| Aiming at the cure of rheumatic arthritis(RA) which is one of the arthralgia-syndrome duing to the cold-dampness, promoting blood circulation and the flow of Qi and warming and activating meridian was selected as the basic treatment principle. Jianggui San was collected in " Shen Ji Zong Lu ",which is composed of Chinese herbs Rhizoma Curcumae Longae and Cortex Cinnamomi.Through systematic research, modern compound sustained-release preparation Feng Shi sustained-release capsules were prepared by sustained-release solid-dispersion techniques. Here is the abstract of our research:According to effects and indications of Jianggui San and pathology characteristic of rheumatic arthritis, tests that xylene caused the mouse ear swelling and the acetic acid resulted the mouse writhing were carried on among the different proportion combination and the dosage and proportion of Rhizoma Curcumae Longae and Cortex Cinnamomi were determined.The result indicated that pharmacologic action of anti-inflammation and analgesia is the strongest when the proportion is 2:1.On the basis of reports and pharmacodynamics experiment, the active fraction of anti-inflammation and analgesia in Rhizoma Curcumae Longae and Cortex Cinnamomi have been carried on screening. The result indicated that the two drugs' active fraction is Curcuminoid and Oleum Cinnamomi respectively.Rhizoma Curcumae Longae is one of the famous-region drugs in Sichuan province. Owing to the angle of rational utilization of resource, and the physical and chemical nature of the Curcuminoid of its main active part, the optimum technology of extraction of Curcuminoid was confirmed by orthogonal design:put 70% ethanol which cubage is 6 times of the drug powder in the percolation vat,percolate it. Then, decompress and retrieve ethanol.The last is Turmeric Oleoresin.Base of systematic trial, the optimum technology of purification of the Curcuminoid was confirmed by orthogonal design:dissolve Turmeric Oleoresin with 10 times of quantities acetone, put 3 times of quantities the benzine into the acetone while stiring, keep standing for 4 hours. Then the supernate is decompressed, retrieved acetone and crystallized.The quality level of the Cinnamomi intermedia of Curcumae Longae is set up that has offered an important way for comprehensive utilization of the Rhizoma Curcumae Longae.Based on the oil-collecting ratio, the optimum technology of extracting from Cortex Cinnamomi adopting method of steam distillation (SD) was confirmed by orthogonal design:put 6 times of quantities water and soak for 1 hour, distill for 5 hours. The result indicated the quality of Oleum Cinnamomi to extract from Cortex Cinnamomi consistented with regulation of the 2005 th edition pharmacopoeia.A daily quanlity is 240mg,according to the ascertained dosage and proportion and intermedium yield of the two drugs. Owing to the weak solubility of Curcuminoid and Oleum Cinnamomi, and considering the clinical need, dispersing technology of solid has been applied to the shaping craft of preparation because of its advantage. EC is regarded as carriers and PVPk30 is regarded as releasing controller. The sustained-release solid dispersion was prepared by evaporating solvent. And by using the external accumulating releasing degree of the Curcumin and Phenylacrolein as the indexs, the best preparation prescription by single factor test(ANOVA) is that EC: PVPk30:Medicine equals 3:1:1. About the dispersed state of medicine in sustained-release solid dispersion, X-ray diffraction test,DSC test and so on,are all indicates the medicine exists within the molecular state in solid dispersion. By utilizing the technology of sustained-release solid, the problem of Curcuminoid's dissolving difference and low EBA and RBA was solved successfully.Quality-evaluation-system of the Fengshi sustained-release capsule has been researched systematically, including of the preparation quality level, release-degree testing outside of the body. In quality level study, the UV content determination method of Curcuminoid and the HPLC content determination method of Curcumin have been set up. The result of releasing degrees test indicated the Fengshi sustained-release capsule has evident effect of sustained-release, and the Curcuminoid and Oleum Cinnamomi accords with the first class dynamics procedure basically in external release.The Pharmacodynamics experiment that Fengshi sustained-release capsule has significant relieving effect on hot-plate-induced mouse pain response in different time period. Also, it has notable action on relieving acetic acid-induced mouse pain and significantly extend the delitescence. The immune test revealed that Fengshi sustained-release capsule has significant inhibition on 2,4-dinitrochlorobenzene(DNCB)-induced mouse ear DTH response, and it has preventing action on mouse thymus growth. And it has strong inhibition on mouse haemolytic antibody production. The Fengshi Capsule effect on Nitrogen monoxide decreased as the dose changed. Reduces the melaic dialdehyde content and decaerse blood serum content TNF-a and IL-1。The result of pharmacodynamics test indicated that Fengshi sustained-release capsule has the effects of anti-inflammation, analgesia, regulating the immunity anti-oxidation and predominant amendment on the adjuvant-induced arthritis (AA) animal models. So it is available in treating rheumatic arthritis.
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