盐酸土霉素泡腾片的制备与品质控制

Preparation and Quality Control of Oxytetracycline Hydrochloride Effervescent Tablets

研制以盐酸土霉素为主药的泡腾片,并建立其品质控制方法。将盐酸土霉素和柠檬酸、碳酸钠等组分制成干燥品,经酸碱分别制粒、整粒、混合后压片,并对其品质控制进行研究,以紫外分光光度法测定盐酸土霉素含量。结果表明,所制制剂pH在4.5-5.0之间,平均每片发泡量12.63 mL崩解时间均在5 min内,片质量差异均在±5%以内。盐酸土霉素的紫外最大吸收波长为274 nm,在5-25μg/mL内质量浓度（C）与吸光度（A）线性关系良好,平均回收率为95.07%（RSD=0.6%）。所研制的盐酸土霉素泡腾片符合要求。

To investigate preparation technique and quality control methods of Oxytetracycline Hydrochloride Effervescent Tablets（OHET）.Stuff of oxytetracycline hydrochloride,citric acid and sodium carbonate was dried firstly,then granulating separately with acidic and alkaline,then size-stabilizing and mixed to press tablets.Content of oxytetracycline hydrochloride was determined by the UV spectrophotometry.The results of quality control of OHET indicated that the quality of tablets conformed to the requirement of the China Pharmacopeia.The tablet was completely broken up within 5 min,the average foaming quantity reached 12.63 mL,the pH was 4.5～5.0,and the weight variation was less than 5%.The maximum absorbance wavelength of oxytetracycline hydrochloride was 274nm.Calibration curve was linear in the range of 5～25 μg/mL,and the average recovery of oxytetracycline hydrochloride was 95.07%（RSD=0.6%）.In conclusion,the Oxytetracycline Hydrochloride Effervescent Tablets prepared in this research meet the requirement of quality control.