| The Kuikening paste tablets are modern compound Chinese medicine that studied by changing form of prepared drugs that used in clinic—Kuikening powder, which is used to cure recurrent ulcer, Behcet's disease, Lichen Planus and other oral mucosal diseases. According to the standard of the Chinese new drugs, we studied its preparation process, quality standard and preliminary stability systematically with modern science and technology. The study details are as the following:1.Study on Literature: 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.2.Study on preparation process: With the index of the power of peeling off, the 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 and orthogonal experiment. The optimal proportion of P and Q guarantees the power of paste, the optimal proportion of Glidant and Lubricant guarantees the productive maneuverability. 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 Kuikening paste tablets with recommend power of peeling off from biological membrane, viscosity, rigidity, and other indications. Set up the composition identified method of Margarita, Calculus Bovis, Indigo Naturalis, and Borneolum Syntheticum by TLC. Establish a method for contend determination in Kuikening paste tablets by GC and stipulate the minimum limit quantity of Borneol. |
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