乳酸杆菌栓剂的研制及其质量控制

目的：研制一种含活乳酸杆菌的栓剂并对其进行质量评价。方法：选用甘油、明胶等基质与乳酸杆菌培养液混合制备栓剂，进行鉴别、含量测定、融变时限和稳定性试验。结果：制备的栓剂符合所定的质量标准，乳酸杆菌栓于4℃冷藏保存1年，乳酸杆菌浓度和外观等几乎无变化；室温保存1年浓度降低；加速试验3个月时无活菌存在。结论：乳酸杆菌栓适宜4℃冷藏保存，其制备工艺简单易行，是一种很有研究价值的新型微生态制剂。

Studies on preparation and quality evaluation of lactobacillus acidophilus suppository

Object To prepare and evaluate lactobacillus acidophilus suppository. Methods Mixing the gelatin and glycerin in certain proportion as the basic formulation of the suppository, the appearance, concentration, disintegration and stability test were investigated. Results Prepared suppository conformed to quality standards. The appearance and living lactobacillus acidophilus concentration of suppository were stable when stored at 4 oC for 12 months. Living lactobacillus acidophilus concentration of suppository was degraded at room temperature for 12 months. Living lactobacillus acidophilus were not observed at 37 oC for 3 months. Conclusion Lactobacillus acidophilus suppository should be stored at 4 oC. The preparation technique is easily operable. The suppository may be a novel microecologic preparation and will be further investigated.