Study On Preparation Process And Quality Standard Of Compound Bao Xin Tablet

Coronary heart disease(CHD) is a common and frequently-occurring disease which is harm for human health. Nearly10-15years, with the improvement of people’s living standard and working pressure increased, cardiovascular disease, With CHD increasing, CHD has been become one of the main diseases of threating the people’s life and health. Compound Bao Xin tablet comes from empirical formula, and its medicinal substances consist of Rhodiola, Safflower, Radix Aucklandiae, Fructus Choerospondiatis and Olibanum. These medicinal substances is all rigorous combined and thoroughly administered, after years of clinical application, it has a good effect to treat the CHD. The powder is not easy to take and carry, so modern preparation should be made to substitute traditional preparation.In the extraction process of compound Bao Xin tablet, according to the different property of medicinal effective components, Rhodiola and Fructus Choerospondiatis were extracted by reflux, The essential oil of Radix Aucklandiae and Olibanum was obtained by steam distillation and the effective ingredient of Safflower were extracted by heating-circumfluence as less time as possible. Using single-factor experiment and orthogonal experiment, the optimum conditions of the extraction were determined by the content of salidroside and Hydroxy Safflower Yellow A. The best condition of the volatile oil extraction of Radix Aucklandiae and Olibanum was adding10times amount of water and extracting for3h. The Volatile oil and extracting solution was obtained to reserve.after filtration, the dregs and Safflower were adding10times amount of water and extracting for0.5h. Rhodiola and Fructus Choerospondiatis were extracted twice, each time adding10times amount of wate for 2h. The best processes of concentration were as follows:relative density been1.05(40℃) of vacuum concentration,70%ethanol, for18hours. The extracta was obtained by vacuum concentration and drying in vacuum.In the preparation process of compound Bao Xin tablet, Using single-factor experiment and central composite design, the optimal preparation prescription and preparation process were determined by comprehensive score. The optimal conditions were as follows:the volatile oil been Included by6timesβ-cyclodextrin for4hours, acquired inclusion complex to reserve. The extracta been pulverized, sieveded, adding into inclusion complex, Starch, MCC, CMS-NaO.05g, been made into particles by95%ethanol.60℃drying, granulation, joining the prescriptions of magnesium stearate, talcum powder, CMS-Na0.1g, mixing, pressing piece. Packaging film, packing.The results showed that compound Bao Xin tablet was prepared by the optimal process was up to the standard of the Chinese Pharmacopoeia (2010th edition).To study quality standard of compound Bao Xin tablet, the characteristics, qualitative identification, and the content and dissolution test were examined. The qualitative identification of Rhodiola, Safflower and Radix Aucklandiae were set up without negative interference. The content of salidroside was determined by high performance liquid chromatography, and methodological tests were studied. The linearity range of salidroside was0～84.00μg·ml-1. The average content of three batches were1.95mg, RSD=0.33%.So the content of salidroside in this quality standard was not less thanl.56mg. The result of dissolution test showed that the dissolution trended to balance in60min, The quality of Compound Bao Xin tablet prepared was in conformity with the requirements of Chinese Pharmacopoeia...