Study On Preparation And Quality Standard Of Compound Shengui Capsule

Purpose: Compound Shengui Capsule is traditional Chinese medicinePreparation, which is made of Salvia miltiorrhiza, Angelica, cortex phellodendri,ovientvine, plantain seed, Achyranthes, and Eucommia etc. The clinical practiceover10years proved it had good effects on gout, gout arthritis and other diseases.The prescription is a good combination integrated with traditional Chinesemedicine theory, modern research, and clinical experience. On the premise ofclinical reliable efficacy, this research combined with the properties ofpharmaceutical ingredient in prescriptions, established extractive fractions ofshengui Capsule, screened process route and conditions and developed a qualitystandard.Method: The preparation process divides into two parts: water extract-alcoholextraction method and alcohol abstraction method, by orthogonal experimentaldesign method, the content of tanshinoneⅡA in ethanol extract as parameter,alcohol extraction technology was investigated. The best process condition wasoptimized; the content of ferulic acid in water extract as index, the water-decoctionextract technology was investigated. The best process condition was optimized; theextracts were purified by ethanol precipitation method; the starch was selected asthe excipient of capsule,and technology of preparations and formation was studied.In quality standard study, Salvia miltiorrhiza, Angelica, Phellodendron,Sinomenium acutum and Achyranthes in the prescriptions were determinedqualitatively by TLC, the content of tanshinoneⅡA in shengui capsule wasmeasured by HPLC, an effective method was established to control the quality ofthe preparations.Result: The preparation process is reasonable and feasible, the quality can becontrolled, the quality of the sample was steady. In quality standard study, Salviamiltiorrhiza, Angelica, Phellodendron, Sinomenium acutum and Achyranthes in theprescriptions were determined qualitatively by TLC, the TLC spots were clear andthe method was exclusive. The content of tanshinoneⅡA in shengui capsule was measured by HPLC, use methanol-water as the mobile phase and UV detection at268nm.The average of three batches tanshinoneⅡA in shengui capsules was0.3527mg/g.conclusion: The results showed that the method had a goodlinear,accurate,stability, responsibility and recovery, all indexes were in accordwith the requirement. The blank test showed no interference, and this method hasproved to be feasible.