The Preparation Process Of The Bone Continued Reinforcement Capsule And Quality Standards

With the development of the society,the flourishing transportation industry, the frequently launched activities, various injuries and fractures have become common clinical diseases and frequentty-occurring diseases,which seriously threaten the health of human being as people's working ability.How to speed up the recovery of fractures is a key research subject in the field of Orthopaedics. Treating fracture with Chinese herbal medicine has a long history and has excellent clinical effects and is one of the main methods to treat fracture at present.Jiegu Xujin Capsule is a compound preparation which consists of nine Chinese herbs (Gusuibu,Xuduan, Zirantong, Sanqi, Chuanxiong, Danggui, Shudihuang, Guizhi, Chuanmuxian g). It has the functions of reuniting bone and muscle and ligameng,eliminating stasis by purging,activating qi and promoting blood circulation,relaxing tendons and activating collaterals, using in the middle and late stage of fracture. Under the guidance of Traditional Chinese medicine theory, applying modern pharmaceutical technology and according to correlative regulations of patent traditional Chinese medicine, we systematically studied the Prepatation process, Quality standard and Preliminary Stability.According to the function and property of chemical ingredients in this prescription,using single factor exploration and orthogonal design mothod,the optimum progress was obtained: The four herbs (Chuanxiong,Danggui, Guizhi ,Chuanmuxiang)be steeped in 12 times warer for four hours, then be distilled volatile oil about 6 hours and combination ofβ-cyclodextin ;Mix the four herbs which distilled with other Chinese herbs,add 12 times water, distill 2 times,each time for 2 hours ,filter, mix all the liquid,condense decompress to the relative density 1.15(room temperature),using 60% ethanol to flocculate. Collect the alcohol solution to vacuum concentration with a relative density 1.08-1.10(room temperature),driedbyspray, collect the powder. Combine the powder ,theβ-cycJodextin , Sanqi and other stuffs,make granules with 80% ethanol and dry,size stabilize and pack to No.0 capsules.The progress was proved to be suitable for small-scale experiment. The quality standard was established,and formulated the limits of the content of naringin: contents at least 2.0mg naringin per cap.Put Jiegu Xujin Capsule at 23℃-27℃,50%-70%(RT),test it at 0,1,2,3 month. The preliminary stability test showed that the product was steady in the observation period of three months.Research results shows:the preparation process of this preparation is reasonable and feasible,the quality is stabilized.