临时配制的对乙酰氨基酚混悬液的稳定性与分剂量研究

Research on Stability and Divided Dose of Extemporaneous Paracetamol Suspension

目的：探讨以单糖浆和水为稀释剂分别临时制备乙酰氨基酚混悬液的分剂量和稳定性。方法：将对乙酰氨基酚片剂研磨成粉状,分别加入至单糖浆和纯化水中配成混悬液,并分别进行稳定性试验和分剂量试验,考察其在室温（25℃）和2~10℃环境下72 h内的药物稳定性与0、4、8、24 h的分剂量准确性。结果：在稳定性试验中,放置72 h后2种混悬剂的浓度均在起始浓度的98%~102%范围内;在24 h内的分剂量试验中,以单糖浆为稀释剂的混悬剂各个时间点浓度的差异无统计学意义（P〉0.05）,而以纯化水为稀释剂的混悬剂的各个时间点浓度的差异有统计学意义（P〈0.05）。结论：在室温（25℃）和2~10℃条件下,对乙酰氨基酚片剂磨粉后加入到单糖浆和水中放置72 h后稳定性均较好;而在24 h内的分剂量试验中,不管是在室温（25℃）还是2~10℃的环境下,以单糖浆为溶剂的药物的分剂量都较以纯化水为溶剂的分剂量准确。

OBJECTIVE： To probe into the stability and divided dose of extemporaneous paracetamol suspension prepared by single syrup and pure water as diluents. METHODS： Paracetamol suspension tablets were crushed into powder,and simple syrup and pure water were added. Meanwhile,stability test and divided dose test were respectively conducted on the paracetamol suspension,the accuracy of the divided dose at 0,4,8,24 h and the stability of the suspension stored at 72 hours afterward at room temperature（ 25 ℃） and the refrigerator（ 2-10 ℃） were evaluated.RESULTS： In the stability test,concentration of the two mixed suspension stored at 72 hours afterward were between 98%-102% of initial concentration; in the 24 h divided dose test,there were no significant difference in simple syrup suspension at different time points（ P〉0. 05）,but there were significant difference in pure water suspension at different time points（ P〈0. 05）. CONCLUSIONS： The stability of paracetamol powder with simple syrup and pure water stored at least 72 hours at room temperature（ 25 ℃） and the refrigerator（ 2-10 ℃） was relatively good; yet drugs in simple syrup are more accurate than those in aqueous solution in divided dose test in both environments.