study on the preparation process: A single factor method is used to observe and study the preparation process of the application to pediatric dyspneic cough from the following aspects: the selection of the matrix raw material and refining devices, the temperature of oil refinery,putting of pellets and adding of white wax and fine material powder in the preparation process,as well as the most suitable method of eliminating the fire toxin.②Study onthe quality standard: In order to control the production quality of the application, microscopic identification is made to examine the sandalwood powder in the finished products, and the content of sinapine thiocyanate in the products is measured through the HPLC method. The chromatographic conditions are as follows: Eighteen alkyl silane bonded silica is taken as the filling agent; acetonitrile-0.08mol·L-1 potassium dihydrogen phosphate(10:90)as the mobile phase; the flow rate is 1.0ml·min-1; the column temperature is25℃; the detection wavelength is 326nm; and the sample size is 10 ul.through the intensity evaluation of its irritation to the rabbit skin and its allergy to the guinea pig skin,we make sure of the skin safety of the applicationResults: ①The pure sesame oil is the optimal vegetable oil for the preparation of the application.The best temperature of putting pure sesame oil and red lead with the purity above 95% is 313±6℃. The first frying temperature is264±9℃,the temperature of later material putting is between 180℃ and200℃,the fire toxin substance really exists, and white wax is used to eliminate the fire toxin instead of the traditional method.This research is conducive to improving the quality of the application.②The primary quality standard of the application has been established in a simple way with high sensitivity and good reproducibility. Through the measuring results of the test in the content of ten batches, the limit content of this product is ultimately confirmed, that is,the sinapine thiocyanate should not be less than 0.17 mg per paste.The study on the skin safety shows that the application to pediatric dyspneic cough is safe and reliable by adding wax to eliminate the fire toxin.Conclusion:The experiment shows that the preparation process of the application to pediatric dyspneic cough is stable and feasible, it meets the requirements of large-scale production, and the quality of the products is stable, controllable, safe and reliable.