铁扇癣痒平凝胶的制备及质量评价

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·g1-1），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）I,Lg·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。

Preparation and evaluation of Tieshan Xuanyangping gel

Objective To optimize the preparation of Tieshan Xuanyangping gel. Methods Carbomer -940 was used as gel the matrix and aqueous phase,Tween-80 as the emulsifier and castor oil as the oil phase. Uniformi- ty, viscosity and stability were evaluated to optimize the formulation. An HPLC method was established to evaluate the content and uniformity using berberine hydrochloride as the index. Rabbits were used to evaluate skin irritation. Results The optimized formula was Carbomer-940 1.4% （ g · g-1 ）, castor oil 8% （ ml · g-1 ）, Tween-80 3% （ ml ·g-1 ）, trolamine 2% （ ml ·g-1 ）, glycerol 10% （ ml ·g-1 ）, ethanol 20% （ ml ·g-1 ）, and powdered extract 3% （g ·g-1 ）. Uniformity, viscosity and stability were perfect. The content of berberine hydroehloride was （119.2 ± 1.0） lxg .g-l（ n =3）. No skin stimulus was observed. Conclusion Tieshan Xuanyangping gel has excellent ap- pearance, uniformity and stability.