Study On Preparation Process Of Paste Tablets Of Shuangliao Houfeng

The Shuangliao Houfeng paste tablets are modern compound Chinese medicine that studied by changing form of prepared drugs that used in clinic--- Shuangliao Houfeng powder made of Vietnamese Sophora Root, Golden Thread , Radix Glycyrrhizae, Natural Indigo, artificial bezoar, Borneol, which is used to cure recurrent ulcer and other oral mucosal diseases. With the guidance of Traditional Chinese Medicine, the source of the prescription, the survey of the studies and the significance of developing the issue are elaborated widely. At the same time, we sum up the chemical compounds and physical and chemical properties of the drugs in the prescription.According to the standard of the Chinese new drugs, we studied its extraction process, preparation process and quality standard with modern science and technology. The study details are as the following:1.Study on extraction process: To study the best extraction process for four herbs Vietnamese Sophora Root, Golden Thread,Radix Glycyrrhizae, Natural Indigo, which are compositions of Shuangliao Houfeng medicament. We studied it with orthogonal design, to extract vitro inhibitory effect as the appraisal index of the first degree, to determinate the content of matrine and berberine hydrochloride in the extract as the second appraisal index. The concentration and the dosage of alcohol extracts, the time and the degree of extraction are factors for the experiment. It proves the optimum process conditions are 8 times of the dosage of 70% ethanol by loop extraction for 3 times, the first time and the second time with 1hour, eventually with 0.5 hour for loop extraction. The optimized process is feasible for the extraction.2.Study on preparation process: With the index of the power of peeling off, the release velocity of paste, the time of paste the power of paste, the productive maneuverability, and so on, the tablet forming technology was studied with parallel-contrast experiment. We guaranteed the optimal proportion of the fillers and the adhesives of paste, the productive maneuverability, and so on. We also progressed the middle test production study and validated the preparation process.3.Study on quality control method: Establish the examination items of the preparation general rules of Shuangliao Houfeng paste tablets with recommend power of peeling off from biological membrane, viscosity, rigidity, and other indications. Set up the composition identified method of Golden Thread,Radix Glycyrrhizae, Natural Indigo, artificial bezoar by TLC. Establish a method for the concentration determination of matrine in Shuangliao Houfeng paste tablets by HPLC and stipulate the minimum limit quantity of matrine.