虎黄烧伤凝胶剂的制备及质量控制

Preparation and quality control of Hu-Huang Burn Gel

目的确定虎黄烧伤凝胶剂的制备工艺并建立其质量控制的方法。方法通过单因素实验以凝胶剂的成型性和稳定性为考察指标,筛选出最适宜的载药基质。采用高效液相色谱法同时测定该制剂中虎杖苷和盐酸小檗碱的含量。结果虎黄烧伤凝胶剂的最佳基质材料为2.5%的羟丙甲基纤维素;虎杖苷质量浓度与峰面积的线性回归方程为Y=79415X-444889（r=0.9994）,线性范围为15.6-78.0μg/mL;盐酸小檗碱质量浓度与峰面积的线性回归方程为Y=65 576X-583 154（r=0.9996）,线性范围为34.75-173.75μg/mL;平均加样回收率分别为99.34%、99.64%（n=6）。结论本研究制剂制备工艺简单,性质稳定,含量测定方法准确可靠,重现性好,促进了该制剂在临床上的应用。

Objective To confirm the preparation technology of Hu-Huang Burn Gel and establish its quality control method. Methods The formability and stability of the gels were taken as examining index by the single factor experiment, and through which the most appropriate matrix for the Chinese medicine extract was selected. The HPLC method was used for simultaneous determination of the content of polydatin and berberine hydrochloride in the formulation. Results 2.5% HPMC-K4M was proved to be the optimum matrix. The linear regression equation of polydatin about concentration and peak area was Y=79415X-444889（r=0.9994）, the linear range was 15.6-78.0 μg/m L;the linear regression equation of berberine hydrochloride about concentration and peak area was Y =65 576X-583154（r =0.9996）, the linear range was 34.75-173.75 μg/m L; and the respectively average recovery was 99.34% and 99.64%（n=6）. Conclusion The preparation of Hu-Huang Burn Gel is simple and the nature of this formulation is stable,the assaying method is accurate with well reproducibility, which can promote the application of the formulation in the clinic.