摘要
目前渗透泵片剂的包衣通常采用喷雾包衣技术,此技术存在有机溶剂易燃易爆、产生粉尘、污染环境、包衣工时长等问题。为此,研发出了渗透泵片剂的一种新包衣技术——热塑包衣。热塑包衣共有3个过程:热挤压成膜、热贴体包衣、激光熔切(HHL法)。其中,热挤压成膜是指将醋酸纤维素、枸橼酸三乙酯和聚乙二醇1500混合物制备成包衣用膜(H膜)过程;热贴体包衣是指将H膜包衣片芯过程;激光熔切是指用激光在片剂中心打孔后,再切除包衣片剂周围多余热封膜的过程。采用转矩流变仪对上述工艺过程及关键参数进行研究。通过热挤压成膜法制备的H膜具有良好热塑性、透明性、延展性、均匀性;采用HHL法成功制备了盐酸二甲双胍渗透泵片和硝苯地平渗透泵片。本文所述的热塑包衣具有无有机溶剂挥发和潜在的粉尘污染、包衣周期短的优势,能适用于渗透泵片剂的大规模连续生产。所以,热塑包衣代表了渗透泵片剂包衣技术发展的重大进步。
At present, spray coating is generally used for osmotic pump tablets coating. This technology has several drawbacks such as the flammability and explosive potential of the organic solvent, dust generation, environmental pollution, long processing time. To avoid such problems, we have developed a new coating technology for osmotic pump tablets through thermoplastic coating. There are three processes involved in the thermoplastic coating: Hot melt extrusion of membrane-Heat skin coating-Laser melt cutting(HHL method). Where the hot melt extrusion of membrane refers to a process of preparing the coating membrane(H membrane) from a mixture of cellulose acetate, triethyl citrate and polyethylene glycol 1500;the heat skin coating refers to a process of coating the tablet core with the H membrane;and the laser melt cutting refers to a process of cutting off excess heat-sealed membrane around the coated tablet following the step of laser drilling of an orifice at the center of the tablet. The coating process and key parameters were studied via the use of a torque rheometer. The H membrane prepared by the hot melt extrusion process exhibited good thermoplasticity, transparency, ductility and uniformity. Metformin hydrochloride osmotic pump tablets and nifedipine osmotic tablets were successfully prepared by adopting the HHL method. In conclusion, the thermoplastic pump tablet coating process described here has the advantages of avoiding volatile organic solvents and potential dust pollution, shortening the coating cycle time, and could be suitable for large-scale continuous production of OPTs. Thus, it represents a significant advance in OPT coating technology for the future.
作者
袁春平
侯惠民
钱明英
张惠平
罗春林
王正方
YUAN Chunping;HOU Huimin;QIAN Mingying;ZHANG Huiping;LUO Chunlin;WANG Zhengfang(National Pharmaceutical Engineering Research Center,State Institute of Pharmaceutical Industry,Shanghai 201203;Sinopharm Group Guangdong Medi-world Pharmaceutical Company Limited,Foshan 528305)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第1期48-58,共11页
Chinese Journal of Pharmaceuticals
基金
supported by National Pharmaceutical Engineering Research Center and R&D Center of China Traditional Chinese Medicine Holding Co., Ltd.
关键词
热塑包衣
热挤压成膜
热贴体包衣
激光熔切
.渗透泵片剂
喷雾包衣
包衣膜
thermoplastic coating
hot melt extrusion of membrane
heat skin coating
laser melt cutting
osmotic pump tablets
spray coating
coating membrane
