琥珀酰壳聚糖人工泪液的制备及质量控制

Study on preparation and quality control of succinyl-chitosan artificial tears eye drops

目的研制琥珀酰壳聚糖人工泪液,并建立其质量控制方法。方法以琥珀酰壳聚糖为主要成分制备琥珀酰壳聚糖人工泪液。通过性状、鉴别、检查、含量测定研究制定其质量控制方法。结果此品处方组成适合干眼症生理及治疗要求,制备工艺符合滴眼剂质量要求。性状、鉴别、检查、含量测定方法可作为该制剂质量控制方法。结论此品处方组成合理,制备工艺可行,符合滴眼剂质量要求,质量控制方法能够控制该制剂内在质量。

Purpose To prepare succinyl-chitosan artificial tears and establish its quality control. Methods Using succinyl-chitosan as essential component, the succinyl-chitosan artificial tears were prepared. Through some tests of character, identification, examination and quantitative determination, the quality control was established. Results This formulation is in accord with the physiology and therapeutic requirements of xerophthalmia. The character, identification, examination and quantitative determination can be defined as quality control. This preparation operation is consistent with the quality requirements of eye drops. Conclusion This formulation is rational, and the preparation procedure is practicable. This eye drops are in line with the quality requirements of eye drops. The quality control may be applied to control the key quality of succinyl-chitosan artificial tears eye drops.