CAJ | 학술논문

目的：测定美托拉宗原研片（规格：0．5 mg ）的晶型。方法通过差示扫描量热法（DSC ）和粉末X射线衍射法（PXRD ）分别对美托拉宗原料药、原研片、无定形样品、载药分别为1，5和50 m g自制片进行检测与分析。结果经检测原料药药物晶型为晶型Ⅰ，原研片存在微弱的晶型Ⅰ熔融峰，无定形在检测过程中吸热发生晶型转变，转变成稳定的晶型Ⅰ，无定形自制片剂未发现晶型I熔融峰，而采用原料药所制备的载药片剂均检出明显的晶型Ⅰ熔融峰。结论原研片中药物的晶型为晶型Ⅰ。
목적：측정미탁랍종원연편（규격：0．5 mg ）적정형。방법통과차시소묘량열법（DSC ）화분말X사선연사법（PXRD ）분별대미탁랍종원료약、원연편、무정형양품、재약분별위1，5화50 m g자제편진행검측여분석。결과경검측원료약약물정형위정형Ⅰ，원연편존재미약적정형Ⅰ용융봉，무정형재검측과정중흡열발생정형전변，전변성은정적정형Ⅰ，무정형자제편제미발현정형I용융봉，이채용원료약소제비적재약편제균검출명현적정형Ⅰ용융봉。결론원연편중약물적정형위정형Ⅰ。
Objective To research the polymorphism of Metolazone Tablets (weight :0 .5 mg) .Methods By using DSC and X-ray powder diffraction (PXRD) ,the tablets of metolazone ,amorphous metolazone ,drug loading of 1 ,5 and 50 mg amorphous self-made tablets were studied .Results The crystal type raw material drug of metolazone is crystal form I .The crystal type of the o-riginator tablets of metolazone existed a weak I absorption peak .Amorphous endothermic crystal in the detection process changed from one crystal into a stable crystal form I .The crystalline absorption peak of form I was not detected in amorphous self-made tablets ,which loaded for the amorphous 1 mg .The raw material of drug preparation for 5 mg and 50 mg imitation products had the peak of form I .Conclusion The original drug crystal in originator tablets of metolazone is crystal type I .