The Pharmaceutical Research Of Xuanfei Zhike Oral Liquid

The formula of Xuanfei Zhike Oral Liquid, a remedy for cough, allergic cough, the respiratory tract infection, cough itching caused by cold, is an experiential prescription of Jiangsu Provincial Hospital of Traditional Chinese Medicine, which is made of several Chinese herbs, including Herba Ephedrae, Platycodon Grandiforum, etc. Systematical research was done on extraction, purification the effective component of Xuanfei Zhike Oral Liquid, on the molding process, and on the appraisal of stability. The Xuanfei Zhike Oral Liquid which was effective, with good taste and high quality, was successfully prepared out.Preparation Section:1.With the content of Ephedrine Hydrochloride, D-Pseudo-Ephedrine and Amygdalin presented in the extract as the index for the water extraction process, orthogonal designs were used to optimize the conditions for it in the research of preparing technology. The optimal process of water extraction was to add 12 times water, decocting 2 times,1 hour for each time.2.The alcohol precipitation technology of the extract has been evaluated by pharmacodynamic method. The result showed that the extract was fit to refine by alcohol precipitation after extracted by water. With the content of Ephedrine Hydrochloride, D-Pseudo-Ephedrine and Amygdalin presented in the extract as the index for the water extraction process, orthogonal designs were used to optimize the conditions for alcohol precipitation technology. The optimal alcohol precipitation conditions were as follows: concentrate water extract until its density was 1.10～1.15(60℃), add alcohol until concentration of ethanol becomes 60%, precipitated 24 h.3. The extract was further purified by pH adjuster, then the flavoring agent was added and the Xuanfei Zhike Oral Liquid was eventually obtained after encapsulation and sterilization.4. Pilot-scale experiments have been carried out using the studied preparation process.Quality Standard Section:1. TLC was used to identify Herba Ephedrae, Platycodon Grandiforum, etc, in the research of quality standard.The result showed that the stains were apparent and hardly disturbed by the negative contrast.2. The major index components, Ephedrine Hydrochloride, D-Pseudo-Ephedrine and Amygdalin in Xuanfei Zhike Oral Liquid were determined by HPLC, All of the 3 compounds were separated well and good linearity was obtained in the ranges of 0.0432～0.684μg (r=0.9999) for Ephedrine Hydrochloride,0.0488～0.976μg (r=0.9999) for D-Pseudo-Ephedrine, and 0.0470～0.9408μg (r=0.9998) for Amygdalin; The average recoveries (n=6) of Ephedrine Hydrochloride, D-Pseudo-Ephedrine and Amygdalin were 96.15%,96.09%,95.74%, and RSD were 0.78%,1.18%,1.80% respectively. So determination methods of Ephedrine Hydrochloride, D-Pseudo-Ephedrine and Amygdalin have been established using HPLC.3. According to the general principles for oral liquid, the preparation has been checked and the results met the requirement of Chinese Pharmacopoeia.Further study was carried out on quality standard.1 Distilling method was used to separate Ephedrine Hydrochloride, D-Pseudo-Ephedrine. The results showed that the method was simple, repeatable and the components could be separated well.2 Investegation was carried out on stability of Amygdalin in alcohol and water. Change rule of Amygdalin in alcohol and water was elaborated carefully, which also provided reference for futher study of Amygdalin.Stability Section:The accelerated stability test of the preparation has been researched. The technologies proved to be reasonable, stable and suitable to industrialized production through accelerated stability test.