兰索拉唑、甲硝唑和枸橼酸铋钾复方片剂的制备

目的制备含兰索拉唑(lansoprazole,LPZ)、甲硝唑(metronidazole,MDZ)与枸橼酸铋钾(bismuth potassium citrate,BPC)的多层复方片剂。方法采用高效液相色谱法测定LPZ和MDZ的含量;采用喷雾干燥法制备兰索拉唑包合物粉末;采用粉末直接压片法制备含兰索拉唑和甲硝唑的片芯;采用压制包衣技术将片芯包肠溶衣;采用粉末直接压片法将枸橼酸铋钾层压制在包肠溶衣片芯的外层,成为枸橼酸铋钾分散片层。结果测定LPZ和MDZ的含量和溶出度、BPC的含量和崩解时限、复方片剂的稳定性均符合《中华人民共和国药典》要求。结论制备的多层复方片剂给药方式简便,有利于提高患者服药顺应性。

Preparations of compound tablets containing lansoprazole, metronidazole and bismuth potassium citrate

Objective To prepare multilayer tablets containing lansoprazole (LPZ), metronidazole (MDZ) and bismuth potassium citrate (BPC). Methods The LPZ and MDZ contents were determined with HPLC method. The powder of LPZ inclusion complex was prepared with spray drying method; the tablet core containing LPZ and MDZ was compressed by direct compression method; the compression coating technique was used to wrap tablet core in enteric coat; the outermost layer was dispersible tablet layer containing BPC that was obtained with direct compression coating technique. Results The content and dissolution of LPZ and MDZ, the drug content and disintegration time of BPC layer and drug stability met requirements. Conclusions The preparations are convenient for the administration, which will be useful to enhance medication compliance.