目的制备复方叶绿素铜钠栓并建立其质量控制标准,满足临床需要。方法以聚乙二醇6000及聚乙二醇400为基质,用熔融法制备,采用紫外分光光度法测定其含量,并对其进行稳定性和临床疗效观察。结果所得制剂工艺简便易行,质量可控,稳定性好,疗效满意。结论该制剂值得临床推广应用。 OBJECTIVE To prepare suppository sodium copper chlorophyllin and establish a method for its quality control.METHODS The suppository was prepared by using PEG-6000 and PEG-400.The drug concentration was determined by UV spectrophotometry.The stability and the curative effect of clinic were studied. RESULTS The suppository could be prepared simply and feasibly.The quality was controllable.The effect and the stability was satisfied.CONCLUSION It is worth expanding the clinical usage of the preparation. |