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目的以正交试验法筛选清开灵温敏眼用凝胶的制备工艺,并研究其体外溶蚀性。方法以泊洛沙姆407(P407)、泊洛沙姆188(P188)和丙二醇为基质,采用正交试验设计,以样品的相变温度及人工泪液稀释后的相变温度为考察指标,优化处方配比,采用恒温振荡法研究其体外释放性。结果清开灵温敏眼用凝胶在室温下为棕红色液体,在35℃时为棕红色胶体,P407、P188和丙二醇的最佳用量分别为25%、3%和6%,清开灵眼用凝胶可以均匀的释放其主要化学成分。结论按该配比制备清开灵温敏眼用凝胶,相变温度适宜,制备工艺简单,能很好地起到缓释效果。
OBJECTIVE To screen the preparation process of Qingkailing temperature-sensitive ophthalmic gel by orthogonal test and study its in vitro dissolution. Methods Poloxamer 407 (P407), poloxamer 188 (P188) and propylene glycol were used as the matrix. The orthogonal experimental design was used. The phase transition temperature of the sample and the phase transition temperature after artificial tear dilution were used as the indexes to optimize Prescription ratio, using constant temperature oscillation method to study its in vitro release. Results Qingkailing temperature-sensitive ophthalmic gel was a reddish-brown liquid at room temperature and was a reddish colloid at 35 ℃. The best dosage of P407, P188 and propylene glycol were 25%, 3% and 6% Eye gel can release its main chemical composition evenly. Conclusions Qingkailing temperature-sensitive ophthalmic gel can be prepared according to the ratio, the phase transition temperature is suitable, the preparation process is simple and the sustained-release effect can be well played.