| Wuweizi chewable tablets are clinical experience prescription with effect of prevention and treatment of alcoholic liver injury by Wuweizi, Danshen, Yejuhua, Fuling and Xiangfu. It has a good taste,taking convenient, dissolve and absorb quickly, the wide applicable people.Wuweizi chewable tablets optimize the extraction technology and molding process to made taste good, take convenient chewable for experimental basis. Establish the quality standards of Wuweizi chewable tablets, and provide experimental basis for the quality control.Through orthogonal test, to optimize the best alcohol and water extraction process technology. According to the taste, appearance and hardness request of chewable tablets, the molding process is determined. TLC qualitative distinction was used to inspect Wuweizi, Danshen, Yejuhua, Fuling and Xiangfu in the prescription, establishing the content determination method and methodology of schisandrin and Buddleoside. Wuweizi Tablets is established by HPLC-DAD Fingerprint Chromatogram. The alcoholic liver injury in mice model was established. Wuweizi Chewable Tablets on alcoholic liver injury model mice weight and liver index, the influence of the alcohol liver injury model mice serum ALT, AST and liver SOD, MDA.Wuweizi and Danshen by alcohol extraction technology, the optimal alcohol extraction process was determined: with 8 times of 90% ethanol by triple, each time for 1.5 hour. After Wuweizi and Danshen alcohol extraction liquid to attached with Yejuhua, Fuling and Xiangfu use water extraction process, the best water extraction process was determined: with 10 times of water by triple, each time for 2 hour. Through study on molding process, the best preparation technology of chewable tablet confirmed as the following: sucrose for medicinal herbs extract is 48%,microcrystalline cellulose, mannitol, starch(1:1:4) for medicinal herbs extract is 21%, 100% ethanol and 1% magnesium stearatewas were used as wetting agent and lubricant respectively. Quality standard of Wuweizi chewable tablets was established by TLC and HPLC method, the fingerprint of the Wuweizi chewable tablets was established by HPLC-DAD and 39 common peaks were found and there source were determined.12 of the common peaks’ composition were confirmed by reference substance contrast method. The similarities of 10 batches samples were over 0.93. Chewing flakes by pharmacological experiments prove that Wuweizi chewable tablets can protect the alcohol liver injury in mice.Technology design of Wuweizi chewable tablets considers the alcohol soluble ingredient and the water-soluble ingredient, good taste, convenient to take. To establish the content determination method and HPLC- DAD fingerprint analysis method is simple feasible, and can effectively control the quality of Wuweizi chewable tablets. |
PDF Full Text Request