Studies Of Preparation Technology Of Chongcao Granules

The thesis has discussed systematically in the preparation technology, the process control and the stability studies of Chongcao Granules which is a new Chinese medicine of 6.2 sort .To achieve the aim of abstracting herbs completely, water abstract and non-sugar granules were chosen according to herbs'nature and characters of patients. Studies focus on the form of prepared drugs, the conditions of abstracting herbs and volatility oil, the alcohol concentration of forming granules, the dosage of corrective taste, the rate of dry paste and production. Orthogonality L9(34) methods on the basis of the concentrations of caladium alkali was used to optimize the preparation technology. The final technology was determined as follow:12 times water soaking herbs, volatility oil distilled by vapor 2h, decoction 2 times every 1.5h and 85% alcohol forming granules.Rationality analysis of chief herbs in prescription and Chongcao fungus as well as the quality control of Caladium, Panax, Chenpi, Almond by negative and positive comparison have been done to ensure the process stabilities. In addition, initial and accelerated stability studies of the target product have been done under the conditions of normal temperature, 37-40°C, 75% relative humidity, high temperature, high humidity, illumination and nature light according to the demand of new drugs examined and approved. As a result, there are no obvious changes in characteristics, authentication, granularity, moisture, solubility, lixivium, content and hygiene test under the condition of the clinic pack. The result has shown that the preparation technology of this product is long-term stable.