聚维酮和共聚维酮对青霉素V钾片质量及性能的影响  

Effects of povidone and copovidone on the quality and properties of penicillin V potassium tablets

作　　者：刘海席 仇俊新 李兰涛 李金彦 Liu Haixi;Qiu Junxin;Li Lantao;Li Jinyan(North China Pharmaceutical Corporation Ltd, Shijiazhuang 050000, China)

机构地区：[1]华北制药股份有限公司

出　　处：《煤炭与化工》2019年第5期130-131,139,共3页Coal and Chemical Industry

摘　　要：以聚维酮和共聚维酮乙醇水溶液为粘合剂,对比2种粘合剂对青霉素V钾片质量、性能的影响。研究了聚维酮K29/30和共聚维酮S630与青霉素V钾原料相容性;分别选择这两种辅料的10%乙醇水溶液作为粘合剂,采用湿法制粒制备青霉素V钾片。通过原辅料相容性结果,片剂的脆碎度、崩解时限和快速稳定性试验结果,比较2种辅料对青霉素V钾片质量和性能的影响。结果表明:共聚维酮S630具有良好疏水性能,可改善产品由于高湿引起的杂质增长问题,并且采用共聚维酮S630粘合剂制备的片剂在脆碎度性能方面更好。The effects of two binders povidone and copovidone aqueous solution on the quality and properties of penicillin V potassium tablets were compared. The compatibility of povidone K29/30 and plasdone S 630 with penicillin V potassium was studied. The 10% ethanol aqueous solution of these two excipients was selected as the binder, and the penicillin V potassium tablets were prepared by wet granulation. The effects of two kinds of excipients on the quality and properties of penicillin V potassium tablets were compared by investigating the compatibility of API and the two auxiliary materials, the friability, the disintegration time and the rapid stability of the tablets. The results show that plasdone S630 has good hydrophobic properties, which can improve the impurity growth problem caused by high humidity, and the tablets prepared by plasdone S630 adhesive have better fragility.

关 键 词：聚维酮K29/30 共聚维酮S630 青霉素V钾片 粘合剂 

分 类 号：TQ465.1[化学工程—制药化工]