浊度法测定吉他霉素片与乙酰吉他霉素干混悬剂中主药的效价

目的:建立测定吉他霉素片及乙酰吉他霉素干混悬剂中主药效价的浊度法。方法:以金黄色葡萄球菌为试验菌,吉他霉素加菌量1.0%～1.5%、乙酰吉他霉素加菌量2.0%～2.5%,于(37±0.5)℃培养4～5h后在530nm波长下测定吸光度。结果:吉他霉素、乙酰吉他霉素检测浓度线性范围分别为0.5～4.0、0.45～6.3IU.mL-1,回收率分别为101.7%、101.1%(RSD=1.9%、2.1%,n=9)。结论:所建立的浊度法灵敏、快速、影响因素较少,可用于测定吉他霉素片和乙酰吉他霉素干混悬剂中主药的效价。

Titer Determination of Main Component in Kitasamycin Tablets and Acetylkitasamycin Dry Suspension by Turbidimetry

OBJECTIVE： To determine the titer of main component in kitasamycin tablets and acetylkitasamycin dry suspension. METHODS： Staphylococcus aureus was used as test organism and which were cultured at （37 ± 0.5）℃ for about 4- 5 hours by adding 1.0%-1.5% kitasamyein and 2.0%-2.5% acetylkitasamycin, then the absorbance was determined at a wavelength of 530 nm. RESULTS： The linear range of kitasamycin was 0.5-4.0 IU · mL ^1 and that of acetylkitasamyein was 0.45-6.3 IU · mL^- 1, and their recovery rates were 101.7% （RSD = 1.9%, n = 9） and 101.1% （RSD - 2.1%, n 9）, respectively. CONCLUSION： The established turbidimetry is sensitive, rapid yet with few influencing factors, thus it is applicable for the titer determination of main component in kitasarnycin tablets and acetylkitasamycin dry suspension.