Gout Granules, Quality Standards And Stability Studies

Goat is a group of diseases that caused by urine metabolic disturbance and/or urine acid goathypoeccrisis. The characteristics of goat are hyperuricemia, characteristic recurrent acute arthritis, gouty tophus sedimentation, chronic arthritis and joint deformity, which cause chronic nephritis and uratic nephrolithiasis. Up till now, there is no optimal remedy for goat in western medicine.The prescription of Tongfeng granule was a proved effective recipe that has been used for many years by doctor Zhu Liang-chun. It consists of prepared Radix Polygoni Multiflori, Rhizoma Smilacis Glabrae, Radix Clematidis, Rhizoma Paridis, Radix Cynanchi Paniculati, Bombyx Mori and Semen Plantaginis. The efficiencies of Tongfeng franulea are clearing away heat and toxic material, purging turbid urine, subduing swelling and alleviating pain, which is used to treat gouty arthritis.This work is to study processing technology, quality standard and stability of "Tongfeng franulea" according to the demands of new drug of Chinese medicine. Preparation: 1. Optimize extracting method. The best factors for extracting paeonol from Radix Cynanchi Paniculati were made certain; the best condition for paeonol inclusion with (-CD was studied; the factors decocting Radix Cynanchi Paniculati, Bombyx Mori and Semen Plantaginis as well as extracting 2,3,5,4'-stilbene glucoside from Radix Polygoni Multiflori etc. by alcohol were selected by orghogonal test; Three methods for extracting 2,3,5,4'-stilbene glucoside from Radix Polygoni Multiflori were compared, and the influence of condensation and drying process on the content of 2,3,5,4'-stilbene glucoside was studied. 2. Optimize dissociationg, purification, condensation and drying method. The content of n-Butanol and 2,3,5,4'-stilbene glucoside as well as the solubility of the granule were selected as the indexes of option process. The stability of 2,3,5,4'-stilbene glucoside under high temperatures and 60Coγ-ray radiation were tested. 3. Optimize preparation process for the granule. The species as well as the amount of supplementary materials were determinate. Quality Standard: 1. The characteristic compositions or standard crude drugs were taken as the indexes with TLC to identify the quality of prepared Polygoni Multiflori, Rhizoma Smilacis Glabrae, Radix Clematidis, Rhizoma Paridis and Radix Cynanchi Paniculati. 2. The contents of 2,3,5,4'- stilbene glucoside in Prepared Radix Polygoni Multiflori from different areas were detected by HPLC . 3. The content of 2,3,5,4'-stilbene glucoside in the granule was determined with HPLC. 4 HPLC was used to establish HPLC fingerprint analysis for Polygoni Multiflori. Stability: 1. The preliminary stability of the granule was tested for three months after made in the factory. 2. The contents of 2,3,5,4'-stilbene glucoside and paeonol in the granule were detected after the granule was undergoing high temperatures for different times, and the expiry date of Tongfeng granule at chamber was calculated.