以黄白汤为例探讨中药袋装汤剂保存期限

Shelf-Life of Bagged Chinese Herbal Decoction:A Case Study of Huangbai Decoction

目的探讨中药袋装汤剂的保存期限。方法制备6批次的黄白汤袋装汤剂,样品分别于常温[(25±2)℃]和冷藏[(5±3)℃]条件下留样储存;根据2020年版《中国药典(四部)》通则对微生物限度检查方法进行适应性验证[黄白汤需氧菌计数、霉菌和酵母菌计数均采用平皿法(1∶10供试液,V/V),控制菌的检查采用常规法],并连续考察4周。结果经验证,上述方法均可用于相应菌株的检测。6批样品初始微生物限度检查3批合格,3批不合格。储存期内,合格样品微生物限度均合格,pH无显著变化,冷藏样品性状未改变,常温样品有2批第4周颜色加深;不合格样品菌落数变化无明显规律,但常温样品的菌落数明显多于冷藏样品,pH明显低于冷藏样品,且常温样品在第2~3周颜色加深并产生絮状沉淀。结论建立的微生物限度检查法适用于黄白汤的微生物限度检查;菌落初始值合格样品在常温和冷藏条件下均可保存4周;对于初始菌落数不明的袋装汤剂,冷藏储存更有利于维持样品质量。

Objective Decoction were prepared and stored at room temperature of(25±2)℃and refrigerated temperature of(5±3)℃,respectively.The applicability of the microbial limit test method was verified according to the general rules of the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ)[the plate method(1∶10 test solution,V/V)was used for the aerobic bacteria count,mold and yeast count of Huangbai Decoction,and the routine method was used for the control bacteria test],and it was continuously investigated for four weeks.ResultsAfter the verification,the above methods could be used for the detection of corresponding strains.Three of the six batches of samples passed the initial microbial limit test,and three batches of samples were unqualified.During the storage period,the microbial limit of qualified samples was qualified,the pH had no significant change,the properties of refrigerated samples had no change,and the color of two batches of samples under room temperature deepened in the fourth week.There was no obvious rule for the change of colony count of unqualified samples,but the colony count of samples under room temperature was significantly higher than that of samples under refrigerated temperature,and the pH value of samples under room temperature was significantly lower than that of samples under refrigerated temperature.The color of samples under room temperature deepened and flocculent precipitated in the second to third weeks.ConclusionThe established method is suitable for the microbial limit test of Huangbai Decoction.Qualified samples can be stored for four weeks under both room temperature and refrigerated temperature.For the bagged decoction with unknown incipient colony count,refrigerated storage is more conducive to maintaining the quality of the sample.