Preparation Technique And The Establishment Of Quality Standards Of Urea Cream

On the basis of the fact that the urea cream prepared in our hospital has better curative effects on the common skin diseases, such as chap, ichthyosis, chilblain and eczema, urea cream was prepared in this thesis and deeply studied by optimizing preparative technology, and establishing normative and perfect quality control standard in order to get the final approval of the preparation qualification quickly.The thesis has mainly studied in the following contents:1. To optimize the formulation Method:In order to optimize the formulation of urea cream and to improve its quality, we use three factors (emulsifiers, dosage of atolin and stearic acid) to examine the affection on the quality by L9 (34) orthogonal experiment. Oil ball granularity of different samples was determined as the evaluation index. Result:According to the result of orthogonal experiment, RA>RC>RB, we found that the main factor that influenced diameter of oil droplets was the matching quantity of emulsifier, followed by dosage of stearic acid. The addition volume of atolin produced a little influence. After comprehensive evaluation, the better process condition was found to be the A2B2C3, in which, the volume of emulsifier was:24/1, the dosage of atolin was 560ml, and the dosage of stearic acid was 7.5g.2. To optimize the preparation method Method:to evaluate the quality of the samples between the common method and reverse-phase transformation method, we determined oil ball granularity of different samples as the evaluation index to optimize the preparation technique of prescriptions. Result:The urea cream confected by reverse-phase transformation method is the better method to obtain the fine and soft dispersed cream. This method is simple to operate and the technical factors are easy to control. 3. To comparatively study the quality with analogy preparations in clinic method: For the comparison, three products prepared by other different prescriptions were used as references to optimize the prescription components. The comparison was made between our hospital's urea cream and Practical hospital preparation notes (original). Practical hospital preparation notes (hydrophilic cream base 4 plus basic remedy), pharmaceutics regulates of hospitals in China (Cream base 1 plus basic remedy) Result:The urea cream prepared according to our hospital's prescription is favorable with suitable viscosity and appropriate ductility. It has the smallest granularity of oil globules, so it is easily spread on skin without harsh and oily feeling.4. The estabishment of quality standards of Urea cream method:To detect the quality of the urea cream according to the relevant regulations of cream in Chinese Pharmacopoeia (edition 2005).â‘ Qualitative identification.â‘¡Examination: Granularity, installed capacity, microbial limitation, etc.â‘¢Content determination: Determining the content of urea in the Urea cream by using uhraviolet spectrophometric method. Result:The urea cream prepared in our hospital is in conformity with relevant requirement of Chinese Pharmacopoeia (edition 2005) and the relevant provisions.5. Stability observation of Urea cream method:Accordng to the relevant requirement of Chinese Pharmacopoeia (edition 2005), we observed the stability of three batches of Urea cream prepared in our hospital by determining the changes of content of urea as index. The observation items are factors of experiment(high temperature experiment, high humidity experiment, strong light irradiation experiment,speed up experiments and the long-term experiment. Result:Stability test indicated that the urea cream should be avoid of high temperature during the storage. Temperature affected the effective component significantly.In this thesis, the formulation of urea cream was optimized by using orthogonal experiment, and the preparation method was selected by evaluating the quality of the samples between the common method and reverse-phase transformation method. In addition, the prescription components were studied by experimental comparison between our hospital's urea cream and other different prescriptions. The result shows that the urea cream prepared according to our hospital's prescription has the smallest granularity of oil globules with suitable viscosity and appropriate ductility. At the same time, we detected the quality of the urea cream according to the relevant regulations in Chinese Pharmacopoeia (edition 2005).We determined the content of urea in the Urea cream by using uhraviolet spectrophometric method and established scientific, reasonable and feasible quality standard. Stability test of the urea cream indicated that the urea cream should be avoid of high temperature during the storage, because temperature affected the effective component significantly. This thesis optimized the preparation technology of the urea cream. At the same time, it established the quality standard of urea cream and provided experimental evidence for the approval of preparation qualification.