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咪唑斯汀缓释片的处方工艺筛选
引用本文:彭朝霞,朱宏吉,李耀湘,孙亚洲. 咪唑斯汀缓释片的处方工艺筛选[J]. 中国医院药学杂志, 2007, 27(6): 732-735
作者姓名:彭朝霞  朱宏吉  李耀湘  孙亚洲
作者单位:1. 天津大学化工学院,天津,300072;北京颐悦医药科技有限公司,北京,100076
2. 天津大学化工学院,天津,300072
3. 北京颐悦医药科技有限公司,北京,100076
摘    要:目的:制备一种能在5h内完全释放的咪唑斯汀缓释片。方法:以体外释放度的测定为主要考察指标,采用单因素筛选法,初步确定缓释片的处方,再对处方进一步的优化调整,确定处方中各辅料的用料量,并对缓释片的工艺在常规方法的基础上进行各项参数的优选,最后将自制缓释片与国外上市产品进行各项体外指标的对比试验。结果:其1000片配方为咪唑斯汀10mg、羟丙甲纤维素(HPMC)11.5mg、酒石酸氢钾40mg、乳糖110mg、微晶纤维素40mg、10%的乙基纤维素(EC)乙醇溶液0.068mL。结论:该处方工艺制备的咪唑斯汀缓释片能达到5h缓释的预期要求,达到了国外该制剂的同等水平,经验证适合扩大生产。

关 键 词:咪唑斯汀  缓释片  释放度  处方工艺
文章编号:1001-5213(2007)06-0732-04
修稿时间:2006-08-20

The formulation and techniques research on mizolastine sustained-release tablets
PENG Zhao-xia,ZHU Hong-ji,LI Yao-xiang,SUN Ya-zhou. The formulation and techniques research on mizolastine sustained-release tablets[J]. Chinese Journal of Hospital Pharmacy, 2007, 27(6): 732-735
Authors:PENG Zhao-xia  ZHU Hong-ji  LI Yao-xiang  SUN Ya-zhou
Affiliation:1. Tianjin University, Tianjin 300072,China; 2. Beljing Evergreen Pharmaceutical Technologies Co. , Ltd, Beijing 100076 ,China
Abstract:OBJIECTIVE To prepare sustained-release tablets of mizolastine, and study its release characteristics in vitro. METHOD The sustained-release tablets of mizolastine could rapidly effect in one hour and release completely in five hours. The factors influencing the release rate of mizolastine from sustained-release tablets were examined. The sustained-release tablets were prepared with HPMC ,tartaric acid.lactose, microcrystalline cellulose ; RESULTS The formulation is mizolastine 10 mg, HPMC 11.5 mg, tartaric acid 40 mg, lactose 110 mg, microcrystalline cellulose 40 mg, 10 % EC alcohol solution 0. 068 mL. CONCLUSION The sustained-release of the tablets complies with the dedigned requirement.
Keywords:mizolastine   sustained-release tablet  releasing data   releasing mode   drug release mechanisms
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