Chinese Medicine Benefits Cardiac Brain Dripping Pills Preparation Process And Quality Standards

'Yi-Xin-Nao'Drop Pills has been used widely in traditional Chinese medicines to tonify the "Qi", activate blood circulation and get rid of blood clot. It comprises five medicinal materials, including Radix Astragali, Panax Notoginseng, Carthamus tinctorius L, Gardenia jasminoides Ellis and Borneol. In clinical practice, it is commonly used for treating cardiovascular disease, such as hypertension, atherosclerosis and coronary heart disease.Combining the traditional experience with modern technology, the extraction procedure, preparation technology of drop pills, borneol-p-cyclodextrin inclusion process and quality standards were studied in this paper.Firstly, Orthogonal design was adopted for conducting the multiple guidelines evaluation and selecting the optimum of extraction technology with astragaloside IV,PNS,HSYA,geniposide and the yield of extracts as the detective marker. The optimal extraction technology was by soaking for 24 h, then starting to percolate with 12 times volume of 60% alcohol at the speed of 5 mL·min-1.Secondly, Selecting inclusion complex yield and inclusion rate of borneol as the evaluation index, orthogonal design was used to optimize the best inclusion process. The simple and stable inclusion process was as follows:the weight ratio of borneol and P-CD was 1:8, the temperature was 40℃, and the reaction time was 1.5 h.Thirdly, the matrixe proportion, proportion between drug and matrix, and temperature of drug were selected as the detective marker to evaluate the molding technology. In addition, the dropping speed, height between dripper and refrigerant, and temperature of refrigerant were used as the evaluation index to optimize the drip procedure of'Yi-Xin-Nao'Drop Pills. The optimized preparation process was as follows:PEG 4000:PEG 6000 (1:2) was melted at 75℃, then the extracts, half the matrix, were added to the matrix, and started to drop. The height between dripper and refrigerant was 10 cm, and the dropping speed was 30 d·min-1. Lastly, the TLC method was adopted to accomplish the identification of materials for 'Yi-Xin-Nao'Drop Pills. Furthermore, the HPLC/UV method was used to the quantitative analysis of astragaloside IV,PNS,HSYA and geniposide in intermediate and preparation, and the GC/FID method was used to evaluate the quality of borneol in preparation. The proposed method could be used to improve the quality control level of'Yi-Xin-Nao' Drop Pills preparations and ensure the stable of the product quality.