鲜鹿茸全成分口腔崩解片制备工艺研究

Preparation technology for orally disintegrating tablets of fresh antler with all ingredients

目的考察影响冻干法制备鲜鹿茸全成分口腔崩解片的关键工艺因素,确定最佳制备工艺。方法以冻干赋形技术制备鲜鹿茸全成分口腔崩解片,采用单因素试验法,以促细胞增殖活性、含水量、崩解时间和外观性状为考察指标,研究关键工艺参数,确定最佳处方及制备工艺。结果优选出的最佳制备工艺条件:鲜鹿茸冻存温度-40℃,以醋酸缓冲液为稀释液,按1∶2的比例与鲜鹿茸细粉混匀,10%海藻糖为冻干保护剂,低温匀浆时间为10 min,匀浆分装后按优选工艺进行真空冷冻干燥制备鲜鹿茸全成分口腔崩解片,所得口腔崩解片能在30 s完全崩解,含水量低于5%,促细胞增殖活性与鲜鹿茸无差异。结论制备的鲜鹿茸全成分口腔崩解片具有生物活性高、服用方便的优点,最佳制备工艺稳定可行,适合工业化生产。

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.