| Traditional Chinese Medicine Preparations (TCMP) is an important part of Traditional Chinese Medicines (TCM) which is the sum of medicine experience of the labouring people in long time and has played a great role in the prosperity of Chinese nation because of their precise composition, good curative effects and little side-effects. However, TCMP is faced with many problems such as outdated dosage forms, backward techniques, which have hindered the development of TCM undertakings and movement toward the world. It is urgent to study TCMP by making full use of advanced science and techniques.Compound Danshen tablets (CDT), listed in the first section of the 2000's edition of "Pharmacopoeia of the People's Republic of China", consists of the extract of radix Salvia miltiorrhiza (Bunge), root ofPanax notoginseng (Burk), borneolum. It is primarily applied to the treatment of coronary artery disease, angina pectoris. In this thesis, CDT was selected as the model drug of Traditional Chinese Medicine compound multi-layer sustained release tablets (TCMCSRT) because of only three herbs in the recipe, more extensive basic researches and good curative effects. The main researches made and results were as follows.1. TLC methods were used to identify the Danshensu (DS), protocatehuic aldehyde (PA), ginsenoside Rgi, Rbi, and borneol. The methods of UV for total panax notogiseng saponins (PNS). The HPLC for SD, PA and ginsenoside Rgi and the GC for borneol were developed to detect their contents in the preparations. The HPLC method with fluorescence detection was the first analytical method for the determination of DS in dog plasma. Above-mentioned analytical methods were simple, accurate and suitable for in future study of compound Danshen multi-Layer sustained release tablets (CDMSRT).2. The factors such as heating temperature, decoction time, alcohol concentration, which was influenced on the extraction and purification of target constituents were investigated. The extraction processes of radix Salvia miltiorrhiza and root Panaxnotoginseng were optimized using the uniform design respectively. The extraction of Salvia miltiorrhiza (ESM) was obtained by boiling the crude herb with water and precipitating with alcohol, whose DS content was 5.7%. Extracts of Panax notoginseng (EPN) was drawn with 30% alcohol and purified with macroporous resin D101, the total saponins content was 85.0%. Ginsenoside Rg1, Rg2, Rb1, Rd1, Re, notoginsenoside R1, R2, R3, R4, DS, PA, protocatechuic acid, salvianolic acid A, B, C, D, E, F were differentiated from the extracts through LC/MSn. It implied that there was no marked difference in the kinds of main constituents between crude herbs and the extracts. The study on the pharmacodynamics indicated that compound Danshen extracts (CDE) could evidently increased isolated guinea pig ardiac coronary artery blood flow (P < 0.05) and nullified the pituitrin-induced electrocardiographic ischemic ST-T (P < 0.05) as compared with control group. But there was no significant difference (P > 0.05) between CDE and Compound Dropping Pills. It seemed that the majority of effective constituents of CDT were still retained in the CDE, and the preparation processes for CDE were proper and practicable.3. The study on physicochemical properties of compound Danshen powders (CDP) showed that ESM and EPN were hydrophilic. Borneol was hydrophobic, whose solubility could be increased when it was compatible with EPN. Treatment with the light, temperature and moisture, the content of DS, PA and Rg1 in ESM and EPN were kept unchanged. The flowbility of CDP was poor. EDS was hygroscopic. Borneol possesed sublimation. Intestinal absorption experiments of rats in situ were used to study the absorption of DS, PA and borneol in CDP for the first time. It was found that the absorption of DS, PA and borneol complied with the first order kinetics by passive transport mechanism and was obviously influenced by pH value of regurgitation fluid, with and without ligation of rat's bile duct. There were no...
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