CAJ | 학술논문

目的：以国外原研的厄贝沙坦氨氯地平片为参比制剂，考察自研制剂与参比制剂在不同pH条件下溶出行为的相似性。方法依据2010年版《中国药典（二部）》和日本《医疗用药品品质情报集》中的溶出度实验条件，采用 H PLC法，分别以盐酸溶液（pH＝2．0）、醋酸盐缓冲液（pH＝4．5）、磷酸盐缓冲液（pH＝6．8）和水为溶出介质进行测定，溶出方法为桨法，转速为50 r · min－1，并通过 f2相似因子法评价自制与参比厄贝沙坦氨氯地平片溶出曲线的相似性。结果3个批号自制片与原研片在不同溶出介质中溶出度相似因子均大于50％。结论自制片与参比片的溶出曲线相似，提示自制厄贝沙坦氨氯地平片处方合理，生产工艺稳定可靠。
목적：이국외원연적액패사탄안록지평편위삼비제제，고찰자연제제여삼비제제재불동pH조건하용출행위적상사성。방법의거2010년판《중국약전（이부）》화일본《의료용약품품질정보집》중적용출도실험조건，채용 H PLC법，분별이염산용액（pH＝2．0）、작산염완충액（pH＝4．5）、린산염완충액（pH＝6．8）화수위용출개질진행측정，용출방법위장법，전속위50 r · min－1，병통과 f2상사인자법평개자제여삼비액패사탄안록지평편용출곡선적상사성。결과3개비호자제편여원연편재불동용출개질중용출도상사인자균대우50％。결론자제편여삼비편적용출곡선상사，제시자제액패사탄안록지평편처방합리，생산공예은정가고。
Objective To investigate the similarity of dissolution behavior between the reference preparation tablets ( the listed a‐broad Irbesartan and Amlodipine Tablets ,and the self‐prepared(domestic) preparations in dissolution media with different pH . Methods The HPLC method was adopted to determine the dissolubility according to Chinese Pharmacopoeia (edition 2010) and referring to the dissolution test condition in Japan′s Medical Drugs Quality Informations Set .Water ,hydrochloride acid(pH=2) , acetate buffer(pH=4 .5) and phosphate buffer (pH=6 .8) were sepatately used as the dissolution media and the paddle method was adopted with the rotational speed of 50 r · min-1 .The similarity of dissolution curve was evaluated by f2 similarity factor method .Results The similarity factor of self‐made tablets in different dissolution media to the imported tablets was above 50% . Conclusion The dissolution curve of self‐made and imported Irbesartan and Amlodipine Tablets is similar ,which prompts that this test preparation has the rational prescription and the production technology is stable and reliable .