复方中草药凝胶的制备和质量控制

Preparation and Quality Evaluation of Vaginal Gel of Chinese Traditional Medicines

目的研制一种以卡波姆为基质,以黄连、虎杖、丁香、五倍子、仙鹤草、白头翁为主要成分的阴道用凝胶并对其进行质量评价。方法选用卡波姆、甘油等基质与中药提取液混合制备凝胶,采用薄层层析法对制剂进行定性鉴别,采用薄层-紫外分光光度法测定其中大黄素的含量。结果大黄素回归方程为C=15.3793A+0.3706,r=0.9999,浓度线性范围是4.0～12.0μg/mL,加样回收率为98.64%。结论制备的凝胶符合所定的质量标准,制备方法操作简便。

Objective To prepare vaginal gel consisted of Rhizoma coptidis, Rhizoma polygoni cusgidati, Flos caryophylli, Galla chinensis, Herba Agrimoniae, Radix Pulsatillac, and to establish a quality control method. Methods Carbopol was used as a gel base, the content of emodin was determined with UV spectrophotometry and the stability test was performed. Results The average recovery rate was 97.57%, RSD was 1.65% （n =5）. The gel was stable. Conclusion The preparation technique is easily operable. The gel may be a novel preparation and will be further investigated.