Studies On The Key Technologies For Process Optimization Of Coldrine Granules

Coldrine granules, with annual sales of over one billion yuan, is the first brand of domestic cold medicine sales. It comes to the market before the implementation of Drug Administration Law. Limited to the present research and development level and production equipment condition, the preparation method and process control parameters are relatively rough. As a result, poor quality consistency among batches frequently appears. Therefore it is urgent to upgrade the technologies of large varieties of traditional Chinese medicine (TCM).As the only TCM quality control indicator of coldrine granules, linarin is thermally unstable. Its content will be changed significantly easily during the production process, which will then affect the quality of the finished product. In order to increase the recovery rate of linarin, this paper systematically explores the process optimization method of TCM extract of coldrine granules from extraction, concentration and drying processes. The research results have provided experiment basis and theoretical guidance for the technology upgrade of the large variety of TCM. The main researches are as follows:1. A new HPLC method was established for determining the content of linarin, specific to quantitative analysis of intermediates and process quality control of coldrine granules. On this basis, the extraction process of coldrine granules was optimized by single factor test and orthogonal experiment. Linarin extraction ratio and 65% ethanol extract were adopted as the double evaluation indexes. At the same time the effects of the extraction time, times, and solid-liquid ratio on linarin were studied thoroughly.2. With respected to the concentration process of coldrine granules, the thermal stability and the law of degradation of linarin were studied. The experimental results showed that degradation reaction of linarin belongs to the first reaction characteristics. The effective methods to reduce the loss of linarin would be strictly controlling the heating temperature and shortening the heating time.3. The new drying process of coldrine granules was studied. The vacuum belt drying was compared to other conventional drying methods and the result conformed that it was the best drying method for coldrine extract. On the basis, the optimum drying process parameters were investigated by orthogonal experiment. The experimental results showed that the vacuum belt drying was suitable for the industrial production of coldrine. In addition, the key for drying process control was controlling the heating temperature and heating time strictly, to ensure that the linarin content and moisture content of the dry products conformed to standard requirements.