摘要
目的建立琥珀酸甲泼尼龙（MPS）聚合物胶束的包封率测定方法。方法采用高速离心法分离MPS聚合物胶束和游离MPS；碱溶液法破坏聚合物胶束，提取MPS；RP．HPLC法测定MPS的包封率，以甲醇．10mmol·L。pH3．0的KH，P04（体积比65：35）为流动相，C18柱（250mmx4．6mm，5μm）为色谱柱，柱温为35℃．流速为0．8mL·min^-1，检测波长为254nm。结果当NaOH溶液浓度为5．0mmol·L^-1、聚合物胶束与NaOH质量比为10：1时，NaOH可破坏聚合物胶束，并溶解MPS，得到pH为7．50的澄清溶液。按建立的包封率测定方法，MPS主峰与杂质峰分离良好，线性范围为10．12。91．08μg·mL^-1（r=0．9999，n=5），平均回收率为101．8％，RSD为1．47％，日内、13间精密度及样品稳定性均良好。采用该法测定3批MPS聚合物胶束的平均包封率为（85．35±1．02）％。结论所建立的琥珀酸甲泼尼龙（MPS）聚合物胶束包封率的测定方法简便快速，准确可靠。
Objective To develop a method for the determination of entrapment efficiency of methylprednisolone hemisuccinate loaded polymeric micelles. Methods High-speed centrifugation method was utilized to separate methylprednisolone hemisuccinate loaded polymeric micelles and free drug. Sample solution was prepared by sodium hydroxide solution method. Methylprednisolone hemisuccinate was detected by RP- HPLC method with the mobile phase of methanol-10 mmol · L^-1 KH2PO4（pH 3.0） （65： 35 ） , a flow rate of 0.8 mL · min^- 1, an analytical column of C js （ 250 mm × 4.6 mm, 5 Ixm ） , temperature of 35 ℃ .Results When the concentration of sodium hydroxide solution was 5.0 mmol · min^- 1 and the weight ratio of polymeric micelles versus sodium hydroxide was 10：1, the clear sample solution of methylprednisolone hemisuccinate loaded polymeric mieelles were obtained and the pH was 7. 50. Methylprednisolone hemisuccinate and impurities were completely separated. The linear range for methylprednisolone hemisuccinate was 10.12-91.08 μg · min^- 1（r=0.999 9,n=5）. The absolute recovery was 101.8% and RSD was 1.47%. The entrapment efficiency of methylprednisolone hemisuccinate loaded polymeric micelles was （85.35 ± 1.02 ）%. Conclusion It is simple, sensitive and accurate to assay methylprednisolone hemisuccinate loaded polymeric micelles by sodium hydroxide solution method to dissolve micelles and RP- HPLC method to test methylprednisolone hemisuccinate.
出处
《广东药学院学报》
CAS
2014年第1期15-18,共4页
Academic Journal of Guangdong College of Pharmacy
关键词
聚合物胶束
琥珀酸甲泼尼龙
包封率
RP
HPLC
polymeric micelles
methylprednisolone hemisuccinate
entrapment efficiency
RP-HPLC
