Study Of Process And Quality Standards Of The Liver Clear Capsules

Objective: Preinvasive liver cancer is one of the familiar cancer in our nation. It's mortality lies in the third place in the malignant tumour. Owing to active materials widely distributing among herbal medicines and plant medicines, TCM plays an important role in restraining or killing tumour cell, regulating body immunity function, ameliorating syndrome and symptome, alleviating toxic and side-effect of actinotheraphy and chemotherapy, as well as taking good care of tumorous patient. This preparation is under the guide of TCM theory, originates from a clinic-empirical recipe, and filters the active components of each herb on the basis of the pharmacological research. Meanwhile, in order to alleviate toxin and side-effect and to increase the curative effect, we select the best extraction process by modern filtering and optimizing design methods with researches on molding and quality specification finished.Methods: 1) Study on process technology: From the view of the content of scutellarin and total flavonoids(determined by scutellarin), the optimum extraction conditions of Scutellaria barbata D·Don were determined by Fibonacci method and the orthogonal design; From the view of the content of curcumin, the optimum extraction conditions of Radix Curcumae were determined by the orthogonal design; With all the work stated above, the feasibility of extraction for Radix Curcumae and Scutellaria barbata D·Don together has been proved; Through determination of the content of tanshinoneⅡA and salviandic acid B, optimizing parameters of the extraction technics of"one-step-only extraction"for Salvia miltiorrhiza Bge, then with the application of Central composite design as filtration method; Scorpio and Scolopendra were extract by bionic extraction imitating the assimilation process of gastraintestinal. After the processing of comminution,sifting out, the mixture of dry powders obtained above were mixed with extractions of total Saponins of Panax ginseng C.A. Mey and some MCC,dextrin. And then, capsules were made after all these process of cranking out granule, evaporating and packing. 2) The study on quality specification and primary stabilization: By using TLC, we have made qualitative analysis on each constitute of Ganqing capsule; By using HPLC, we have made quantitative analysis on scutellarin and have studied the primary stabilization from the view of the content of scutellarin.Conclusion: According to modern research results of pharmacology and chemistry, with the innovative methods of technic designs, we filtrated the extraction process, and manufactured the capsule. Furthermore, we also studied the quality specification and primary stabilization.With all the pharmaceutical studies being done, it sets the stage for a valuable preparation whose curative effect was confirmed and quality was controllable for the medicinal market and has some learning meaning.