Feiyanqing Micro Enema Pharmaceutical Research

"Feiyanqing micro-enema" is developed on the basis of the experimental prescription of Hubei hospital of Tradional Chinese Medicne, which is composed of several Chinese herbs, including Scutellaria baicalensis Georgi, Fructus gardeniae, Herba ephedrae, Radix peucedani, Radix salviae miltiorrhizae, Radix sophorae flavescentis, etc. It has the functions to ventilate lung and stop cough, disperse sputum and relieve asthma, clear away heat and remove toxins, low down Qi and promote blood circulation. It is used in clinic to treat children viral-pneumonia and bacterial-pneumonia with significant effects. We have made reforms on its original decoction form. By using the modern technology, we have produced a high-concentrate and low-dosage liquid medicine: micro enema. Thus the drug can make effect on some specific areas or the holistic body through rectum absorbing, and it has the virtue of high bioavailability, quick absorbing and effect. So that it will be more suitable for patients of children or those could not take medicine by oral. We have researched this drug according to the national standard of new-drug, including pharmaceutical technology, quality standard, stability test, pharmacology experiment and so on. Therefore, it provides the scientific proof for its clinic effect.In the way of researching, we adopted natural clarifying method (ZTC, PCC-Agent) and ethanol subsiding method to refine the water decoction of scutellaria baicalensis and Feiyanqing micro-enema prescription. Natural clarifying agent sort, concentrate proportion and temperature were set as study factors, and three levels were set respectively, using HPLC method to measure baicalin content by way of review guideline, combining finished product's meet standards, using L9(33) orthogonal experiment to optimize the preparation process of Feiyanqing oral liquid. The best clarifying condition is: IV ZTC1+1 natural clarifying agent, concentrate proportion 1:1, temperature 25℃.In the research of formulation process, we set the final concentrate proportion at 300%(ml*g-1) and single package at 10ml for each piece of drug according to its clinic dose.In the research of pharmaceutical technology stability, we studied three bulks of pilotscale experiments, including such quality examinations as character, content uniformity, PH, microorganisms limit, identification by TLC and content determination. The results showed that all the three bulks of productions had met the corresponded standard.In aspects of the quality standard and stability test, we investigated the use of TLC on the separation and identification for Herba ephedrae, Radix peucedani, Radix salviae miltiorrhizae, Radix sophorae flavescentis, Fructus gardeniae in the prescription. The results showed that all the spots were separated satisfied. The content of geniposide in Fructus gardeniae and baicalin in Radix scutellariae were determined by HPLC. HPLC method for baicalin was as follow: Agilent Zerbax Extend C18 column (5μm, 4.6mm×250mm) . The mobile phase was consisted of CH3OH:H2O: phosphate acid(53 : 47 : 0.0282). The detection wavelength was at 278nm. Flow as 1.0mL. min-1, temperature at 25℃, inject volume was 10μL. HPLCmethod for geniposide was as follow: Agilent Zerbax Extend C18 column 4.6mm×250mm), The mobile phase was consisted of CH3OH : H2O(21 : 79), The detection wavelength was at 240nm, Flow as 1.2mL.min-1, temperature at 35℃, inject volume was 10μL. The results showed that the methods were simple, special and accurate, and it could be used as a reliable base for quality control of this drug.In order to inspect the stability of "Feiyanqing micro-enema", the room temperature and the accelerate test(T:40℃, RH:75%) for three months had been carried out. The results showed that every index mark were normal in the experiment period.In the studies on pharmacological effects and toxicology experiments, we adopted latent period observing method, sprayer to asthma method and phenol red in trachea method respectively to study the effect of cough relieving, asthma relieving and phlegm...