重组人Kringle 1-3血管抑素滴眼剂制备及相关研究

目的制备重组人Kringle 1-3血管抑素滴眼剂,并对制剂稳定性及刺激性进行考察。方法选择玻璃酸钠为赋形剂,苯扎氯铵为抑菌剂,EDTA-2Na为稳定剂组成适宜的重组人Kringle 1-3血管抑素滴眼剂处方,按滴眼剂配制要求配制,以外观、理化性质、含量等为考察指标,采用紫外光谱法及Draize法分别对其稳定性与刺激性进行评价。结果重组人Kringle 1-3血管抑素滴眼剂为无色透明液体,制剂在低温条件下可稳定保存至少3个月,Draize评分〈3分,其余各项指标符合国家标准。结论重组人Kringle 1-3血管抑素滴眼剂处方合理,性质较稳定,无刺激性。

Preparation and Related Research of Recombinant Human Angiostatin Kringle 1-3 Eye Drops

Objective To prepare recombinant human angiostatin Kringle 1-3 eye drops and investigate their basic property in terms of stability and eye irritation.Methods The recombinant human angiostatin Kringle 1-3 eye drops were prepared by selecting proper formulations.The appearance and physicochemical properties were inspected.The UV spectroscope and Draize method were used to test the stability and eye irritation of the eye drops respectively.Results The eye drops were clear colourless liquid and met national standards.The preparation could be stably stored at low temperature.The Draize method showed no irritation to rabbit eyes.Conclusion The recombinant human angiostatin Kringle 1-3 eye drops have appropriate formulations,which have stable properties and cause no irritation.