【摘要】 目的:优化羚黄宝儿丸的包衣工艺,并评价其制剂稳定性。方法:采用流化床薄膜包衣技术,对包衣工艺的重要参数进行单因素试验;采用气相色谱法测定制剂中龙脑的含量,并比较薄膜包衣样品与铝箔包衣样品的稳定性。结果:最优包衣工艺包衣液浓度为12%,包衣液喷入方式为底喷,进风温度为50℃,雾化压力为0.20 MPa,蠕动泵转速为5 r/min,引风频率为25 Hz,包衣理论增质量比例为3%。两种包衣样品加速稳定性试验的含量范围为4.59～5.11 mg/g,平均损失率均小于5%;长期稳定性试验的含量范围为4.80～5.11 mg/g,平均损失率均小于1%。结论:优化所得羚黄宝儿丸薄膜包衣工艺稳定、可行;所制微丸外观圆整、色泽均匀,且稳定性较好。更多还原

【Abstract】 OBJECTIVE:To optimize the coating technology of Linghuang bao’er pellets,and to evaluate the stability of preparation. METHODS:The film coating process was performed on fluid bed,and single factor investigation was conducted for key parameters of technology. The content of borneol was determined by GC method. The stability of film coated samples was compared with that of aluminum foil coated samples. RESULTS:The optimal coating technology was as follows that coating solution concentration was 12%;coating solution was sprayed by bottom spraying;inlet air temperature was 50 ℃;atomization pressure was 0.20 MPa;peristaltic pump speed was 5 r/min;air induction frequency was 25 Hz;coating weight was increased by 3%. The content of borneol ranged 4.59-5.11 mg/g and the loss rate of borneol was less than 5% in accelerated stability test;the content of borneol ranged 4.80-5.11 mg/g and the loss rate of borneol was less than 1% in long-term stability test. CONCLUSIONS:The optimal coating technology is stable and feasible. Prepared pellets are round in appearance,uniform in color and stable.更多还原