| Based on the prescription of Danqi Tablet in national drug standards, this project aimed at the clinic characteristic and property of the effective part, and systematically studied the extraction, separation, purification and preparation procedure of the sustained-release. As a result, the sustained-release capsule with better quality has been made. Furthermore, the bio-adhesion, quality control and absorption principles had been studied deeply. It has provided a new research route for the development of compound and sustained-release dosage form of Chinese medicine.Taking the contents of effective components or parts as the evaluation indexes, the procedure of three effective parts was studied with orthogonal test and mono-factorial test. Firstly, the more effective way to extract effective part from Danshen was to percolate with 12 times amount of 60% alcohol. With the technique of macroporous adsorbing resin, the liposoluble effective part was adsorbed by macroporous adsorbing resin B in advance, and the water-soluble effective part was adsorbed by macroporous adsorbing resin Y. Then 95% alcohol was used to elute the former; the liposoluble effective part of Danshen was prepared. Its yield was 0.3% and content was 50%. Secondly, 70% alcohol was used to elute macroporous adsorbing resin (Y); the water-soluble effective part of Danshen was prepared. Its yield was 11% and content was 14%. Finally, the more effective way to extract effective part from Shanqi was to percolate with 9 times amount of 80% alcohol. With the technique of macroporous adsorbing resin S, the total saponins part was adsorbed.60% alcohol was used to elute, and the liposoluble effective part of Danshen was prepared. Its yield was 8% and content was 90%.Taking Tanshinone IIA as the evaluation indexes of extra-corporealsustained-release, the capsule procedure was studied in such aspects, i.e. the category, amount and ratio of addendum with monofactorial test. The optimum prescription of 1000 capsules is 83.8g effective parts, 50g addendum A-b, 40gaddendum B and 10g lactose. Furthermore, the quality standard of the semi-finished articles was given in such aspects, i.e. the critical relative humidity (68%), bulk density (0.347g/ml) and angle of rest (37.8?. With the foundation of above, the environment, condition of produce and the type capsule (size 2) was confirmed.Rarga's methods, which are simple and prone to operate, were employed to determine the subsistence quantity of Danqi sustained-release capsule contents in the rats' stomach and small intestine mucosa. Then the bio-adhesion of the capsule with rats' stomach and small intestine mucosa was detected. Results showed that the subsistence ratio is 63.98% in rats' stomach mucosa and 74.28% in small intestine mucosa. Therefore, it has a good bio-adhesion that can meet the need of sustained-release preparation.According to the sustained-release and controlled-release preparation guidance in"Chinese Pharmacopoeia" 2000 edition 2nd part (appendix XIX D) and requirements under capsule items in 1st part (appendix IID), TLC was adopted to distinguish tanshinone II A, salviatic acid and notoginseng saponins. Targeting at tanshinone II A, releasing regularity has been measured. HPLC method has beenadopted to measure the content of tanshinone II A, salviatic acid and notoginsengsaponins, and the according limits have also been formulated. Meanwhile, the exterior character check of Danqi and other regular check related to capsule have also been done. The results indicate that the quality of this capsule is stable andcontrollable. Furthermore, regarding tanshinone IIA as evaluate index, primaryexplore of pharmacokinetics of the effective components in Danqi sustained-release capsule has been carried out.In the research on the absorption principle of the effective composition in the Danqi sustained-release capsule, in situ rat intestinal absorption model has been built to look into the absorption principle of the effective composition in Danshen oral prepar...
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