甲硝唑乳膏处方及制备工艺的改进

Improvement of the Formula and Preparation Technology of Metronidazole Cream

目的:改进甲硝唑乳膏的质量。方法:通过调整甲硝唑乳膏的基质组成等改进处方,通过改变主药甲硝唑的加入方法等改进制备工艺对甲硝唑乳膏进行改进,并对改进处方与原处方所制制剂进行1年的留样观察试验。结果:改进处方所制制剂质地更细腻,无砂粒感,放置无变硬、变干现象,制剂质量稳定性明显优于原方法所制制剂。结论:改进的甲硝唑乳膏处方合理、制备工艺简单可行,质量稳定可控。

OBJECTIVE： To improve the quality of metronidazole cream. METHODS： The composition of matrix of metroni-dazole cream was adjusted to improve the formula and the way to adding principal composition was improved to promote the preparation technology. The preparation prepared by improved formula and primary formula were sampled for one-year sample observation test. RESULTS： The preparation prepared by improved formula was characterized with delicate and no grit perception. It did not become hard or dry. Its stability was significantly superior to the preparation prepared by primary formula. CONCLUSION： The formula of metronidazole cream is reasonable and preparation technology is simple, practical, controllable and reliable in quality.