盐酸米诺环素膜剂的溶出度考察与质量控制

Quality Control and Dissolution Rate of Minocycline Hydrochloride Film

摘要: 目的测定盐酸米诺环素膜剂的溶出度，考察制剂质量。方法根据中国药典2010年版溶出度测定法项下规定，进行盐酸米诺环素膜剂体外溶出度实验，用高效液相色谱法测定样品含量，计算累积溶出量，按Weibull模型求得Td、m参数，并对参数进行相关性检验。结果 5个批号膜剂组内、组间溶出参数均无显著性差异(P>0.05)。结论盐酸米诺环素膜剂的处方设计合理，制备工艺可行，质量可靠。

Abstract: OBJECTIVE To determine the dissolution rate of minocycline hydrochloride film and study its quality. METHODS The dissolution test of minocycline hydrochloride film was conducted according to Ch.P(2010), the main content of them was determined by HPLC, the accumulative dissolution rate was computed, the dissolution parameters of Td and m were caculated by Weibull formula, then correlation test was carried out. RESULTS There were no significant differences interclass parameters and interblock parameters of five batches of simples(P>0.05). CONCLUSION The formulation of minocycline hydrochloride film is reasonable, the process of preparation is feasible and the quality is dependable.