薄膜包衣在中药胶囊剂中的防潮应用研究

【作者】 龙章宇；

【导师】 吴纯洁；

【作者基本信息】 成都中医药大学 ， 中药药剂学， 2005， 硕士

【摘要】 胶囊剂是一种常见的口服固体制剂,分硬胶囊剂、软胶囊剂(胶丸)和肠溶胶囊剂。硬胶囊剂系指将一定量的药材提取物加药粉或辅料制成均匀的粉末或颗粒,充填于空心胶囊中制成,或将药材粉末直接分装于空心胶囊中制成。在现代中药制剂生产中,硬胶囊剂因工艺过程相对简单,又有服用方便、起效快并能有效地隔离药物的不良气味等优点,近年来得到了广泛的应用。由于填充胶囊的颗粒成分和形式复杂多样,大部分胶囊在贮藏过程常出现颗粒吸潮、粘结甚至霉变现象,这成为影响药品质量和疗效的重要原因。 据有关文献报道,解决胶囊吸湿性问题的方法比较多,也一直为行业所关注。本文从薄膜包衣角度,运用现代制药技术与设备,选择吸湿性很强的天麻头风灵胶囊作为研究对象。从包衣材料的选择、包衣参数和包衣增重等方面进行研究,重点考察了常见的胃溶包衣材料的防潮性能,通过加速实验,结合胶囊剂的质量标准,采用数理统计分析方法,以收得率、包衣时间和防潮性能为指标,筛选出适合胶囊防潮要求的包衣材料和工艺。 研究结果表明:包衣材料能满足天麻头风灵胶囊的防潮要求,包衣工艺参数合理、稳定、可控。同时,这也为解决胶囊剂防潮提供了一种可借鉴的模式。更多还原

【Abstract】 Capsule is a kind of popular oral solid preparation, including hard capsule, soft capsule and enteric release capsule. Hard capsule is filled into some powder or granule which is made from medicinal materials and some excipients mixed. The hard capsule of the traditional Chinese medicine gets more and more extensive application in modern pharmaceutical industry in recent years, Because of the simple manufacture process, being taken conveniently , the quick effect and the advantage of masking bad smell availably. Most granules are easy to absorb moisture, whereafter become mass, even milden and rot due to different forms and ingredient’ s complexity. It is a key reason that affects the drugs’ quantity and curative.It is reported in some literatures that to resolve the capsule’ s hygroscopic problem is paid attention by pharmaceutical industry all along, and there are some measures to solve it too. With the film coating ways, the trial uses modern pharmaceutical equipments and technology to study the model named Tian Ma Tou Feng Ling Capsule which absorbs moisture easily. With the index of moisture proof capacity, gain rate and coating time, Using the mathematical statistics methods, Through accelerated trial, The trial studies the familiar gastric release film coating product’s moisture barrier capability mainly , studies the selection of film coating products and coating parameter and the suitable weight gain. The suitable film coating product and coating technical processes are screened out. The study result indicates that film coating can provide satisfied moisture proof for Tian Ma Tou Feng Ling Capsule. The technical parameter is reasonable and controllable. It is also offers a way to improve capsule’ s moisture proof capability.更多还原