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目的以外观、稳定性、含量和刺激性为评价指标,筛选铁扇癣痒平凝胶剂的最佳处方工艺。方法以卡波姆为基质及水相,吐温为乳化剂,蓖麻油为油相,制备乳剂型凝胶剂。以均匀性、黏稠度和稳定性为指标,筛选处方用量。以盐酸小檗碱为指标,建立HPLC含量测定方法,评价含量和稳定性。采用家兔皮肤刺激性实验评价局部使用的安全性和刺激性。结果优选处方为卡波姆-940:1.4%(g·g-1),蓖麻油:8%(ml·g-1),吐温-80:3%(ml·g-1),三乙醇胺:2%(ml·g-1),甘油:10%(ml·g-1),乙醇:20%(ml·g-1),浸膏粉:3%(g·g-1)。制得凝胶剂的均匀性、黏稠度和稳定性良好;含盐酸小檗碱(119.2±1.0)μg·g-1(n=3);6个月后剩余含量为100.5%,含量无明显下降。凝胶剂对局部皮肤无刺激性。结论铁扇癣痒平凝胶外观细腻、易涂布、含量均匀、性质稳定。
OBJECTIVE To screen the best prescription of iron ring ring itch gel by the appearance, stability, content and irritation as the evaluation index. Methods Carbopol as matrix and aqueous phase, Tween as emulsifier, castor oil as the oil phase, preparation of emulsion gel. To uniformity, consistency and stability as an indicator, screening prescription dosage. Taking berberine hydrochloride as index, the HPLC method was established to evaluate the content and stability. Rabbit skin irritation tests were used to assess the safety and irritation of topical use. Results The preferred prescriptions were carbomer-940: 1.4% (g · g -1), castor oil 8% (ml · g -1), tween-80: 3% : 2% (ml · g -1), glycerol 10% (ml · g -1), ethanol 20% (ml · g -1) and extract powder 3% (g · g -1). The uniformity, consistency and stability of the prepared gels were good. Berberine hydrochloride (119.2 ± 1.0) μg · g-1 (n = 3) was obtained. The remaining content was 100.5% after 6 months, decline. Gel on the local skin non-irritating. Conclusion The appearance of Tiechuan ring itching gel is exquisite, easy to apply, uniform in content and stable in nature.