醋酸氯己定泡腾滴丸的制备及质量控制

Study on preparation of chlorhexidine acetate effervescent pills and its quality standards

目的:探讨醋酸氯己定泡腾滴丸的制备工艺及质量标准。方法:以碳酸氢钠和酒石酸为泡腾崩解剂,以PEG400和PEG6000为混合基质制备醋酸氯己定泡腾滴丸。建立质量检测方法,采用UV法测定醋酸氯己定的含量,检测波长260nm。结果:鉴定方法专属性强,本品丸重差异、溶散时限等均符合要求,平均回收率99.58%,RSD为0.95%。结论:该泡腾滴丸处方组成合理,制备方法可行,质量控制方法能够控制该制剂的质量。

OBJECTIVE To explore the preparation of chlorhexidine acetate effervescent pills hibitane and study its quality standards. METHODS The effervescent pills hibitane was prepared using NaHCO3 and tartaric acid as disintegrating,while u sing PEG400 and PEG6000 as mixed matrix. The content of the drug was determined by UV, with the detection wavelength 260 nm. RESULTS The recipe was rational, quality control was reliable and accurate. The average recovery was 99.58% and RSD was 0.95%. CONCLUSION The recipe component was reasonable, and the preparation procedure was practicable. The quality control was able to control the quality of the product.