硫酸沙丁胺醇延迟释药片的制备及质量控制

目的:制备硫酸沙丁胺醇延迟释药片,并建立其质量控制方法。方法:用硫酸沙丁胺醇、乳糖、羧甲基淀粉钠、羟丙基甲基纤维素、乙基纤维素、微晶纤维素制备成缓释片,再用肠溶型丙烯酸树脂包衣,制备成延迟释药片;采用高效液相色谱法测定该延迟释药片中硫酸沙丁胺醇的含量,同时对其体外释放度进行测试,并考察其稳定性。结果:硫酸沙丁胺醇检测浓度在1.25～20.00μg/ml范围内与吸收峰面积积分值线性关系良好;平均回收率为98.60%(RSD=0.66%);制备的延迟释药片在服用后约5h定时释药,且在各项稳定性试验中,释放度均无明显变化。结论:本制剂组方合理,制备工艺简便可行,质量稳定可控。

Preparation and Quality Control of Sustained Release Tablets of Salbutamol Sulfate

OBJECTIVE : To prepare the sustained release tablets of salbutamol sulfate,and to establish the method of quality control.METHODS: The sustained release tablets were prepared by using salbutamol sulfate, lactose, sodium carboxymethyl starch, HPMC, EC, and MCC and coated with enteric soluble acrylic resin.HPLC was employed to determine the content of salbutamol sulfate, while at the same time dissolution grade in vitro was determined, and stability was investigated.RESULTS: : The detectable concentration of salbutamol sulfate showed a good linear correlation with peak area in the range of 1.25～20.00μg/ml.The average recovery of salbutamol sulfate was 98.60% (RSD=0.66%).The prepared tablets showed a timing release 5 hours after administration.No evident changes in dissolution were found in all tests of stability.CONCLUSION: The formulation of the preparation is reasonable; the preparation technique is simple and feasible, and the quality is stable and controllable.