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目的:制备塞克硝唑温敏性水凝胶,并建立其质量控制方法。方法:以泊洛沙姆P407和P188为基质,以塞克硝唑为主药制备温敏性水凝胶;采用高效液相色谱法测定其中塞克硝唑含量。结果:塞克硝唑温敏性水凝胶黏度适中,稳定性较好;塞克硝唑在2.86~28.6mg.L-1(r=0.999 8)范围内呈良好线性关系,平均加样回收率为98.94%,RSD为1.55%。结论:本制剂制备工艺简单,质量可控。
OBJECTIVE: To prepare seclnidazole thermosensitive hydrogel and to establish its quality control method. Methods: Poloxamer P407 and P188 were used as matrix to prepare sebacic-acid-based thermo-sensitive hydrogel. The content of Secnidazole was determined by high performance liquid chromatography. Results: The viscosity of seccitonol thermosensitive hydrogels was moderate and the stability was good. Secondidazole showed a good linearity in the range of 2.86 ~ 28.6mg.L-1 (r = 0.999 8) The rate was 98.94% and the RSD was 1.55%. Conclusion: The preparation process is simple, quality controllable.