盐酸大观霉素泡腾片的研制及其含量测定方法

Preparation of Spectinomycin hydrochloride effervescent tablets and determination of content by microbiological method

目的 :研制盐酸大观霉素泡腾片 ,并建立其含量测定方法。方法 :采用正交设计法进行试验 ,以泡腾量为指标筛选处方。用微生物检测法测定制剂的含量 ,并对含量测定进行方法学研究。结果 :最佳处方为A3 B1C3 ,即洒石酸和碳酸氢钠总量为 35 % ,聚乙烯吡咯烷酮为 3% ,羧甲淀粉钠为 6 % ;建立的微生物检测法在 4 5 8u/ml～ 2 18 4u/ml,范围见线性良好 (r=0 9992 ) ,回收率为 98 88%～ 10 0 6 % ,相对标准偏差平均为 1 85 %。结论 :盐酸大观霉素泡腾片的制备工艺方便、科学 ,建立的含量测定方法简便、可靠。

Objective: To prepare Spectinomycin hydrochloride effervescent tablets and determine the content of Spectinomycin hydrochloride in the tablets Methods: Experiments were conducted by orthogonal design and the formulations were evaluated by effervescent effect The content of Spectinomycin hydrochloride in the tablets was determined by microbiological method Results: The optimum procedure condition was A 3B 1C 3 The total amount of tartaric acid and sodium bicarbonate was 35%, polyvinylpyrrolidone was 3%, sodium starch glycolate was 6% The standard curves were obtained with a liner range of 45 8u/ml～218 4u/ml (r=0 9992) The recovery was from 98 88%～100 6%, the average relative standard deviation was 1 85% Conclusion: The Preparation of Spectinomycin hydrochloride efferescent tablets was convenient and feasible The established microbiological method was convenient and precise