Study On The Pharmaceutical Preparation Technology And Quality Control Of Agastache Rugosa Righteousness (Huo Xiang Zheng Qi Pian)

huo xiang zheng qi prescription is one of most general used Chinese traditional medicines. It supports the health of the nervous, immune, and gastrointestinal systems. It also helps restore alertness when experiencing fatigue, and reduces flatulence. Recently, its external efficacy was proved by the clinical practice, in particularly, the curative effect on the disease of dermatology was outstanding. There are many kinds of huo xiang zheng qi herbal prescriptions in market, for example huoxiang zhengqi tincture,huoxiang zhengqi pills, huoxiang zhengqi tablet, huoxiang zhengqi capsules, oral liquid, etc.. Compare to other prescription types, huoxiang zhengqi tablet has several advantages, e. g., storage durability,convenience for carry and volatilization resistance. In this paper, the optimization of technological condition of the pharmaceutical preparation and quality control are discussed.Through the experiments, the original technological condition was improved and optimized. Using the collected amount of the essential oil (an active component) from atractylodes lancea rhizome as standard, the effects of extraction time and water amount were studied. Using amount of extract ointment and hesperidin as index, the effects of (i) water amount in areca catechu pericarp and poria cocos, and (ii) 60% ethanol amount in angelica dahurica root, atractylodes lancea rhizome and magnolia officinalis bark, extraction process were also studied. Orthogonal design was used to optimize the preparation technology of experiments.The quality control of industrial process of huo xiang zheng qi tablet was established by the experiment. This paper also describes a method to identify the composition in perilla frutescens and angelica dahurica root. We demonstrate that the method has excellent separation effect, specificity and reproducibility. A HPLC-based quantitative determination of active component in Citrus reticulata pericarp was established, and the linear relation, stability, reproducibility, accuracy and recovery of the method were also studied. The experimental results show that the method has high sensitivity and good stability. In addition, heavy metals, arsenic and microbes in production process were monitored. In this experiment, critical relative humidity and pharmaceutical parameters of coating were determined. Based on the optimized process, middle scale production of Huxiang Zhengqi tablet was applied. The results indicate that the optimized process is stable and feasible, advanced in theory and practical in technology, which is suitable for the large scale production.