重组人干扰素α2b阴道泡腾片制备工艺研究.docVIP

重组人干扰素α2b阴道泡腾片制备工艺研究 　　[摘要] 目的：研究重组人干扰素α2b阴道泡腾片的制备工艺。方法：采用酸碱混合非水制粒，微粉硅胶吸附干扰素原液室温干燥，与酸碱颗粒混合压片制备干扰素阴道泡腾片，对泡腾片处方采用正交设计的方法进行优化。结果：微粉硅胶吸附干扰素能够较好地保持干扰素生物学活性不受损失，酸碱混合非水制粒泡腾效果好、片剂更均匀。处方中硼酸、酒石酸、碳酸氢钠、羧甲基淀粉钠的质量在片剂中所占的百分比分别为20%、15%、20%、2%。结论：该制备工艺简单，合理可行，操作性强，成本低，适合工业大生产。 　　[关键词] 干扰素α2b；阴道泡腾片；制备；非水制粒 　　[中图分类号]R94[文献标识码] B[文章编号] 1673-7210（2009）05（b）-065-03 　　 　　Study on preparation procedure for recombinant human interferon α2b vaginal effervescent tablets 　　XU Xiao, GUAN Jinghua, CHEN Xinling, ZHANG Chunli, LIN Yanhong 　　(Beijing Kayin Bio-Tech Co.,LTD National Engineering Research Centre for Viral Bio-Technology, Beijing100176, China) 　　[Abstract] Objective: To study the production processes of recombinant human interferon α2b vaginal effervescent tablets. Methods: Granulation by mixing acid alkaline under no naqueous condition. Used silicone powder to absorb concentrated solution of Interferon α2b, let it dry under room temperature. Then mixed the silicone powder with the acid alkaline granule and squash to produce the vaginal effervescent tablets. Orthogonal design was employed to optimize the prescription. Results: Interferon absorbed by silicone powder could remain high biological potency. The effervescent effect produced by mixing acid alkaline under nonaqueous condition was very good; and the ingredients were also better-distributed. In the prescription, the weight of boric acid, tartaric acid, sodium bicarbonate and sodium carboxy nethy accounted for 20%, 15%, 20% and 2% respectively of the total weight. Conclusion: This production method is simple and feasible. And due to its strong operability and low cost, it is suitable for large scale production. 　　[Key words] Interferon α2b; Vaginal effervescent tablets; Production; Nonaqueous granulation 　　 　　干扰素作为广谱抗病毒的生物制品，局部外用使损害处干扰素浓度高，可充分发挥其抗病毒、抗增生及免疫调节作用，以较小剂量取得较好疗效[1]。干扰素阴道泡腾片，经阴道给药，直接作用于病变部位，作用直接、安全、有效；泡腾片有起效快、吸收完全、不伤黏膜等特点[2]，能够遇体液快速崩解、均匀分散，利用气泡产生的推动力，使药物充分地分布于宫颈口和阴道中，并与感染病灶部位充分接触，从而达到更加有效的治疗效果。邵为荣等[3]报道重组