喷昔洛韦注射液的制备及质量研究

目的制备喷昔洛韦注射液并建立其质量控制方法。方法考察溶液pH值对喷昔洛韦溶解度的影响．筛选工艺条件．得出最佳处方和制备工艺。建立了高效液相色谱法测定其含量及有关物质，并以含量、有关物质为主要指标考察其质量；另外进行了动物安全性评价。结果确定溶液pH值为11．0左右；含量测定中平均回收率为99．9％（RSD=0．7％）。喷昔洛韦注射液的各项检测指标均达到质量标准的要求．动物安全性试验结果符合规定。结论处方合理，制备工艺可行，产品质量可控。

Study on the preparation and quality evaluation of penciclovir injection

Objective To prepare penciclovir injection and establish a quality control method for this preparation.Methods The formulation and preparation techniques of the injection by investigating effect in various pH values on solubility of penciclovir and other process conditions were selected and optimized.The penciclovir content and the related substances,which were determined by HPLC,were studied as main subjects.The safety on animals was evaluated.Results The optimal pH value was about 11.0;the average recovery of the method was 99.9%(RSD=0.7 %);all parameters of the preparation,as well as the results on animal safety data,were in line with requirements.Conclusion The formulation was reasonable,the preparation technique was feasible and the quality was controllable.