Study On The Process And Quality Standard Of Compound FJ Spray

As a traditional Chinese Medicine with great therapeutic effect, FJ is recorded in the first edition of 2005 Chinese Pharmacopeia. It has anti-bacteria, immunity-adjusting, anti-oxidizing and tissue recovery expediting functions. This article is to develop FJ Compound Spray by taking FJ’functional fraction as the principal agent and combining other adjuvant medicines together.The main contents and results of our study are as follows:The FJ’s functional fraction for infective dermatitis was obtained for the first time with a process of separation and purification. The optimal method for extraction from the selected crude FJ through the orthogonal experiment is ultrasound refining the 10-time concentrated 95% ethanol solvent for half an hour. The best method to refine FJ through ethyl acetate extraction technique is extracting FJ from double acetic ether mother liquor with 1g/ml concentration for 4 times. The experiment proved that the total amount of flavones was up to 50% in the effective fraction.This paper has made a systematic research about the manufacturing technique of compound FJ spray at the first time. The spray is a laky and pellucid liquid that meets the criteria of Pharmacopeia. The manufacturing technology of this spry is simple without any special equipment requirement. Thus, it has high feasibility of production.A systemic research on the packaging of FJ spray was carried out in our study. The volume Disparity of each package, the spraying availability of each bottle, the content of the principal agent at every spray and the Asepsis inspection all meet the criteria of Pharmacopeia.A thin layer chromatography (TLC) method was firstly established with the quality standard of the compound FJ spray. The UV-Vis and HPLC methods were established to control the contents of the effective fraction. This content detection technique has been proved to be a convenient, accurate, stable and effective one to control the quality effectively.This paper has also undergone the observations upon the acceleration test and the influencing factor test. After inspection, it meets all the quality standards.