Studies On Optimizing The Preparation Technique And Improving Quality Standard Of Shuanghuang Tongfeng Capsules

ObjectiveShuanghuang Tongfeng capsule is composed of Astragali Radix, Phellodendri Chinensis Cortex, Fraxini Cortex, Paeoniae Radix Rubra and Green tea, supplementing qi and activating blood circulation, used in the treatment of Hyperuricemia of damp-turbidity due to qi deficiency and blood stasis syndrome. Because there are deficiencies in the original preparation technique and quality standard of Shuanghuang Tongfeng Capsules, it is necessary to optimize the preparation technique, find out the most influential factors. To make sure the quality and stability can be controlled effectively. The quality standard of Shuanghuang Tongfeng Capsules should be improved.Methods1. Preparation technique research:On the basis of the original preparation technique, the resarches focused on extraction process:water extraction experiments of Astragali Radix, Fraxini Cortex, Paeoniae Radix Rubra, Green tea and alcohol abstraction experiments of Phellodendri Chinensis Cortex, by orthogonal experimental design method and multi-index evaluation as parameter. The process parameters were optimized.2. In quality standard study, Astragali Radix, Fraxini Cortex, Paeoniae Radix Rubra were identified by TLC, the content of Astragaloside IV was measured by HPLC. The HPLC fingerprint of Shuanghuang Tongfeng Capsules was also studied.Results1. The optimum conditions for the extraction process were as follow: Astragali Radix, Fraxini Cortex, Paeoniae Radix Rubra were soaked in 15 times of water for 30 mins, and extracted for two times,40 mins each time. Comminuted Green tea is sifted on a 24-mesh screen, soaked in 20 times of 80℃ water for 1 h, and extracted for 45 mins. Comminuted Phellodendri Chinensis Cortex is sifted on a 24-mesh screen, soaded in 20 times of 75% alcohol for 30 mins, and extracted for three times,30 mins each time.2. The TLC identification methods for Astragali Radix, Fraxini Cortex and Paeoniae Radix Rubra were well in specificity. Astragali Radix and Paeoniae Radix Rubra could be detected with the same TLC method.3. The HPLC determining methodology of content of Astragaloside IV has been established, which is well in accuracy, reproducibility and recovery.4. The HPLC fingerprints have good repeatability and characteristics, They show the characteristic peaks of Shuanghuang Tongfeng Capsules clearly, including 5 substance peaks of 3 medicinal materials, Esculin hydrate, Esculetin, fraxetin, EGCG, Paeoniflorin.ConclusionThe optimized preparation process is stable and feasible. The TLC identification methods and the HPLC determining methodology are simple, accurate and well in reproducibility. The peaks are separated effectively in the HPLC fingerprint of Shuanghuang Tongfeng Capsules, including characteristic peaks. The research result provides reference for preparation process and quality standard of Shuanghuang Tongfeng Capsules.