ABSTRACT
Objective: To study the critical influence factors in the preparation of orally disintegrating tablets of fresh antler with all ingredients (ODT-FA) by lyophilized method and to optimize the preparation technology. Methods: The lyophilized molding technology was used to prepare the ODT-FA and the optimal formulation and preparation were obtained by means of single factor test with promoting cell proliferation activity, moisture content, disintegration time, and appearance as evaluation criterion. Results: The optimal preparation conditions of ODT-FA were as follows: The frozen storage temperature of fresh antler was -40°C, acetate buffer was used as diluent to mix with the fresh antler powder according to ratio of 1:2, then to homogenize for 10 min under liquid nitrogen protection with 10% trehalose as lyoprotectant, and the homogenate was lyophilized in vacuum after poured into the mold to prepare the ODT-FA. The tablets could disintegrate within 30 s completely and its moisture content was less than 5%. In addition, there was no difference in promoting cell proliferation compared with fresh antler. Conclusion: The ODT-FA prepared by optimal technology has highly biological activity and is easy to take. The optimal preparation process is stable and suitable for industrial production.