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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。
Objective To prepare multi-layered tablets containing lansoprazole (LPZ), metronidazole (MDZ) and bismuth potassium citrate (BPC). Methods The contents of LPZ and MDZ were determined by high performance liquid chromatography (HPLC). The lansoprazole clathrate powder was prepared by spray drying method. The tablets containing lansoprazole and metronidazole were prepared by powder direct compression method. The tablet coating technology will enteric coated tablets; using powder direct compression method bismuth potassium citrate laminate in the package enteric coated core outer layer, a bismuth potassium citrate dispersible tablets. Results The content and dissolution of LPZ and MDZ, the content of BPC, the time of disintegration and the stability of compound tablets were all in accordance with the requirements of Pharmacopoeia of the People's Republic of China. Conclusion The preparation of multi-layer compound tablets is simple and convenient to administer, which is beneficial to improve patient compliance.