重组人干扰素α2b阴道泡腾片制备工艺的研究(1)
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[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]报道重组人干扰素α2b阴道泡腾片治疗宫颈糜烂疗效确切，使用安全，并对HPV、HSV-Ⅱ及HCMV感染有一定的转阴作用，值得临床推广和使用。但干扰素为蛋白类药物，性质不稳定，容易受到酸碱度、温度等的影响而失活，所以在干扰素阴道泡腾片的制备过程中如何保持其生物学活性，是干扰素阴道泡腾片制备的难点，本文以制备过程中干扰素生物学活性的保持和发泡量等为检验指标，研究和优化了干扰素阴道泡腾片的处方和制备工艺。
1 仪器与试药
1.1 仪器
FW-100型高速万能粉碎机(北京市永光明医疗仪器厂) ......
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