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目的:考察季胺化程度为60%的N-三甲基壳聚糖(TMC60)对以泊洛沙姆为基质的液体栓剂的物理化学性质的影响,为两者的配伍使用提供试验依据。方法:将5种不同浓度的TMC60(0%,0.2%,0.4%,0.6%,0.8%)合并泊洛沙姆溶液(P407:P188=15%:19%)作为液体栓剂的基质,测定不同浓度TMC60对液体栓剂基质的胶凝温度、胶凝强度和生物粘附力的影响。结果:当TMC60的浓度从0%上升至0.8%时,基质的胶凝温度(℃)依次为27.2,28.2,28.8,29.6,30.8;胶凝强度(s)依次为10,30,66,97,146;生物粘附力值(×10~2dyne/cm~2)依次为35.0,46.5,50.2,60.2,82.6。表明随着TMC60浓度增高,泊洛沙姆液体栓剂基质的胶凝温度、胶凝强度和生物粘附力均逐渐升高(P<0.05)。结论:TMC60可改善以泊洛沙姆为基质的液体栓剂的体外物化性质,值得进一步研究。
OBJECTIVE: To investigate the effect of 60% quaternized N-trimethyl chitosan (TMC60) on the physicochemical properties of poloxamer-based liquid suppositories, and to provide experimental evidence for their compatibility. METHODS: Five different concentrations of TMC60 (0%, 0.2%, 0.4%, 0.6%, 0.8%) combined with poloxamer solution (P407: P188 = 15%: 19%) were used as the matrix for liquid suppositories and tested for differences Effect of TMC60 on the gelling temperature, gelling strength and bioadhesion of liquid suppository base. Results: When the concentration of TMC60 increased from 0% to 0.8%, the gelation temperature (℃) of matrix was 27.2,28.2,28.8,29.6,30.8, and the gel strength (s) was 10,30,66,97,146 ; Bioadhesive value (× 10 ~ 2dyne / cm ~ 2) were 35.0,46.5,50.2,60.2,82.6. The results showed that the gelation temperature, gel strength and bioadhesion of poloxamer liquid suppository matrix increased gradually with the increase of TMC60 concentration (P <0.05). Conclusion: TMC60 can improve the physico-chemical properties of poloxamer-based liquid suppositories in vitro and deserve further study.