复合亚氯酸钠泡腾胶囊的制备及质量研究
林 翠，董静文，王田田
河北科技大学 化学与制药工程学院，河北 石家庄 050018
Preparation and quality research of compound sodium chlorite effervescent capsules
Lin Cui, Dong Jingwen, Wang Tiantian
College of Chemistry and Pharmaceutical Engineering, Hebei University of Science and Technology,
摘要 通过单因素试验及正交试验对复合亚氯酸钠泡腾胶囊的处方进行了研究，并对所制备的样品胶囊进行了质量研究、体外杀菌性能研究、安全性能研究及稳定性能研究。结果表明，泡腾胶囊的性状、发泡量、崩解时限和含量等指标均符合2020年版中国兽药典标准；样品溶液浓度为100 mg/L时，体外杀菌性能良好；样品胶囊对兔子皮肤无刺激性，安全性能性能良好；高湿是影响本制剂质量的主要因素，采用密封隔湿包装的样品胶囊在12个月内质量稳定。本文所研发的复合亚氯酸钠泡腾胶囊处方合理，制备工艺简单可行，制剂产品质量稳定，能够有效治疗奶牛子宫内膜炎。
关键词 ：
泡腾胶囊 ,
二氧化氯 ,
质量研究 ,
杀菌 ,
稳定性
Abstract ：The prescription of composite sodium chlorite effervescent capsule was studied by single factor test and orthogonal test, and the quality, in vitro bactericidal performance, safety performance and stability of the prepared sample capsule were studied. The results showed that the properties, foaming amount, disintegration time limit and content of effervescent capsule were in line with the standard of the Chinese Veterinary Pharmacopoeia in 2020. When the concentration of sample solution was 100 mg/L, the bactericidal performance in vitro was good. The sample capsule had no irritation to rabbit skin and good safety performance. High humidity was the main factor affecting the quality of the preparation. The quality of the sample capsule packaged with sealed moisture-proof packaging was stable within 12 months. The compound sodium chlorite effervescent capsule developed in this paper had reasonable prescription, simple and feasible preparation process, stable product quality and could effectively treat cow endometritis.
Key words ：
effervescent capsules
carbon dioxide
quality research
sterilization
methodology
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