羚黄宝儿丸包衣工艺的优化及制剂稳定性研究
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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。
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.
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.
引文
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[11]黎莉,曹芹,曹旭静,等.HS-SPME-GC-MS法测定水中2-甲基异冰片及土臭素[J].化学分析计量,2014,23(2):63-65.
[12]张新庄,狄留庆,单进军,等.祖师麻总香豆素缓释微丸的制备及释放特性[J].中国医院药学杂志,2010,30(11):891-894.
[13]石洋,潘博文,王慧娟,等.天麻微丸的制备及薄膜包衣防潮的考察[J].时珍国医国药,2015,26(8):1919-1921.
[14]李小娜,郭红霞,时银萍.薄膜包衣在中药防潮中的应用[J].中草药,2008,39(10):1583-1586.
[15]付磊,潘五九,王伟明.中药缓控释微丸包衣材料处方及成型工艺研究进展[J].黑龙江中医药,2014,43(1):49-50.
[16]曲建博.中药新药稳定性研究常见问题及案例分析[J].中南药学,2013,11(6):477-479.
[17]霍秀敏.稳定性试验与药品的有效期[J].药品评价,2007,4(1):56-58.
[2]卫生部药典委员会.WS3-B-2787-97中药成方制剂[S].1997.
[3]BAMJI MS,KALADHAR M,KALADHAR M.Risk of increased aluminiumburden in the Indian population:contribution from aluminium cookware[J].Food Chem,2000,70(1):57-61.
[4]马翛然,高丽华,安薪憬,等.食品中铝元素的测定方法[J].中国酿造,2015,34(12):5-9.
[5]甘良春,胡海燕,杨得坡.薄膜包衣的成型工艺及其在中药微丸上的应用[J].时珍国医国药,2004,15(3):177-178.
[6]尚坤,李敬文,常美月,等.冰片化学成分及药理作用研究[J].吉林中医药,2018,38(1):93-95.
[7]蔡瑞宏,姚宏,张亚锋,等.芦荟冰片烧伤膏的生肌、镇痛及抗炎作用[J].中国医院药学杂志,2007,27(2):170-172.
[8]孙艳涛,夏春秋,宋美育,等.气相色谱法测定小儿奇应丸中冰片的含量[J].吉林师范大学学报(自然科学版),2017,38(2):93-96.
[9]朱殿龙,梁云,孙楠,等.气相色谱法测定田七痛经胶囊中冰片的含量[J].中国医院用药评价与分析,2017,17(5):664-666.
[10]高文分,袁文娟,王梅.GC法同时测定醒脑静注射液中麝香酮、龙脑的含量及其有关物质[J].中国药师,2011,14(11):1607-1608.
[11]黎莉,曹芹,曹旭静,等.HS-SPME-GC-MS法测定水中2-甲基异冰片及土臭素[J].化学分析计量,2014,23(2):63-65.
[12]张新庄,狄留庆,单进军,等.祖师麻总香豆素缓释微丸的制备及释放特性[J].中国医院药学杂志,2010,30(11):891-894.
[13]石洋,潘博文,王慧娟,等.天麻微丸的制备及薄膜包衣防潮的考察[J].时珍国医国药,2015,26(8):1919-1921.
[14]李小娜,郭红霞,时银萍.薄膜包衣在中药防潮中的应用[J].中草药,2008,39(10):1583-1586.
[15]付磊,潘五九,王伟明.中药缓控释微丸包衣材料处方及成型工艺研究进展[J].黑龙江中医药,2014,43(1):49-50.
[16]曲建博.中药新药稳定性研究常见问题及案例分析[J].中南药学,2013,11(6):477-479.
[17]霍秀敏.稳定性试验与药品的有效期[J].药品评价,2007,4(1):56-58.