【摘要】 目的:研制对乙酰氨基酚中空栓并对其进行质量考查。方法:用中空栓模具,制备了对乙酰氨基酚中空栓。在波长257.4 nm处测定对照品溶液吸光度(A)计算含量及溶出度。结果:得标准曲线,回归方程为A=0.065 C+0.058,r=0.999 9(n=6),在浓度范围内呈良好线性关系。平均回收率为(99.6±0.47)%,RSD=0.47%(n=9),稳定性试验表明,对乙酰氨基酚中空栓供试品溶液至少在48 h内测试稳定,精密度试验RSD=0.35%,重现性试验RSD=0.37%。结论:本制剂制备工艺可行,质量可控,扩大了对乙酰氨基酚的剂型,主要指标符合规定。更多还原

【Abstract】 Object: To prepare paracetamol hollow type suppository (HTS) and study its quality. Methods: Paracetamol hollow type suppository was produced by the model of HTS. The absorbance of the standard solution was determined at 257.4 nm and the vitro dissolubility was calculated. Results: The standard curve with good linearity was A=0.065 C+0.058, r=0.999 9 (n=6). The average recovery was (99.6±0.47)% with RSD of 0.47% (n=9).The stability study showed that no obvious changes were found within 48 h. The RSD, measuring 5 times with the same check drug, was 0.35%. The precision, measuring 5 samples within the batch, was 0.37%. Conclusion: Paracetamol hollow type suppository could be prepared well and its quality also can be controlled. The major properties of the preparation conformed to the criteria.更多还原