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目的:制备苯麻鼻用温敏凝胶,并建立其质量控制方法。方法:以胶凝温度为指标,通过正交试验考察泊洛沙姆407(P407)、泊洛沙姆188(P188)及聚乙二醇6000(PEG 6000)的用量;采用高效液相色谱法测定制剂中盐酸苯海拉明和盐酸麻黄碱的含量。结果:P407、P188及PEG 6000的最佳处方量分别为19%、2%和1%;盐酸麻黄碱在1.600 0~2.400 0 mg·ml~(-1)浓度范围内线性关系良好(r=0.999 6),平均加样回收率为99.76%,RSD为1.02%(n=9);盐酸苯海拉明在0.160 0~0.240 0mg·ml~(-1)浓度范围内线性关系良好(r=0.999 7),平均加样回收率为101.27%,RSD为1.10%(n=9)。结论:该制剂处方设计和工艺方法可行,建立的高效液相色谱法可用于该制剂的质量控制。
OBJECTIVE: To prepare a thermosensitive gel for treating benzene nose and to establish its quality control method. Methods: The dosage of poloxamer 407 (P407), poloxamer 188 (P188) and polyethylene glycol 6000 (PEG 6000) were investigated by orthogonal test with the gelling temperature as the index. The content of diphenhydramine hydrochloride and ephedrine hydrochloride in the preparation was determined. Results: The optimal prescriptions of P407, P188 and PEG 6000 were 19%, 2% and 1%, respectively. The linear range of ephedrine hydrochloride was 1.600 0-2.400 0 mg · ml -1 (r = 0.999 6). The average recovery was 99.76% and the RSD was 1.02% (n = 9). Diphenhydramine hydrochloride had a good linearity in the range of 0.160 0-0.240 0 mg · ml -1 (r = 0.999 7). The average recovery was 101.27% and the RSD was 1.10% (n = 9). Conclusion: The prescription design and the process are feasible. The established HPLC can be used for the quality control of the preparation.