摘要
目的筛选盐酸利多卡因凝胶-口服液处方,制备适合电子胃镜检查的辅助制剂。方法以卡波姆-940为基质、二甲基硅油为消泡剂制备盐酸利多卡因凝胶-口服液,详细考察其性状均匀性、消泡能力、含量、pH,确定最优处方,并通过高温、低温及离心试验考察样品的初步稳定性。结果2%盐酸利多卡因凝胶-口服液主要成分的最优处方为卡波姆-9400.3%,甘油15%,三乙醇胺0.8%,二甲基硅油2%。除高温下会使样品主药含量略有下降外,其他性质均稳定。结论2%盐酸利多卡因凝胶-口服液的制备工艺简便,质地细腻均匀,室温下稳定性好,消泡能力强,符合临床应用要求。
Objective To screen the formulations of Lidocaine Hydrochloride Gel- Oral Liquid and to prepare the auxiliary preparation suitable to electronic gastroscopy. Methods Lidocaine Hydrochloride Gel- Oral Liquid was made by using carbopol-940 and dimethicone as base material and antifoaming agent respectively. The homogeneity, defoaming power, content and pH value were selected as indexes to optimize the formula. The physical and chemical stability of the formulations was investigated by high temperature, freezing and centrifugal- ization. Results The optimum preparation was established as 0. 3% carbopol 940, 15% glycerol, 0. 8% triethanolamine, and 2% dimethieone. The quality of Lidocaine Hydrochloride Gel- Oral Liquid was stable except that the content of the main component decreased a little under high temperature. Conclusion Lidocaine Hydrochloride Gel- Oral Liquid prepared by the optimum formula has simple preparation technology and fine, smooth and even character with strong defoaming power and good stability under room temperature, which satisfies the demand of clinical application.
出处
《中国药业》
CAS
2010年第13期48-50,共3页
China Pharmaceuticals
关键词
盐酸利多卡因
凝胶
口服液
消泡能力
卡波姆-940
lidocaine hydrochloride （DH）
gel
oral liquid
defoaming power
carbopol - 940 （CP - 940）
