不同厂家左氧氟沙星片体外溶出度考察

Study on the dissolution of levofloxacin tablets from different manufacturers in vitro

目的测定左氧氟沙星片剂的溶出度,考察不同厂家片剂的质量。方法采用转篮法进行体外溶出度试验,以紫外分光光度法进行含量测定,在波长293 nm处测其吸收度,计算累积溶出百分率。用Origin 8.0软件计算各个厂家的溶出参数T50、Td、T80、m,再对参数进行方差分析。结果不同厂家左氧氟沙星片溶出度均符合2005年版《中华人民共和国药典》规定,但各个厂家T50、Td、T80、m值间均有显著性差异(P<0.01)。结论有关厂家应严格按照规定控制产品的内在质量,以保证临床用药安全、有效。

Objective To determine the dissolution of levofloxacin tablets and study on the quality of the tablets by different manufacturers. Methods The dissolution test was carried out with rotating basket. The con- centration of levofloxacin was determined by UV spectrophotometry. Measuring the degree of absorption in the wavelength of 293 nm and the accumulative dissolution was calculate. The dissolution parameters T50, Td, T80 and m was calculated by origin 8.0 software. The difference between different groups was statistically evaluated by variance analysis. Results The result showed that the dissolution of levofloxacin from different manufacturers conformed to the requirements of Chinese Pharmacopoeia （2005）. But significant difference was found among levofloxacin preparations from different factories in dissolution parameter m, T50, Td and T80 （P 〈 0. 01 ）and different batches of the dissolution parameters from the same factory. Conclusions Manufacturers should according to stipulation and strictly control the quality of products to ensure the safety and effective of clinical medicine.