博莱霉素凝胶剂处方筛选及体外药效学研究

Study prescription screening and in vitro pharmacodynamics effect of the bleomycin gel

目的 为制备稳定、疗效好的博莱霉素凝胶剂，对其处方进行筛选及体外药效学评价。方法 以卡波姆934、940、941型作为凝胶基质制备博菜霉素凝胶剂，通过质量评价筛选最佳处方；并将博莱霉素凝胶剂作用于离体尖锐湿疣皮损组织中的人乳头瘤病毒，应用荧光定量聚合酶链反应（FQ—PCR）技术，通过定量检测HPV-DNA的扩增情况，考察其体外抗病毒作用。结果 制备的博莱霉素凝胶剂，细腻、光洁、稳定性好、对皮肤无刺激性；经博莱霉素凝胶剂作用后，人乳头瘤病毒DNA扩增受到抑制，检测结果为阴性。结论 该凝胶剂配方合理、制备简便、性质稳定，符合中国药典2005版的规定，具有明显的抗人乳头瘤病毒作用。

Objective To study prescription screening and in vitro pharmacodynamics effect of the bleomycin gel. Methods The bleomycin gel was prepared with carbopol 934, 940, 941 as base material. Quality appraise was used to select the optimal formulation of the Bleomycin Gel. The gel was acted on the HPV in the tissue of the isolated CA. The polymerase chain reaction （FQ-PCR） was used for the study of antiviral effect by determining the HPV-DNA amplification. Results The gel of bleomycin have exquisite, glabrous, good stability, and no stimulate in cutis. After using the drug, the HPV-DNA amplification were restrained, the test showed negative. Conclusion The optimal and applicable formulation for prescription for the preparation bleomycin gel was screened. The formulation of the gel is reasonable, Accord pharmacopoeia of china 2005. bleomycin gel is effective to anti-human papillo-mavirus.