硝酸毛果芸香碱滴眼液稳定性提升的处方工艺研究

Study on the prescription process of improving the stability of pilocarpine nitrate eye drops

目的 立足工业化生产,开发提高硝酸毛果芸香碱滴眼液稳定性的处方工艺。方法 通过阅读文献、剖析参比制剂特性,设计并筛选出合适的处方工艺。结果 采用低温配制的方法、控制处方pH值、筛选合适的滤膜等措施,得到可以工业化生产的处方工艺。该处方中硝酸毛果芸香碱为主要成分、硼酸和枸橼酸钠为pH调节剂、氯化钠为渗透压调节剂、苯扎氯铵为抑菌剂。结论 本研究设计的硝酸毛果芸香碱滴眼液处方工艺合理,稳定性较原研制剂优越,可以进行大规模的工艺化生产。

Objective Based on industrial production,develop a prescription process to improve the stability of pilocarpine nitrate eye drops.Methods By reading literatures,analyzing the characteristics of reference formulations,the appropriate prescription process was designed and screened.Results By using a low-temperature preparation method,controlling the pH value of the prescription and selecting suitable filter membranes,a prescription process that can be industrialized was obtained.The main component in the prescription was pilocarpine nitrate,boric acid and sodium citrate were used as pH regulators,sodium chloride was used as osmotic pressure regulator,and benzalkonium chloride was used as antibacterial agent.Conclusion The prescription process design of pilocarpine nitrate eye drops designed in this study is reasonable,with superior stability compared to the original preparation,and it can be used for large-scale industrial production.