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目的以酵母细胞壁为囊材,制备盐酸氯丙嗪微囊,并观察其稳定性。方法以载药量为评价指标,采用正交试验设计确定制备盐酸氯丙嗪微囊最佳处方和工艺,并对微囊含量的检测方法进行精密度、稳定性及准确性验证。光学显微镜观察微囊形态,考察其体外释放、高湿度和强光照射的稳定性。结果在40℃,盐酸氯丙嗪与酵母细胞壁质量比为1∶3,时间为6 h,微囊的平均载药量可达41.76%。改进的含量检测方法精密度、稳定性、准确性良好。光学显微镜下可见微囊囊壁完整,呈球形或椭球形,形态均一。盐酸氯丙嗪微囊500 min体外累积释放为94.89%。盐酸氯丙嗪微囊对湿度和光度稳定性显著增加。结论酵母细胞壁可作为囊材用于制备微囊,且能增加药物的稳定性。
OBJECTIVE To prepare the chlorpromazine microcapsules by using the cell wall of yeast as the material, and observe its stability. Methods Taking the drug loading as the evaluation index, the orthogonal test design was used to determine the optimal formulation and process of preparation of chlorpromazine hydrochloride microcapsules. The precision, stability and accuracy of the method were tested. The morphology of the microcapsules was observed under an optical microscope to investigate the stability of the microcapsules in vitro release, high humidity and light irradiation. Results At 40 ℃, the mass ratio of chlorpromazine to yeast cell wall was 1: 3, the time was 6 h, and the average drug loading of microcapsules was 41.76%. Improved detection of content precision, stability, accuracy and good. Optical microscope shows the integrity of the microcapsule wall, spherical or ellipsoid, uniform morphology. In vitro cumulative release of chlorpromazine hydrochloride microcapsules was 94.89% after 500 min. Chlorpromazine hydrochloride microcapsules to humidity and photometric stability increased significantly. Conclusion Yeast cell wall can be used as a material for the preparation of microcapsules, and can increase the stability of the drug.