摘要:
目的 制备盐酸罗哌卡因温敏凝胶注射剂,并建立其含量测定方法。 方法 采用泊洛沙姆作为温敏材料,以冷法制备,利用反相高效液相色谱法测定其中药物的含量。 结果 温敏凝胶注射剂中辅料泊洛沙姆P407与P188的质量比为28:1,盐酸罗哌卡因含量为2%,相变温度为37℃。盐酸罗哌卡因在2.03~48.72 μg/ml范围内线性关系良好(r=0.999 8),精密度和重复性良好,低、中、高浓度盐酸罗哌卡因的回收率分别为(99.58±0.20)%、(97.80±0.35)%、(103.60±0.63)%,n=3,3批样品中盐酸罗哌卡因的平均含量分别为标示量的(98.92±0.35)%、(99.18±0.38)%、(98.72±0.62)%,n=3。 结论 采用泊洛沙姆为基质制备的盐酸罗哌卡因温敏凝胶注射剂质量可控,是一种很有开发前景的新型止痛剂。
Abstract:
Objective To prepare ropivacaine hydrochloride thermosensitive gel injection and establish the determination methods of contents. Methods Ropivacaine hydrochloride thermosensitive gel injection was prepared by cold methods with poloxamer as thermosensitive materials. The contents of ropivacaine hydrochloride were determined by RP-HPLC. Result The formulation contained 2% ropivacaine hydrochloride, poloxamer P407 and P188 (28:1) with phase-transition temperature of 37℃. Ropivacaine hydrochloride presented a good linearity in the range of 2.03~48.72 μg/ml (r=0.999 8), which had good precision, and reproducibility. The recovery rate of low, middle and high concentrations of ropivacaine hydrochloride were (99.58±0.20)%, (97.80±0.35)% and (103.60±0.63)%,n=3,respectively. The average contents of ropivacaine hydrochloride in three batches of sample were (98.92±0.35)%, (99.18±0.38)% and (98.72±0.62)%,n=3. Conclusion The quality of Ropivacaine hydrochloride thermosensitive gel injection with poloxamer as matrix could be controlled. It had a new development prospects for relieving pain.
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