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目的:制备一种中药烫伤凝胶,并建立质量控制方法。方法:以卡波姆940作为凝胶基质,采用高效液相色谱法测定盐酸小檗碱含量,并进行稳定性考察和皮肤刺激性实验。结果:盐酸小檗碱含量测定线性范围为11.6~116mg.L-1,r=0.999 7,平均回收率为99.7%,RSD为1.9%,制剂稳定性良好,对皮肤无刺激作用。结论:本制剂制备工艺简便,性质稳定,质量可控,适用于医院制剂。
Objective: To prepare a traditional Chinese medicine scald gel and establish a quality control method. Method: The content of berberine hydrochloride was determined by HPLC with Carbopol 940 as the matrix. The stability and skin irritation were also studied. Results: The linear range of berberine hydrochloride was 11.6-116 mg.L-1, r = 0.999 7, the average recovery was 99.7% and the RSD was 1.9%. The stability of the preparation was good and no irritation to the skin was observed. Conclusion: The preparation preparation process is simple, stable in nature, quality controllable, suitable for hospital preparations.