注射用喷昔洛韦的制备及质量研究

摘  要

目的：制备注射用喷昔洛韦冻干粉针剂并建立其质量控制方法。方法：考察pH值对喷昔洛韦溶解度的影响、赋形剂对产品成型外观的影响，筛选工艺条件，得出最佳处方和制备工艺，并对筛选出的处方及制备工艺进行验证，确认其可行性。然后以紫外分光光度法测定其含量，并以含量、有关物质为主要指标考察其质量。结果：确定溶液pH值在11.3~11.5，喷昔洛韦浓度在10.0μg~50.0μg/ml范围内，浓度与吸收度呈良好的线性关系，含量测定中平均回收率为 99.34%（RSD=0.31%）。注射用喷昔洛韦的各项检测指标均标均达到质量标准的要求。结论：处方合理，制备工艺可行，产品质量可控。

关键词：喷昔洛韦，处方，制备工艺，紫外分光光度法

Abstract

Goal: The preparation injection with spurts the past Luo river Wei freezing and drying medicine in powder form for injections medicinal preparation and establishes its quality control method. Method: Inspects the pH value to spurt the past Luo river Wei solubility the influence, the excipient to the product formation outward appearance influence, the screening technological conditions, obtains the best prescription and the preparation craft, and to the prescription which and the preparation craft screens carries on the confirmation, confirms its feasibility. Then determines its content by the ultraviolet spectrophotometric method, and take the content, the related material inspects its quality as the major targets or quotas. Finally: The definite solution pH value in 11.3~11.5, spurts the past Luo river Wei density in 10.0μg~50.0μg/ml the scope, the density and the absorbancy assume the good linear relationship, in the content determination the average returns-ratio are 99.34% (RSD=0.31%). The injection with spurts the past Luo river Wei's each examination target even sign to achieve the quality specification the request. Conclusion: The prescription is reasonable, the preparation craft is feasible, the product quality is controllable.

Keywords: penciclovir，prescription，preparation，UV spectropHotometry

目   录

1  引言………………………………………………………………………………………1

1.1国内研究现状………………………………………………………………………………1

1.2 实验设计…………………………………………………………………………………3

1.3 理论意义和实用价值 …………………………………………………………………3

1.4 本文拟待解决的问题 …………………………………………………………………3

2 处方及工艺研究…………………………………………………………………………4

2.1处方研究 ………………………………………………………………………………… 4

2.2工艺研究…………………………………………………………………………………5

3 注射用喷昔洛韦的工艺验证…………………………………………………………9

3.1验证内容…………………………………………………………………………………9

4质量标准及评价………………………………………………………………………14

4.1原料的质量标准 ………………………………………………………………………14

4.2成品的质量标准…………………………………………………………………………14

4.3 材料与仪器 ……………………………………………………………………………16

4.4 实验方法与结果  ……………………………………………………………………16

5结论 ……………………………………………………………………………………19

6讨论………………………………………………………………………………………20

参考文献………………………………………………………………………20

致谢…………………………………………………………………………………………21