CAJ | 학술논문

目的：建立麝香保心丸溶出度和含量均匀性检查方法，并对企业不同批次样品质量进行对比研究。方法溶出度检查采用小杯法，以150 ml 0.5%十二烷基磺酸钠溶液为溶出介质，转速为35转/ min，溶出时间60 min，考察制剂的溶出行为；含量均匀性样品以2丸为1份，以华蟾酥毒基和酯蟾酥毒基的含量为检测指标，利用高效液相色谱法对制剂含量均匀性进行考察。结果结果显示企业内批间与批内样品溶出行为相似度良好，且含量差异较小，说明企业制剂工艺稳定，重现性良好。结论本方法简便、灵敏、准确，可用于麝香保心丸内在质量和批间、批内均一性检查。
목적：건립사향보심환용출도화함량균균성검사방법，병대기업불동비차양품질량진행대비연구。방법용출도검사채용소배법，이150 ml 0.5%십이완기광산납용액위용출개질，전속위35전/ min，용출시간60 min，고찰제제적용출행위；함량균균성양품이2환위1빈，이화섬소독기화지섬소독기적함량위검측지표，이용고효액상색보법대제제함량균균성진행고찰。결과결과현시기업내비간여비내양품용출행위상사도량호，차함량차이교소，설명기업제제공예은정，중현성량호。결론본방법간편、령민、준학，가용우사향보심환내재질량화비간、비내균일성검사。
Objective To establish the test method of dissolution and content uniformity of shexiang baoxin pills and have the comparative study of the quality of the samples in different batches from the compa-ny. Methods The small cup method was used for the dissolution test. The SDS,150 ml,0. 5% was taken as the medium,35 r/ min in speed and 60 min for dissolution. The dissolution behavior of preparation was inves-tigated. Two pills were as 1 piece of sample for content uniformity. The content cinobufagin and resibufogenin was taken as the determination indexes. HPLC was adopted for the study of the content uniformity of the sam-ple. Results The results showed that the similarity was good in the dissolution behavior among the batches of companies and among the batches,the content was less in difference. It was indicated that the preparation technique was stable and reproducibility was good in companies. Conclusion The method is simple,sensi-tive and accurate and is applicable for the test of the quality and uniformity of shexiang baoxin pills among the sample batches or with the sample batch.