复合益生菌制剂"海生元"制备各阶段效力稳定性观察

目的 :检测复合益生菌制剂“海生元”制备储存各阶段益生菌的存活数量及其生物表型的稳定性 ,以判定该制剂的效力稳定性。方法 :在有效期内 (1年 ) ,每月定期随机取 5个“海生元”胶囊 ,按常规对M9(乳杆菌QJ4 0 5 )和T9(双歧杆菌QJ4 0 5 )两株益生菌进行活菌培养计数和菌种鉴定。结果 :(1)在常温保存条件下的一年效期内 ,制剂中的 2种益生菌 (M9和T9)存活数量略有下降趋势 ,但各次结果均符合产品的效力要求 (活菌数 >10 8/ g)。 (2 )M9和T9各次纯培养的形态学、生化反应模式及终末代谢产物气相色谱定量分析结果均分别符合其乳杆菌和双歧杆菌的菌种鉴定特征。结论 :复合益生菌制剂“海生元”在常温保存的 1年有效期内 ,可保持制剂中益生菌的活菌数量及稳定的生物表型特征 ,从而保证该制剂的效力稳定性和疗效要求。

EFFICIENCY STABILITY OBSERVATION OF THE COMPLEX-PROBIOTIC-PREPARATION"HAI SHENG YUAN"AT THE EACH STAGE DURING ITS EXPIRY

Objective:To observe the complex-probiotic-preparation"Hai Sheng Yuan"(HSY) at its each stage during the period of validity for evaluating its efficiency stability. Methods:In the period of validity,five capsules were taken randomly and periodically from stored HSY' capsules per month and the bacterial culture and viable counting along with the strains identification were made for the two probiotics(M 9 and T 9) in the capsules by routine ways. Results:(1)Stored at the ordinary temperature condition during the period of validity(1 year),the survival quantity of the two probiotics(M 9 and T 9) of HSY had the fairly decreasing tendency but was still in keeping with the efficiency demand of the products(the number of viable probiotics was more than 10 8/g).(2)As to the pure culture of M 9 and T 9,both the morphosis and the biochemical reaction pattern along with the quantitative analysis of the terminal products of metabolism by gas chromatography were accorded with the strain's identifying features of the lactobcillus and bifidobacterium respectively. Conclusion:Our study suggested that the complex-probiotic-preparation "Hai Sheng Yuan" could keep the survival quantity and the stable biogenic phenotype of its two probiotics(M 9 and T 9 ) in the period of validity at the ordinary temperature's stored condition,which could assure the efficiency stability and therapeutic effect of the preparation.