ABSTRACT
Objective: With Bletillae Rhizoma gelatin as the main film-forming materials, Erhuangsan was developed into a sustained-release double-layer membrane for vagina. Method: Taking hydroxypropyl methyl cellulose(HPMC) and Bletillae Rhizoma gelatin as the film-forming materials of Coptidis Rhizoma-Alumen membrane layer, sodium carboxymethyl cellulose(CMC-Na) and Bletillae Rhizoma gelatin as the film-forming materials of Catechu membrane layer, glycerol as plasticizer, Erhuangsan Bletillae Rhizoma gelatin sustained release double-layer membrane was prepared.Central composite design-response surface methodology was used to optimize formulation of this preparation with appearance quality score, adhesion force and in vitro cumulative release as indexes. Result: Optimum formulation of Catechu membrane layer was 1.61% of CMC-Na, 3.81% of Bletillae Rhizoma gelatin and 8.49% of glycerol;optimum formulation of Coptidis Rhizoma-Alumen membrane layer was 1.15% of HPMC, 3.41% of Bletillae Rhizoma gelatin and 10.02% of glycerol. Conclusion: The optimized formulation is stable and feasible.Erhuangsan Bletillae Rhizoma gelatin sustained release double-layer membrane has characteristics of advanced dosage form and convenient use, providing a feasible modern Chinese medicine preparation for treatment of cervical cancer, and accumulating data for the research of Chinese medicine film agent.