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目的:比较不同厂家交沙霉素片剂的体外溶出度。方法:采用紫外分光光度法(检测波长232nm)测定国内两个厂家4批交沙霉素片剂的体外溶出度,并以桨法和转篮法加以比较。结果:4批产品的溶出度参数有非常显著的差异(P<0.01)。其中A2产品溶出迅速,在桨法测量中40min可溶出95％以上,而B1产品溶出最慢,同一方法40min仅溶出30％左右。结论:由于不同厂家的交沙霉素片剂差异明显,建议规定详细的溶出标准并严格控制其制剂质量。
OBJECTIVE: To compare in vitro dissolution rates of jasminemycin tablets from different manufacturers. Methods: The elution rate of 4 batches of jasamycin tablets in two domestic manufacturers was determined by ultraviolet spectrophotometry (detection wavelength of 232 nm) and compared by paddle method and spin basket method. Results: The dissolution parameters of four batches of products had very significant differences (P <0.01). Among them, the product of A2 was dissolved rapidly, which was more than 95% soluble in 40 min in paddle measurement, while the dissolution rate of B1 was the slowest. Only about 30% was dissolved in 40 min in the same method. CONCLUSIONS: Due to the significant differences in jasamycin-resistant tablets from different manufacturers, it is advisable to provide detailed dissolution criteria and to strictly control the quality of the formulations.